(136 days)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.
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 on adults only.
The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic 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 unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FloPatch FP120 device, structured to answer your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes product modifications to an already cleared device and demonstrates substantial equivalence through various tests. The acceptance criteria, while not explicitly stated as numerical values for all tests, are implied by a "Pass" result for each test performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets Class B EMC requirements (CISPR B). | Pass |
| Adhesive meets biocompatibility requirements. | Pass |
| Adhesive satisfies material and shelf life performance testing. | Pass |
| Packaging meets ISTA3 and performance testing. | Pass |
| Device meets applied part BF electrical safety requirements. | Pass |
| Software application satisfies functional requirements and performs as intended; algorithms and calculations were verified. | Pass |
| Device meets IP6X dust ingress requirements. | Pass |
| Device meets transport medical equipment requirements (shock, vibration, free fall). | Pass |
| Global maximum derated ISPTA ≤ 720 mW/cm² and global maximum MI ≤ 1.9 (Acoustic Output). | Pass |
| Device meets IEC 60601-2-37 for ultrasound safety. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets for the various engineering validation and verification tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified in this summary. These tests appear to be laboratory-based engineering and software validation tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the tests are primarily engineering and software verification, the "ground truth" would likely be established by technical specifications and standards rather than expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not provided. For engineering and software tests, adjudication usually involves technical review against predefined specifications rather than a multi-expert clinical review process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in this document. The device, FloPatch FP120, is a cardiovascular blood flowmeter that directly assesses blood flow and does not appear to involve human interpretation of images or data that would typically necessitate such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The "Software Testing" mentioned includes verification that "Algorithms and calculations were also verified." This implies that the algorithms were tested for their accuracy in isolation (standalone), but the details of this testing (e.g., specific metrics, dataset) are not provided. The device itself is user-operated by medical professionals, so an entirely "standalone" clinical performance might not be applicable in the same way it would be for an AI-powered diagnostic image analysis tool.
7. The Type of Ground Truth Used
For the engineering tests (EMC, Biocompatibility, Material/Shelf Life, Packaging, Electrical Safety, Dust Ingress, Emergency Services Equipment, Acoustic Output, Ultrasound Safety), the ground truth is based on regulatory standards and recognized industry specifications (e.g., Class B requirements, ISTA3, applied part BF requirements, IP6X, IEC 60601-1, IEC 60601-2-37, global maximum derated ISPTA, global maximum MI limits).
For "Software Testing," the ground truth for "Algorithms and calculations" would be based on mathematical correctness and predefined functional requirements of the device's calculations (Max Velocity trace, Max VTI, Corrected Flow Time).
8. The Sample Size for the Training Set
The document does not mention any training sets. This submission is for modifications to a previously cleared device, not for the development of a new AI model that typically requires a training set. The "Software Testing" focuses on verification of existing algorithms and calculations rather than training a new machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2022
Flosonics Medical Caleb Chin Director of Quality and Regulatory 325 Front St W, Floor 4 Toronto. Ontario M5V 2Y1 Canada
Re: K222242
Trade/Device Name: FloPatch FP120 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: October 20, 2022 Received: November 7, 2022
Dear Mr. Chin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski - S
for
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name FloPatch FP120
Indications for Use (Describe)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.
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 on adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Flosonics Medical. The logo features a stylized blue and black icon above the company name. The icon resembles a stylized letter 'f' with curved lines emanating from it, suggesting a wave or signal. Below the icon, the word "FLOSONICS" is printed in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller, lighter font.
SECTION 5 – 510(k) Summary
1. Submitter Information
| Submitter: | Flosonics Medical |
|---|---|
| Address: | 325 Front St W, Floor 4Toronto, ONCanada M5V 2Y1 |
| Telephone: | 1-289-998-2982 |
| Contact: | Caleb Chin |
| Date Prepared: | July 19, 2022 |
2. Device Information
| Trade Name: | FloPatch FP120 |
|---|---|
| Common Name: | Cardiovascular Blood Flowmeter |
| Classification: | Class II per CFR 870.2100 |
| Classification Name: | Cardiovascular blood flowmeter |
| Product Code: | DPW |
3. Purpose of Submission
The purpose of this submission is to gain clearance for product modifications to the previously cleared device.
Product modifications include:
- Adhesive material ●
- . Device packaging
- . Software including but not limited to:
- Addition of a Guided Assessment workflow with smart window algorithm O
- New software features o
- Signal Processing Algorithm Changes o
- . Instructions for use to update acoustic output values
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Image /page/4/Picture/1 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with three curved lines emanating from it, resembling radio waves or sound waves. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font, with each letter separated by a space.
4. Predicate Device Information
| 510(k) No. | Device | Manufacturer |
|---|---|---|
| K200337 | FloPatch FP120 | Flosonics Medical |
5. Device Description
The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic 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 unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
6. Intended Use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospital and professional environments The device is intended for prescription use on adults only.
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Image /page/5/Picture/1 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with three curved lines emanating from the top right of the 'f', resembling radio waves. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size and a lighter blue color underneath.
