December 8, 2017

Advanced Instrumentations, Inc.

Jorge Millan
Regulatory Affairs Manager
6800 NW 77th. Ct.
Miami, Florida 33166

Re: K172966
Trade/Device Name: CMS-2000 Central Monitoring System
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)
Regulatory Class: Class II
Product Code: MHX
Dated: August 22, 2017
Received: September 26, 2017

Dear Jorge Millan:

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. 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.

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); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.03
Silver Spring, MD 20993
www.fda.gov
Page 2 - Jorge Millan K172966

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).

y
Sincerely,

for
Bram D.
B D ZZuckerman, MM.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
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: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

.
Device Name

CMS-2000 Central Monitoring System

Indications for Use (Describe)


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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
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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:
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Office of Chief Information Officer
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[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

3DJHRI
 K172966

510K SUMMARY
CMS-­‐2000  Central  Monitoring  System  

SUBMITTER                            ADVANCED  INSTRUMENTATIONS,  INC  

6800  NW  77th  Ct,  Miami,  FL  33166  
Phone:    (305)  477-­‐6331  

US  AGENT   JORGE  MILLAN,  PHD  

REGULATORY  AFFAIRS  CORRESPONDENT  
Email:  regulatory@advanced-­‐inst.com    
Web:  https://www.sigmabiomedical.com  

DEVICE  NAME  AND  CLASSIFICATION  

TRADE  NAME:   CMS-­‐2000  Central  Monitoring  System  

CLASSIFICATION  NAME:   870.1025   monitor,   physiological,   patient   (with   arrhythmia  

detection  or  alarms)  

Product  Code:  MHX  

REGULATORY  CLASS:   Class  II  

PANEL  IDENTIFICATION   Cardiovascular  

DEVICE  DESCRIPTION  
The   CMS-­‐2000   Central   Monitoring   System   is   a   software   production,   which   runs   on   a   PC  
platform   running   under   the   Microsoft   Windows   XP   or   Windows   7   operating   system.  
Through   specified   protocol,   one   CMS-­‐2000   can   connect   with   multi-­‐monitors   from  
ADVANCED   INSTRUMENTATIONS   to   collect   patients’   information   and   monitoring   data  
such  as  physiological  waveforms,  physiological  parameters  and  alarms.  The  CMS-­‐2000  can  
also   send   bidirectional   control   instruction   to   bedside   monitors   to   change   patients’  
information,   alarm   limits   and   conduct   NIBP   measurements.   The   bedside   Patient  
Physiological   Monitors   have   been   cleared   by   the   FDA   under   K123048   separately.   The  
monitoring  information  collected  by  the  CMS-­‐2000  can  be  saved  and  printed.  At  the  same  
time,  the  old  records  can  be  searched  conveniently  and  quickly.    

Indications   for   Use:   The   CMS-­‐2000   Central   Monitoring   System   provides   centralized  
monitoring   and   critical   care   management   for   patients   monitored   by   bedside   monitors.  
From   the   CMS-­‐2000,   clinicians   can   gain   access   to   patient   information   for   patients   on   the  
Network.   The   CMS-­‐2000   displays   waveforms,   parameters   and   alarm   status   of   bedside  
monitors  for  up  to  32  patients  on  a  single  screen  or  up  to  64  patients  using  two  screens.  

 
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 K172966

Predicate   Devices:   The   CMS-­‐2000   Central   Monitoring   System   is   equivalent   to   the   EDAN  
Central  Monitoring  System,  model  MFM-­‐CMS  cleared  under  K120727.  

Comparison  with  the  Predicate  Devices  [21  CFR  807.92(a)  (6)]  

The   CMS-­‐2000   Central   Monitoring   System   is   comparable   with   and   substantially  equivalent  
to   the   EDAN   Central   Monitoring   System,   model   MFM-­‐CMS   cleared   under   K120727.  
Compared   with   the   MFM-­‐CMS   the   Subject   Device   CMS-­‐2000   has   the   same   intended   uses  
and  functionality.  

Technical  Characteristics  Comparison:  

The  basic  and  main  technical  features  of  the  subject  device  CMS-­‐2000  are  the  same  as  the  
predicated   device   MFM-­‐CMS   including   Design,   Operation   Controls,   Display   Modes   and  
performance  results.    Table  1  provides  the  comparison  of  features  and  functionality:  

