(90 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as a monitor intended for diagnostic purposes (evaluating symptoms, documenting interventions, assessing ST segment changes, etc.). It does not mention treating or intervening in any condition.
Yes
The device is used for "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia," which are diagnostic activities.
No
The description refers to a "Biosensor Holter Monitor System," which strongly implies the presence of hardware (biosensors and a monitor) in addition to any potential software components. The lack of a detailed device description prevents a definitive confirmation, but the name itself suggests a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "Biosensor Holter Monitor System" for "ambulatory (Hotter) monitoring" of patients. This involves monitoring physiological signals (ECG) from the patient's body.
- 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.
The Biosensor Holter Monitor System is a device that monitors the electrical activity of the heart in vivo (within the living body), not in vitro (outside the living body using samples).
N/A
Intended Use / Indications for 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.)
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Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
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Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
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Evaluation of patients for ST segment changes.
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Evaluation of patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
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Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.
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Clinical and epidemiological research studies.
Product codes
74 DQK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physician (Prescription Use)
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 (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/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
2
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.)
-
Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
-
Evaluation of patients for ST segment changes.
-
Evaluation of patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
-
Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.
-
Clinical and epidemiological research studies.
Prescription Use
(Per 21 CFR 801.109)
V. Dousk. Telle
diovascular, Respiratory. 51000