The FlowMet-R™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate. The FlowMet-R™ is a miniaturized clip-on probe, designed to be affixed to the fingers or toes. The FlowMet-R™'s clamshell housing blocks the laser output when not in use or when applied to a digit.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

The document does not explicitly state "acceptance criteria" for performance metrics in a table format. However, it presents performance tests and their outcomes, implying that successful completion of these tests demonstrates the device meets the necessary performance standards for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the performance data section, here's a reconstructed table of implied acceptance criteria and reported performance:

Acceptance Criterion (Implied)	Reported Device Performance
Benchtop Testing (Comparison to PeriCam PSI)
Similar response and high linearity (R²) to known flow rates	FlowMet-R™ R² > 0.999, PeriCam PSI R² > 0.95. Both devices demonstrated similar response and high linearity between data output and flow rate for volumetric flow rates from 2-20ml/min.
Benchtop Testing (Impact of Skin Coloration)
No significant impact of skin coloration on flow rate measurements	The degree of absorption within a skin tissue analog (simulating skin color) did not significantly affect the flow rate within the sample as determined by the FlowMet-R™.
Clinical Testing (Comparison to Laser Doppler Flowmeter)
Measures expected decrease in flow rates during occlusion	FlowMet-R™ system measures the expected decrease in flow rates during occlusion.
Measured decrease within +/-22% of Laser Doppler system	Resulting measured decrease is within +/-22% of the laser Doppler system.
Significant correlation with Laser Doppler flowmeter	Flow measurements from the FlowMet-R™ and laser Doppler devices were found to be significantly correlated for all patients with significant p values (<0.05) and average correlation coefficient >0.8.
Clinical Testing (Impact of Skin Color)
No significant difference in mean flow value among different skin colors	An ANOVA test demonstrated no significant difference in the mean flow value among all grouped skin color/ethnicity groups (White/Caucasian, Hispanic/Latino, Asian, African American).
No significant decrease in light source throughput due to skin tone	The difference in mean transmitted intensity between light-skinned (White/Caucasian) patients and any other group demonstrated that skin tone did not significantly decrease light source throughput.

2. Sample Sizes Used for the Test Set and Data Provenance

Benchtop Test (FlowMet-R™ vs. PeriCam PSI): No specific sample size in terms of test runs or repeated measurements is provided, but it states "flow rates were varied from 2-20ml/min" and "data was collected concurrently from both systems for a specified length of time (30 seconds) at each flow rate." The data provenance is controlled laboratory conditions using a "tissue analog."
Benchtop Test (Impact of Skin Coloration): No specific sample size is provided beyond "FlowMet-R™ data was collected under known flow rate conditions using a tissue analog." Skin colors were "simulated by creating silicone-based skin analogs with varying optical absorption." The data provenance is controlled laboratory conditions using "tissue analogs."
Clinical Test (FlowMet-R™ vs. Laser Doppler):
- Sample Size: 10 patients (5 male, 5 female).
- Data Provenance: Not explicitly stated, but it is a prospective clinical test on human subjects ("Data was collected from 10 patients before, during, and after vascular disruption induced via brachial artery occlusion.").
Clinical Test (Impact of Skin Color):
- Sample Size: 91 patients (181 total limbs, 84 from females, 97 from males). Grouped by ethnicity/skin color: White/Caucasian (N=144), Hispanic/Latino (N=23), Asian (N=11), and African American (N=3).
- Data Provenance: Not explicitly stated, but implies prospective collection from human subjects ("FlowMet-R™ blood flow and sensor intensity data was collected from 91 patients").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of experts to establish ground truth in the context of adjudication for the test set.

For the benchtop tests, the "ground truth" was established by known volumetric flow rates or controlled optical properties of tissue analogs.
For the clinical tests, the "ground truth" was established by:
- The expected physiological response to vascular occlusion.
- Comparison to a legally marketed predicate device (Laser Doppler flowmeter, K974285, specifically PeriFlux System 5000), which itself serves as a clinical reference.

