May 25, 2022

Stryker
Michelle Hughes
Senior Staff Regulatory Affairs Specialist
5900 Optical Court
San Jose, California 95138

Re: K214046
Trade/Device Name: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and
Safelight Cable
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ, OWN, FCS, FCW, GWG
Dated: April 22, 2022
Received: April 25, 2022

Dear Michelle Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.33
Silver Spring, MD 20993
www.fda.gov
K214046 - Michelle Hughes Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva U. Pandya -S
Purva Pandya, D.Eng.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K214046

Device Name
780nm Advanced Imaging Modality (AIM) System

Indications for Use (Describe)

780 nm 1688 4K Camera System :
The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy,
neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The
1688 4K Camera System is indicated for adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair,
Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy,
Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small
joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy,
Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where
endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve
replacement.

The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic
surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

780 nm L11 LED Light Source with AIM and Safelight Cable:
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm L11 LED

visible and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable
surgeons to perform minimally invasive surgery using standard endoscopic vis light as well as visual assessment of
vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and
visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic
duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended
for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not
intended for standalone use for biliary duct visualization.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally
invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric
patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and
related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight
Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including
lymphatic vessels and lymph nodes.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic
surgical procedures.

FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF

9-192
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]

FORM FDA 3881 (6/20)

9-193
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the
requirements of 21 C.F.R Part 807.92(c).

510(k) Number: K214046

Submitter:

Applicant: Stryker Endoscopy

5900 Optical Court
San Jose, CA 95138
Contact Person: Michelle Hughes
Senior Staff Regulatory Affairs Specialist
Email: [email protected]
Date Prepared: December 22, 2021

Subject Device:

The subject device is the 780 nm AIM (Advanced Imaging Modality) System, specifically the following
system components:

Name of Device: 780 nm 1688 4K Camera System

Common or Usual 3-chip Video Camera
Name
Classification Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)
Name: Endoscope, Neurological (21 C.F.R. §882.1480)
Regulatory Class: II
Product Code: GCJ
GWG
510(k) Review General & Plastic Surgery
Panel: Neurology

Name of Device: 780 nm L11 LED Light Source with Advanced Imaging Modality
Common or Usual Light Source, Illuminator
Name
Classification Confocal Optical Imaging1 (21 C.F.R. §876.1500)
Name: Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020)
Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020)
Endoscope, Neurological4 (21 C.F.R. §882.1480)
Regulatory Class: II
Product Code: OWN1
FSC2
FCW3
GWG4
510(k) Review General & Plastic Surgery1
Panel: Gastroenterology/ Urology2,3
Neurology4
1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile
ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging
2When used to transilluminate the ureter during open or laparoscopic surgical procedures
3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.

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4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial

neurosurgery and endonasal skull base surgery.

Predicate Device(s):

AIM System: 1688 4K Camera System, L11 LED Light Source with AIM and K211202
SafeLight Cable

NOTE: The predicate device has not been subject to a design-related recall.

Device Description:

The 780nm Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light
and near-infrared light illumination and imaging system. Near-infrared illumination is used for both
fluorescence imaging using SPY AGENT TM GREEN (indocyanine green for injection, USP) and
transillumination of the ureters during minimally invasive and open surgical procedures, respectively.
The 780nm AIM System includes the following components: (1) A Camera System for processing near-
infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the
visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared
light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY
AGENT TM GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

Indications for Use:

780 nm 1688 4K Camera System with Advanced Imaging Modality:

The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear
endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/
arthroscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and
pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic
cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph
node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal
fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy,
Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy,
Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass
grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber
during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric
surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons,
ENT surgeons, neurosurgeons and urologists.

780 nm L11 LED Light Source with Advanced Imaging Modality

Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the
780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to
provide real-time endoscopic visual and near infrared fluorescence imaging. The 780 nm L11 LED Light
Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using
standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue
perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of
the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and
pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary
ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with

Page 2 of 5
standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not
intended for standalone use for biliary duct visualization. Additionally, the 780 nm L11 LED Light
Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial
neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric
patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels,
blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of
SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to
perform intraoperative fluorescence imaging and visualization of the lymphatic system, including
lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to
transilluminate the ureter during open or laparoscopic surgical procedures.

Comparison of Technological Characteristics with the Predicate Device:

Item Subject Device Predicate Device

780 nm Advanced Advanced Imaging Modality (AIM)
Imaging Modality System
(AIM) System
Manufacturer Stryker Same as subject device.
Submission Reference Current Submission K211202
Intended Use Endoscopic visible and Same as subject device
near-infrared light
illumination and imaging
during surgical
endoscopic procedures
Indications for Use NOTE 1 Same as subject device
Imaging Modes White Light Same as subject device.
Near-infrared –
fluorescence
Near-infrared –
transillumination
System Components Camera System Same as subject device.
Light Source and Light
Cable
Endoscopes
IRIS Ureteral Kit
SPY AGENT GREEN
Principles of Operations Via an optical endoscope Same as subject device.
and coupler, light is
projected from a light
source onto one or more
complementary metal
oxide semiconductor
image sensors which
acquire a continuous
stream of image data.
The image data is
processed to provide a
video stream that is then
sent to a display for
viewing.

Page 3 of 5
 Item Subject Device Predicate Device
780 nm Advanced Advanced Imaging Modality (AIM)
Imaging Modality System
(AIM) System
Safety Standards IEC 60601-1 Same as subject device.
IEC 60601-2-18
IEC 60601-1-2
IEC 60601-1-6
IEC 60825-1
Camera Image Digital Same as subject device.
System Processing/Video
Output
Light Light Source/ RGB LEDs Same as subject device.
Source Laser Infrared Laser
Laser Safety Class 1M Same as subject device.
Classification
Infrared 780nm (used for NIR 806nm (used for NIR fluorescence)
Wavelengths fluorescence) 830nm (used for NIR transillumination).
830nm (used for NIR
transillumination)

NOTE 1: The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear
endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated
for use. The 1688 4K Camera System is indicated for adults and pediatric patients. A few examples of the more common
endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic
pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion,
Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection,
Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass,
Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber
during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons,
gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and
urologists.

Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light
Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visual and near
infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform
minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and
related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major
extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years
of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM
and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative
cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the 780 nm L11
LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults
and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic
visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon
interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to
perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph
nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic
surgical procedures.

Page 4 of 5
Performance Data:

Testing was completed in accordance with the following:

Test Method Result

Electrical Safety ANSI IEC 60601-1:2005 + A1:2012 PASS
IEC 60601-2-18:2009
IEC 60601-1-6:2013
EMC Testing IEC 60601-1-2:2014 PASS
Laser Safety IEC 60825-1:2014 PASS
Sterilization AAMI TIR12:2020 PASS
ISO 17664-1:2021
AAMI ST58:2013
ISO 14937:2009
Software Validation & IEC 62304:2015 PASS
Verification
Usability IEC 62366-1:2020 PASS
Performance - Bench In accordance with device input specifications PASS
Spatial Uniformity PASS
Minimum Detectable Fluorescence PASS
Fluorescence Detection Depth PASS
Clinically Meaningful Limits of Detection PASS
Signal to noise PASS
Dynamic Range PASS
Localization PASS
Performance - Animal Testing completed utilizing predicate AIM System, in PASS
accordance with device user needs

Conclusions:

The 780 nm AIM System is substantially equivalent in design, intended use, principles of operation,
technological characteristics and safety features to the predicate devices. In summary, the 780 nm
Advanced Imaging Modality System is substantially equivalent with respect to safety and effectiveness to
the legally marketed predicate device.

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