(80 days)
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.
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 rotation is proportional to the flow rate. With flow rate and correspondent time, FEV1 can be calculated.
The provided document is a 510(k) summary for a medical device called the Microlife Electronic Peak Flow Monitor. This document is a premarket notification to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and direct performance metrics in the way a clinical trial or algorithm validation might for a novel AI device.
Therefore, many of the requested items regarding acceptance criteria, sample sizes, expert ground truth, and AI-specific studies are not directly applicable or available in this specific document, as it predates widespread AI in medical devices and focuses on mechanical and electrical safety and performance standards for a peak flow meter.
However, I can extract information related to the device's performance based on the standards it claims to meet.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical/Flow Measurement: | |
| American Thoracic Society (ATS) recommendations for Spirometry (PEF accuracy) | "Both devices meet the American Thoracic Society (ATS) recommendations for Spirometry." "meeting ATS accuracy testing using the 26 flow-time waveform and the 24 volume-time waveform." |
| ATS recommendations for Spirometry (FEV1 accuracy) | "Both devices meet the American Thoracic Society (ATS) recommendations for Spirometry." |
| Electrical Safety: | |
| IEC 60601-1 (electrical safety) | "Product Safety Testing included successful completion of testing to the IEC 60601-1 (electrical safety) standard." |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2 (electromagnetic compatibility) | "Product Safety Testing included successful completion of testing to... IEC 60601-1-2 (electromagnetic compatibility) standards." |
2. Sample size used for the test set and the data provenance
The document refers to "bench testing" and "non-clinical testing" using "ATS Standard Waveforms" and "a waveform generator." It does not specify a "sample size" in terms of human subjects or a dataset in the way an AI study would. The testing appears to involve simulated waveforms rather than real patient data. There is no information on data provenance (country of origin, retrospective/prospective) because human data was not used for this evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the device's accuracy was established by the ATS standards themselves, which define ideal flow and volume waveforms. Experts would have developed these standards, but not specifically for this device's testing.
4. Adjudication method for the test set
Not applicable. The testing was against established technical standards and simulated waveforms, not human expert consensus.
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
Not applicable. This device is a peak flow meter, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a standalone hardware device that measures physical parameters. It does not contain an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance validation was based on technical standards and simulated waveforms defined by the American Thoracic Society (ATS). This refers to the precise, known characteristics of the flow-time and volume-time waveforms that a spirometer should accurately capture.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
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.
{1}------------------------------------------------
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 (301) 594-4646. 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 (301) 443-6597 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
{2}------------------------------------------------
Attachment #1
Page 1 of 1
510(k) Number (if known):
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
{3}------------------------------------------------
JUN 1 0 2004
EXHIBIT # 1
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
{4}------------------------------------------------
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
{5}------------------------------------------------
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.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).