PEAK FLOW METER

• K Number: K970507
• Device Name: PEAK FLOW METER
• Manufacturer: INTL. MEDICAL, INC.
• Date Cleared: 1997-06-13 ( 123 days)
• Product Code: BZH
• Regulation Number: 868.1860
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use.

Device Description

IMI Peak Flow Meter

AI/ML Overview

I am sorry, but the provided text from the FDA document does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria for the IMI Peak Flow Meter (K970507).

The document is an FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and points regarding marketing and labeling. It also includes an "Intended Use" statement. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study proving device performance against acceptance criteria. This would typically involve specific metrics like accuracy, precision, sensitivity, specificity, etc., and the results obtained.
3. Sample size used for the test set or its data provenance.
4. Number or qualifications of experts used for ground truth.
5. Adjudication method.
6. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
7. Information about a standalone (algorithm only) performance study.
8. Type of ground truth used (e.g., pathology, outcomes data).
9. Sample size for the training set or how its ground truth was established.

To obtain this information, you would typically need to consult the 510(k) summary or the full 510(k) submission for K970507, which might contain the scientific and clinical data supporting the substantial equivalence determination, including performance testing results. The provided document is only the clearance letter itself.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 13 1991

Mr. Warren V. Bigelow International Medical, Inc. · 14470 Burnsville Parkway Burnšville, Minnesota 55337

Re: K970507 *IMI Peak Flow Meter Requlatory Class: II (two) Product Code: 73 BZH Dated: May 8, 1997 Received: May 12, 1997

Dear Mr. Bigelow:

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, qood manufacturing practice, labelinq, and prohibitions aqainst 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 (CMP) regulation (21 CFR Part 820) and that, through periodic GME inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.

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Page 2 - Mr. Warren V. Bigelow

This letter will allow you to beqin 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. Callahon

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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SECTION 3, STATEMENT OF INTENDED USE

The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non=-sterile. The device is for prescription use. See package lable under Section 3, page 4. The device is not MRI compatible.

Prescription use only

参

(Division Sign-Off) (4-9-05-07)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).