(28 days)
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.
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.
I understand that you're asking for details about the acceptance criteria and the study that proves a device meets those criteria, specifically concerning the FloPatch (FP110) based on the provided FDA 510(k) summary.
However, after carefully reviewing the provided text, I can determine the following:
- Trade/Device Name: FloPatch (FP110)
- Regulation Number: 21 CFR 870.2100
- Regulation Name: Cardiovascular blood flowmeter
- Regulatory Class: Class II
- Product Code: DPW
- Intended Use: The FloPatch (FP110) is intended for the detection of blood flow in peripheral vasculature. It is intended to be used by medical professionals (physicians and nurses) in hospitals and professional environments and is for prescription use only.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Edan SD3 Vascular Doppler, K140579) based on design features, intended use, and compliance with various non-clinical performance standards (EMC, electrical, thermal & mechanical safety, biocompatibility, acoustic output, etc.).
The provided text does not contain the following information:
- A table of acceptance criteria and the reported device performance. While it mentions "performance verification testing" and that the device "complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment," specific quantitative acceptance criteria and the FloPatch's performance against them are not detailed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This device does not appear to involve AI/algorithms for "human improvement" as it's a basic blood flow detection device).
- If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done. (Again, not applicable to the type of device described).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance studies.
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion based on the provided text:
The 510(k) summary indicates that the FloPatch (FP110) was deemed substantially equivalent to its predicate device (Edan SD3 Vascular Doppler) based on the following:
-
Non-clinical Performance Data: The device was tested and found compliant with relevant recognized consensus standards for:
- ES60601-1:2005/(R)2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
- IEC 60601-2-37 Edition 2.1 2015 (Ultrasonic Medical Diagnostic and Monitoring Equipment)
- IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic Disturbances)
- ISO 10993-1, -5, -10 (Biocompatibility: cytotoxicity, sensitization, skin irritation)
- IEC 62127-1 Edition 1.1 2013-02 (Ultrasonics - Measurement and Characterization of Medical Ultrasonic Fields)
- IEC 61161:2013 (Ultrasonics - Power measurement)
- IEC 62359 Edition 2.1 2017-09 (Ultrasonics - Field characterization - Thermal and mechanical indices)
- IEC 62304:2006 (Software Life Cycle Process)
-
Performance Verification Testing: The summary generally states that "performance testing to compare the performance of the device to predicate was conducted besides verification of performance, packaging and labelling." It concludes that "The results of the performance testing and testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP110 are equivalent to the recognized predicate in terms of acoustic output and performance."
Without further documentation (e.g., specific test reports linked in the 510(k) submission), the detailed acceptance criteria and the specific performance results from clinical or comprehensive bench performance studies are not available in this summary. The substantial equivalence argument relies heavily on adherence to recognized safety and performance standards for similar devices and a comparison of features to the predicate.
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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 (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, SudburyOntario, 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 SD3Vascular Doppler (4 MHz);(K140579) | |
|---|---|---|---|
| Class/Classification/Product Code | Class II/DPW (21 CFR 870.2100Cardiovascular blood flowmeter) | Class II/DPW (21 CFR 870.2100Cardiovascular blood flowmeter) | |
| Intended Use | The FloPatch(FP110) is intendedfor the detection of blood flow inperipheral vasculature.The device is intended to beused by medical professionalssuch as physicians and nurses inhospitals and professionalenviroments such as clinics anddoctor's offices. The device isintended for prescription useonly. | The SD3 Series UltrasonicPocketDopplers (hereinafter called"the Doppler") are intended to beused by health care professionalsincluding registered nurses,practical nurses, midwives,ultrasound technicians, andphysician assistants, by prescriptionfrom licensed physicians inhospitals, clinics and private offices.The 4 MHz, 5 MHz and/or 8 MHzwaterproof vascular probes areindicated for the detection of bloodflow in veins and arteries forassisting in the detection ofperipheral vascular disease. | |
| Intended Users | Medical professionals such asPhysicians and Nurses | Health care professionals includingregistered nurses, practical nurses,midwives, ultrasound technicians,and physician assistants, byprescription from licensedphysicians | |
| Use Environment | Hospitals and professionalenviroments such as clinics anddoctor'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 toevaluate the flow velocity ofblood in peripheral vasculature. | Use of the Doppler effect toevaluate the flow velocity of bloodin peripheral vasculature. | |
| Center Frequency | 4 MHz | 4 MHz | |
| Global MaximumOutputs/WorstCase 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 SD3Vascular 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 | <450 gms (including battery) | <350 gms (including battery) | |
| The degree of protectionagainst harmful ingress of liquid | IPX1 for vascular flowtransducer.IPX0 for enclosure | IPX8 for transducer.IP rating for the device enclosureunknown or assumed to be IPX0based on IEC 60601-1 | |
| Type of Power Source | Internal (AA Batteries) | Internal (AA Batteries) | |
| Battery Operating Voltage | 1.5V (single AA cell)4.5V for battery (3 AA Cells) | 1.5V (single AA cell) | |
| Battery Chemistry | Alkaline | AlkalineLithium | |
| The degree of protectionagainst 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 AndA1:2012, C1:2009/(R)2012 AndA2:2010/(R)2012 | IEC 60601-1:2005 | |
| EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| Ultrasound Basic Safety andEssential 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.
§ 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).