PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441

K091176 · Philips Medical Systems · MSX · Nov 13, 2009 · Cardiovascular

Device Facts

• Record ID: K091176
• Device Name: PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
• Applicant: Philips Medical Systems
• Product Code: MSX · Cardiovascular
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The HeartStart Telemedicine Server software displays patient vitals, waveforms and 12-lead ECG information transmitted from Philips HeartStart defibrillators in remote locations. The HeartStart Telemedicine server allows viewing, diagnostic quality printing, archiving and further distribution of digitized clinical data. The HeartStart Telemedicine Server is also able to forward the 12-lead ECG information into ECG management systems that can process XML format ECG reports such as the TraceMasterVue ECG Management System

Device Story

HeartStart Telemedicine Server receives physiological data, waveforms, and 12-lead ECG information transmitted from Philips defibrillators; data processed via XML format; server enables viewing, diagnostic-quality printing, archiving, and distribution of clinical data; system forwards 12-lead ECG reports to compatible management systems (e.g., TraceMasterVue); used in clinical settings by healthcare providers to facilitate patient admission and clinical decision-making; benefits include remote access to patient vitals and ECG data during transport.

Clinical Evidence

Bench testing only. Verification, validation, and integration testing were performed to confirm system functionality and performance. Pass/Fail criteria were based on established specifications; results demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Software-based system; utilizes XML data format for transmission and receipt of physiological data, waveforms, and 12-lead ECGs; networked connectivity for data transfer from remote defibrillators to a central server; compatible with existing ECG management systems.

Indications for Use

Indicated for the display, viewing, printing, archiving, and distribution of physiological data, waveforms, and 12-lead ECG information transmitted from Philips defibrillators for patients in remote locations.

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

• Philips HeartStart 12 Lead transfer station

Reference Devices

• TraceMasterVue ECG Management System

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Philips logo. On the left is the Philips shield logo, which contains the word "PHILIPS" at the top and a circular design below. To the right of the shield is the word "PHILIPS" in large, bold, sans-serif font. The text is in all capital letters and is black.

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## 8. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. \$807.92.

- 1. The submitter of this pre-market notification is:
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

NOV 1 3 2009

Contact Person: Mr. Paul Schrader Senior Regulatory Affairs Mgr Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on April 16, 2007.

- 2. The name of this device is the Philips HeartStart Telemedicine System. Classification names are as follows:

| Classification | Pro Code | Description |
|----------------|----------|--------------------------------------------------------------|
| 870.2300 | 74 MSX | System, Network and Communication,<br>Physiological Monitors |

- 3. The HeartStart Telemedicine Server facilitates transmission of physiological data, waveforms and reports from Philips Defibrillators to a remote server that is located in a facility that is prepared to admit patients being transported by an ambulance.
- 4. The new device is substantially equivalent to the previously cleared Philips HeartStart 12 Lead transfer station.

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- 5. The product has a similar clinical intended use as the legally marketed predicate device. The only difference is that this SW now adds the capability to receive patient vital sign data and physiologic waveforms in addition to 12-lead ECG information obtained from Philips defibrillator monitors.
- 6. The product utilizes the same basic technology (receipt of XML data format) as the legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the performance and functionality characteristics of the new device. Testing involved system level tests, integration tests and regression tests from hazard analysis. Pass/Fail criteria were based on the specifications and test results showed substantial equivalence. The results demonstrate that the functionality of the modified 12 lead transfer station meets all performance claims.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is an image of a bird with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

> ﻴﻨﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ ﻳﺔ ﺍﻟﺘﻲ :

Philips Medical Systems c/o Mr. Paul Schrader Regulatory Affairs Manager Cardiac Care Business 3000 Minuteman Road, Mail Stop 220 Andover, MA 01810-1099

NOV 1 3 2009

Re: K091176

Trade/Device Name: Telemedicine Server/System Model 861441 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitors Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: September 17, 2009 Received: September 21, 2009

Dear Mr. Schrader:

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.

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.

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Page 2 - Mr. Paul Schrader

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Duna R. bechner

Bram D. Zuckerman, M.D.

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

Enclosure

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## 7. Indications for Use Statement

Page 1 of 1

510(k) Number (if known): KO9 \ 176

Device Name: HeartStart 12 Lead Transfer Station

Indications for Use:

## Intended use of HeartStart Telemedicine Server:

The HeartStart Telemedicine Server software displays patient vitals, waveforms and 12-lead ECG information transmitted from Philips HeartStart defibrillators in remote locations. The HeartStart Telemedicine server allows viewing, diagnostic quality printing, archiving and further distribution of digitized clinical data. The HeartStart Telemedicine Server is also able to forward the 12-lead ECG information into ECG management systems that can process XML format ECG reports such as the TraceMasterVue ECG Management System

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Sume R. Revere
(Division Sign-Off)
Division of Cardiovascular Devices

Division of Cardiovascular Devices

Ko91176 510(k) Number_