(28 days)
The FloPatch(FP110) is intended for the detection of blood flow in peripheral vasculature.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use only.
The FloPatch (FP110) is a non-invasive blood flow detection device intended to be used in a medical/hospital setting for use by medical professionals. The device uses ultrasound and the Doppler effect to evaluate the flow of blood. The device consists of signal processing box (main unit) and an ultrasonic vascular flow transducer. The device transmits ultrasonic waves from the vascular flow transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing box (main unit) which outputs the doppler signal to the device speaker.
I understand that you're asking for details about the acceptance criteria and the study that proves a device meets those criteria, specifically concerning the FloPatch (FP110) based on the provided FDA 510(k) summary.
However, after carefully reviewing the provided text, I can determine the following:
- Trade/Device Name: FloPatch (FP110)
- Regulation Number: 21 CFR 870.2100
- Regulation Name: Cardiovascular blood flowmeter
- Regulatory Class: Class II
- Product Code: DPW
- Intended Use: The FloPatch (FP110) is intended for the detection of blood flow in peripheral vasculature. It is intended to be used by medical professionals (physicians and nurses) in hospitals and professional environments and is for prescription use only.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Edan SD3 Vascular Doppler, K140579) based on design features, intended use, and compliance with various non-clinical performance standards (EMC, electrical, thermal & mechanical safety, biocompatibility, acoustic output, etc.).
The provided text does not contain the following information:
- A table of acceptance criteria and the reported device performance. While it mentions "performance verification testing" and that the device "complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment," specific quantitative acceptance criteria and the FloPatch's performance against them are not detailed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This device does not appear to involve AI/algorithms for "human improvement" as it's a basic blood flow detection device).
- If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done. (Again, not applicable to the type of device described).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance studies.
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion based on the provided text:
The 510(k) summary indicates that the FloPatch (FP110) was deemed substantially equivalent to its predicate device (Edan SD3 Vascular Doppler) based on the following:
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Non-clinical Performance Data: The device was tested and found compliant with relevant recognized consensus standards for:
- ES60601-1:2005/(R)2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
- IEC 60601-2-37 Edition 2.1 2015 (Ultrasonic Medical Diagnostic and Monitoring Equipment)
- IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic Disturbances)
- ISO 10993-1, -5, -10 (Biocompatibility: cytotoxicity, sensitization, skin irritation)
- IEC 62127-1 Edition 1.1 2013-02 (Ultrasonics - Measurement and Characterization of Medical Ultrasonic Fields)
- IEC 61161:2013 (Ultrasonics - Power measurement)
- IEC 62359 Edition 2.1 2017-09 (Ultrasonics - Field characterization - Thermal and mechanical indices)
- IEC 62304:2006 (Software Life Cycle Process)
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Performance Verification Testing: The summary generally states that "performance testing to compare the performance of the device to predicate was conducted besides verification of performance, packaging and labelling." It concludes that "The results of the performance testing and testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP110 are equivalent to the recognized predicate in terms of acoustic output and performance."
Without further documentation (e.g., specific test reports linked in the 510(k) submission), the detailed acceptance criteria and the specific performance results from clinical or comprehensive bench performance studies are not available in this summary. The substantial equivalence argument relies heavily on adherence to recognized safety and performance standards for similar devices and a comparison of features to the predicate.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).