PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521

K071391 · Philips Medical Systems, Inc. · MSX · Sep 7, 2007 · Cardiovascular

Device Facts

• Record ID: K071391
• Device Name: PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
• Applicant: Philips Medical Systems, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system. The HeartStart 12 Lead Transfer Station also allows viewing, printing, archiving and further distribution of digitized ECG records.

Device Story

The Philips HeartStart 12 Lead Transfer Station acts as a communication bridge; it receives diagnostic 12-lead ECG data from Philips defibrillators and transmits it to ECG management systems (e.g., TraceMasterVue) that support the Philips XML ECG schema. The device enables clinical staff to view, print, archive, and distribute digitized ECG records within a hospital network. It functions as a software interface within a client/server network, facilitating the integration of emergency cardiac data into broader hospital information systems. By streamlining the transfer of ECG records, the device supports timely clinical review and decision-making regarding patient cardiac status.

Clinical Evidence

Bench testing only. Verification and validation activities, including system-level, integration, and regression testing, were performed to confirm functionality and performance against specifications. No clinical data was required or provided.

Technological Characteristics

Software-based communication interface; utilizes industry-standard client/server network architecture; processes digitized ECG records via Philips XML schema; compatible with Philips defibrillators and ECG management systems (e.g., TraceMasterVue).

Indications for Use

Indicated for use as a diagnostic 12-lead ECG interface between Philips defibrillators and ECG management systems capable of processing XML-formatted ECG records. Intended for clinical environments to facilitate viewing, printing, archiving, and distribution of digitized ECG data.

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

• M5100A TraceMasterVue ECG Management System (K032103)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP - 7 2007

Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in bold, black letters. To the left of the word is the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield is a stylized image of a wave and four stars. The logo and the word "PHILIPS" are the branding for the electronics company Philips.

## 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. 8807.92.

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

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

This summary was prepared on February 13, 2007.

- 2. The name of this device is the Philips HeartStart 12 Lead Transfer Station (catalog #989803142521). Classification names are as follows:

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

- 3. The 12 Lead Transfer Station facilitates transmission of diagnostic 12 Lead ECG reports from Philips Defibrillators to ECG Management systems that recognize and accept digitized ECG records using the Philips published ECG schema. The Philips TraceMasterVue ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records. TraceMasterVue communicates with Web-based clients, faxes, printers etc through an industry-standard client/server network with other hospital information systems.

{1}------------------------------------------------

- 4. The new device is substantially equivalent to the previously cleared M5100A TraceMasterVue ECG Management System cleared under K032103.
- 5. The product has a similar clinical intended use as the legally marketed predicate device. The only difference is that this SW is specific to 12 lead ECG records obtained from Philips defibrillator monitors.
- 6. The product has a subset of the technological characteristics as the legally marketed predicate devices.
- 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 ECG Management System meets all performance claims.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Philips Medical Systems c/o Paul Schrader Senior Regulatory Affairs Manager 3000 Minuteman Rd. Andover MA, 01810-1099

Re: K071391

Trade/Device Name: Philips Heartstart 12 lead transfer station, Model 9898031 Regulation Number: 21 CFR 870.2300 Regulation Name: Regulatory Class: Class II Product Code: MSX Dated: August 9, 2007 Received: August 15, 2007

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 such 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

{3}------------------------------------------------

## Page 2 - Mr. Paul Schrader

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

B.Zimmermanfe

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K071391

HeartStart 12 Lead Transfer Station Device Name:

## Indications For Use:

The HeartStart 12 Lead Transfer Station SW provides a diagnostic 12 lead ECG interface between Philips defibrillators and ECG management systems that can process XML formatted ECGs, such as the TraceMasterVue ECG Management system.

The HeartStart 12 Lead Transfer Station also allows viewing, printing, archiving and further distribution of digitized ECG records.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K/Brummer

ardlovascular Devices

Page 1 of 1