(119 days)
The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
Here's a breakdown of the acceptance criteria and the study details for the RxPeakFlow Meter, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (RxPeakFlow) |
|---|---|
| Range | 60-800 L/Min |
| Accuracy | +/- 10% |
| Intra-device Precision | +/- 5% |
| Inter-device Precision | +/- 5% |
Note: The document only provides the performance of the RxPeakFlow against these criteria, stating it "passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry". It doesn't explicitly list a separate "acceptance criteria" column versus "reported device performance," but rather presented these as the requirements the device met.
2. Sample Size and Data Provenance for the Test Set
The document states that "bench testing" was performed. However, it does not provide specific details regarding:
- Sample size used for the test set (e.g., number of devices tested, number of individual measurements).
- Data provenance (e.g., country of origin, retrospective or prospective nature of the "bench testing").
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not provided in the document. Bench testing typically relies on standardized reference instruments or methods rather than human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1, none) are typically used when multiple human experts are involved in interpreting results, especially in imaging or diagnostic studies. Since the testing was "bench testing," and no human experts or interpretation are mentioned for establishing ground truth, information on an adjudication method is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The device is a "Meter, Peak Flow," which measures a physical parameter directly, rather than providing an interpretation that a human would then use to make a decision. The performance evaluation was through "bench testing," not a clinical study involving human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document explicitly states: "The RxPeakFlow has been tested for performance through bench testing. The device passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing." This describes the algorithm's (or device's mechanical) performance without human intervention.
7. Type of Ground Truth Used
The ground truth used was based on standards and requirements from the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing. This implies that the device's measurements were compared against known, standardized flow-time waveforms or reference measurements adhering to these professional guidelines.
8. Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. This is common for mechanical devices that are calibrated and tested against physical standards, rather than "trained" using a dataset in the way a machine learning algorithm would be.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The device is a mechanical measurement tool rather than an AI/ML-driven diagnostic.
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RxPeakFlow Meter
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510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
| Submitter Information | Noble MarketingJeff BakerPresident & CEO100 East Pine Street, Suite 305Orlando, FL 32801 | SEP 13 2010 |
|---|---|---|
| Contact Person | Laura LyonsSr. Regulatory Consultant317-569-9500317-569-9520 (fax) | |
| Date | May 14, 2010 | |
| Trade Name | RxPeakFlow | |
| Common Name | Meter, Peak Flow | |
| Classification Name | BZH | |
| Classification Number | 21 CFR 868.1860 | |
| Predicate Devices | MicroPeak K030586 BZH 868.1860 | |
| Device Description | The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults. | |
| Intended Use | The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults | |
| Comparison to Predicate Devices | The RxPeakFlow is similar to the predicate in intended use, materials, measuring principle and performance. |
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| Device Comparisons | RxPeakFlow | MicroPeak |
|---|---|---|
| Indicated use | Measures a patient'speak expiratory flowrate. | Measures a patient'speak expiratory flowrate. |
| Target Population | Children to Adults | Patients requiring themeasurement of peakexpiratory flow. |
| Environment of use | Anywhere a patient mayrequire themeasurement of peakexpiratory peak flow. | Anywhere a patient mayrequire themeasurement of peakexpiratory peak flow. |
| Design | Single Patient Use | Single Patient Use |
| Measuring Principle | Tension SpringPiston/Pointer | Tension SpringPiston/Pointer |
| Performance | ||
| Range | 60-800 L/Min | 60-900 L/Min |
| Accuracy | +/- 10% | +/- 10% |
| Intra device Precision | +/- 5% | +/- 5% |
| Inter device Precision | +/-5% | +/-5% |
| Materials | Housing- ABS | Housing- ABS |
| Differences | Small difference inmeasurement range. |
The RxPeakFlow uses a tension spring piston/pointer measuring principle. Technological Characteristics
The RxPeakFlow has been tested for performance through bench testing. The Performance device passed all testing and met the criteria for range, accuracy and precision of Non-Clinical required by the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing.
The RxPeakFlow is substantially equivalent to a legally marketed predicate Conclusion device and meets recommended ATS standards.
End of document.
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Image /page/2/Picture/0 description: The image shows a logo or symbol that appears to be associated with a department or organization. The logo features a stylized design with three vertical lines that are connected by curved segments, creating a wave-like pattern. The text "DEPARTMENT OF" is partially visible along the left side of the image, suggesting that the logo belongs to a government or institutional entity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Noble Marketing C/O Ms. Laura Lyons Anson Group, LLC 11460 N. Meridian Street, Suite 150 Carmel, Indiana 46032
SEP 1 3 2010
Re: K101380 Trade/Device Name: RxPeakFlow Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: August 30, 2010 Received: August 30, 2010
Dear Ms. Lyons:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Lyons
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W for
Anthony D. Watson, B.S., M.S., M.B.A. 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
101380
510(k) Number: Pending
SEP 1 3 2010
Device Name: RxPeakFlow
Indications For. Use:
The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
Prescription Use __ AND/OR Over-The-Counter Use __ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
510(k) Number:
§ 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).