ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN

K042058 · Clement Clarke Intl., Ltd. · BZG · Mar 23, 2005 · Anesthesiology

Device Facts

• Record ID: K042058
• Device Name: ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
• Applicant: Clement Clarke Intl., Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneFlow FVC is a handheld, battery operated, electronic spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

Device Story

Handheld, battery-operated electronic spirometer; measures maximal lung volume and airflow. Uses venturi pressure system to generate primary signal from pressure sensor; replaces mechanical resistance backpressure. Microprocessor-based; surface-mount PCB components. Models include kit version for PC-based statistical analysis and Screen version for displaying data against stored predicted values. Used in clinical settings by healthcare providers. Provides quantitative respiratory measurements; aids in clinical assessment of lung function. Benefits patients through accurate, repeatable monitoring of respiratory performance.

Clinical Evidence

Bench testing only. Evaluated per American Thoracic Society 'Standardization of Spirometry' 1994 update. Simulation of three years of typical use performed; accuracy and repeatability remained within limits before and after simulation.

Technological Characteristics

Handheld electronic spirometer; 6V power; venturi pressure sensing; ABS plastic construction; microprocessor-based; surface-mount PCB; LED indicators for measurement display. Connectivity via PC software for kit model.

Indications for Use

Indicated for pediatric and adult patients to measure maximal lung volume and airflow in clinical settings.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Wright Ventilometer VM-1 (K895953)

Submission Summary (Full Text)

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K042058

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MAR 2 3 201

Precision byTradition

# 510(k) Summary

Applicant: Clement Clarke Int. Ltd Edinburgh Way Harlow Essex CM20 2TT United Kingdom

Establishment Registration No: 9610639

The product is manufactured at the above address

Contact: Mr Philip Hallybone (Quality Manager)

Telephone: [phone] Fax [phone]

| Proprietary Name: | OneFlow FVC, OneFlow FVC (kit), OneFlow FVC Screen |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spirometer |
| Classification Name: | Diagnostic Spirometer |
| Medical speciality: | Anaesthesiology |
| Classification: | Class II (performance Standard - National Asthma<br>Education Program's statement on technical standards for<br>Peak Flow meters and the recommendations of the<br>American Thoracic Society, Standardization of<br>Spirometery 1994 Update) |
| Classification panel | 868.1840 [Product code 73 BZG] |
| Equivalence: | This device is substantially equivalent to the predicate<br>device: Wright Ventilometer VM-1 510(K) ref. K895953 |

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## Indications For Use

The OneFlow FVC is a handheld, battery operated, electronic spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.

Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

## Technological Differences with Predicate Device

The technological differences between the OneFlow FVC and the Wright Ventilometer VM-1 are.

- Changes in design to take advantages of advancements in components design and . miniaturization namely a more powerful microprocessor and surface mount components on the printed circuit board.
- Changes to plastics used to use up to date formulations of ABS .
- Use of a venturi pressure system in place of backpressure derived from a mechanical . resistance device to provide the primary signal from the pressure sensor.
- . Lower voltage requirement (VM-1 9V, OneFlow 6V)
- The ability of the OneFlow to store measurements for later analysis (Not FVC Screen) .
- The use of illuminated diodes to inform the user of which measurement is being . displayed.

#### Performance Data

Non-clinical performance data has been compiled to support this application by testing the OneFlow FVC in accordance with the methods described in the American Thoracic Society's document "Standardization of Spirometery" 1994 update, and comparing the results with the limits for a monitoring device during evaluation.

Simulation of three years typical use has been performed and the difference between the accuracy / repeatability has been evaluated for values obtained before and after the simulation.

## Conclusion From Testing & Evaluation

All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer.

Testing to simulate 3 years of use did not alter the accuracy or repeatability of the device.

signature

Signed ... .

......................................... Date Prepared: 16 November 2004

Mr P Hallybone Quality Manager

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2005

Mr. Philip Hallybone Quality Manager Clement Clarke International Limited Edinburgh Way, Harlow, Essex CM20 2TT United Kingdom

Re: K042058

Trade/Device Name: OneFlow FVC Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 9, 2005 Received: March 14, 2005

Dear Mr. Hallybone:

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 cither 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.

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Page 2 -- Mr. Hallybone

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); 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sophie Michael. DMD

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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## Indications for Use

510(k) Number (if known): K042058 Device Name: OneFlow FVC

Indications For Use:

The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.

Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

Prescription Use Only (Part 21 CFR 801 Subpart D) AND/OR or The Gounter Use GER 801 Subpart G

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | |
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| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K042058 |

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