MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM

K011999 · Data Critical Corp. · MSX · Jul 24, 2001 · Cardiovascular

Device Facts

• Record ID: K011999
• Device Name: MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
• Applicant: Data Critical Corp.
• Product Code: MSX · Cardiovascular
• Decision Date: Jul 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms. The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure. The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care. The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.

Device Story

FlexView™ Clinical Monitoring System is a PC-based central station; acquires data from primary medical devices (pulse oximeters, infusion pumps, ventilators); provides secondary annunciation of alarms. Used in hospitals and surgical centers by trained healthcare professionals. Device supplements primary monitoring; does not replace primary device procedures or physician care. Output displayed on central monitor; enables simultaneous remote monitoring of multiple devices. Benefits include centralized oversight of patient status and improved alarm awareness for clinicians.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through risk assessment, verification, and validation testing.

Technological Characteristics

PC-based central monitoring station; networked connectivity to primary medical devices (pulse oximeters, infusion pumps, ventilators). Functions as secondary alarm annunciator. Software-based system.

Indications for Use

Indicated for patient populations monitored by healthcare professionals using compatible pulse oximeters, infusion pumps, and ventilators in clinical settings (hospitals, surgical centers). Used as secondary alarm annunciation; not for primary diagnostic use.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• FlexView™ Clinical Monitoring System (K003998)

Submission Summary (Full Text)

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<011999

# 510(k) SUMMARY

This 510(k) summary is submitted in accordance with 21 CFR 807.92.

| Submitter's Name: | Data Critical Corporation |
|--------------------------------|-----------------------------------------------------------|
| Submitter's Address: | 19820 North Creek Parkway |
| | Bothell, WA 98011 |
| Telephone: | 425-482-7000 |
| Fax: | 425-482-7010 |
| Contact Person: | Teresa M. Davidson |
| Date Prepared: | June 26, 2001 |
| Device Trade Name: | FlexView™ Clinical Monitoring System |
| Device Classification<br>Name: | System, Network and Communication, Physiological Monitors |
| Device Classification: | Class II |
| Predicate Device(s): | FlexView™ Clinical Monitoring System (K003998) |

### Device Description

The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.

#### Intended Use

The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.

#### Indications For Use

The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.

The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.

The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care.

The Flex\lew™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.

The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.

## Performance Data

The safety and effectiveness of the modified FlexView™ Clinical Monitoring System described in this submission has been demonstrated through risk and verfication and validation testing. Test results demonstrated that the modified FlexView™ Clinical Monitoring System performance, functionality and safety characteristics are substantially equivalent to the predicate device.

## Conclusions

Based on the information provided in this submission, the modified FlexView™ Clinical Monitoring System is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.

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JUL 2 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Teresa M. Davidson Director of Regulatory Affairs and Quality Assurance Data Critical Corporation 19820 North Creek Parkway Bothell, WA 98011

Re: K011999

Trade Name: FlexViewTM Clinical Monitoring System Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MSX Dated: June 26, 2001 Received: June 27, 2001

Dear Ms. Davidson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I substantially of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the

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Page 2 - Ms. Teresa M. Davidson

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

V. O. K. Teller

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number: Koll1999 --------

Device Name: FlexView™ Clinical Monitoring System

## Indications For Use:

The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.

The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is The FlexYlew - Olinour mornitoring oyears, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.

The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the use of the rries lox in on onlined monitored. The FlexView™ Clinical Monitoring System is not primally modiour de noce that the ut skilled interpretation and does not replace physician's care.

The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.

The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, outpatient clinics or free standing surgical centers.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011999

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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