(14 days)
No
The summary describes a system for viewing, editing, printing, and archiving ECG records, with no mention of AI or ML capabilities.
No
Explanation: The device is an ECG management system for viewing, editing, printing, and archiving ECG records. It does not provide any therapeutic function or treatment.
No
The device description states its function as "viewing, manual editing, printing, and archiving of digitized ECG records." It does not mention interpretation or analysis for diagnostic purposes. The "Intended Use" section also confirms these functions and does not include diagnostic capabilities.
Yes
The device description explicitly states it is a "computer system" for managing digitized ECG records and communicates via a network. There is no mention of hardware components being part of the device itself, only communication with external systems like faxes and printers. The performance studies focus on system-level and software testing.
Based on the provided information, the TraceMaster ECG System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is for "viewing, manual editing, printing, and archiving of digitized ECG records." This involves processing and managing data from a medical device (an ECG machine), not analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Device Description: The description reinforces its function as a computer system for managing ECG data and communicating with other systems. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document lacks any mention of typical IVD elements such as:
- Analysis of biological specimens.
- Providing diagnostic information based on the analysis of biological samples.
- Reagents, calibrators, or controls used in laboratory testing.
The TraceMaster ECG System appears to be a medical device software that manages data generated by another medical device (the ECG machine). While it plays a role in the overall diagnostic process by making the ECG data accessible and manageable, it is not performing the in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.
Product codes
74 DSH, DSH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
0
JUL 2 2 2003
Image /page/0/Picture/1 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-like shape with wavy lines and stars inside. The logo is in white, contrasting with the black text.
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.
-
- The submitter of this premarket notification is:
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
- The submitter of this premarket notification is:
Contact Person: Mr. Songhua Zhang Regulatory Engineer Tel: 978-659-7319 Fax: 978-659-3712 Email: songhua.zhang@philips.com
This summary was prepared on July 2, 2003.
-
- 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 |
-
- 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.
-
- The new device is substantially equivalent to the previously cleared M1730B/M3700A TraceMaster ECG Management System cleared under K974420.
1
Image /page/1/Picture/0 description: The image shows the Philips logo. The logo consists of a shield-shaped emblem on the left and the word "PHILIPS" in bold, sans-serif font on the right. The emblem features wavy lines and stars within the shield.
-
- The new device has the same Indications for Use as the legally marketed predicate device.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- 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 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
3
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
4
7. Indications for Use Statement
of Page
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