(42 days)
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.
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.
The provided text is a 510(k) summary for the FloPatch (FP120) and mainly focuses on showing substantial equivalence to predicate devices based on intended use, technology, and compliance with recognized standards. It lacks detailed information about specific acceptance criteria for device performance and the study that proves those criteria are met.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, precision) or provide a table with these criteria alongside reported performance data. It broadly mentions compliance with consensus standards and performance verification testing.
It states:
"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)."
This indicates that acceptance criteria are tied to:
- Compliance with electrical safety, EMC, thermal, and mechanical safety standards (e.g., ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
- Biocompatibility (ISO 10993 standards).
- General performance verification (likely comparing its outputs like Max Velocity, VTI, and Corrected Flow Time to a reference method, though the specific targets and results are not detailed).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the given text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The FloPatch (FP120) is described as a "non-invasive blood flow detection device" that processes Doppler signals and displays metrics (Max Velocity trace, Max VTI, Corrected Flow Time) on a mobile medical application. It is used by medical professionals. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance or any AI components in its operation that would involve human "readers" or "interpretation" by AI beyond signal processing and data display. Its function appears to be a measurement device rather than an AI-assisted diagnostic interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device operates as an "algorithm only" in the sense that it processes signals and calculates metrics, the document does not specifically describe a "standalone" performance study in the context typically used for AI/CADe devices, which would involve evaluating its agreement with a ground truth independently of human intervention. It states that "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," indicating algorithm-driven data presentation. Therefore, it implicitly operates in a standalone manner to generate these outputs, but a formal "standalone study" with detailed metrics is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the provided text. For a blood flowmeter, ground truth would typically be established using a highly accurate, often invasive, or more complex reference method for blood flow measurement.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
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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 OneElevenToronto, Ontario, Canada M5V 2Y1 |
| Company Contact: | info@flosonicsmedical.com |
| Contact Person: | Andrew Eibl, Director Operations and InterimQuality 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.
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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 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 (PrimaryPredicate Device)[K183574] | DPW | II | 21 CFR 870.2100 |
| Edan Acclarix LX8 DiagnosticUltrasound 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/Characteristic | FloPatch(FP120)(SubjectDevice) | DMX HandheldDoppler[K183574](Primary PredicateDevice) | Edan AcclarixLX8 DiagnosticUltrasoundSystem[K180862](ReferenceDevice) | FloPatch FP110[K191388](ReferenceDevice) |
|---|---|---|---|---|
| Class/Classification/Product Code | Class II/DPW (21CFR 870.2100Cardiovascularblood flowmeter) | Class II/DPW (21CFR 870.2100Cardiovascular bloodflowmeter) | Class II/ IYN, IYO,ITX (21 CFR892.1550)Ultrasonic pulseddoppler imagingsystem | Class II/DPW (21CFR 870.2100Cardiovascularblood flowmeter) |
| Intended Use | The FloPatchFP120 is indicatedfor use for thenoninvasiveassessment ofblood flow in thecarotid artery.FloPatch FP120operates in asingle mode, theContinuous Wave(CW) mode, andis not capable ofoperating in anyother mode.The device isintended to beused by medicalprofessionals,such as physiciansand nurses, inhospitals andprofessional | Indicated for use byqualified healthcarepractitioners inprimary, acute andcommunityhealthcareenvironments, for thenon-invasiveassessment ofvascular blood flowto assist in diagnosis. | Diagnosticultrasound imagingor fluid flowanalysis of thehuman body | The FloPatch(FP110) is intendedfor the detection ofblood flow inperipheralvasculature.The device isintended to be usedby medicalprofessionals suchas physicians andnurses in hospitalsand professionalenviroments suchas clinics anddoctor's offices.The device isintended forprescription useonly. |
| Indications for Use | Identical to Intended Use | The Acclarix AX8 | Identical to Intended Use | |
| The FloPatchFP120 is indicatedfor use for thenoninvasiveassessment ofblood flow in thecarotid artery.FloPatch FP120operates in asingle mode, theContinuous Wave(CW) mode, andis not capable ofoperating in anyother mode.The device isintended to beused by medicalprofessionals,such as physiciansand nurses, inhospitals andprofessionalenvironments.The device isintended forprescription useon adults only. | Identical to IntendedUse | DiagnosticUltrasound Systemis intended for useby a qualifiedphysician orsonographer forultrasoundevaluation. Clinicalapplicationsinclude: Abdominal,Gynecology(includingendovaginal),Obstetric, Cardiac,Small parts (Breast,Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheral vascular,Intra-operative,Pediatric andNeonatal (includingabdominal andcephalic), and Adultcephalic. | Identical toIntended Use | |
