(90 days)
Not Found
No
The summary describes a standard electrocardiograph without any mention of AI/ML features or related performance metrics.
No
The "Intended Use / Indications for Use" section clearly states the device is intended for use as a diagnostic device. A therapeutic device is used for treatment, while a diagnostic device is used for diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is intended for use as a diagnostic device..."
No
The device description explicitly states it is a "battery-operated, portable, 12 lead electrocardiograph," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living body.
- Device Function: This device is an electrocardiograph (ECG). It measures the electrical activity of the heart directly from the body surface. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "retrieves, records, and produces a visual display of the electrical signal produced by the heart." This is a measurement of a physiological signal, not an analysis of a biological sample.
Therefore, based on the provided information, this device falls under the category of a medical device that measures physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display of the electrical signal produced by the heart.
Product codes
74DPS
Device Description
The device is a battery-operated, portable, 12 lead electrocardiograph which produces a single channel strip chart output.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUL 28 1998
510(k) SUMMARY
981951
- Macquarie Medical Systems A. Manufacturer: 17 Moore Street P.O. Box 86 Leichhardt Sydney N.S.W. 2040 Australia
- Ferquson Medical Submitted By: Consultant to Macquarie Medical
- Phone: +61.2.9692.7900 Contact Information: B. FAX: +61.2.9692.5865
- Electrocardiograph C. Classification Name:
Electrocardiograph, ECG, ECG Common/Usual Name: monitor, ECG recorder, and others.
CT 100 Electrocardiograph Proprietary Name:
- Classification Number: 74DPS D.
- AT-1 Substantial Equivalence: Schiller Cardiovit E. (K946205), Burdick Elite II (K904032), and others.
- The device is a battery-operated, F. Device Description: portable, 12 lead electrocardiograph which produces a single channel strip chart output.
- device is intended for use as a G. Intended Use: The diagnostic device which retrieves, records, and produces a visual display of the electrical signal produced by the heart.
- CT 100 device is H. Technological Characteristics: The similar other standard technologically to electrocardiographs which produce a one-channel The device is powered by a rechargeable printout. battery, and is portable.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with two intertwined snakes and a staff. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1998
Mr. Frank Ferguson Macquarie Medical Systems c/o Ferquson Medical 3407 Bay Avenue Chico, CA 95973
Re: K981951 CT 100 Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: July 6, 1998 Received: July 15, 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 requlation may result in regulatory 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 requlations.
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Page 2 - Mr. Frank Ferquson
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 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 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 requlation 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
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510(k) Number: K981951
Macquarie CT 100 Portable Electrocardiograph Device Name: 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O
Division of Card
and Neurologica
510(k) Number_
V Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) (Division Sign-Oft)
Division of Cardiovascular, Respiratory,
Division of Cardios) Devices Division of Sical Devices
OR
Over-The-Counter Use __
(Optional Format 1-2-96)