(117 days)
No
The description focuses on mechanical measurement and adherence to established standards for peak flow meters, with no mention of AI or ML.
No.
The document states that the device is a "monitoring device that measures Peak Expiratory Flow (PEF)" and "can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns." It is used to monitor PEF for patients whose medication dosage depends on measured PEF obstruction, and as part of a treatment program for respiratory conditions, but it does not treat any condition itself.
No
The device is described as a "monitoring device" that measures PEF. While it helps monitor a patient's condition, there is no indication that it is used to diagnose a new condition. Its output helps manage medication doses based on measured obstruction.
No
The device description explicitly states it is a "hand-held monitoring device" and describes physical components like a "range selector" and "color-coded zone indicators," indicating it is a hardware device, not software-only.
Based on the provided text, the Strive™ Dual Zone PFM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Strive™ PFM Function: The Strive™ PFM measures Peak Expiratory Flow (PEF) directly from the patient's breath during a forced exhalation. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to monitor PEF to help manage respiratory conditions, not to diagnose or provide information based on in vitro analysis of samples.
Therefore, the Strive™ Dual Zone PFM is a monitoring device that measures a physiological parameter (PEF) directly from the patient, not an IVD.
N/A
Intended Use / Indications for Use
The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.
Product codes
BZH
Device Description
The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.
The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.
The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.
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 five years or older and adults
Intended User / Care Setting
home, hospitals and clinics
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 Strive™ Dual Zone PFM was tested for performance, including: Functional testing per the American Thoracic Society (ATS) Standard of Spirometry: 2005, ISO 23747 International Standard for peak expiratory meter, Environmental Testing, Operational Testing, Mechanical Life Cycle.
The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM. All other testing was found to be comparable to the TruZone® PFM.
Clinical testing was not completed as it is not required to show substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K123945
APR 1 7 2013
510(k) SUMMARY
· Date Prepared: March 12, 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
1. Submitter Information
| Name: | Monaghan Medical Corporation |
|---|---|
| Address: | 5 Latour Avenue; Suite 1600 |
| Plattsburgh, New York 12901 | |
| Telephone#: | 518-561-7330 |
| Fax#: | 518-561-5660 |
| Contact Person: | Cari J. Reil |
| Regulatory Affairs Manager |
- Device Information Device Trade Name: Common Name: Classification Name: Classification Number: Classification Product Code:
Strive™ Dual Zone Peak Flow Meter Peak Flow Meter Peak-flow meter for spirometry 868.1860 BZH
-
- Legally Marketed Predicate Device
| Device Trade Name: | TruZone® Peak Flow Meter |
|---|---|
| 510(k) Number: | K023097 |
| Manufacturer: | Monaghan Medical Corporation |
- Device Description
The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.
The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.
The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.
1
5. Intended Use
The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.
The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.
6. Technological Characteristics
The Strive™ Dual Zone PFM has the same function and intended use as the predicate device, TruZone® PFM.
The Strive™ PFM is a dual zone device suitable for both pediatric (5+ years) and adult patients who use a PFM as part of their treatment program. It has improved accuracy at low flow-rates.
The device has color-coded zone markers that can be adjusted by the patient so readings can be taken quickly and easily and can be readjusted as recommended by their healthcare provider.
The Strive™ Dual Zone PFM has an ergonomically shaped mouthpiece to assist in creating a secure seal and has an optional disposable mouthpiece with one-way valve for clinical applications.
7. Non-Clinical Test Summary
The Strive™ Dual Zone PFM was tested for performance, including: Functional testing per the American Thoracic Society (ATS) Standard of Spirometry: 2005, ISO 23747 International Standard for peak expiratory meter, Environmental Testing, Operational Testing, Mechanical Life Cycle.
The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM. All other testing was found to be comparable to the TruZone® PFM.
8. Clinical Performance Summary
Clinical testing was not completed as it is not required to show substantial equivalence.
9. Conclusions
The Strive™ Dual Zone PFM meets performance requirements and raises no new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines emanating from a central point. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2013
Mr. Carl J. Reil Regulatory Affairs Manager Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 PLATTABURGH NY 12901
Re: K123945
Trade/Device Name: Strive™ Dual Zone Peak Flow Meter (PFM) Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: March 12, 2013 Received: March 18, 2013
Dear Mr. Reil:
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
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Kwame O. Ulme
-S FDA
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "monaghan" in a bold, sans-serif font. To the left of the word is a circular logo. The logo contains a stylized letter "M" inside the circle, with the word "monaghan" written around the inside of the circle.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K123945
Strive™ Dual Zone Peak Flow Meter (PFM) Device Name:
Indications for Use:
The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.
The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Albert E | |
| Moyal -SFIL c=US, o=U.S. Government, |
ou=HHS; ou=FDA, ou=People,
0.9.2342:19200300.100.1.1=1300
059331; cn=Albert E. Moyal -S
2013.04.17 12:31:33 -04'00' (for LS) |
| (Division Sign-Off) | |
| Division of Anestheslology, General Hospital
Infection Control, Dental Devices | |
| 510(k) Number: | K123945 |
Prescription Use
✓
or
Over-The-Counter Use
(Per 21 CFR 801.109)
Monaghan Medical Corporation · 5 Latour Avenue, Suite 1600 · Platisburgh, NY 12901 · Toll Free 800-833-9853 · Fax 518-561-5088 · www.monaghanmed.com