(119 days)
Not Found
No
The description focuses on standard peak flow measurement and performance testing against established standards, with no mention of AI/ML terms or functionalities.
No.
The device measures lung function for monitoring purposes but does not actively treat or alleviate a medical condition.
Yes
The device measures a patient's a patient's peak expiratory flow rate, which is a key physiological parameter used to monitor respiratory conditions such as asthma. This qualifies it as a diagnostic device because it provides information used to assess a medical condition.
No
The device description and performance studies clearly indicate that the RxPeakFlow is a physical device used to measure peak expiratory flow rate, not a software application. The performance studies describe bench testing and meeting criteria for range, accuracy, and precision, which are characteristic of hardware device testing.
Based on the provided information, the RxPeakFlow device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RxPeakFlow Function: The RxPeakFlow measures a physical parameter (peak expiratory flow rate) directly from the patient's breath. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to monitor respiratory conditions by measuring a physical function, not by analyzing a biological sample.
Therefore, the RxPeakFlow falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
BZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children to adults
Intended User / Care Setting
Anywhere a patient may require the measurement of peak expiratory peak flow.
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)
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 Non-Clinical required by the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Range: 60-800 L/Min
Accuracy: +/- 10%
Intra device Precision: +/- 5%
Inter device Precision: +/-5%
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.
MicroPeak K030586
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
§ 868.1860 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).
0
RxPeakFlow Meter
)
i
510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
| Submitter Information | Noble Marketing
Jeff Baker
President & CEO
100 East Pine Street, Suite 305
Orlando, FL 32801 | SEP 13 2010 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Laura Lyons
Sr. Regulatory Consultant
317-569-9500
317-569-9520 (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's | |
| peak expiratory flow | ||
| rate. | Measures a patient's | |
| peak expiratory flow | ||
| rate. | ||
| Target Population | Children to Adults | Patients requiring the |
| measurement of peak | ||
| expiratory flow. | ||
| Environment of use | Anywhere a patient may | |
| require the | ||
| measurement of peak | ||
| expiratory peak flow. | Anywhere a patient may | |
| require the | ||
| measurement of peak | ||
| expiratory peak flow. | ||
| Design | Single Patient Use | Single Patient Use |
| Measuring Principle | Tension Spring | |
| Piston/Pointer | Tension Spring | |
| Piston/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 in | |
| measurement 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.
2
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.
3
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
4
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: