FloPatch (FP110)

K191388 · Flosonics Medical (R/A 1929803 Ontario Corp.) · DPW · Jun 21, 2019 · Cardiovascular

Device Facts

• Record ID: K191388
• Device Name: FloPatch (FP110)
• Applicant: Flosonics Medical (R/A 1929803 Ontario Corp.)
• Product Code: DPW · Cardiovascular
• Decision Date: Jun 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 environments. The device is intended for prescription use only.

Device Story

FloPatch (FP110) is a non-invasive, body-worn blood flow detection device; utilizes ultrasound and Doppler effect to evaluate blood flow velocity in peripheral vessels (e.g., carotid artery). System comprises a signal processing main unit and an ultrasonic vascular flow transducer. Transducer transmits ultrasonic waves; reflected Doppler-shifted waves from moving blood cells are received by the main unit and output as an audible signal via a speaker. Used by physicians and nurses in hospitals and clinical environments. Device is single-use for a single patient. Provides real-time audible feedback to clinicians to assist in peripheral vascular assessment; aids in clinical decision-making regarding vascular status.

Clinical Evidence

Bench testing only. No clinical data presented. Performance evaluated via compliance with recognized consensus standards for electrical, thermal, and mechanical safety, EMC, and ultrasonic acoustic output. Performance compared to predicate device to demonstrate equivalence in acoustic output and functional performance.

Technological Characteristics

Non-invasive Doppler ultrasound flowmeter. 4 MHz center frequency. Single-use transducer. Powered by 3 AA alkaline batteries (4.5V). Dimensions: 135mm x 108mm x 43.3mm. Weight: <450g. Patient contact: surface, limited duration (<24 hrs). Biocompatibility per ISO 10993-1, -5, -10. Electrical safety: ES60601-1, IEC 60601-2-37, IEC 60601-1-2. Software life cycle: IEC 62304.

Indications for Use

Indicated for detection of blood flow in peripheral vasculature in adults 18 years and older. Intended for use by medical professionals (physicians, nurses) in hospitals, clinics, and doctor's offices.

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

• Edan SD3 Vascular Doppler (4 MHz) (K140579)

Submission Summary (Full Text)

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June 21, 2019

Flosonics Medical (r/a 1929803 Ontario Corp.) % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K191388

Trade/Device Name: FloPatch (FP110) Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW Dated: May 22, 2019 Received: May 24, 2019

Dear Mark Job:

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known)

K191388

Device Name FloPatch (FP110)

Indications for Use (Describe)

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 environments. The device is intended for prescription use only.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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Image /page/3/Picture/0 description: The image contains the logo for Flosonics Medical. The logo features the company name in a sans-serif font, with "FLOSONICS" in black and "MEDICAL" in blue. Above the text is a stylized graphic consisting of a blue curved line that transitions into three black curved lines, resembling a signal or wave pattern.

Section 5. 510 (k) Summary

510(k) Submission

## 510 (k) Summary

#### Submitter Information 1.

| Company Name: | Flosonics Medical (1929803 Ontario Corp.) |
|------------------|-------------------------------------------------------|
| Company Address: | 204-73 Elm Street, Sudbury<br>Ontario, Canada P3C 1R7 |
| Company Contact: | [e-mail] |
| Contact Person: | Joe Eibl, CEO |

#### 2. Device Identification

Trade Name: Classification: Generic Device Name:

FloPatch (FP110) II 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 (FP110) is a non-invasive blood flow detection device intended to be used in a medical/hospital setting for use by medical professionals. The device uses ultrasound and the Doppler effect to evaluate the flow of blood. The device consists of signal processing box (main unit) and an ultrasonic vascular flow transducer. The device transmits ultrasonic waves from the vascular flow 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 box (main unit) which outputs the doppler signal to the device speaker.

#### റ. Intended Use

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 environments. The device is intended for prescription use only.

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Image /page/4/Picture/0 description: The image shows the logo for Flosonics Medical. The logo consists of the word "FLOSONICS" in black, with the word "MEDICAL" in a smaller, teal font below it. Above the word "FLOSONICS" is a stylized symbol that resembles a blue letter "f" with three curved black lines emanating from it.

