MICROPEAK

K030586 · Micro Direct, Inc. · BZH · Aug 27, 2003 · Anesthesiology

Device Facts

• Record ID: K030586
• Device Name: MICROPEAK
• Applicant: Micro Direct, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.

Device Story

MicroPeak is a mechanical peak flow meter used to measure a patient's peak expiratory flow rate (PEFR). The device operates via a tension spring and piston/pointer mechanism that translates expiratory airflow into a numerical reading in liters/minute. It is intended for single-patient use in any environment where monitoring of respiratory conditions like asthma is required. The patient performs the maneuver, and the device provides a direct visual output via the pointer position. This output allows patients and healthcare providers to track respiratory status and inform clinical management decisions.

Clinical Evidence

Bench testing only. Performance data provided includes measurement range (60-900 L/Min), accuracy (+/- 10%), intra-device precision (+/- 5%), and inter-device precision (+/- 5%).

Technological Characteristics

Mechanical peak flow meter. Materials: ABS housing. Sensing principle: Tension spring with piston/pointer. Measurement range: 60-900 L/Min. Accuracy: +/- 10%. Precision: +/- 5%. Single-patient use. No software or electronic components.

Indications for Use

Indicated for patients requiring measurement of peak expiratory flow rate to monitor respiratory conditions such as asthma.

Regulatory Classification

Identification

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

Predicate Devices

• Vitalograph Asmaplan+ (K781922)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K030586" and is written in black ink on a white background. The text is slightly rotated, with the top right corner being higher than the bottom left.

Image /page/0/Picture/2 description: The image shows the logo for Micro Direct. The word "Micro" is stacked on top of the word "Direct". Above the word "Micro" is a black square. The text is in a simple sans-serif font.

Non-Confidential Summary of Safety and Effectiveness February 18, 2003

page 1 of 2

| Micro Direct, Inc.<br>803 Webster Street<br>Lewiston, ME 04240 | | |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------|
| | Tel - [phone] | Fax - [phone] |
| Official contact: | David R. Staszak, President | |
| Proprietary or Trade Name: | MicroPeak | |
| Common/Usual Name: | Peak Flow Meter | |
| Classification Name: | BZH - Meter, Peak Flow | |
| Intended device: | Peak Flow Meter | |
| Predicate devices: | Vitalograph Asmaplan+ - K781922 | |
| Device description: | A peak flow meter is a device used to measure a person's peak<br>expiratory flow rate. | |

#### Indicated use:

The intended device measures a patient's peak expiratory flow rate.

#### Targeted population:

Patients requiring the measurement of peak expiratory flow.

#### Environment of use:

Anywhere that a patient may require the measurement of peak expiratory flow.

#### Comparison to predicate devices:

| Attribute | Intended<br>device | Vitalograph<br>Asmaplan+ |
|------------------------------------------|--------------------|--------------------------|
| Use<br>Intended as a peak flow meter | Yes | Yes |
| Intended to measure peak expiratory flow | Yes | Yes |
| Design | | |
| Single patient Use | Yes | Yes |

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## Comparison to predicate devices (continued)

| Attribute | Intended<br>device | Vitalograph<br>Asmaplan+ |
|--------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------|
| Materials<br>Housing - ABS | Yes | Yes |
| Measuring Principle | Tension Spring<br>Piston/Pointer | Tension Spring<br>Piston/Pointer |
| Performance<br>Range<br>Accuracy<br>Intra device Precision<br>Inter device Precision | 60 - 900 L/Min<br>+/- 10%<br>+/- 5%<br>+/- 5% | 50 - 800 L/M<br>+/- 10%<br>+/- 5%<br>+/- 5% |

### Differences

The only difference is a small difference in the measurement range

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Mr. David R. Staszak President Micro Direct, Incorporated 803 Webster Street Lewiston, Maine 04240

Re: K030586

Trade/Device Name: MicroPeak Regulation Number: 21 CFR 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: II Product Code: 73 BZH Dated: May 30, 2003 Received: June 3, 2003

Dear Mr. Staszak:

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. Staszak

systems (QS) 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 yours,

Susan Ruane

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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# Indications for Use Statement

| 510(k) Number | K030586 (To be assigned) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroPeak Peak Flow Meter |
| Indications for Use: | The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma. |
| Targeted population: | Patients requiring the measurement of peak expiratory flow rate. |
| Environment of use: | Places where a patient may require the measurement of their peak expiratory flow rate. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rurr

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

510(k) Number:_

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use √

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