ITEM   PROPOSED  DEVICE   PREDICATE  DEVICE  

CMS-­‐2000   MFM-­‐CMS  
K#  TBD   K120727  
PRODUCT  CODE   MHX   MHX  
REGULATION  NO.   870.1025   870.1025  
CLASS   II   II  
INTENDED  USE   The   CMS-­‐2000   Central   The   MFM-­‐CMS   Central  
Monitoring   System   provides   Monitoring   System   provides  
centralized   monitoring   and   centralized   monitoring   and  
critical   care   management   for   critical  care  management  for  
patients   monitored   by   patients   monitored   by  
bedside   monitors.   From   the   bedside   monitors.   From   the  
CMS-­‐2000,  clinicians  can  gain   MFM-­‐CMS  clinicians  can  gain  
access   to   patient   information   access  to  patient  information  
for   patients   on   the   Network.   for  patients  on  the  Network.  
The   CMS-­‐2000   displays   The   MFM-­‐CMS   displays  
waveforms,   parameters   and   waveforms,   parameters   and  
alarm   status   of   bedside   alarm   status   of   bedside  
monitors  for  up  to  32  patients   monitors   for   up   to   32  
on  a  single  screen  or  up  to  64   patients   on   a   single   screen  
patients  using  two  screens.   or   up   to   64   patients   using  
two  screens.  
WAVEFORMS   2  ECG  Waveforms   2  ECG  Waveforms  
1  RESP  waveform   1  RESP  waveform  
1  PLETH  waveform   1  PLETH  waveform  

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 K172966

8  IBP  waveform   8  IBP  waveform  

1  CO2  waveform   1  CO2  waveform  
4   AG   waveforms   for   CO2,   O2,   4  AG  waveforms  for  CO2,  O2,  
N2O  and  AA   N2O  and  AA  
PARAMETERS   ECG:  HR,  ST  value,  PVCs   ECG:  HR,  ST  value,  PVCs  
RESP:  RR   RESP:  RR  
NIBP:  SYS,  DIA,  MAP   NIBP:  SYS,  DIA,  MAP  
SPO2:  SPO2,  PR   SPO2:  SPO2,  PR  
IBP:   ART,   PA,   CVP,   RAP,   ICP,   IBP:  ART,  PA,  CVP,  RAP,  ICP,  
LAP,   P1,   P2   (only   IBP   LAP,   P1,   P2   (only   IBP  
supported  by  the  monitor  will   supported   by   the   monitor  
be  displayed)   will  be  displayed)  
CO2:  EtCO2,  FiCO2,  AwRR   CO2:  EtCO2,  FiCO2,  AwRR  
TEMP:  T1,  T2,  TD   TEMP:  T1,  T2,  TD  
AG:   EtCO2,   FiCO2,   AwRR,   AG:   EtCO2,   FiCO2,   AwRR,  
EtO2,   FiO2,   EtN2O,   FuN2O,   EtO2,   FiO2,   EtN2O,   FuN2O,  
HAL/ISO/ENF/SEV/DES:   Et,   HAL/ISO/ENF/SEV/DES:   Et,  
Fi,  MAC   Fi,  MAC  
C.O:  C.O.,  TB   C.O:  C.O.,  TB  
DISPLAY   The   Central   Monitoring   The   Central   Monitoring  
supports  one  or  two  displays.   supports   one   or   two  
It   can   display   up   to   32   displays.  It  can  display  up  to  
bedside   monitors   on   one   32   bedside   monitors   on   one  
display   and   64   bedside   display   and   64   bedside  
monitors   on   two   displays   monitors   on   two   displays  
simultaneously   simultaneously  
RECORD  CAPACITY   240-­‐hour   trend   data,   72   hour   240-­‐hour   trend   data,   72  
waveform,   720   alarm   events,   hour   waveform,   720   alarm  
1~2   hours   short   trend,   720   events,   1~2   hours   short  
group   NIBP   measurement   trend,   720   group   NIBP  
review   for   each   bedside   measurement   review   for  
monitor   each  bedside  monitor  
CALCULATION   Drug   calculation   and   titration   Drug   calculation   and  
table   titration  table  
REVIEW   Print   patient   information,   Print   patient   information,  
wave   review,   alarm   review,   wave   review,   alarm   review,  
trend   review,   NIBP   review,   trend   review,   NIBP   review,  
and  drug  calculation  result   and  drug  calculation  result  
ALARMS   Audible  and  visible  alarms   Audible  and  visible  alarms  

 
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 K172966

NETWORK/CONNECTIVITY   Web   observation   in   the   Web   observation   in   the  

hospital  local  area  network   hospital  local  area  network  
Bidirectional  control   Bidirectional  control  
HL7   HL7  

Clinical  Test:    
Clinical  testing  is  not  required.  

Non-­‐clinical  Test:    
The   following   quality   assurance   measures   were   applied   to   the   development   of   the   CMS-­‐
2000  System:  
• Software  testing
• Risk  analysis
• Safety  testing
• Performance  test

Substantially  Equivalent  Determination  

The   subject   device   has   similar   technology   characteristics   and   has   the   same   intended   use,  
same   design   principle   and   same   functionality   as   the   predicate   device.   There   are   no  
differences   between   the   devices.   In   accordance   with   the   21   CFR   Part   807   and   based   on   the  
information  provided  in  this  premarket  notification,  Advanced  Instrumentations  concludes  
that  the  CMS-­‐2000  Central  Monitoring  System  is  substantially  equivalent  to  the  predicate  
device.    

 
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