PULMOLIFE

K061283 · Micro Medical, Ltd. · BZG · Dec 14, 2006 · Anesthesiology

Device Facts

• Record ID: K061283
• Device Name: PULMOLIFE
• Applicant: Micro Medical, Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.

Device Story

PulmoLife is a battery-operated, handheld portable spirometer. It utilizes a uni-directional, rotating vane, flow-sensing turbine to measure lung function parameters, specifically Forced Expiratory Volume in the 1st second (FEV1) and FEV1 as a percentage of predicted value. It also provides a lung age estimation. The device is intended for use by qualified clinicians in hospitals, clinics, physicians' offices, and laboratories. The clinician operates the device to measure a patient's exhaled breath. The output, displayed to the clinician, assists in the screening and diagnosis of COPD in adult smokers.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

Handheld, battery-operated diagnostic spirometer. Sensing mechanism: uni-directional, rotating vane, flow-sensing turbine. Form factor: portable, handheld. Software: embedded firmware for parameter calculation (FEV1, FEV1 %predicted, lung age).

Indications for Use

Indicated for adult patients of either gender requiring lung function evaluation, specifically smokers for early detection of Chronic Obstructive Pulmonary Disease (COPD).

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

• Micro Medical Ltd. Micro Spirometer, Model No. MS01/3 (K963035)

Submission Summary (Full Text)

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## Section B PulmoLife 510(k)

K061283

# 510(k) Summary of Safety and Effectiveness Information

The following information is furnished in accordance with 21 CFR 807.92(a):

#### Submitter's name and address: 1.

Micro Medical Limited Quayside Chatham Maritime Chatham Kent ME4 4QY United Kingdom

DEC : 4 2006

Postal Box Address Micro Medical Ltd, PO Box 6, Rochester, Kent. ME1 2AZ. UK

- Submitter's telephone number and fax number: 2. Tel: [phone] Fax: [phone]
- 3. Contact person: Mr. Glen Hillsley - Regulatory Affairs Manager
- Trade/proprietary name of the device: 4. Pulmolife (Catalogue No. PL10)
- 5. Classification name and number of the device: Diagnostic Spirometer, 21CFR 868.1840
- Legally marketed predicate devices to which substantial 6. equivalence is claimed:

Micro Medical Ltd. Micro Spirometer, Model No. MS01/3. Ref. 510(k) No. K963035, approved by FDA on November 1, 1996.

pulmolife-510ksecB

Section B Page 1 of 2 :

:

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### Section B PulmoLife 510(k)

### 8. Description of the device that is the subject of this premarket notification:

The PulmoLife is a battery operated hand held portable spirometer. It uses a uni-directional, rotating vane, flow sensing turbine to measure lung function parameters, specifically Forced Expiratory Volume in the 1st second of expiration (FEV1) and FEV1 as a percentage of the predicted value (FEV1 %predicted). Lung age estimation is also given. It is supplied with one way valve safety mouthpieces, carrying pouch and instruction manual.

#### 9. Intended use and indication for use:

The device measures the exhaled breath of a patient, specifically FEV1. The results can be used for the diagnosis of COPD in adult smokers.

#### 10. Targeted Population

Adult patients of either gender requiring lung function evaluations, particularly smokers for the early detection of Chronic Obstructive Pulmonary Disease (COPD)

#### Environment of Use 11.

Places where a qualified clinician desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories.

#### 12. Technological characteristics:

The design, packaging, and other technological characteristics of the Micro Medical PulmoLife device are considered to be substantially equivalent to those of the predicate devices.

This concludes the 510(k) summary.

pulmolife-510ksecB

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Glen Hillsley Regulatory Affairs Manager Micro Medical, Limited Quayside Chatham Maritime Chatham. Kent. ME4 4QY UNITED KINGDOM

DEC 1 4 2006

Re: K061283

Trade/Device Name: PulmoLife Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: December 1, 2006 Received: December 8, 2006

Dear Mr. Hillsley:

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.

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Page 2 - Mr. Hillsley

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

Sincerely yours,

Chiu Lin, Ph.D.

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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## 510(k) Number (if known):

Unknown - not yet assigned by FDA KO 6 12 83

### Device Name:

PulmoLife

### Indications For Use:

The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.

(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 Use

(Optional Fornat 1-2-96)

LOUL Devices
K06 1243.