(818 days)
The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.
The device is a battery-operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.
The provided text is a 510(k) summary for the Macquarie CT 200 Portable Electrocardiograph. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth.
Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.
Based on the content, the document is primarily focused on:
- Device Identification: K961798, Macquarie CT 200 Portable Electrocardiograph.
- Classification: Class II (74 DSP).
- Intended Use: As a diagnostic device to receive, record, and produce a visual display of the electrical signal produced by the heart.
- Technological Similarity: To other standard electrocardiographs producing multipage printouts and utilizing application software.
- Regulatory Communication: FDA's letter granting market clearance based on substantial equivalence to predicate devices.
The text does not include sections typically found in a clinical study report or a performance validation document, such as:
- Specific performance metrics (e.g., sensitivity, specificity, accuracy).
- Details of a test set, its size, or its provenance.
- Information about expert review, adjudication, or ground truth establishment.
- Any mention of standalone algorithm performance or human-in-the-loop studies.
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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical along with the date AUG 5 1998. The logo is a stylized letter M next to the words "FERGUSON MEDICAL" in bold, block letters. The date is printed in a simple, sans-serif font above the logo.
916-342-413 FAX: 916-343-4541
17 March 1996
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Electrocardiograph Classification name: A.
Electrocardiograph, ECG, ECG Common/usual name: monitor, and others
CT 200 Electrocardiograph Proprietary name:
- Schiller AT-1 (K946205) Substantial equivalence: B. and AT-5/6 series of devices, as well as others.
- The device is a battery-Device description: C. operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.
- The device is intended for use as a Intended use: D. diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.
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- Technological characteristics: The CT 200 device E. . is technologically similar to other standard
electrocardiographs which produce a 1, 3, 6, or 12 channel printout, and is also similar to electrocardiographs utilizing other other application software.
device is powered by proposed a The rechargeable battery, and is portable.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Fraule Feur
Frank Ferguson Official Correspondent
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & 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 pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1638 AUG
Mr. Frank Ferguson Macquarie Medical Systems c/o Ferguson Medical 3407 Bay Avenue Chico, CA 95973
Re: K961798 CT 2000 Electrocardiograph Regulatory Class: II (two) Product Code: 74 DSP Dated: July 23, 1998 Received: July 27, 1998
Dear Mr. Ferguson:
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 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 (Premarket Approval), 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 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 requlatory 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 Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Frank Ferguson
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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
senioryears,
Thomas J. Callehan
Thomas J. Callahan, Ph.D.
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Macquarie CT 200 Portable Electrocardiograph
Indications For Use:
The device is intended for use as a diagnostic device which receives, records, and produces a visual display of the electrical signal produced by the heart.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark Krame | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K96 1798 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ------------------------------------------ | -------------------------------------------------- |
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).