510(k) Submission

#### Comparison to Predicate Device 6.

| Feature/Characteristic | FloPatch (FP110)<br>(Subject Device) | Primary Predicate: Edan SD3<br>Vascular Doppler (4 MHz);<br>(K140579) | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Class/Classification/Product Code | Class II/DPW (21 CFR 870.2100<br>Cardiovascular blood flowmeter) | Class II/DPW (21 CFR 870.2100<br>Cardiovascular blood flowmeter) | |
| Intended Use | The FloPatch(FP110) is intended<br>for the detection of blood flow in<br>peripheral vasculature.<br><br>The device is intended to be<br>used by medical professionals<br>such as physicians and nurses in<br>hospitals and professional<br>enviroments such as clinics and<br>doctor's offices. The device is<br>intended for prescription use<br>only. | The SD3 Series Ultrasonic<br>PocketDopplers (hereinafter called<br>"the Doppler") are intended to be<br>used by health care professionals<br>including registered nurses,<br>practical nurses, midwives,<br>ultrasound technicians, and<br>physician assistants, by prescription<br>from licensed physicians in<br>hospitals, clinics and private offices.<br><br>The 4 MHz, 5 MHz and/or 8 MHz<br>waterproof vascular probes are<br>indicated for the detection of blood<br>flow in veins and arteries for<br>assisting in the detection of<br>peripheral vascular disease. | |
| Intended Users | Medical professionals such as<br>Physicians and Nurses | Health care professionals including<br>registered nurses, practical nurses,<br>midwives, ultrasound technicians,<br>and physician assistants, by<br>prescription from licensed<br>physicians | |
| Use Environment | Hospitals and professional<br>enviroments such as clinics and<br>doctor's offices. | Hospitals, Clinics and Private offices | |
| Patient Population | Adults, ages 18 years and older | Not Available | |
| Intended for Prescription Use | Yes | Yes | |
| Installation and Use | Body Worn | Hand Held | |
| Theory of Operation | Use of the Doppler effect to<br>evaluate the flow velocity of<br>blood in peripheral vasculature. | Use of the Doppler effect to<br>evaluate the flow velocity of blood<br>in peripheral vasculature. | |
| Center Frequency | 4 MHz | 4 MHz | |
| Global Maximum<br>Outputs/Worst<br>Case Setting | Max ISPTA.3<br>(mW/cm²) | 21.47 | 18.83 |
| | Min ISPTA.3<br>(mW/cm²) | 8.23 | 14.85 |
| | Max MI | 0.01 | 0.01 |
| Feature/Characteristic | FloPatch (FP110)<br>(Subject Device) | Primary Predicate: Edan SD3<br>Vascular Doppler (4 MHz);<br>(K140579) | |
| Min MI | 0.01 | 0.01 | |
| Modes of Operation | One mode, continuous | One mode, continuous | |
| Reusable | No, single use for a single patient. | Yes, with cleaning. | |
| Dimensions | 135 mm x 108mm x 43.3 mm | 168mm x 67 mm × 31 mm | |
| Weight | <450 gms (including battery) | <350 gms (including battery) | |
| The degree of protection<br>against harmful ingress of liquid | IPX1 for vascular flow<br>transducer.<br>IPX0 for enclosure | IPX8 for transducer.<br>IP rating for the device enclosure<br>unknown or assumed to be IPX0<br>based on IEC 60601-1 | |
| Type of Power Source | Internal (AA Batteries) | Internal (AA Batteries) | |
| Battery Operating Voltage | 1.5V (single AA cell)<br>4.5V for battery (3 AA Cells) | 1.5V (single AA cell) | |
| Battery Chemistry | Alkaline | Alkaline<br>Lithium | |
| The degree of protection<br>against electric shock | Type B | Type B | |
| Buttons | One Power Button | One Power Button | |
| Volume Slider | Absent | Present | |
| Status LED | One, power and battery Indicator | One, power and battery Indicator | |
| Calibration Required | No | No | |
| Maintenance | Single Use Transducer | Reusable Transducer | |
| Contact Classification | Limited Contact Duration (<24 hrs), Intact Skin, Surface Device | Not Available | |
| Electrical Safety | ES60601-1:2005/(R)2012 And<br>A1:2012, C1:2009/(R)2012 And<br>A2:2010/(R)2012 | IEC 60601-1:2005 | |
| EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| Ultrasound Basic Safety and<br>Essential Performance | IEC 60601-2-37:2015 | IEC 60601-2-37:2007 | |
| Ultrasound Acoustic Output | IEC 62127-1 | Not Available | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | |
| Software Life Cycle Process | IEC 62304:2006 | IEC 62304:2006 | |

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Image /page/5/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 stylized sound wave or a series of curved lines, with the blue line being the largest and the black lines being smaller. The text "FLOSONICS" is in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size below it.

510(k) Submission

#### Determination of Substantial Equivalence 7.

The FloPatch FP110 is substantially equivalent to the predicate device. The FloPatch FP110 has been tested to comply with relevant recognized consensus standards. The combination of testing to recongised consensus standard and performance verification testing substantiates the claim of substantial equivalnce of the FloPatch FP110.

## Non-clinical Performance Data

Non-clinical tests performed on in this premarket notification for a determination of substantial equivalence demonstrates compliance with the following standards:

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Image /page/6/Picture/0 description: The image contains the logo for Flosonics Medical. The logo consists of a stylized letter 'F' with curved lines emanating from it, resembling sound waves. Below the logo, the word 'FLOSONICS' is written in a bold, sans-serif font, with the word 'MEDICAL' underneath in a smaller font.

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 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

IEC 62127-1 Edition 1.1 2013-02 Ultrasonics -- Part 1: Measurement And Characterization Of Medical Ultrasonic Fields Up To 40 MHz

IEC 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements

IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diaqnostic ultrasonic fields

## 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, performance testing to compare the performance of the device to predicate was conducted besides verification of performance,packaging and The results of the performance testing and testing to recognized consensus standards labelling. demonstrate that the characteristics of the FloPatch FP110 are equivalent to the recognized predicate interms of acoustic output and performance.

#### 8. Biocompatibility

The patient contact part in the device is suface contacting, for 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.

#### 9. Conclusion

The FloPatch FP110 is substantially equivalent to the identified predicate.