| Intended Users | Medicalprofessionals suchas Physicians andNurses | Indicated for use byqualified healthcarepractitioners inprimary, acute andcommunityhealthcareenvironments | Intended for use bya qualifiedphysician orsonographer | Medicalprofessionals suchas Physicians andNurses |
| UseEnvironment | Hospitals andprofessionalenvironmentssuch as clinicsand doctor'soffices. | In primary, acuteand communityhealthcareenvironments | Not specified | Hospitals andprofessionalenvironments suchas clinics anddoctor's offices. |
| PatientPopulation | Adults, ages 18years and older | Not specified | Pediatric and Adult | Adults, ages 18years and older |
| Intended forPrescription Use | Yes | Yes | Yes | Yes |
| Installation and Use | Body Worn | Hand-Held | Portable (laptop) Mobile Equipment | Body Worn |
| 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. | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. (Doppler mode only) | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. |
| Center Frequency | 4 MHz | 4 MHz | 2.5-15.0 MHz | 4 MHz |
| Global Maximum Outputs /Worst Case Setting | MaxISPTA.3 (mW/cm²)15.78 | 92 | 21.47 | 720 |
| /Worst Case Setting | Max MI1.11E-02 | Not reported | 0.01 | 1.9 |
| Modes of Operation | One mode, continuous | One mode, continuous | Multi-Mode, Only Doppler mode relevant to this comparison | One mode, continuous |
| Reusable | No, the device is single-use for a single patient. | Reusable with cleaning | Reusable with cleaning | No, single use for a single patient. |
| Dimensions | With adhesiveHeight 200 mmWidth 65 mmDepth 30mmWithout AdhesiveHeight 54mmWidth 35 mmDepth 18 mm | Height 140mm (5.5")Width 75mm (3.0")Depth 30mm (1.2") | 407mm(W) x388mm(L) x77mm(H) | 135 mm x 108mm x 43.3 mm |
| Weight | 22 gms | 310 gms | 8.6Kg (with rechargeable battery and monitor glass, without power adaptor or transducers) | <450 gms (including battery) |
| The degree of protection against harmful ingress of liquid | IPX7 for the device | IP20 for the main unitIPX1 for the probe tip | Console Panel: IPX1Transducers: IPX7 | IPX1 for vascular flow transducer.IPX0 for enclosure |
| Type of Power Source | LiPo Battery (IEC 62133 certified) | Internal (AA Batteries) | Rechargeable Lithium Ion | Internal (AA Batteries) |
| Battery Operating Voltage | 4.2 V for the battery | 1.5V (single AA cell)4.5V for battery (3 AA Cells) | 14.4V | 1.5V (single AA cell)4.5V for battery (3 AA Cells) |
| Battery Chemistry | Lithium Polymer | Alkaline | Lithium-Ion | Alkaline |
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Image /page/5/Picture/0 description: The image shows the logo for Flosonics Medical. The logo features a stylized letter 'f' in blue, with three curved lines emanating from it, resembling radio waves. Below the symbol, the word 'FLOSONICS' is written in bold, black capital letters, with the word 'MEDICAL' in smaller, blue capital letters underneath.
Section 5. 510 (k) Summary
510(k) Submission – FloPatch FP120
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Image /page/6/Picture/0 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 word "FLOSONICS" is written in bold, uppercase letters below the symbol, and the word "MEDICAL" is written in a smaller font size below "FLOSONICS".
K200337 Section 5. 510 (k) Summary
510(k) Submission – FloPatch FP120
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Image /page/7/Picture/0 description: The image contains the logo for Flosonics Medical. The logo consists of a stylized blue and black symbol resembling sound waves above the company name. The word "FLOSONICS" is in bold black letters, and the word "MEDICAL" is in smaller blue letters below it.
Section 5. 510 (k) Summary
510(k) Submission – FloPatch FP120
| The degree ofprotectionagainst electricshock | Type B(DefibrillationProtected) | Type B (NotDefibrillationProtected) | Type BF AppliedPart | Type B |
|---|---|---|---|---|
| Buttons | One Power Buttonon FloPatchFP120 hardware | Three buttons | One power button | One Power Button |
| Status LED | One, power andbattery Indicator | None | None | Absent |
| Onboard Screen | None - MultiTouch MobileMedicalApplication screen | LCD Screen | LCD Screen | One, power andbattery Indicator |
| Displays DopplerWaveform | Yes | Yes | Yes | No |
| Displays MaxVelocityWaveform | Yes | Yes (DisplaysFrequency instead ofmax velocity) | Yes | No |
| Displays VTICalculation | Yes | No | Yes | No |
| DisplaysCorrected FlowTime Calculation | Yes | No | No, however it canbe calculated onthe device basedon the datacaptured by thedevice. | No |
| Wireless MobileApplication | Yes. | No. Has an offlinedata processingsoftware called theHuntleigh DR5(MDDS) which canonly be used withDopplex DMX device. | No. The softwareand screen areintegrated with theultrasound unit. | No |
| CalibrationRequired | No | No | No | No |
| Maintenance | Single-use device | Reusable Device-with cleaning | Reusable Device-with cleaning | Single UseTransducer |
| ContactClassification | Surface Device,Intact SkinContacting,Contact Duration:<24 hrs | Surface Device,Intact SkinContacting, ContactDuration: <24 hrs | Not Specified | Limited ContactDuration (<24 hrs),Intact Skin, SurfaceDevice |
| Electrical Safety | IEC 60601-1:2005(Third Edition) +CORR. 1:2006 +CORR.2:2007 +A1:2012 | IEC 60601-1:2005(Third Edition) +A1:2012 | IEC 60601-1version notspecified | IEC 60601-1:2005(Third Edition) +CORR. 1:2006 +CORR.2:2007 +A1:2012 |
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Image /page/8/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 curved line with three segments, the first segment is blue and the other two are black. Below the graphic, the word "FLOSONICS" is written in bold, black capital letters, and below that, the word "MEDICAL" is written in smaller, blue capital letters.
