Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound Doppler technology and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No
The device is indicated for the "noninvasive assessment of blood flow," which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate a medical condition.

Diagnostic

Yes

The Intended Use / Indications for Use section states that the device is "indicated for use for the noninvasive assessment of blood flow in the carotid artery." Assessment of a bodily function for medical purposes is a diagnostic function. Additionally, the Summary of Performance Studies mentions compliance with "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," explicitly naming it a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of a signal processing unit and an adhesive strap, in addition to the mobile medical application. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FloPatch FP120 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
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 specimens taken from the body.
Intended Use: The intended use clearly states "noninvasive assessment of blood flow in the carotid artery." This is a direct measurement on the body, not an analysis of a sample.

Therefore, the FloPatch FP120 falls under the category of a non-invasive diagnostic or monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

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, 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)

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 (

Regulation Number and Section

§ 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).

Summary

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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.

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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

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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)

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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.