Who is the manufacturer of FloPatch (FP120)?

Flosonics Medical (R/A 1929803 Ontario Corp.) filed the 510(k) submission for FloPatch (FP120) (K200337).

What is the FDA product code for FloPatch (FP120)?

DPW. It is classified under 21 CFR 870.2100 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for FloPatch (FP120)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FloPatch (FP120)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FloPatch (FP120)

Q: What are the predicate devices for FloPatch (FP120)?

DMX Handheld Doppler (K183574).

K200337 · Flosonics Medical (R/A 1929803 Ontario Corp.) · DPW · Mar 24, 2020 · Cardiovascular

Device Facts

Record ID	K200337
Device Name	FloPatch (FP120)
Applicant	Flosonics Medical (R/A 1929803 Ontario Corp.)
Product Code	DPW · Cardiovascular
Decision Date	Mar 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2100
Device Class	Class 2
Attributes	3rd-Party Reviewed

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.

Device Story

FloPatch (FP120) is a non-invasive, battery-operated, single-use, body-worn ultrasound device for carotid artery blood flow assessment. It utilizes the Doppler effect to transmit ultrasonic waves and receive reflected signals from moving blood cells. The device consists of a signal processing unit and an adhesive strap. It wirelessly transmits Doppler signals to a mobile medical application, which processes the data to display a Max Velocity trace, Max VTI (Velocity Time Integral), and Corrected Flow Time. Used by physicians and nurses in clinical settings; output assists in hemodynamic monitoring and clinical decision-making.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety), IEC 60601-2-37 (ultrasonic performance), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility) was demonstrated. No clinical trial data presented.

Technological Characteristics

4 MHz center frequency; CW Doppler mode; LiPo battery (IEC 62133); IPX7 ingress protection; Type B defibrillation-protected applied part. Dimensions: 54x35x18mm (without adhesive). Wireless connectivity to mobile application. Biocompatibility per ISO 10993-1, -5, -10, -12.

Indications for Use

Indicated for noninvasive assessment of blood flow in the carotid artery in adults (18+ years). Intended for use by medical professionals (physicians, nurses) in hospitals and professional environments.

Regulatory Classification

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.

Predicate Devices

DMX Handheld Doppler (K183574)

Reference Devices

Edan Acclarix LX8 Diagnostic Ultrasound System (K180862)
FloPatch FP110 (K191388)

