(236 days)
Not Found
No
The summary describes standard spirometry measurements and statistical analysis, with no mention of AI or ML terms, training data, or complex algorithms beyond comparison to predicted values.
No
The device is intended to measure the maximal volume and flow of air moved through a patient's lungs, which is a diagnostic/monitoring function, not a therapeutic one.
Yes
The device is described as a spirometer intended to measure lung function (volume and flow of air), which is a diagnostic tool for respiratory conditions. The mention of comparing gathered data with stored predicted values in the OneFlow FVC Screen model also indicates a diagnostic function.
No
The device description explicitly states that the OneFlow FVC is a "handheld, battery operated, electronic Spirometer," indicating it is a hardware device. While additional models include software components, the core device is hardware.
Based on the provided information, the OneFlow FVC is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OneFlow FVC Function: The OneFlow FVC measures the volume and flow of air moved through a patient's lungs. This is a direct measurement of a physiological function, not an analysis of a biological specimen.
- Intended Use: The intended use describes measuring lung function in patients, not analyzing biological samples.
Therefore, the OneFlow FVC falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BZG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
1 - 1
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 Asthma |
| Education Program's statement on technical standards for | |
| Peak Flow meters and the recommendations of the | |
| American Thoracic Society, Standardization of | |
| Spirometery 1994 Update) | |
| Classification panel | 868.1840 [Product code 73 BZG] |
| Equivalence: | This device is substantially equivalent to the predicate |
| device: Wright Ventilometer VM-1 510(K) ref. K895953 |
1
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
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve and merge together, resembling a caduceus or a symbol of health and medicine.
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.
3
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
4
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 | |
|---|---|
| ----------- | -- |