4. Adjudication Method for the Test Set

No adjudication method involving experts is mentioned for any of the described tests. The comparisons are against physical ground truths (known flow rates, simulated skin colors) or against established medical devices (predicate PeriCam PSI, PeriFlux System 5000 Laser Doppler).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study involving human readers and AI assistance is reported. This device is a measurement tool, not an AI for image interpretation that would typically involve human-in-the-loop performance studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described performance tests are all standalone (algorithm only) performance studies, as the device directly measures and quantifies tissue blood flow rate. There is no human intervention in the interpretation of the raw data that the device outputs; the output itself is the measurement. The studies compare the device's measurements against known physical parameters or another established device, not against human judgment.

7. The Type of Ground Truth Used

Benchtop Test (FlowMet-R™ vs. PeriCam PSI): Ground truth was based on a known, controlled volumetric flow rate using a pump system and tissue analog.
Benchtop Test (Impact of Skin Coloration): Ground truth was based on known, controlled optical absorption (simulating skin color) in tissue analogs.
Clinical Test (FlowMet-R™ vs. Laser Doppler): Ground truth was established by:
- Physiological changes (expected decrease in flow during occlusion).
- Comparison to measurements from a legally marketed predicate device (Laser Doppler flowmeter), which serves as a clinical reference standard.
Clinical Test (Impact of Skin Color): Ground truth was based on statistical analysis of measured flow values across self-reported or observed ethnicity/skin color groups, to determine if significant differences existed.

8. The Sample Size for the Training Set

The document describes performance testing (validation) of the device. It does not provide information about a "training set" because this device is not presented as an AI/machine learning device that requires a training set in the conventional sense. The device uses "Laser Speckle Imaging" principles, implying fixed algorithms based on physics rather than learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this type of device, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

Laser Associated Sciences, Inc. Sean White President and CEO 16 Foxglove Way Irvine, California 92612

February 27, 2019

Re: K182494

Trade/Device Name: FlowMet-R Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: August 31, 2018 Received: September 11, 2018

Dear Sean White:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 C. Browning -S5

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182494

Device Name FlowMet-R

Indications for Use (Describe)

The FlowMet-R is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter's Name and Address

Laser Associated Sciences, Inc. 16 Foxglove Way Irvine, CA 92612 Tel: (949) 662-8892 Contact Person for this submission: Sean White

Date of Summary

The summary was prepared 15 of June 2018 and revised 21 of February 2019.

Device Information

Trade name:	FlowMet-R™
Model No:	FlowMet-R™
Type of product:	Finished product
Panel:	Cardiovascular
Common Name:	Peripheral Blood Flow Monitor
Classification Name:	Cardiovascular blood flow meter
Indications for Use:	The FlowMet-R is a non-invasive probe that is affixed tothe fingers or toes and intended to quantify tissue bloodflow rate.
Class:	II
Classification Regulation:	870.2100
Product Code:	DPW
Pre-Submission No.	Q171467

Predicate Device Information

Trade name:	PeriCam PSI
Model No:	PeriCam PSI NR, PeriCam PSI HR
510(k) No:	K120884
Type of product:	Finished product
Panel:	Cardiovascular
Common Name:	Blood Perfusion Imager
Classification Name:	Cardiovascular blood flow meter
Indications for Use:	The PeriCam PSI is intended for non-invasive two-dimensional imaging of peripheral tissue blood perfusion.
Class:	II

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Classification Regulation:	870.2100
Product Code:	DPW
510(k) No.	K120884

Device Description

Intended Use of the Device

The FlowMet-R™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.

Summary of technological characteristics of Device and Predicate Device

Both the PeriCam PSI and the FlowMet-R™ use the same fundamental technology for the assessment of peripheral tissue blood flow: Laser Speckle Imaging. The main difference between the two devices is the location and placement of the source (laser) and detector (camera). For the predicate device, the PeriCam PSI, the source and detector are on the same side of the sample being imaged; whereas in the FlowMet-R™, the source and detector are on opposite sides of one another. The other difference is that the FlowMet-R™ is fixed to the sample of interest, much like a pulse oximeter, which offers two key benefits: 1) reduced motion artifact 2) reduced light (laser) exposure to the eyes, thus making the FlowMet-R™ device potentially safer than the predicate.

