FloPatch FP120

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} 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- {2} K251114 - Prithul Bom Page 3 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 {3} 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov &gt; "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} FloPatch FP120 FLOSONICS # 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: | November 2, 2023 | 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 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 Traditional 510(k) K251114 {5} FloPatch FP120 FLOSONICS 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 | Traditional 510(k) K251114 {6} FloPatch FP120 FLOSONICS H E D I C K L | | 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 | Traditional 510(k) K251114 {7} FloPatch FP120 FLOSONICS HEDISK | 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 | <450 gms (including battery) | | The degree of protection against harmful ingress of liquid | IP67 | Same | IPX1 for vascular flow transducer. IPX0 for enclosure | | Type of Power Source | LiPo Battery (IEC 62133 certified) | Same | Internal (AA Batteries) | | Battery Operating Voltage | 4.2 V for the battery | Same | 1.5V (single AA cell) 4.5V for battery (3 AA Cells) | | Battery Chemistry | Lithium Polymer | Same | Alkaline | | The degree of protection against electric shock | Type BF (Defibrillation Protected) | Same | Type B | | Buttons | One Power Button on FloPatch FP120 hardware | Same | One Power Button | | Status LED | One, power and battery Indicator | Same | Absent | | Onboard Screen | None - Multi Touch Mobile Medical Application screen | Same | One, power and battery Indicator | | Displays Doppler Waveform | Yes | Same | No | | Displays Max Velocity Waveform | Yes | Same | No | | Displays VTI Calculation | Yes | Same | No | Traditional 510(k) K251114 {8} FloPatch FP120 FLOSONICS # 8. Performance Data This submission is for modifications to the FloPatch FP120 cleared in 510(k) K223843. The following tests were performed to demonstrate the substantial equivalence of the modified device to its predicate. | Test | Brief Description | Result | | --- | --- | --- | | Acoustic Output (Track 3) | Verified that global maximum derated ISPTA ≤720 mW/cm2 and the global maximum MI should be ≤ 1.9 | Pass | Traditional 510(k) K251114 {9} FloPatch FP120 FLOSONICS H E D I C K L | Ultrasound Safety | Verified that the device meets IEC 60601-2-37 | Pass | | --- | --- | --- | | Ultrasound Performance | Verified that the device meets performance and ultrasound transducer requirements | Pass | | Electrical and Basic Safety Testing | Verified that the device meets IEC 60601-1 requirements | Pass | | EMC | Verified that the device meets IEC 60601-1-2 requirements | Pass | | Emergency Service Environment Testing | Verified that the device meets IEC 60601-1-12 requirements | Pass | | Ingress Protection (IP) Testing | Verified that the device meets IP67 ingress requirements | Pass | | Material and Shelf Life | Verified and validated that the adhesive and device enclosure satisfies performance requirements | Pass | | Usability Testing | Validated that the device meets new indications for use | Pass | | Hardware Testing | Verified that the device meets mechanical and electrical requirements | 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. | Pass | | Biocompatibility Testing • Cytotoxicity • Sensitization • Irritation | Verified that the adhesive and device enclosure met biocompatibility requirements | Pass | | Simulated Use Cycles | Verified that the device can be reprocessed (consisting of soiling, cleaning and disinfection). | Pass | Traditional 510(k) K251114 {10} FloPatch FP120 FLOSONICS MEDICAL | Low Level Disinfection (LLD) with Visual Inspection | Validate a low level disinfection process during the reprocessing of the FloPatch FP120. | Pass | | --- | --- | --- | | Physical Integrity | Verified that repeated reprocessing does not adversely affect the physical integrity of the FloPatch FP120. | Pass | | Cumulative Runtime | Verified that repeated reprocessing does not adversely affect the battery runtime | 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. Traditional 510(k) K251114