Related Devices

K191388 — FloPatch (FP110) · Flosonics Medical (R/A 1929803 Ontario Corp.) · Jun 21, 2019
K222242 — FloPatch FP120 · Flosonics Medical · Dec 9, 2022
K223843 — FloPatch FP120 · Flosonics Medical · May 3, 2023
K251114 — FloPatch FP120 · Flosonics Medical · Jun 20, 2025
K242487 — Laminar P1 (LDH-HW-001) · Laminar Digital Health, Inc. · Dec 13, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 24, 2020 Flosonics Medical (r/a 1929803 Ontario Corp.) % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K200337 Trade/Device Name: FloPatch (FP120) Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: February 10, 2020 Received: February 11, 2020 ## 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 (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. {1}------------------------------------------------ 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 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 (OS) 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. LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200337 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) | ## 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 "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with curved lines extending from it, resembling radio waves or a signal. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font and a lighter blue color. 510(k) Submission - FloPatch FP120 ## 510 (k) Summary #### 1. Submitter Information | Company Name: | Flosonics Medical (R/A 1929803 Ontario Corp.) | |--------------------------|-----------------------------------------------------------------------------| | Company Address: | 325 Front St W., Fourth Floor OneEleven Toronto, Ontario, Canada M5V 2Y1 | | Company Contact: | info@flosonicsmedical.com | | Contact Person: | Andrew Eibl, Director Operations and Interim Quality Manager | | 2. Device Identification | | | Trade Name: | FloPatch (FP120) | |----------------------|--------------------------------| | Classification: | II | | Generic Device Name: | Cardiovascular Blood Flowmeter | #### 3. Classification Name | Classification Name | Product Code | Class | Regulation Number | |--------------------------------|--------------|-------|-------------------| | Cardiovascular blood flowmeter | DPW | II | 870.2100 | #### 4. 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. #### 5. 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. #### 6. 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Flosonics Medical. The logo consists of the word "FLOSONICS" in large, bold, black letters, with the word "MEDICAL" underneath in smaller, teal letters. Above the word "FLOSONICS" is a stylized symbol that looks like a blue letter "F" with three curved black lines emanating from the top right corner. 510(k) Submission – FloPatch FP120 #### Predicate/Reference Device Identification 7. | Predicate Device (s) | Product Code (s) | Class | Requlation Number | |--------------------------------------------------------------------------------------|------------------|-------|-------------------| | DMX Handheld Doppler (Primary Predicate Device) [K183574] | DPW | II | 21 CFR 870.2100 | | Edan Acclarix LX8 Diagnostic Ultrasound System (Reference Device) [K180862] | IYN, IYO, ITX | II | 21 CFR 892.1550 | | FloPatch FP110 [K191388] | DPW | II | 21 CFR 870.2100 | #### Comparison to Predicate Device 8. #### 8.1 Comparison Table | Feature/Chara cteristic | FloPatch (FP120) (Subject Device) | DMX Handheld Doppler [K183574] (Primary Predicate Device) | Edan Acclarix LX8 Diagnostic Ultrasound System [K180862] (Reference Device) | FloPatch FP110 [K191388] (Reference Device) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Class/Classificati on/ Product Code | Class II/DPW (21 CFR 870.2100 Cardiovascular blood flowmeter) | Class II/DPW (21 CFR 870.2100 Cardiovascular blood flowmeter) | Class II/ IYN, IYO, ITX (21 CFR 892.1550) Ultrasonic pulsed doppler imaging system | Class II/DPW (21 CFR 870.2100 Cardiovascular blood flowmeter) | | 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 | Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. | Diagnostic ultrasound imaging or fluid flow analysis of the human body | 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 enviroments such as clinics and doctor's offices. The device is intended for prescription use only. | | Indications for Use | | Identical to Intended Use | The Acclarix AX8 | Identical to 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. | | Identical to Intended Use | Diagnostic Ultrasound System is intended for use by a qualified physician or sonographer for ultrasound evaluation. Clinical applications include: Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric and Neonatal (including abdominal and cephalic), and Adult cephalic. | Identical to Intended Use | | Intended Users | Medical professionals such as Physicians and Nurses | Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments | Intended for use by a qualified physician or sonographer | Medical professionals such as Physicians and Nurses | | Use Environment | Hospitals and professional environments such as clinics and doctor's offices. | In primary, acute and community healthcare environments | Not specified | Hospitals and professional environments such as clinics and doctor's offices. | | Patient Population | Adults, ages 18 years and older | Not specified | Pediatric and Adult | Adults, ages 18 years and older | | Intended for Prescription Use | Yes | Yes | Yes | Yes | | Installation and Use | Body Worn | Hand-Held | Portable (laptop) Mobile Equipment | Body