(236 days)
The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.
Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
The OneFlow FVC is a handheld, battery operated, electronic spirometer. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
The provided document describes the OneFlow FVC, a handheld electronic spirometer. The performance data section refers to adherence to the American Thoracic Society's "Standardization of Spirometery" 1994 update. However, the document does not explicitly define specific numerical acceptance criteria for this device beyond stating that "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." Therefore, a table of acceptance criteria and reported device performance with specific values cannot be fully populated from the given text.
Based on the provided information, here's a breakdown of the requested details:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as per ATS "Standardization of Spirometry" 1994 Update) | Reported Device Performance |
|---|---|---|
| Accuracy | Recommended limits for a monitoring device (as per ATS 1994 update) | "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." |
| Repeatability | Recommended limits for a monitoring device (as per ATS 1994 update) | "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." |
| Durability/Longevity | Accuracy/repeatability maintained after 3 years typical use simulation | "Testing to simulate 3 years of use did not alter the accuracy or repeatability of the device." |
Note: The specific numerical values for accuracy and repeatability limits, as defined by the ATS 1994 update for a monitoring device, are not present in the provided text. The document only confirms the device met these unstated recommendations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document mentions "testing the OneFlow FVC" but does not give a number of devices or data points in the test set.
- Data Provenance: The testing was "Non-clinical performance data" compiled by the applicant (Clement Clarke Int. Ltd) in the United Kingdom. It is a retrospective evaluation of the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The ground truth for this spirometer performance evaluation is not based on expert consensus on image interpretation or clinical diagnosis. It's based on adherence to technical standards.
- Qualifications of Experts: Not applicable. The evaluation relies on the methods described in a recognized technical standard (ATS "Standardization of Spirometery" 1994 update) rather than a panel of clinical experts establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of performance testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the device against technical standards, not on human reader performance with or without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the study evaluates the standalone performance of the OneFlow FVC device. The testing described focuses solely on the device's ability to accurately measure spirometry parameters according to the ATS 1994 update, without human interpretation in the loop as part of the performance evaluation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is based on technical standards and simulated conditions. Specifically, performance was evaluated "in accordance with the methods described in the American Thoracic Society's document 'Standardization of Spirometery' 1994 update," with a focus on meeting the "limits for a monitoring device during evaluation." Additionally, a "simulation of three years typical use" was conducted as part of the durability ground truth.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The OneFlow FVC is a measurement device, not an AI/ML algorithm that requires a training set. The device's design and calibration would be based on engineering principles and established physical processes, not a data-driven training set in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device. The device's functionality is based on its hardware design (venturi pressure system, microprocessor, sensors) and software algorithms for measurement, which are calibrated and developed according to engineering specifications and industry standards.
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MAR 2 3 201
Precision byTradition
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 Manager)
Telephone: +44 (0)1279 414969 Fax +44 (0)1279 635232
| Proprietary Name: | OneFlow FVC, OneFlow FVC (kit), OneFlow FVC Screen |
|---|---|
| Common Name: | Spirometer |
| Classification Name: | Diagnostic Spirometer |
| Medical speciality: | Anaesthesiology |
| Classification: | Class II (performance Standard - National AsthmaEducation Program's statement on technical standards forPeak Flow meters and the recommendations of theAmerican Thoracic Society, Standardization ofSpirometery 1994 Update) |
| Classification panel | 868.1840 [Product code 73 BZG] |
| Equivalence: | This device is substantially equivalent to the predicatedevice: Wright Ventilometer VM-1 510(K) ref. K895953 |
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Indications For Use
The OneFlow FVC is a handheld, battery operated, electronic spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.
Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
Technological Differences with Predicate Device
The technological differences between the OneFlow FVC and the Wright Ventilometer VM-1 are.
- Changes in design to take advantages of advancements in components design and . miniaturization namely a more powerful microprocessor and surface mount components on the printed circuit board.
- Changes to plastics used to use up to date formulations of ABS .
- Use of a venturi pressure system in place of backpressure derived from a mechanical . resistance device to provide the primary signal from the pressure sensor.
- . Lower voltage requirement (VM-1 9V, OneFlow 6V)
- The ability of the OneFlow to store measurements for later analysis (Not FVC Screen) .
- The use of illuminated diodes to inform the user of which measurement is being . displayed.
Performance Data
Non-clinical performance data has been compiled to support this application by testing the OneFlow FVC 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 three years 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 Spirometer.
Testing to simulate 3 years of use did not alter the accuracy or repeatability of the device.
signature
Signed ... .
......................................... Date Prepared: 16 November 2004
Mr P Hallybone Quality Manager
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2005
Mr. Philip Hallybone Quality Manager Clement Clarke International Limited Edinburgh Way, Harlow, Essex CM20 2TT United Kingdom
Re: K042058
Trade/Device Name: OneFlow FVC Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 9, 2005 Received: March 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 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 cither 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 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sophie Michael. DMD
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): K042058 Device Name: OneFlow FVC
Indications For Use:
The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.
Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
Prescription Use Only (Part 21 CFR 801 Subpart D) AND/OR or The Gounter Use GER 801 Subpart G
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K042058 |
| Page 1 of | |
|---|---|
| ----------- | -- |
§ 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).