(136 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's operation relies on standard signal processing of Doppler ultrasound data. There is no mention of training or test sets, which are typically associated with ML model development.
No
The device is indicated for noninvasive assessment of blood flow, which is a diagnostic function, not a therapeutic one. It does not treat or manage a disease or condition.
Yes.
The device's intended use is for the "noninvasive assessment of blood flow," and it "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." This indicates the device is used to generate data for evaluation and diagnosis of blood flow.
No
The device description explicitly states it consists of a "signal processing unit and an adhesive strap" and uses "ultrasound and the Doppler effect," indicating hardware components are integral to its function.
Based on the provided information, this 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. They are performed outside of the body (in vitro).
- FloPatch FP120 Function: The FloPatch FP120 is a non-invasive device that uses ultrasound to assess blood flow within the carotid artery. It does not analyze samples taken from the body.
The device is a medical device used for physiological assessment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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 hospitals and professional environments. The device is intended for prescription use on adults only.
Product codes
DPW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
carotid artery
Indicated Patient Age Range
Adults, ages 18 years and older
Intended User / Care Setting
Medical professionals, such as physicians and nurses, in hospitals and professional environments.
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 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 biocompatibility requirements | Pass |
| Material and Shelf Life Test | Verified and validated that the adhesive satisfies performance testing | Pass |
| Packaging Test | Verified that the packaging met ISTA3 and performance testing | Pass |
| Electrical Safety Testing | Verified that the device meets applied part BF requirements | Pass |
| 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 |
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
§ 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).
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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
1
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 4 |
| Toronto, ON | |
| Canada 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.
5
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/Product
Code | Class II/DPW (21 CFR 870.2100
Cardiovascular blood
flowmeter) | Same |
| 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 hospitals and professional
environments. The device is
intended for prescription use on
adults only. | Same |
| Indications for Use | Identical to Intended Use | Same |
| Intended Users | Medical professionals such as
Physicians and Nurses | Same |
| Use environment | Hospitals and professional
environments such as clinics
and 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 to
evaluate the flow velocity of
blood in peripheral vasculature. | Same |
| Center Frequency | 4 MHz | Same |
| Global Maximum
Outputs/Worst Case Setting | Max ISPTA.3 (mW/cm2) - 172.05
Max MI - 5.22E-02 | Max ISPTA.3 (mW/cm2) - 15.78
Max MI - 1.11E-02 |
| Modes of Operation | One mode, continuous | Same |
| Reusable | No, the device is single use for a
single patient. | Same |
| Dimensions | With adhesive
Height 114 mm
Width 70 mm
Depth 32 mm
Without Adhesive
Height 54mm
Width 35 mm
Depth 18 mm | With adhesive
Height 200 mm
Width 65 mm
Depth 30mm
Without Adhesive
Height 54mm
Width 35 mm
Depth 18 mm |
| Weight | 22 gms | Same |
| The degree of protection
against harmful ingress of liquid | IP67 | IPX7 |
| Type of Power Source | LiPo Battery (IEC 62133
certified) | Same |
| Battery Operating Voltage | 4.2 V for the battery | Same |
| Battery Chemistry | Lithium Polymer | Same |
| The degree of protection
against electric shock | Type BF (Defibrillation
Protected) | Type B (Defibrillation Protected) |
| Buttons | One Power Button on FloPatch
FP120 hardware | Same |
| Status LED | One, power and battery
Indicator | Same |
| Onboard Screen | None - Multi Touch Mobile
Medical Application screen | Same |
| Displays Doppler Waveform | Yes | Same |
| Displays Max Velocity
Waveform | Yes | Same |
| Displays VTI Calculation | Yes | Same |
| Displays Corrected Flow Time
Calculation | 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 Skin
Contacting, Contact Duration: