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 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.

AI/ML Overview

The provided text is a 510(k) summary for the FloPatch FP120 device, focusing on modifications related to reprocessing of "Single-Use Only" devices. It refers to a previous 510(k) submission (K222242) for the original device. This document primarily details performance data for the reprocessing capabilities of the device, rather than the initial clinical performance or diagnostic accuracy of the device itself.

Therefore, much of the requested information regarding acceptance criteria for device performance and the study proving it (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, type of ground truth) is not directly available in the provided document. The document focuses on demonstrating that reprocessing does not degrade the device's technical characteristics, assuming its original performance was already established in K222242.

However, I can extract the information related to the acceptance criteria and the study for the reprocessing modifications.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for reprocessing modifications):

The acceptance criteria for the reprocessing modifications were that repeated reprocessing does not adversely affect specific device characteristics. The reported performance confirms that these criteria were met.

Test	Brief Description	Acceptance Criteria	Reported Performance
Simulated Use Cycles	Verified that the device can be reprocessed up to six cycles (consisting of soiling, cleaning and disinfection).	Device functions correctly after up to six reprocessing cycles.	Pass
Manual Cleaning	Validate a manual cleaning process during the reprocessing of the FloPatch FP120.	Manual cleaning process is validated and effective.	Pass
Low Level Disinfection	Validate a low level disinfection process during the reprocessing of the FloPatch FP120.	Low level disinfection process is validated and effective.	Pass
Acoustic Output	Verified that repeated reprocessing does not adversely affect the acoustic output of the transducer.	Acoustic output unaffected by reprocessing.	Pass
Transducer Performance	Verified that repeated reprocessing does not adversely affect transducer performance characteristics: • Velocity Accuracy • Flow Velocity and Depth	Transducer performance characteristics (Velocity Accuracy, Flow Velocity & Depth) unaffected by reprocessing.	Pass
Physical Integrity	Verified that repeated reprocessing does not adversely affect the physical integrity of the FloPatch FP120.	Physical integrity unaffected by reprocessing.	Pass
Cumulative Runtime	Verified that repeated reprocessing does not adversely affect the battery runtime.	Battery runtime unaffected by reprocessing.	Pass

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in this document. The description only mentions "repeated reprocessing" and "up to six cycles," implying a limited number of devices were tested for these engineering/validation tests.
Data Provenance: Not specified. These are likely internal validation studies conducted by Flosonics Medical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for these engineering/reprocessing validation tests. Ground truth would be based on objective measurements and established standards for cleaning, disinfection, and device performance specifications.

4. Adjudication method for the test set:

Not applicable. The tests described are objective engineering and validation tests, not subjective expert reviews.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done, as this submission is for reprocessing modifications, not the initial clinical efficacy of the device's diagnostic capabilities.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this refers to the effects of reprocessing on the physical device and its components, not the performance of an algorithm. The device "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." The performance of this application and its underlying algorithm would have been assessed in the K222242 submission, not in this document.

7. The type of ground truth used:

For these reprocessing tests, the "ground truth" would be the pre-reprocessing performance specifications of the device and established engineering/biomedical standards for cleaning, disinfection, acoustic output, and physical integrity.

8. The sample size for the training set:

Not applicable. These are validation tests for reprocessing, not machine learning model training.

9. How the ground truth for the training set was established:

Not applicable.

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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2023

Flosonics Medical Caleb Chin Senior Director, Operations 325 Front St W, Floor 4 Toronto, Ontario M5V 2Y1 Canada

Re: K223843

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 3, 2023 Received: April 4, 2023

Dear Caleb Chin:

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 (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 (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

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The item numbers included in the scope of this submission are as follows:

Description	Item Number
FloPatch FP120	FloPatch FP120

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223843

Device Name FloPatch FP120

Indications for Use (Describe)

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/4/Picture/3 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 upper portion of the 'f' and the first curved line are in a light blue color, while the remaining lines are black. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller, spaced-out font, also in light blue.

SECTION 5 – 510(k) Summary

1. Submitter Information

Submitter:	Flosonics Medical
Address:	325 Front St W, Floor 4Toronto, ONCanada M5V 2Y1
Telephone:	1-289-998-2982
Contact:	Caleb Chin
Date Prepared:	January 24, 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 reprocessing of "Single-Use Only" devices.

4. Predicate Device Information

510(k) No.	Device	Manufacturer
K222242	FloPatch FP120	Flosonics Medical

5. Device Description

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Image /page/5/Picture/2 description: The image shows the logo for Flosonics Medical. The logo features a stylized blue and black graphic above the company name. The graphic resembles a stylized letter 'f' with curved lines emanating from it, suggesting a wave or signal. Below the graphic, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller, lighter font.

6. Intended Use

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 of Technological Characteristics

This modification does not alter the device's fundamental scientific technology in comparison to the predicate device (K222242) and therefore has the same technological characteristics.

8. Performance Data

This submission is for modifications to the FloPatch FP120 cleared in 510(k) K222242.

The following tests were performed to demonstrate the substantial equivalence of the modified device to its predicate.

Test	Brief Description	Result
Simulated Use Cycles	Verified that the device can be reprocessed upto six cycles (consisting of soiling, cleaning anddisinfection).	Pass
Manual Cleaning	Validate a manual cleaning process during thereprocessing of the FloPatch FP120.	Pass
Low Level Disinfection	Validate a low level disinfection process duringthe reprocessing of the FloPatch FP120.	Pass
Acoustic Output	Verified that repeated reprocessing does notadversely affect the acoustic output of thetransducer.	Pass
Transducer Performance	Verified that repeated reprocessing does notadversely affect transducer performancecharacteristics• Velocity Accuracy• Flow Velocity and Depth	Pass
Physical Integrity	Verified that repeated reprocessing does notadversely affect the physical integrity of theFloPatch FP120.	Pass

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Image /page/6/Picture/2 description: The image shows the logo for Flosonics Medical. The logo features a stylized blue "F" with three curved lines emanating from it, resembling sound waves. Below the symbol, the word "FLOSONICS" is written in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size beneath it.

Cumulative Runtime	Verified that repeated reprocessing does notadversely affect the battery runtime	Pass
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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.

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).