7. Comparison to Predicate Device
| Feature/Characteristic | FloPatch (FP120)[Subject Device] | FloPatch (FP120)Primary Predicate [K200337] |
|---|---|---|
| Class/Classification/ProductCode | Class II/DPW (21 CFR 870.2100Cardiovascular bloodflowmeter) | Same |
| Intended Use | The FloPatch FP120 is indicatedfor use for the noninvasiveassessment of blood flow in thecarotid artery. FloPatch FP120operates in a single mode, theContinuous Wave (CW) mode,and is not capable of operatingin any other mode.The device is intended to beused by medical professionals,such as physicians and nurses,in hospitals and professionalenvironments. The device isintended for prescription use onadults only. | Same |
| Indications for Use | Identical to Intended Use | Same |
| Intended Users | Medical professionals such asPhysicians and Nurses | Same |
| Use environment | Hospitals and professionalenvironments such as clinicsand doctor's offices. | Same. |
| Patient Population | Adults, ages 18 years and older | Same |
| Intended for Prescription Use | Yes | Same |
| Installation and Use | Body Worn | Same |
| Theory of Operation | Use of the Doppler effect toevaluate the flow velocity ofblood in peripheral vasculature. | Same |
| Center Frequency | 4 MHz | Same |
| Global MaximumOutputs/Worst Case Setting | Max ISPTA.3 (mW/cm2) - 172.05Max MI - 5.22E-02 | Max ISPTA.3 (mW/cm2) - 15.78Max MI - 1.11E-02 |
| Modes of Operation | One mode, continuous | Same |
| Reusable | No, the device is single use for asingle patient. | Same |
| Dimensions | With adhesiveHeight 114 mmWidth 70 mmDepth 32 mmWithout AdhesiveHeight 54mmWidth 35 mmDepth 18 mm | With adhesiveHeight 200 mmWidth 65 mmDepth 30mmWithout AdhesiveHeight 54mmWidth 35 mmDepth 18 mm |
| Weight | 22 gms | Same |
| The degree of protectionagainst harmful ingress of liquid | IP67 | IPX7 |
| Type of Power Source | LiPo Battery (IEC 62133certified) | Same |
| Battery Operating Voltage | 4.2 V for the battery | Same |
| Battery Chemistry | Lithium Polymer | Same |
| The degree of protectionagainst electric shock | Type BF (DefibrillationProtected) | Type B (Defibrillation Protected) |
| Buttons | One Power Button on FloPatchFP120 hardware | Same |
| Status LED | One, power and batteryIndicator | Same |
| Onboard Screen | None - Multi Touch MobileMedical Application screen | Same |
| Displays Doppler Waveform | Yes | Same |
| Displays Max VelocityWaveform | Yes | Same |
| Displays VTI Calculation | Yes | Same |
| Displays Corrected Flow TimeCalculation | Yes | Same |
| Displays Peak Systolic Velocity | Yes – in a different form | Yes |
| Wireless Mobile Application | Yes | Same |
| Calibration Required | No | Same |
| Maintenance | Single-use device | Same |
| Contact Classification | Surface Device, Intact SkinContacting, Contact Duration:<24 hrs | Same |
| Electrical Safety | IEC 60601-1:2005 (Third Edition)+ CORR. 1:2006 + CORR.2:2007+ A1:2012 | Same |
| EMC | IEC 60601-1-2:2014 | Same |
| Ultrasound Basic Safety andEssential Performance | IEC 60601-2-37:2015 | Same |
| Biocompatibility | ISO 10993-1, -5, -10, -12 | Same |
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Image /page/6/Picture/1 description: The image shows the logo for Flosonics Medical. The logo consists of a stylized blue and black symbol resembling a curved sound wave or radio wave above the company name. The company name "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" in a smaller, lighter blue font below it.
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Image /page/7/Picture/1 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with three curved lines emanating from the top right of the 'f', resembling radio waves or sound waves. Below the symbol, the word "FLOSONICS" is written in a sans-serif font, with the word "MEDICAL" written in a smaller font size below it.
8. Performance Data
This submission is for modifications to the FloPatch FP120 cleared in 510(k) K200337.
The following tests were performed to demonstrate the substantial equivalence of the modified device to its predicate.
| Test | Brief Description | Result |
|---|---|---|
| EMC | Verified that the device meets Class B requirements.CISPR B | Pass |
| Biocompatibility | Verified that the adhesive met biocompatibilityrequirements | Pass |
| Material and Shelf Life Test | Verified and validated that the adhesive satisfiesperformance testing | Pass |
| Packaging Test | Verified that the packaging met ISTA3 andperformance testing | Pass |
| Electrical Safety Testing | Verified that the device meets applied part BFrequirements | Pass |
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Image /page/8/Picture/1 description: The image contains the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with three curved lines emanating from it, resembling radio waves or sound waves. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller, lighter font.
| Software Testing Display Metrics Flow Accuracy and Depth Velocity Accuracy Saved Measurement Unit Appearance Session Length | Verified that the software application satisfies functional requirements and performs as intended. Algorithms and calculations were also verified. | Pass |
|---|---|---|
| Dust Ingress Testing | Verified that the device met IP6X dust ingress requirements | Pass |
| Emergency Services Equipment Testing | Verified the device met transport medical equipment requirements. Shock testing Vibration testing Free fall testing | Pass |
| Acoustic Output (Track 3) | Verified that global maximum derated ISPTA ≤720 mW/cm2 and the global maximum MI should be ≤ 1.9 | Pass |
| Ultrasound Safety | Verified that the device meets IEC 60601-2-37 | Pass |
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the FloPatch FP120 has been shown to be substantially equivalent to the legally marketed predicate device identified in this submission and does not present any changes to safety or effectiveness.
§ 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).