Comparison to the predicate device K120884, PeriCam PSI

Laser safety

The FlowMet-R™ and PeriCam PSI are classified as a Class I laser product according to IEC 60825-1:2014. Additionally, the FlowMet-R™'s clamshell housing blocks the laser output when not in use or when applied to a digit.

Acquisition rate

The FlowMet-R™ acquires data at a higher speed (250fps) vs. the PeriCam PSI (~10fps). This allows the FlowMet-R™ to display the data in real time and provide feedback to the clinician.

Affixed sensor

The PeriCam PSI instrument is a mounted imaging head on a control arm, whereas the FlowMet-R™ is a miniaturized clip-on probe, designed to be affixed to the fingers or toes. LAS has taken steps to reduce hazards associated with skin contact by using biocompatible materials and certifying these skin-contacting materials per ISO 10993-1.

Performance Data

The FlowMet-R™ system was compared to the legally marketed predicate device (K120884) and to a laser Doppler flowmeter (K974285) in nonclinical benchtop and clinical testing.

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The first benchtop test compared output from the FlowMet-R™ system with the PeriCam PSI system under known flow rate conditions. Both systems measured the same sample concurrently: a tissue analog containing fluid pumped through at predetermined volumetric flow rates. The flow rates were varied from 2-20ml/min, which includes and exceeds the normal human physiological range. At each flow rate, data was collected concurrently from both systems for a specified length of time (30 seconds). The test results demonstrate similar response and high linearity (FlowMet-R™ R² > 0.999, PeriCam PSI R2 > 0.95) between data output and flow rate for both devices, showing equivalence between the performance of FlowMet-R™ and PeriCam PSI in determining flow rate within the sample.

The second benchtop test was performed to determine the impact of skin coloration on FlowMet-R™ measurements. FlowMet-R™ data was collected under known flow rate conditions using a tissue analog. Skin colors were simulated by creating silicone-based skin analogs with varving optical absorption (us). which was controlled by adding different concentrations of nigrosine dye. The test results demonstrate that the degree of absorption within a skin tissue analog, and thus skin color, does not significantly affect the flow rate within the sample as determined by the FlowMet-R™.

The first clinical test was performed to determine the relationship between FlowMet-RTM measurements and a contact laser Doppler flowmeter (PeriFlux System 5000). Device probes were placed on the same digit, adjacent to one another, to measure analogous tissue volumes. Data was collected from 10 patients before, during, and after vascular disruption induced via brachial artery occlusion. 5 patients were male and 5 patients were female. The test results demonstrate that the FlowMet-R™ system measures the expected decrease in flow rates during occlusion, and that the resulting measured decrease is within +/-22% of the laser Doppler system. Flow measurements from the FlowMet-R™ and laser Doppler devices were found to be significantly correlated for all patients with significant p values (<0.05) and average correlation coefficient >0.8.

The second clinical test was performed to determine if there exists significant differences in flow values resulting from differing skin colors. FlowMet-R™ blood flow and sensor intensity data was collected from 91 patients (181 total limbs, 84 of which were from females, and 97 of which were from males). Data was grouped by ethnicity/skin color: White/Caucasian (N=144), Hispanic/Latino (N=23), Asian (N=11), and African American (N=3). An ANOVA test demonstrated that there was no significant difference in the mean flow value among all groups, indicating the skin color did not significantly affect FlowMet-R™ measurements. Additionally, the difference in mean transmitted intensity between light-skinned (White/Caucasian) patients and any other group demonstrated that skin tone did not significantly decrease light source throughput.

Conclusion

The FlowMet-R™ and the PeriCam PSI both use the fundamental principles of Laser Speckle Imaging for the measurement of blood hemodynamics in tissue, by quantifying

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the change in speckle contrast due to the blurring phenomena associated with moving objects. The FlowMet-R™'s differing source and detector configuration makes the FlowMet-R™ less susceptible to motion artifact and reduces the light (laser) exposure to the eyes. The FlowMet-R™ demonstrated substantial equivalence to the PeriCam PSI through benchtop testing and significant correlation to a laser Doppler flowmeter in clinical evaluation. Combined benchtop and clinical testing demonstrated that FlowMet-RTM measurements are not significantly affected by physiological differences in skin tone.

Regulation Number and Section

§ 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).