(132 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's operation relies on standard signal processing of Doppler ultrasound data.
No
The device is used for noninvasive assessment of blood flow, which is a diagnostic function, not a therapeutic one. It assesses flow but does not treat any condition.
Yes
The device is intended for the noninvasive assessment of blood flow, collecting data (Doppler signal) that is processed and displayed for medical professionals to use in hospitals and professional environments. This process of assessing and evaluating physiological parameters for medical purposes constitutes a diagnostic function.
No
The device description explicitly states that the device consists of a signal processing unit and an adhesive strap, which are hardware components.
Based on the provided information, the FloPatch FP120 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- FloPatch FP120 Function: The FloPatch FP120 is a non-invasive device that uses ultrasound and the Doppler effect to assess blood flow directly within the carotid artery of a living patient. It does not analyze samples taken from the body.
Therefore, the FloPatch FP120 falls under the category of a non-invasive diagnostic device used for in-vivo assessment, not an in-vitro diagnostic device.
N/A
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
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
Indicated Patient Age Range
adults only
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)
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 up to six cycles (consisting of soiling, cleaning and disinfection). | Pass |
| Manual Cleaning | Validate a manual cleaning process during the reprocessing of the FloPatch FP120. | Pass |
| Low Level Disinfection | Validate a low level disinfection process during the reprocessing of the FloPatch FP120. | Pass |
| Acoustic Output | Verified that repeated reprocessing does not adversely affect the acoustic output of the transducer. | Pass |
| Transducer Performance | Verified that repeated reprocessing does not adversely affect transducer performance characteristics • Velocity Accuracy • Flow Velocity and Depth | 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
2
The item numbers included in the scope of this submission are as follows:
| Description | Item Number |
|---|---|
| FloPatch FP120 | FloPatch FP120 |
3
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 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/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 4 |
| Toronto, ON | |
| Canada 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
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
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 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 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 up | |
| to six cycles (consisting of soiling, cleaning and | ||
| disinfection). | Pass | |
| Manual Cleaning | Validate a manual cleaning process during the | |
| reprocessing of the FloPatch FP120. | Pass | |
| Low Level Disinfection | Validate a low level disinfection process during | |
| the reprocessing of the FloPatch FP120. | Pass | |
| Acoustic Output | Verified that repeated reprocessing does not | |
| adversely affect the acoustic output of the | ||
| transducer. | Pass | |
| Transducer Performance | Verified that repeated reprocessing does not | |
| adversely affect transducer performance | ||
| characteristics | ||
| • Velocity Accuracy | ||
| • Flow Velocity and Depth | Pass | |
| Physical Integrity | Verified that repeated reprocessing does not | |
| adversely affect the physical integrity of the | ||
| FloPatch 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 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.