MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)

K040723 · Microlife Intellectual Property GmbH · BZH · Jun 10, 2004 · Anesthesiology

Device Facts

• Record ID: K040723
• Device Name: MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
• Applicant: Microlife Intellectual Property GmbH
• Product Code: BZH · Anesthesiology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients.

Device Story

Handheld microprocessor-based monitor; measures respiratory flow via removable digital volume transducer. Transducer uses acrylic tube with rotating vane; infrared beam detects vane rotation; phototransistor converts rotation to electrical pulse train. Pulse frequency proportional to flow rate; pulse count proportional to volume. Calculates PEF and FEV1 from flow rate and time. Used by patients at home; data viewed on device display or transferred via USB to PC. Assists in respiratory monitoring; enables tracking of lung function trends. Benefits patients by providing objective data for asthma or COPD management.

Clinical Evidence

No clinical data. Bench testing only; device passed ATS standard waveform testing using a waveform generator.

Technological Characteristics

Acrylic tube transducer with rotating vane on jeweled bearings; infrared sensor; microprocessor-based. Measures PEF and FEV1. Connectivity: USB port. Standards: ATS recommendations for spirometry, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for monitoring PEF and FEV1 in pediatric to adult patients for home use.

Regulatory Classification

Identification

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

Predicate Devices

• Microlife Peak Flow Meter, Model PF100 (K031024)
• Accutrax Electronic Peak Flow Meter, Model EPF840 (K982995)

Submission Summary (Full Text)

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# JUN 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Microlife Intellectual Property GmbH C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K040723

Trade/Device Name: Microlife Electronic Peak Flow Meter with PEF and FEV1, Models PF-100 and PF-100-1 (with software) Regulation Number: 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: March 19, 2004 Received: March 23, 2004

Dear Ms. Goldstein-Falk:

This letter corrects our substantially equivalent letter of June 10, 2004, regarding the correction of OTC designation from prescription designation and correction of the indications for use statement to read "This device is intended for monitorion of the expired flow rate) and FEV1 (forced expiratory volume in one second) for patient home use. The device is designed for pediatric to adult use."

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 provice
the Federal Facel D 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.

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Page 2 - Ms. Goldstein-Falk

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 systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); all 11
21 CED 1900-1959 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 ing or cassification for your device and this, 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,

Carls

Chiu Lin, Ph.D. 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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Attachment #1

Page 1 of 1

510(k) Number (if known):

K040723

Device Name: Microlife Electronic Peak Flow Monitor, with PEF and FEV1, Models PF-100 and PF-100-1 (with Software)

Indications For Use:

This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use × (21 CFT 807 Subpart C)

21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Syhom

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

510(k) Number: K04

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JUN 1 0 2004

EXHIBIT # 1

K040723

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

#### 1. Submitter's Identification:

Microlife Intellectual Property GmbH Max Schmidheiny- Strasse 201 9435 Heerbrugg Switzerland Contact: Mr. Gerhard Frick Date Summary Prepared: March 19, 2004

#### Name of the Device: 2.

Microlife Electronic Peak Flow Monitor, with PEF and FEV1, Models PF-100 and PF-100-1 (with software)

#### Predicate Device Information: 3.

Microlife Peak Flow Meter, Model PF100, K#031024, Microlife Intellectual Property GmbH

Accutrax Electronic Peak Flow Meter, Model EPF840, Korr Medical Technologies, Inc., Salt Lake City, Utah, K#982995

#### Device Description: 4.

The Microlife Electronic Peak Flow Monitor, Model PF-100, comprises a hand held microprocessor based unit, incorporating a removable micro medical digital volume transducer. The transducer consists of an acrylic tube with a freely rotating vane supported on jeweled bearings positioned between a fixed swirl plate and a cross bar. As air is passed through the transducer, a vortex is created by the swirl plate, which causes the low inertia vane to rotate. The rotation of the vane is detected by the interruption of an infrared beam which produces an electrical pulse train at the output of a phototransistor. The number of rotations is proportional to the volume of air passed through the turbine, and the rate of

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rotation is proportional to the flow rate. With flow rate and correspondent time, FEV1 can be calculated.

#### Intended Use: 5.

This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1(forced exhalation in the first second) for patient home use. The device is designed for pediatric to adult patients.

## 6. Comparison to Predicate Device:

Both devices meet the American Thoracic Society (ATS) recommendations for Spirometry. The new PF-100 (subject device) measures PEF and FEV1 parameters; the predicate, model PF100, measures only PEF (Peak Expired Flow Rate). The new PF100 measuring principle is exactly the same as the one in PF100 determination of respiratory flow-infrared rotary flow sensor (meeting ATS accuracy testing using the 26 flow-time waveform and the 24 volume-time waveform).

The new PF100 is identical in functionality and performance with the only difference being the FEV1 measurement is added to the new device, and the PC connection is with USB port instead of RS232. Others like shape, material remain the same.

### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

The subject device was tested to and passed the ATS Standard Waveforms using a waveform generator. Product Safety Testing included successful completion of testing to the IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility) standards.

#### Discussion of Clinical Tests Performed: 8.

Not Applicable

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#### Conclusions: 9.

The subject device, Microlife Electronic Peak Flow Monitor, with PEF and FEV1, Models PF-100 and PF-100-1 (with software) has a similar intended use and similar characteristics as the predicate device. Moreover, bench tenting contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, Microlife Electronic Peak Flow Monitor, Model PF-100 is substantially equivalent to the predicate devices.