Worn | | Theory of Operation | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. (Doppler mode only) | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | | Center Frequency | 4 MHz | 4 MHz | 2.5-15.0 MHz | 4 MHz | | Global Maximum Outputs /Worst Case Setting | Max ISPTA.3 (mW/cm²) 15.78 | 92 | 21.47 | 720 | | /Worst Case Setting | Max MI 1.11E-02 | Not reported | 0.01 | 1.9 | | Modes of Operation | One mode, continuous | One mode, continuous | Multi-Mode, Only Doppler mode relevant to this comparison | One mode, continuous | | Reusable | No, the device is single-use for a single patient. | Reusable with cleaning | Reusable with cleaning | No, single use for a single patient. | | Dimensions | With adhesive Height 200 mm Width 65 mm Depth 30mm Without Adhesive Height 54mm Width 35 mm Depth 18 mm | Height 140mm (5.5") Width 75mm (3.0") Depth 30mm (1.2") | 407mm(W) x388mm(L) x77mm(H) | 135 mm x 108mm x 43.3 mm | | Weight | 22 gms | 310 gms | 8.6Kg (with rechargeable battery and monitor glass, without power adaptor or transducers) | <450 gms (including battery) | | The degree of protection against harmful ingress of liquid | IPX7 for the device | IP20 for the main unit IPX1 for the probe tip | Console Panel: IPX1 Transducers: IPX7 | IPX1 for vascular flow transducer. IPX0 for enclosure | | Type of Power Source | LiPo Battery (IEC 62133 certified) | Internal (AA Batteries) | Rechargeable Lithium Ion | Internal (AA Batteries) | | Battery Operating Voltage | 4.2 V for the battery | 1.5V (single AA cell) 4.5V for battery (3 AA Cells) | 14.4V | 1.5V (single AA cell) 4.5V for battery (3 AA Cells) | | Battery Chemistry | Lithium Polymer | Alkaline | Lithium-Ion | Alkaline | {5}------------------------------------------------ Image /page/5/Picture/0 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. Below the symbol, the word 'FLOSONICS' is written in bold, black capital letters, with the word 'MEDICAL' in smaller, blue capital letters underneath. # Section 5. 510 (k) Summary # 510(k) Submission – FloPatch FP120 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' with curved lines emanating from it, resembling sound waves or a signal. The word "FLOSONICS" is written in bold, uppercase letters below the symbol, and the word "MEDICAL" is written in a smaller font size below "FLOSONICS". K200337 Section 5. 510 (k) Summary 510(k) Submission – FloPatch FP120 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Flosonics Medical. The logo consists of a stylized blue and black symbol resembling sound waves above the company name. The word "FLOSONICS" is in bold black letters, and the word "MEDICAL" is in smaller blue letters below it. K200337 # Section 5. 510 (k) Summary 510(k) Submission – FloPatch FP120 | The degree of protection against electric shock | Type B (Defibrillation Protected) | Type B (Not Defibrillation Protected) | Type BF Applied Part | Type B | |----------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Buttons | One Power Button on FloPatch FP120 hardware | Three buttons | One power button | One Power Button | | Status LED | One, power and battery Indicator | None | None | Absent | | Onboard Screen | None - Multi Touch Mobile Medical Application screen | LCD Screen | LCD Screen | One, power and battery Indicator | | Displays Doppler Waveform | Yes | Yes | Yes | No | | Displays Max Velocity Waveform | Yes | Yes (Displays Frequency instead of max velocity) | Yes | No | | Displays VTI Calculation | Yes | No | Yes | No | | Displays Corrected Flow Time Calculation | Yes | No | No, however it can be calculated on the device based on the data captured by the device. | No | | Wireless Mobile Application | Yes. | No. Has an offline data processing software called the Huntleigh DR5 (MDDS) which can only be used with Dopplex DMX device. | No. The software and screen are integrated with the ultrasound unit. | No | | Calibration Required | No | No | No | No | | Maintenance | Single-use device | Reusable Device- with cleaning | Reusable Device- with cleaning | Single Use Transducer | | Contact Classification | Surface Device, Intact Skin Contacting, Contact Duration: <24 hrs | Surface Device, Intact Skin Contacting, Contact Duration: <24 hrs | Not Specified | Limited Contact Duration (<24 hrs), Intact Skin, Surface Device | | Electrical Safety | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.2:2007 + A1:2012 | IEC 60601-1:2005 (Third Edition) + A1:2012 | IEC 60601-1 version not specified | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.2:2007 + A1:2012 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Flosonics Medical. The logo features a stylized blue and black graphic above the company name. The graphic resembles a curved line with three segments, the first segment is blue and the other two are black. Below the graphic, the word "FLOSONICS" is written in bold, black capital letters, and below that, the word "MEDICAL" is written in smaller, blue capital letters. K200337 # Section 5. 