(28 days)
Not Found
No
The device description relies on established ultrasound and Doppler principles for blood flow detection and does not mention any AI/ML components or processes. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "blood flow detection device" that "uses ultrasound and the Doppler effect to evaluate the flow of blood." Its intended use is "for the detection of blood flow in peripheral vasculature." This indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states: "The FloPatch(FP110) is intended for the detection of blood flow in peripheral vasculature." Detecting a physiological condition like blood flow falls under the definition of a diagnostic device. The "Device Description" further elaborates on how it "evaluate[s] the flow of blood" using ultrasound and the Doppler effect.
No
The device description explicitly states it consists of a "signal processing box (main unit)" and an "ultrasonic vascular flow transducer," which are hardware components.
Based on the provided information, the FloPatch (FP110) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- FloPatch Function: The FloPatch (FP110) is a non-invasive device that uses ultrasound and the Doppler effect to detect blood flow within the body (in peripheral vasculature). It does not analyze samples taken from the body.
The device description clearly states it's a non-invasive device that transmits and receives ultrasonic waves to evaluate blood flow directly in the patient. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DPW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
peripheral vasculature, carotid artery
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 in this premarket notification 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 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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,
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)
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) | |
|---|---|
| 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 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 |
| Ontario, Canada P3C 1R7 | |
| Company Contact: | info@flosonicsmedical.com |
| 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)
(Subject Device) | Primary Predicate: Edan SD3
Vascular Doppler (4 MHz);
(K140579) | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Class/Classification/Product Code | Class II/DPW (21 CFR 870.2100
Cardiovascular blood flowmeter) | Class II/DPW (21 CFR 870.2100
Cardiovascular blood flowmeter) | |
| 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
enviroments such as clinics and
doctor's offices. The device is
intended for prescription use
only. | The SD3 Series Ultrasonic
PocketDopplers (hereinafter called
"the Doppler") are intended to be
used by health care professionals
including registered nurses,
practical nurses, midwives,
ultrasound technicians, and
physician assistants, by prescription
from licensed physicians in
hospitals, clinics and private offices.
The 4 MHz, 5 MHz and/or 8 MHz
waterproof vascular probes are
indicated for the detection of blood
flow in veins and arteries for
assisting in the detection of
peripheral vascular disease. | |
| Intended Users | Medical professionals such as
Physicians and Nurses | Health care professionals including
registered nurses, practical nurses,
midwives, ultrasound technicians,
and physician assistants, by
prescription from licensed
physicians | |
| Use Environment | Hospitals and professional
enviroments such as clinics and
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
evaluate the flow velocity of
blood in peripheral vasculature. | Use of the Doppler effect to
evaluate the flow velocity of blood
in peripheral vasculature. | |
| Center Frequency | 4 MHz | 4 MHz | |
| Global Maximum
Outputs/Worst
Case Setting | Max ISPTA.3
(mW/cm²) | 21.47 | 18.83 |
| | Min ISPTA.3
(mW/cm²) | 8.23 | 14.85 |
| | Max MI | 0.01 | 0.01 |
| Feature/Characteristic | FloPatch (FP110)
(Subject Device) | Primary Predicate: Edan SD3
Vascular Doppler (4 MHz);
(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 |