RESPALERT

K992618 · Harwill Medical (Pty) , Ltd. · BZH · Oct 29, 1999 · Anesthesiology

Device Facts

• Record ID: K992618
• Device Name: RESPALERT
• Applicant: Harwill Medical (Pty) , Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control. The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control. The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective. Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

RESPALERT is a mechanical peak flow monitor for adult patients with respiratory conditions (asthma, COPD, bronchitis, emphysema). Device requires initial calibration by a physician or healthcare worker using clinical lung function apparatus to set a target threshold. Patient operates device by blowing into it; device produces an audible whistle if the patient's expiratory flow rate meets or exceeds the pre-set threshold. Absence of whistle indicates potential need for medical intervention or ineffective treatment. Used by patients for home monitoring to assess respiratory status; provides binary feedback (whistle/no whistle) rather than numerical data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical peak flow monitor; threshold-based whistle mechanism; calibrated by clinician using external lung function apparatus; non-electronic; no software.

Indications for Use

Indicated for adults with respiratory diseases including asthma, chronic bronchitis, emphysema, or COPD to monitor respiratory status via peak flow measurement. Requires professional calibration by a clinician.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

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

Re: K992618 RESPALERT Regulatory Class: II (two) Product Code: 73 BZH Dated: July 29, 1999 Received: August 4, 1999

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 A substantially equivalent determination assumes compliance to 895. 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 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 ¾800). 638-2041 or [phone], or at its internet-address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Christy touman for

Ceila M. Witten, Ph.D., M.D. Acting 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: Whistle Watch RESPALERT

Classification Panel: 73BZH, 868.1860

## Indications for Use:

The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.

The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.

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

Christy Loumen

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| Prescription Use | ✓ |
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| | or |
| | Over the Counter Use |

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