(70 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found". The device description details signal processing and display of Doppler signal derivatives (Max Velocity trace, Max VTI, Corrected Flow Time) but does not suggest any AI-driven interpretation or decision-making.
No
The device is indicated for "noninvasive assessment of blood flow," which means it gathers information about a patient's condition, rather than providing treatment. It is a diagnostic device for assessment.
Yes
The device is intended for the noninvasive assessment of blood flow in peripheral vasculature, which involves measuring and displaying data (Max Velocity trace, Max VTI, and Corrected Flow Time) to aid in understanding a patient's physiological state. This assessment provides information that can be used to diagnose conditions related to blood flow.
No
The device description clearly states it consists of a "signal processing unit and an adhesive strap" and "transmits ultrasonic waves." It also undergoes extensive hardware verification and validation tests like "Acoustic Output," "Ultrasound Performance," "Electrical and Basic Safety Testing," and "Hardware Testing." While it includes a mobile application, it is an integral part of a physical ultrasound device.
No. An IVD is a device used to examine specimens derived from the human body, such as blood or tissue, to provide information for diagnosis or treatment. This device is an ultrasound device that directly measures blood flow in peripheral vasculature non-invasively, not by analyzing in vitro specimens.
N/A
Intended Use / Indications for Use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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. 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
peripheral vasculature
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.
- Acoustic Output (Track 3): Verified that global maximum derated ISPTA ≤720 mW/cm2 and the global maximum MI should be ≤ 1.9. Result: Pass.
- Ultrasound Safety: Verified that the device meets IEC 60601-2-37. Result: Pass.
- Ultrasound Performance: Verified that the device meets performance and ultrasound transducer requirements. Result: Pass.
- Electrical and Basic Safety Testing: Verified that the device meets IEC 60601-1 requirements. Result: Pass.
- EMC: Verified that the device meets IEC 60601-1-2 requirements. Result: Pass.
- Emergency Service Environment Testing: Verified that the device meets IEC 60601-1-12 requirements. Result: Pass.
- Ingress Protection (IP) Testing: Verified that the device meets IP67 ingress requirements. Result: Pass.
- Material and Shelf Life: Verified and validated that the adhesive and device enclosure satisfies performance requirements. Result: Pass.
- Usability Testing: Validated that the device meets new indications for use. Result: Pass.
- Hardware Testing: Verified that the device meets mechanical and electrical requirements. Result: Pass.
- Software Testing (Flow Accuracy and Depth, Saved Measurement, Mobile Appearance): Verified that the software application satisfies functional requirements and performs as intended. Algorithms and calculations were also verified. Result: Pass.
- Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation): Verified that the adhesive and device enclosure met biocompatibility requirements. Result: Pass.
- Simulated Use Cycles: Verified that the device can be reprocessed (consisting of soiling, cleaning and disinfection). Result: Pass.
- Low Level Disinfection (LLD) with Visual Inspection: Validate a low level disinfection process during the reprocessing of the FloPatch FP120. Result: Pass.
- Physical Integrity: Verified that repeated reprocessing does not adversely affect the physical integrity of the FloPatch FP120. Result: Pass.
- Cumulative Runtime: Verified that repeated reprocessing does not adversely affect the battery runtime. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.06.05
June 20, 2025
Flosonics Medical
℅ Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, Minnesota 55114
Re: K251114
Trade/Device Name: FloPatch FP120
Regulation Number: 21 CFR 870.2100
Regulation Name: Cardiovascular blood flowmeter
Regulatory Class: Class II
Product Code: DPW
Dated: April 11, 2025
Received: April 11, 2025
Dear Prithul Bom:
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 (the 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 available 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.
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K251114 - Prithul Bom
Page 2
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K251114 - Prithul Bom
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assistance/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
LCDR 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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K251114
Device Name: FloPatch FP120
Indications for Use (Describe)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
FloPatch FP120
Page 1 of 7
Traditional 510(k) K251114
510(k) Summary
1. Submitter Information
| Field | 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: | November 2, 2023 |
2. Device Information
| Field | 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 previous cleared device.
Product modification include:
- Device Indications for Use
- Adhesive Material
- Shelf Life
- Hardware Changes
- Ultrasound Transducer
- Electronics
- Enclosure
- Software including but not limited to:
- Algorithm changes
- User Interface changes
- Logging of system and device metrics
Page 6
FloPatch FP120
Page 2 of 7
Traditional 510(k) K251114
4. Predicate Device Information
| 510(k) No. | Device | Manufacturer |
|---|---|---|
| Primary: K223843 | FloPatch FP120 | Flosonics Medical |
| Reference: K191388 | FloPatch FP110 | 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. 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 peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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.
7. Comparison to Predicate Devices
| Feature/Characteristic | FloPatch (FP120)
[Subject Device] | FloPatch (FP120)
Primary Predicate
[K223843] | FloPatch (FP110)
Reference Device
[K191388] |
|------------------------|--------------------------------------|---------------------------------------------------|--------------------------------------------------|
| Class/Classification/Product Code | Class II/DPW
(21 CFR 870.2100
Cardiovascular blood flowmeter) | Same | Same |
| Intended Use | The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only. | 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 | 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 |
Page 7
FloPatch FP120
Page 3 of 7
Traditional 510(k) K251114
| Feature/Characteristic | FloPatch (FP120)
[Subject Device] | FloPatch (FP120)
Primary Predicate
[K223843] | FloPatch (FP110)
Reference Device
[K191388] |
|------------------------|--------------------------------------|---------------------------------------------------|--------------------------------------------------|
| | 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. | 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. | as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use only. |
| Indications for Use | Identical to Intended Use | Same | Same |
| Intended Users | Medical professionals such as Physicians and Nurses | Same | Same |
| Use environment | Hospitals. professional environments such as clinics and doctor's offices. | Same | Same |
| Patient Population | Adults, ages 18 years and older | Same | Same |
| Intended for Prescription Use | Yes | Same | Same |
| Installation and Use | Body Worn | Same | Same |
| Theory of Operation | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | Same | Same |
| Center Frequency | 4 MHz | Same | Same |
| Global Maximum Outputs/Worst Case Setting | Max ISPTA.3 (mW/cm2) – 53.58
Max MI – 3.09E-02 | Max ISPTA.3 (mW/cm2) – 105.99
Max MI - 3.76E-02 | Max ISPTA.3 (mW/cm2) – 720
Max MI – 1.9 |
| Modes of Operation | One mode, continuous | Same | Same |
| Reusable | No, the device is single use for a single patient. | Same | Same |
Page 8
FloPatch FP120
Page 4 of 7
Traditional 510(k) K251114
| Feature/Characteristic | FloPatch (FP120)
[Subject Device] | FloPatch (FP120)
Primary Predicate
[K223843] | FloPatch (FP110)
Reference Device
[K191388] |
|------------------------|--------------------------------------|---------------------------------------------------|--------------------------------------------------|
| Dimensions | With adhesive
Height 145 mm
Width 76 mm
Depth 32 mm
Without Adhesive
Height 54 mm
Width 35 mm
Depth 14 mm | With adhesive
Height 114 mm
Width 70 mm
Depth 32 mm
Without Adhesive
Height 54mm
Width 35 mm
Depth 18 mm | 135 mm x 108mm x 43.3 mm |
| Weight | 21 gms | 22 gms |