(78 days)
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.
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.
The provided text describes the 510(k) summary for the Mini-Wright Digital, a Peak Flow/FEV1 Meter. It outlines its indications for use, technological differences from a predicate device, and performance data.
Here's an analysis of the acceptance criteria and study information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Limits for a monitoring device as described in the American Thoracic Society's document "Standardization of Spirometry" 1994 update. | "All tests undertaken where found to be within the stated recommendations for a monitoring device." |
| Accuracy/Repeatability before and after simulation of two years' typical use. | "Testing to simulate two years of use did not alter the accuracy or repeatability of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of number of patients or individual measurements. Instead, it mentions "Non-clinical performance data has been compiled by testing the Mini-Wright Digital in accordance with the methods described in the American Thoracic Society's document 'Standardization of Spirometery' 1994 update." This implies laboratory or bench testing rather than a clinical study with human subjects.
The data provenance is not explicitly stated as retrospective or prospective human data, given it's non-clinical performance data. It is implied to be laboratory-generated. The applicant is Clement Clarke Int. Ltd from the United Kingdom, so the testing was likely conducted there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing appears to be based on a recognized technical standard (American Thoracic Society's "Standardization of Spirometery" 1994 update), which would define objective performance metrics rather than relying on expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As the testing was non-clinical and based on objective standards, there wouldn't be a need for an adjudication method among experts.
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
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a standalone peak flow/FEV1 meter, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study in the sense that the device's accuracy and repeatability were tested as a unit. While it's an electronic device, the term "algorithm only" in the context of AI isn't directly applicable here, as it's a measurement device, not an AI diagnostic algorithm. Its performance was evaluated on its own based on established spirometry standards.
7. The Type of Ground Truth Used
The ground truth for the performance reported was based on technical standards and established recommendations for monitoring devices, specifically the "American Thoracic Society's document 'Standardization of Spirometery' 1994 update." This implies a comparison to a gold standard of measurement defined by the ATS guidelines.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is an electronic measurement instrument, not an AI system that undergoes "training" in the typical machine learning sense. Its design and calibration would be based on engineering principles and conformity to standards rather than a training dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
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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: +44 (0)1279 414969 Fax +44 (0)1279 635232
| 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 AsthmaEducation Program's statement on technical standardsfor Peak Flow meters and the recommendations of theAmerican Thoracic Society, Standardization ofSpirometery 1994 Update) |
| Product code: | 73 BZH |
| Equivalence: | This device is substantially equivalent to the predicatedevice: 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.
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 (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-firee number (800) 638-2041 or (301) 443-6597 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ceneral Ho
Cool Dental Devices
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§ 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).