RXPEAKFLOW

K101380 · Noble Marketing · BZH · Sep 13, 2010 · Anesthesiology

Device Facts

• Record ID: K101380
• Device Name: RXPEAKFLOW
• Applicant: Noble Marketing
• Product Code: BZH · Anesthesiology
• Decision Date: Sep 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

RxPeakFlow is a mechanical peak flow meter for monitoring respiratory conditions like asthma. Device measures peak expiratory flow rate (PEFR) via a tension spring piston/pointer mechanism. Patient exhales into device; mechanical movement of piston/pointer indicates flow rate on a scale. Used by patients (children to adults) in any setting. Output is a visual reading of PEFR in L/min, used by patients/clinicians to track lung function and manage respiratory health.

Clinical Evidence

Bench testing only. Device performance evaluated against American Thoracic Society (ATS) Standardization of Spirometry, specifically ATS 26 flow-time waveform testing. Results confirmed device met criteria for range (60-800 L/min), accuracy (+/- 10%), and precision (intra/inter-device +/- 5%).

Technological Characteristics

Mechanical peak flow meter. Materials: ABS housing. Measuring principle: Tension spring piston/pointer. Range: 60-800 L/min. Accuracy: +/- 10%. Precision: +/- 5%. Single patient use. No software or electronic components.

Indications for Use

Indicated for children to adults to measure peak expiratory flow rate (L/min) for monitoring respiratory conditions such as asthma.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• MicroPeak (K030586)

Submission Summary (Full Text)

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## RxPeakFlow Meter

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K101380

## 510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness

| Submitter Information | Noble Marketing<br>Jeff Baker<br>President & CEO<br>100 East Pine Street, Suite 305<br>Orlando, FL 32801 | SEP 13 2010 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Laura Lyons<br>Sr. Regulatory Consultant<br>317-569-9500<br>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<br>peak expiratory flow<br>rate. | Measures a patient's<br>peak expiratory flow<br>rate. |
| Target Population | Children to Adults | Patients requiring the<br>measurement of peak<br>expiratory flow. |
| Environment of use | Anywhere a patient may<br>require the<br>measurement of peak<br>expiratory peak flow. | Anywhere a patient may<br>require the<br>measurement of peak<br>expiratory peak flow. |
| Design | Single Patient Use | Single Patient Use |
| Measuring Principle | Tension Spring<br>Piston/Pointer | Tension Spring<br>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<br>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.

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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 [phone] or [phone] 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)
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510(k) Number: