(70 days)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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. 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.
I cannot provide a specific study that proves the device meets acceptance criteria, as the provided text is a 510(k) clearance letter and 510(k) summary, not a detailed clinical study report. The document describes the device, its intended use, comparison to predicates, and lists performance tests conducted. It asserts that these tests passed, but doesn't provide the detailed methodology, specific acceptance criteria values (beyond general descriptions like "≤720 mW/cm2"), or the results in a manner that would allow for a complete reconstruction of a clinical study or performance evaluation.
However, I can extract and infer information based on the typical content of a 510(k) submission and the provided text to address your points regarding acceptance criteria and the "study" (referring to the performance testing described).
It's crucial to understand that 510(k) clearance primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical efficacy studies. The "performance data" section in this document describes a series of engineering and bench tests, along with usability testing, to support this claim of substantial equivalence for the modifications made to the device.
Here's an attempt to answer your questions based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance (Inferred from 510(k) Summary)
The "acceptance criteria" for a 510(k) are generally defined by compliance with recognized standards (e.g., IEC, ISO) and demonstrating that the modified device performs as intended and is as safe and effective as the predicate. The document lists the specific tests and states that they "Pass." The table below summarizes the implied acceptance criteria based on industry standards and the reported (binary: Pass/Fail) device performance from the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Implied Acceptance Criteria (Based on Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Acoustic Output | Global maximum derated ISPTA ≤ 720 mW/cm²; Global maximum MI ≤ 1.9 | Pass (Reported: Max ISPTA.3 – 53.58 mW/cm², Max MI – 3.09E-02) |
| Ultrasound Safety | Meets IEC 60601-2-37 | Pass |
| Ultrasound Performance | Meets performance and ultrasound transducer requirements | Pass |
| Electrical and Basic Safety Testing | Meets IEC 60601-1 requirements | Pass |
| EMC | Meets IEC 60601-1-2:2014+A1:2020 | Pass |
| Emergency Service Environment Testing | Meets IEC 60601-1-12 requirements | Pass |
| Ingress Protection (IP) Testing | Meets IP67 ingress requirements | Pass |
| Material and Shelf Life | Adhesive and device enclosure satisfy performance requirements | Pass |
| Usability Testing | Validated device meets new indications for use | Pass |
| Hardware Testing | Meets mechanical and electrical requirements | Pass |
| Software Testing | Software application satisfies functional requirements, performs as intended; Algorithms and calculations verified. | Pass |
| Biocompatibility Testing | Adhesive and device enclosure met biocompatibility requirements (ISO 10993-1, -5, -10, -12, -21) | Pass |
| Simulated Use Cycles (Reprocessing) | Device can be reprocessed (soiling, cleaning, disinfection) without adverse effects on physical integrity or battery runtime. | Pass |
| Low Level Disinfection (LLD) with Visual Inspection | Validate a low level disinfection process during reprocessing. | Pass |
| Physical Integrity | Repeated reprocessing does not adversely affect physical integrity. | Pass |
| Cumulative Runtime | Repeated reprocessing does not adversely affect battery runtime. | Pass |
Study Details (Inferred/Not Applicable)
The document refers to "Performance Data" which are a series of tests to demonstrate substantial equivalence, rather than a single, comprehensive "study" with a defined clinical protocol to prove efficacy or diagnostic accuracy in the way a clinical trial would.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. These tests are typically bench and engineering tests, and possibly a limited usability test. They are not clinical trials with large patient cohorts. For example, "Usability Testing" likely involves a small number of representative users, not a large patient sample.
- Data Provenance: The document does not specify the country of origin of the data for these performance tests. Given that Flosonics Medical is based in Canada and the submission is to the US FDA, the tests could have been conducted in Canada, the US, or other locations. These are primarily engineering/bench tests, not retrospective or prospective clinical data in the traditional sense, except possibly for the usability testing which would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For bench and engineering tests (Acoustic Output, Electrical Safety, EMC, etc.), "ground truth" is typically established by calibrated measurement devices and compliance with international standards, not by human experts.
- For "Usability Testing," it's implied that medical professionals (physicians and nurses) were involved as the intended users, but the specific number or their qualifications are not stated. They would provide feedback on the user interface and operation.
4. Adjudication Method for the Test Set
- For engineering and bench tests, adjudication methods (like 2+1, 3+1 consensus) are not typically applicable. The results are quantitative measurements against defined thresholds.
- For Usability Testing, the "adjudication" would involve assessment against predefined usability goals and heuristics, likely by product designers and human factors specialists. It's not a consensus reading of medical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for AI/ML-driven diagnostic imaging devices where human reading performance with and without AI assistance is being evaluated.
- The FloPatch FP120 is described as a "Cardiovascular blood flowmeter" that uses ultrasound and the Doppler effect to assess blood flow. While it has "Software including but not limited to: Algorithm changes," it's not presented as a device that assists human readers in interpreting complex medical images in the way an AI diagnostic algorithm would. Its purpose is to output calculated values (Max Velocity trace, Max VTI, Corrected Flow Time). Therefore, an MRMC study comparing human readers with AI assistance would not be applicable to this device's reported function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The software testing explicitly states: "Verified that the software application satisfies functional requirements and performs as intended. Algorithms and calculations were also verified." This constitutes a form of standalone performance evaluation for the algorithms and calculations embedded in the device/app.
- The device outputs quantitative values (Max Velocity trace, Max VTI, Corrected Flow Time), which implies its core function is to produce quantitative readings based on its algorithms, rather than requiring subjective human interpretation of raw data.
7. The Type of Ground Truth Used
- Benchmarking/Reference Standards: For the technical performance tests (acoustic output, electrical safety, EMC, etc.), the ground truth is established by adherence to recognized international standards (e.g., IEC 60601 series, ISO 10993) and comparison to calibrated reference instruments.
- Engineering Specifications: For hardware and software testing, the ground truth is adherence to the device's predefined engineering specifications and functional requirements.
- User Feedback/Expert Opinion: For usability testing, the 'ground truth' comes from medical professionals' feedback on the device's ease of use and ability to perform its function in a simulated environment, validating that it "meets new indications for use."
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This document describes a 510(k) for a medical device that uses "Algorithm changes," but it does not specify if these algorithms are machine learning/AI algorithms that require a "training set" in the typical sense. Even if ML components are present, information on training sets is not commonly disclosed in the high-level 510(k) summary provided in a clearance letter. The focus here is on demonstrating the device's overall performance and safety after modifications, not on describing its underlying ML development process.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As the existence and nature of a "training set" are not specified, neither is the method for establishing its ground truth.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.06.05
June 20, 2025
Flosonics Medical
℅ Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, Minnesota 55114
Re: K251114
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 11, 2025
Received: April 11, 2025
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 (the 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 available 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.
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K251114 - Prithul Bom
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251114 - Prithul Bom
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assistance/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K251114
Device Name: FloPatch FP120
Indications for Use (Describe)
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
FloPatch FP120
Page 1 of 7
Traditional 510(k) K251114
510(k) Summary
1. Submitter Information
| Field | Information |
|---|---|
| Submitter: | Flosonics Medical |
| Address: | 325 Front St W, Floor 4Toronto, ONCanada M5V 2Y1 |
| Telephone: | 1-289-998-2982 |
| Contact: | Caleb Chin |
| Date Prepared: | November 2, 2023 |
2. Device Information
| Field | 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 product modifications to the previous cleared device.
Product modification include:
- Device Indications for Use
- Adhesive Material
- Shelf Life
- Hardware Changes
- Ultrasound Transducer
- Electronics
- Enclosure
- Software including but not limited to:
- Algorithm changes
- User Interface changes
- Logging of system and device metrics
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FloPatch FP120
Page 2 of 7
Traditional 510(k) K251114
4. Predicate Device Information
| 510(k) No. | Device | Manufacturer |
|---|---|---|
| Primary: K223843 | FloPatch FP120 | Flosonics Medical |
| Reference: K191388 | FloPatch FP110 | 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. 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.
6. Intended Use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.
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 to Predicate Devices
| Feature/Characteristic | FloPatch (FP120)[Subject Device] | FloPatch (FP120)Primary Predicate[K223843] | FloPatch (FP110)Reference Device[K191388] |
|---|---|---|---|
| Class/Classification/Product Code | Class II/DPW(21 CFR 870.2100Cardiovascular blood flowmeter) | Same | Same |
| Intended Use | The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only. | 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 | 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 |
Page 7
FloPatch FP120
Page 3 of 7
Traditional 510(k) K251114
| Feature/Characteristic | FloPatch (FP120)[Subject Device] | FloPatch (FP120)Primary Predicate[K223843] | FloPatch (FP110)Reference Device[K191388] |
|---|---|---|---|
| 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. | 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. | as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use only. | |
| Indications for Use | Identical to Intended Use | Same | Same |
| Intended Users | Medical professionals such as Physicians and Nurses | Same | Same |
| Use environment | Hospitals. professional environments such as clinics and doctor's offices. | Same | Same |
| Patient Population | Adults, ages 18 years and older | Same | Same |
| Intended for Prescription Use | Yes | Same | Same |
| Installation and Use | Body Worn | Same | Same |
| Theory of Operation | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | Same | Same |
| Center Frequency | 4 MHz | Same | Same |
| Global Maximum Outputs/Worst Case Setting | Max ISPTA.3 (mW/cm2) – 53.58Max MI – 3.09E-02 | Max ISPTA.3 (mW/cm2) – 105.99Max MI - 3.76E-02 | Max ISPTA.3 (mW/cm2) – 720Max MI – 1.9 |
| Modes of Operation | One mode, continuous | Same | Same |
| Reusable | No, the device is single use for a single patient. | Same | Same |
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FloPatch FP120
Page 4 of 7
Traditional 510(k) K251114
| Feature/Characteristic | FloPatch (FP120)[Subject Device] | FloPatch (FP120)Primary Predicate[K223843] | FloPatch (FP110)Reference Device[K191388] |
|---|---|---|---|
| Dimensions | With adhesiveHeight 145 mmWidth 76 mmDepth 32 mmWithout AdhesiveHeight 54 mmWidth 35 mmDepth 14 mm | With adhesiveHeight 114 mmWidth 70 mmDepth 32 mmWithout AdhesiveHeight 54mmWidth 35 mmDepth 18 mm | 135 mm x 108mm x 43.3 mm |
| Weight | 21 gms | 22 gms | <450 gms (including battery) |
| The degree of protection against harmful ingress of liquid | IP67 | Same | IPX1 for vascular flow transducer.IPX0 for enclosure |
| Type of Power Source | LiPo Battery (IEC 62133 certified) | Same | Internal (AA Batteries) |
| Battery Operating Voltage | 4.2 V for the battery | Same | 1.5V (single AA cell)4.5V for battery (3 AA Cells) |
| Battery Chemistry | Lithium Polymer | Same | Alkaline |
| The degree of protection against electric shock | Type BF (Defibrillation Protected) | Same | Type B |
| Buttons | One Power Button on FloPatch FP120 hardware | Same | One Power Button |
| Status LED | One, power and battery Indicator | Same | Absent |
| Onboard Screen | None - Multi Touch Mobile Medical Application screen | Same | One, power and battery Indicator |
| Displays Doppler Waveform | Yes | Same | No |
| Displays Max Velocity Waveform | Yes | Same | No |
| Displays VTI Calculation | Yes | Same | No |
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FloPatch FP120
Page 5 of 7
Traditional 510(k) K251114
| Feature/Characteristic | FloPatch (FP120)[Subject Device] | FloPatch (FP120)Primary Predicate[K223843] | FloPatch (FP110)Reference Device[K191388] |
|---|---|---|---|
| Displays Corrected Flow Time Calculation | Yes | Same | No |
| Displays Peak Systolic Velocity | Yes | Same | No |
| Wireless Mobile Application | Yes | Same | No |
| Calibration Required | No | Same | Same |
| Maintenance | Single-use device | Same | Same |
| Contact Classification | Surface Device, Intact Skin Contacting, Contact Duration: <30 days | Surface Device, Intact Skin Contacting, Contact Duration: <24 hrs | Limited Contact Duration (<24 hrs), Intact Skin, Surface Device |
| Electrical Safety | IEC 60601-1:2005+A1:2012+A2:2020 | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.2:2007 + A1:2012 | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.2:2007 + A1:2012 |
| EMC | IEC 60601-1-2:2014+A1:2020 | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 |
| Ultrasound Basic Safety and Essential Performance | IEC 60601-2-37:2015 | Same | Same |
| Biocompatibility | ISO 10993-1, -5, -10, -12, -21 | ISO 10993-1, -5, -10, -12 | ISO 10993-1, -5, -10, -12 |
8. Performance Data
This submission is for modifications to the FloPatch FP120 cleared in 510(k) K223843.
The following tests were performed to demonstrate the substantial equivalence of the modified device to its predicate.
| Test | Brief Description | Result |
|---|---|---|
| Acoustic Output (Track 3) | Verified that global maximum derated ISPTA ≤720 mW/cm2 and the global maximum MI should be ≤ 1.9 | Pass |
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FloPatch FP120
Page 6 of 7
Traditional 510(k) K251114
| Test | Brief Description | Result |
|---|---|---|
| Ultrasound Safety | Verified that the device meets IEC 60601-2-37 | Pass |
| Ultrasound Performance | Verified that the device meets performance and ultrasound transducer requirements | Pass |
| Electrical and Basic Safety Testing | Verified that the device meets IEC 60601-1 requirements | Pass |
| EMC | Verified that the device meets IEC 60601-1-2 requirements | Pass |
| Emergency Service Environment Testing | Verified that the device meets IEC 60601-1-12 requirements | Pass |
| Ingress Protection (IP) Testing | Verified that the device meets IP67 ingress requirements | Pass |
| Material and Shelf Life | Verified and validated that the adhesive and device enclosure satisfies performance requirements | Pass |
| Usability Testing | Validated that the device meets new indications for use | Pass |
| Hardware Testing | Verified that the device meets mechanical and electrical requirements | Pass |
| Software Testing• Flow Accuracy and Depth• Saved Measurement• Mobile Appearance | Verified that the software application satisfies functional requirements and performs as intended. Algorithms and calculations were also verified. | Pass |
| Biocompatibility Testing• Cytotoxicity• Sensitization• Irritation | Verified that the adhesive and device enclosure met biocompatibility requirements | Pass |
| Simulated Use Cycles | Verified that the device can be reprocessed (consisting of soiling, cleaning and disinfection). | Pass |
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FloPatch FP120
Page 7 of 7
Traditional 510(k) K251114
| Test | Brief Description | Result |
|---|---|---|
| Low Level Disinfection (LLD) with Visual Inspection | Validate a low level disinfection process during the reprocessing of the FloPatch FP120. | 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 |
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.
§ 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).