Section 5. 510 (k) Summary
510(k) Submission - FloPatch FP120
| EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | IEC 60601-1-2:2014 |
|---|---|---|---|---|
| Ultrasound BasicSafety andEssentialPerformance | IEC 60601-2-37:2015 | EN 60601-2-37:2008+A11:2011 | IEC/EN 60601-2-37 | IEC 60601-2-37:2015 |
| Biocompatibility | ISO 10993-1, -5, -10, -12 | ISO 10993-1 | ISO 10993-1, -5, -10, -12 | ISO 10993-1, -5, -10, -12 |
8.2 Summary of Substantial Equivalence Argument and Identification of Predicate/Reference Device
The FloPatch FP120 is a battery-operated, non-invasive medical device that utilizes ultrasound and the Doppler effect to detect blood flow in peripheral vasculature, such as the carotid artery.
The primary predicate device DMX Handheld Doppler [K183574], was selected because it has the same intended use and similar technological characteristics to the FloPatch FP120.
| No. | Identified PredicateDevice/Reference | Rationale for Selection |
|---|---|---|
| 1. | DMX Handheld Doppler[K183574] (PrimaryPredicate Device) | The DMX Handheld doppler has the same intended use andindications for use as the FloPatch FP120. It can capture andautomatically trace the Doppler spectrogram and calculate heartrate but does not calculate the VTI and Corrected Flow Timefrom the Doppler Waveform. |
| 2. | Edan Acclarix LX8Diagnostic UltrasoundSystem [K180862](Reference Device) | The intended use and indications for use of the FloPatch FP120are a subset of the intended use and indications for use of theEdan Acclarix LX8. The Edan Acclarix LX8 Ultrasound Systemdevice can display and automatically trace the captured Dopplerspectrogram, calculate the VTI (velocity time integral) and heartrate in the CW Doppler mode. |
| 3. | FloPatch FP110 [K191388](Reference Device) | The FloPatch FP110 has the same intended use andindications for use as the FloPatch FP120. The method ofattachment of the ultrasound probe to the human body used inthe FloPatch FP120 is identical to that of the FloPatch FP110. |
The following table summarises the rationales for selecting the predicate devices:
The subject device and the predicate has the same intended use and indications for use (Intended use and indications of use of the FloPatch FP120 are a subset of the intended use and indications for use of the Edan Acclarix LX8 Diagnostic Ultrasound System [K180862]).The subject device and the predicate use Continuous Wave (CW) Doppler to detect blood flow in peripheral vasculature. The subject device and the predicate can trace the Doppler flow spectrogram and can calculate metrics from the Doppler waveform. The main difference between the predicate and the subject device exists in the way the ultrasonic transducer is placed on the human body. This different method of placing the ultrasonic transducer on the body has been evaluated as part of a usability study, it has also been evaluated by the FDA as part of a previous submission for a the FloPatch FP110 [K191388] and it has been determined that those differences do not raise different concerns of safety or efficacy.
Hence, the FloPatch FP120 is substantially equivalent to the identified predicate device. Further the reference devices provide legally marketed devices that are intended to provide scientific and/or technical information (e.q., test methodology) to help address the safety and effectiveness of a new technological characteristic.
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Image /page/9/Picture/0 description: The image shows the logo for Flosonics Medical. The logo features the company name in a sans-serif font, with the word "FLOSONICS" in a larger, bolder font and the word "MEDICAL" in a smaller, lighter font. Above the company name is a stylized graphic consisting of a blue arc and three black curved lines, resembling a sound wave or signal.
K200337 Section 5. 510 (k) Summary
510(k) Submission - FloPatch FP120
9. Determination of Substantial Equivalence
The FloPatch FP120 is substantially equivalent to the predicate device(s). The FloPatch FP120 has been tested to comply with relevant recognized consensus standards. The combination of testing to recognized consensus standard and performance verification testing substantial equivalnce of the FloPatch FP120.
Non-Clinical Performance Data
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 (<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.
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Image /page/10/Picture/0 description: The image shows the logo for Flosonics Medical. The logo consists of the company name in bold, sans-serif font, with the word "FLOSONICS" in black and "MEDICAL" in teal. Above the name is a stylized graphic of curved lines, resembling sound waves or a stylized "F", with the top portion in teal and the lower portion in black.
510(k) Submission – FloPatch FP120
10. Conclusion
The FloPatch FP120 is substantially equivalent to the identified predicate(s).
§ 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).