510 (k) Summary 510(k) Submission - FloPatch FP120 | EMC | IEC 60601-1- 2:2014 | IEC 60601-1-2:2014 | IEC 60601-1- 2:2007 | IEC 60601-1- 2:2014 | |------------------------------------------------------------|-------------------------------|---------------------------------|-------------------------------|-------------------------------| | Ultrasound Basic Safety and Essential Performance | IEC 60601-2- 37:2015 | EN 60601-2- 37:2008+A11:2011 | IEC/EN 60601-2-37 | IEC 60601-2- 37:2015 | | Biocompatibility | ISO 10993-1, -5, - 10, -12 | ISO 10993-1 | ISO 10993-1, -5, - 10, -12 | ISO 10993-1, -5, - 10, -12 | #### 8.2 Summary of Substantial Equivalence Argument and Identification of Predicate/Reference Device The FloPatch FP120 is a battery-operated, non-invasive medical device that utilizes ultrasound and the Doppler effect to detect blood flow in peripheral vasculature, such as the carotid artery. The primary predicate device DMX Handheld Doppler [K183574], was selected because it has the same intended use and similar technological characteristics to the FloPatch FP120. | No. | Identified Predicate Device/Reference | Rationale for Selection | |-----|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | DMX Handheld Doppler [K183574] (Primary Predicate Device) | The DMX Handheld doppler has the same intended use and indications for use as the FloPatch FP120. It can capture and automatically trace the Doppler spectrogram and calculate heart rate but does not calculate the VTI and Corrected Flow Time from the Doppler Waveform. | | 2. | Edan Acclarix LX8 Diagnostic Ultrasound System [K180862] (Reference Device) | The intended use and indications for use of the FloPatch FP120 are a subset of the intended use and indications for use of the Edan Acclarix LX8. The Edan Acclarix LX8 Ultrasound System device can display and automatically trace the captured Doppler spectrogram, calculate the VTI (velocity time integral) and heart rate in the CW Doppler mode. | | 3. | FloPatch FP110 [K191388] (Reference Device) | The FloPatch FP110 has the same intended use and indications for use as the FloPatch FP120. The method of attachment of the ultrasound probe to the human body used in the FloPatch FP120 is identical to that of the FloPatch FP110. | The following table summarises the rationales for selecting the predicate devices: The subject device and the predicate has the same intended use and indications for use (Intended use and indications of use of the FloPatch FP120 are a subset of the intended use and indications for use of the Edan Acclarix LX8 Diagnostic Ultrasound System [K180862]).The subject device and the predicate use Continuous Wave (CW) Doppler to detect blood flow in peripheral vasculature. The subject device and the predicate can trace the Doppler flow spectrogram and can calculate metrics from the Doppler waveform. The main difference between the predicate and the subject device exists in the way the ultrasonic transducer is placed on the human body. This different method of placing the ultrasonic transducer on the body has been evaluated as part of a usability study, it has also been evaluated by the FDA as part of a previous submission for a the FloPatch FP110 [K191388] and it has been determined that those differences do not raise different concerns of safety or efficacy. Hence, the FloPatch FP120 is substantially equivalent to the identified predicate device. Further the reference devices provide legally marketed devices that are intended to provide scientific and/or technical information (e.q., test methodology) to help address the safety and effectiveness of a new technological characteristic. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Flosonics Medical. The logo features the company name in a sans-serif font, with the word "FLOSONICS" in a larger, bolder font and the word "MEDICAL" in a smaller, lighter font. Above the company name is a stylized graphic consisting of a blue arc and three black curved lines, resembling a sound wave or signal. # K200337 Section 5. 510 (k) Summary 510(k) Submission - FloPatch FP120 #### 9. Determination of Substantial Equivalence The FloPatch FP120 is substantially equivalent to the predicate device(s). The FloPatch FP120 has been tested to comply with relevant recognized consensus standards. The combination of testing to recognized consensus standard and performance verification testing substantial equivalnce of the FloPatch FP120. ## Non-Clinical Performance Data Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalence demonstrates compliance with the following standards: ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD) IEC 60601-2-37 Edition 2.1 2015 Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests ISO 10993-1 Fourth Edition 2009-10-15 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)] ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials ## Summary of Non-Clinical Performance Testing The FloPatch has been evaluated to and found compliant with recognized consensus standards for EMC, electrical, thermal & mechanical safety. Additionally, the device has been evaluated to and complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Further testing was conducted to verify performance, labelling, packaging and shelf life. The results of the performance testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP120 are equivalent to the recognized predicate(s). ## Biocompatibility The patient contact part in the device is suface contacting, for intact skin, intended for a limited duration of contact (<24hrs). The patient contact part was tested to ISO 10993 for cytotoxicity, sensitization and skin irritation. The patient contact part met all the requirements identified in the FDA Guidance for biocompatibility. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Flosonics Medical. The logo consists of the company name in bold, sans-serif font, with the word "FLOSONICS" in black and "MEDICAL" in teal. Above the name is a stylized graphic of curved lines, resembling sound waves or a stylized "F", with the top portion in teal and the lower portion in black. 510(k) Submission – FloPatch FP120 # 10. Conclusion The FloPatch FP120 is substantially equivalent to the identified predicate(s).