BIOSENSOR HOLTER MONITOR SYSTEM

• K Number: K974546
• Device Name: BIOSENSOR HOLTER MONITOR SYSTEM
• Manufacturer: BIOSENSOR CORP.
• Date Cleared: 1998-03-04 ( 90 days)
• Product Code: DQK
• Regulation Number: 870.1425
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Hotter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below, (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Reingquist I, Year Book Medical Publishers, 1981.)

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.

6. Clinical and epidemiological research studies.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Biosensor Holter Monitor System, which declares the device substantially equivalent to a predicate device.

While it mentions the intended use of the device, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods for ground truth, or types of ground truth used in any specific study.
• Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

This type of information would typically be found in a separate clinical study report or a more detailed section of the 510(k) submission, not in the clearance letter itself.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

MAR - 4 1998

Mr. Steve Springrose Biosensor Corporation 7001 East Fish Lake Road Maple Grove, Minnesota 55311-2833

Re: K974546 Biosensor Holter Monitor System with QT Interval Trade Name: Regulatory Class: II Product Code: 74 DQK Dated: October 27, 1997 Received: December 4, 1997

Dear Mr. Springrose:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 regulations.

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Page 2 - Mr. Steve Springrose

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callshan

Thomas J. Callahan, Ph Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intended Use

Caution: Federal law restricts this device to sale by or on the order of a physician.

The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Hotter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below, (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Reingquist I, Year Book Medical Publishers, 1981.)

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.

6. Clinical and epidemiological research studies.

Prescription Use
(Per 21 CFR 801.109)

V. Dousk. Telle

diovascular, Respiratory. 51000

K974546

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).