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

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the PulmoLife device, structured to answer your specific questions.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's basic information. It does not contain the detailed study results, acceptance criteria, or ground truth establishment that would typically be found in a comprehensive clinical study report. Therefore, many of your questions cannot be answered directly from the provided text.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance

The summary states, "The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices." This implies that the device is expected to meet the accuracy and precision requirements set forth by the American Thoracic Society (ATS) standards for spirometry. However, the specific numerical acceptance criteria (e.g., accuracy within X% or Y liters) and the reported device performance against those criteria are not provided in this 510(k) summary.

Without the actual study report, a table cannot be constructed with specific numerical data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. A mention of a clinical study or performance data is absent, other than the general statement about conforming to ATS standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. For spirometry, "ground truth" often refers to measurements obtained from highly accurate laboratory spirometers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The PulmoLife is a diagnostic spirometer, not an AI-assisted diagnostic tool for image interpretation or similar. Therefore, an MRMC study as typically understood in AI/imaging is not applicable here, and no such study is mentioned or implied. The device measures lung function directly.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The PulmoLife is a standalone device in that it measures FEV1 directly. The "algorithm" here would be the processing of the flow signal to calculate FEV1. There isn't a human interpreting an "output" from the device in the same way an AI system might provide a result that a human then reviews. The performance of the device itself in generating the FEV1 measurement would be the focus. The summary implies that "standalone" performance was the focus, as it claims conformance to ATS standards for "diagnostic devices."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For spirometry, ground truth would typically be established by:

Reference spirometers: Highly calibrated and accurate laboratory spirometers used to validate the measurements of the new device.
Simulators: Mechanical or electronic simulators that produce known flow and volume signals.

The summary itself does not specify the ground truth mechanism used, but it's implied to be based on physical measurements and comparisons with established methods (ATS standards).

8. The sample size for the training set

This information is not provided in the 510(k) summary. For a hardware device like a spirometer, there might not be a "training set" in the machine learning sense. The device's calibration and validation would be based on engineering principles and comparison to reference standards.

9. How the ground truth for the training set was established

As above, a "training set" in the AI sense is unlikely to apply directly to this device. The establishment of ground truth for device calibration and validation would involve highly accurate physical measurements or simulations, conforming to spirometry standards. The specifics are not detailed in the provided document.

Summary of Limitations based on the provided document:

The provided 510(k) summary is very high-level and serves the purpose of demonstrating substantial equivalence to a predicate device. It does not include the detailed clinical or validation study reports that would contain the specific acceptance criteria, performance data, sample sizes, ground truth methodologies, and expert qualifications for a rigorous assessment. To obtain this level of detail, one would typically need to refer to the full 510(k) submission or any referenced performance studies, which are not part of this snippet.

Summary

{0}------------------------------------------------

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: 011 44 1634 893500 Fax: 011 44 1634 893600
1. Contact person: Mr. Glen Hillsley - Regulatory Affairs Manager
Trade/proprietary name of the device: 4. Pulmolife (Catalogue No. PL10)
1. 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 :

{1}------------------------------------------------

Section B PulmoLife 510(k)

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

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------

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)

Over-The-Counter Use

(Optional Fornat 1-2-96)

LOUL Devices
K06 1243.

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).