GALEMED PEAK FLOW METER, MODELS 3751/3752

K022124 · Galemed Corp. · BZH · Apr 3, 2003 · Anesthesiology

Device Facts

• Record ID: K022124
• Device Name: GALEMED PEAK FLOW METER, MODELS 3751/3752
• Applicant: Galemed Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.

Device Story

GaleMed Peak Flow Meter (Models 3751/3752) is a mechanical device designed to measure peak expiratory flow (PEF). Patient exhales forcefully into device; internal mechanism (likely piston or vane) moves in response to airflow; position of mechanism indicates flow rate on calibrated scale. Used by patients for monitoring respiratory conditions; provides objective data for clinical assessment of airway obstruction. Simple, non-powered, handheld design; no electronic components or software. Output is visual reading on device scale; used by patients/clinicians to track lung function trends and adjust treatment plans.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical peak flow meter; non-powered; handheld form factor. Materials and construction consistent with standard peak flow meter specifications for accuracy and repeatability per 21 CFR 868.1860.

Indications for Use

Indicated for measuring peak expiratory flow in adults (Model 3751) and children (Model 3752).

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

Mr. Bruce Kuo GaleMed Corporation 87, Li-Gong 2nd Road Wu-Jia, I-Lan TAIWAN, ROC 268

Re: K022124

Trade/Device Name: GaleMed Peak Flow Meter, Models 3751/3752 Regulation Number: 21 CFR 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: Class II (two) Product Code: 73 BZH Dated: March 8, 2003 Received: March 14, 2003

Dear Mr. Kuo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Mr. Bruce Kuo

systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Gunner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. INDICATIONS FOR USE STATEMENT

Applicant:____GALEMED CORPORATION_

510(k) Number: _ K022124

Device Name:_GALEMED PEAK FLOW METER 3751 / 3752

Indications for Use :

The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: