WHISTLE WATCH

K980550 · Harwill Medical (Pty) , Ltd. · BZH · Aug 27, 1998 · Anesthesiology

Device Facts

• Record ID: K980550
• Device Name: WHISTLE WATCH
• Applicant: Harwill Medical (Pty) , Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Aug 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Whistle Watch is a peak flow meter that has been designed to enable asthmatic children to check their respiratory status. Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Whistle Watch is a peak flow meter for asthmatic children; enables self-monitoring of respiratory status. Device functions as a mechanical flow-measuring instrument; user exhales into device; airflow produces whistle sound or visual indicator corresponding to peak expiratory flow rate. Used in home or clinical settings; operated by pediatric patients under physician guidance. Output provides immediate feedback on respiratory function; assists patients and caregivers in tracking asthma control and identifying potential exacerbations.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence pathway.

Technological Characteristics

Mechanical peak flow meter; handheld form factor; operates via airflow-driven acoustic or visual signaling. No electronic components, software, or external power source described.

Indications for Use

Indicated for asthmatic children to monitor respiratory status via peak flow measurement. Prescription use only.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1998

Harwill Medical (PTY) Ltd. c/o Smith Associates P.O. Box 4341 Crofton, MD 21114 Attn: Mr. E.J. Smith

Re: K980550 Whistle Watch Regulatory Class: II (two) Product Code: 73 BZH Dated: June 11, 1998 Received: June 11, 1998

Dear Mr. Smith:

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 Requlation (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 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. E.J. Smith

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 requlation (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/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 (if known)

Device Name: Harwill Medical Whistle Watch

#### Classification Panel:

# -- Indications for Use:

The Whistle Watch is a peak flow meter that has been designed to enable asthmatic children to check their respiratory status.

Federal (USA) law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | or | Over the Counter Use | <span style="text-decoration: overline;"></span> |
|------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|
|------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|

*Lak W. Madero* 8-25-98

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number | K980550 |
|---------------|---------|
|---------------|---------|