PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A

K032103 · Philips Medical Systems · DSH · Jul 22, 2003 · Cardiovascular

Device Facts

• Record ID: K032103
• Device Name: PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
• Applicant: Philips Medical Systems
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.

Device Story

TraceMaster ECG Management System is a computer-based system for managing digitized ECG records. It functions as a central repository and workstation allowing clinicians to view, manually edit, print, and archive ECG data. The system operates within a hospital network, communicating with web-based clients, fax machines, and printers via a client/server architecture. It integrates with other hospital information systems to facilitate ECG data management. By providing a centralized platform for ECG review and documentation, the device assists healthcare providers in clinical decision-making related to cardiac diagnostics. It is intended for professional use in clinical environments.

Clinical Evidence

Bench testing only. Verification and validation activities, including system-level tests, integration tests, and regression tests derived from hazard analysis, were performed. Pass/Fail criteria were based on established specifications, and results demonstrated that the system meets all performance claims.

Technological Characteristics

Computer-based ECG management system; client/server network architecture; supports connectivity with web-based clients, faxes, and printers; integrates with hospital information systems. Software-based processing for viewing, editing, and archiving digitized ECG records.

Indications for Use

Indicated for the viewing, manual editing, printing, and archiving of digitized ECG records in a clinical setting.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• M1730B/M3700A TraceMaster ECG Management System (K974420)

Submission Summary (Full Text)

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JUL 2 2 2003

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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 premarket notification is:
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

Contact Person: Mr. Songhua Zhang Regulatory Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on July 2, 2003.

- 2. The name of this device is the M5100A/M5101A TraceMaster ECG Management System. Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|----------------------------------|
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |

- 3. The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records. TraceMaster communicates with Webbased clients, faxes, printers etc through a client/server industry-standard network with other hospital information systems.
- 4. The new device is substantially equivalent to the previously cleared M1730B/M3700A TraceMaster ECG Management System cleared under K974420.

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- 5. The new device has the same Indications for Use as the legally marketed predicate device.
- 6. The new device has the same 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.

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Public Health Service

Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2 2003

Philips Medical Systems c/o Mr. Songhua Zhang Regulatory Engineer 3000 Minuteman Road Andover, MA 01810

Re: K032103

Trade Name: TraceMaster ECG Management System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: DSH Dated: July 2, 2003 Received: July 8, 2003

Dear Mr. Zhang:

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

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Page 2 - Mr. Songhua Zhang

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); 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Kolegm

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

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K032103 510(k) Number (if known):

Device Name: TraceMaster ECG Management System

Indications for Use: The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.

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

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

De la rue

510(k) N