MINI-WRIGHT DIGITAL, MODEL 3120001

K053156 · Clement Clarke Intl., Ltd. · BZH · Jan 31, 2006 · Anesthesiology

Device Facts

• Record ID: K053156
• Device Name: MINI-WRIGHT DIGITAL, MODEL 3120001
• Applicant: Clement Clarke Intl., Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV1 monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.

Device Story

Handheld, battery-operated electronic peak flow and FEV1 meter; used by patients or clinicians in home/clinical settings. Device measures airflow; stores up to 240 readings in internal memory. No PC connectivity; results recorded manually via provided diary sheet. Sealed design allows liquid submersion for cleaning. Benefits include portable, long-term monitoring of asthma or respiratory conditions under professional guidance. Healthcare providers use stored data to assess patient status and adjust treatment plans.

Clinical Evidence

Bench testing only. Evaluated per American Thoracic Society 'Standardization of Spirometry' 1994 update. Two-year simulated use testing performed; accuracy and repeatability maintained post-simulation.

Technological Characteristics

Handheld electronic peak flow/FEV1 meter; microprocessor and pressure sensor based; battery-powered; sealed, liquid-submersible enclosure; 240-reading memory; no external connectivity.

Indications for Use

Indicated for paediatric and adult patients for monitoring respiratory conditions such as asthma in home and clinical settings.

Regulatory Classification

Identification

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

Predicate Devices

• OneFlow Tester (K980951)

Submission Summary (Full Text)

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K 053156

1-2

JAN 3 ] 2006

Image /page/0/Picture/2 description: The image contains a logo for Clement Clarke International. The logo consists of a black square with the letters "HS" in white, followed by the words "CLEMENT CLARKE" in bold, black letters. Below that, the word "INTERNATIONAL" is written in a similar font and color.

Precision by Tradition

# 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/Regulatory affairs Manager)

Telephone: [phone] Fax [phone]

| Date of preparation: | 01 November 2005 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Mini-Wright Digital |
| Common Name: | Peak Flow/FEV1 Meter (per 21 CFR section 868.1860) |
| Classification Name: | METER, PEAK FLOW, SPIROMETRY |
| Medical speciality: | Anaesthesiology |
| Classification: | Class II (performance Standard - National Asthma<br>Education Program's statement on technical standards<br>for Peak Flow meters and the recommendations of the<br>American Thoracic Society, Standardization of<br>Spirometery 1994 Update) |
| Product code: | 73 BZH |
| Equivalence: | This device is substantially equivalent to the predicate<br>device: OneFlow Tester, 510(k) K980951, class II |

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#### Indications for Use & Device Description

The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV I monitoring device with an internal memory capable of storing 240 sets of readings, This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.

#### Technological Differences with Predicate Device

The technological differences between the Mini-Wright Digital and the OneFlow Tester are

- Changes in design to incorporate smaller, more efficient, components such as the . microprocessor and pressure sensor making the Mini Wright Digital smaller and requiring less power so that the battery does not need to be changed during the design life.
- . The Mini Wright Digital is totally scaled so that it can be submerged in liquid for cleaning.
- The Mini Wright Digital can store 240 measurement results whereas the OneFlow . Tester could only store 120 results.
- . The Mini Wright Digital cannot be linked to a personal computer for the downloading of results for further analysis; this enabled the device to be totally sealed and a cost reduction. A diary sheet is provided with each device for the recording of measurements taken.

#### Performance Data

Non-clinical performance data has been compiled to support this application by testing the Mini-Wright Digital 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 two years (design life) 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 device. Testing to simulate two years of use did not alter the accuracy or repeatability of the device.

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Mr P Hallybone Quality/Regulatory Affairs Manager

Signed: ...

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 ] 2006

Mr. Philip Hallybone Quality/Regulatory Affairs Manager Clement Clarke International, Limited Edinburgh Way Harlow, Essex CM20 2TT UNITED KINGDOM

Re: K053156

Trade/Device Name: Mini-Wright Digital Regulation Number: 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: November 4, 2005 Received: November 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 cquivalent (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.

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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 practize requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 vour device to proceed to the market.

If vou 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-firee number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sytie y. Mchice OMD.

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): K053156

Device Name: Mini-Wright Digital

Indications For Use:

The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV1 monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ceneral Ho
Cool Dental Devices

K053156

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