(79 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The performance studies describe a direct measurement and comparison to a predicate device, not the training or testing of an AI/ML model.
No
The device is described as quantifying tissue blood flow rate, which is a diagnostic function, not a therapeutic one. It provides information about a physiological state rather than treating or preventing a disease.
Yes
The device is intended to "quantify tissue blood flow rate," which provides information about a physiological state, serving a diagnostic purpose for assessing health conditions related to blood flow.
No
The device description explicitly states it includes hardware components: "Light source (laser diode) and detector (CMOS camera) secured in ABS/PC housings". This indicates it is not a software-only device.
Based on the provided information, the FlowMet device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "quantify tissue blood flow rate" by being "affixed to the fingers or toes." This describes a measurement taken directly from a living patient's body.
- Device Description: The description details a non-invasive probe that uses light to measure blood flow in the digits. This is an in vivo measurement.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body, such as blood, urine, or tissue, outside of the body.
The FlowMet is designed to measure a physiological parameter directly from the patient, making it an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlowMet is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
Product codes (comma separated list FDA assigned to the subject device)
DPW
Device Description
The FlowMet™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
Light source (laser diode) and detector (CMOS camera) secured in ABS/PC housings which are affixed to the digit using medical tape. Light source and detector are oriented to allow transillumination of digit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser Speckle Imaging
Anatomical Site
fingers or toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FlowMet-R™ and FlowMet™ performance was verified under known flow rate conditions using the same performance test that established substantial equivalence between the FlowMet-R™ and its predicate. The FlowMet-R™ and FlowMet™ measured the same sample concurrently: a tissue analog containing fluid pumped through at controlled 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 devices. Both devices exhibited high linearity (FlowMet-R™ R2 > 0.99, FlowMet™ R2> 0.99) between data output and flow rate, and both devices exhibited a coefficient of variation between trials of less than 5%. Additionally, the correlation coefficient of measured flow rate between the devices was R>0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: FlowMet-R™ R2 > 0.99, FlowMet™ R2> 0.99
Coefficient of variation between trials: less than 5%
Correlation coefficient of measured flow rate between the devices: R>0.999
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2021
Laser Associated Sciences, Inc. Sean White President and CEO 5171 California Ave., Suite 150 Irvine, California 92617
Re: K192966 Trade/Device Name: FlowMet Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW
Dear Sean White:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 10, 2019. Specifically, FDA is updating this SE Letter to correct the SE letter date to January 10, 2020 as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, with phone number of 240-402-5241, and email address of Stephen.Browning@fda.hhs.gov.
Sincerely.
Stephen C. Browning -S
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
1
Image /page/1/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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
January 10, 2019
Laser Associated Sciences, Inc. Sean White President and CEO 5171 California Ave., Suite 150 Irvine, California 92617
Re: K192966
Trade/Device Name: FlowMet Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: December 10, 2019 Received: December 11, 2019
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
2
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 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,
Stephen C. Browning -S5
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) K192966
Device Name FlowMet
Indications for Use (Describe)
The FlowMet 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. 5171 California Ave. Suite 150 Irvine, CA 92617 Tel: (949) 662-8892 Contact Person for this submission: Sean White
Date of Summary
The summary was prepared 1 of September 2019 and revised on 6 of December 2019.
Device Information
| Trade name: | FlowMet™ |
|---|---|
| Model No: | FlowMet™ |
| Type of product: | Finished product |
| Panel: | Cardiovascular |
| Common Name: | Peripheral Blood Flow Monitor |
| Classification Name: | Cardiovascular blood flow meter |
| Indications for Use: | The FlowMet™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate. |
| Class: | II |
| Classification Regulation: | 870.2100 |
| Product Code: | DPW |
Predicate 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 to |
| the fingers or toes and intended to quantify tissue blood | |
| flow rate. |
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| Class: | II |
|---|---|
| Classification Regulation: | 870.2100 |
| Product Code: | DPW |
| 510(k) No. | K182494 |
Device Description
Intended Use / Indications for Use
The FlowMet™ 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 FlowMet-R™ and the FlowMet™ use the same fundamental scientific technology for the assessment of peripheral tissue blood flow: Laser Speckle Imaging. Both devices also share the same indications for use. The predicate device, the FlowMet-R™, affixes to the digit via a spring-loaded clip-on mechanism; whereas the FlowMet™ device affixes to the digit using medical tape. Additionally, the FlowMet-R™ can be cleaned and re-used, whereas the FlowMet™ is a single use device.
Comparison to the predicate device K182494, FlowMet-R™
Laser safety
The FlowMet-R™ and FlowMet™ are classified as a Class I laser product according to IEC 60825-1:2014, and employ identical laser diodes as the energy source.
Measurement Site
The FlowMet-R™ and FlowMet™ use the same measurement site: finger or toe.
Sterility
The FlowMet-R™ and FlowMet™ are both supplied non-sterile.
Affixed sensor
The FlowMet™ probe is affixed to the digit (finger or toe) using a medical tape that is wrapped around the digit, whereas the FlowMet-R™ uses a clip-on probe designed to be affixed to the fingers or toes via pressure/friction.
Performance Data
FlowMet-R™ and FlowMet™ performance was verified under known flow rate conditions using the same performance test that established substantial equivalence between the FlowMet-R™ and its predicate. The FlowMet-R™ and FlowMet™ measured the same sample concurrently: a tissue analog containing fluid pumped through at controlled 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 devices. Both devices exhibited high linearity (FlowMet-R™ R2 > 0.99, FlowMet™ R2> 0.99) between data output and flow rate, and both devices exhibited a coefficient of variation between trials of less than 5%. Additionally, the correlation coefficient of measured flow rate between the devices was R>0.999.
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Clinical Data
No clinical testing was performed.
A description of the technological characteristics of the FlowMet-R™ system and FlowMet™ system is provided below.
| Device | FlowMet-RTM,
K182494 | FlowMetTM,
Pending |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Use | A non-invasive probe that is
affixed to the fingers or toes and
intended to quantify tissue blood
flow rate. | Same as predicate. |
| Intended Use | A non-invasive probe that is
affixed to the fingers or toes and
intended to quantify tissue blood
flow rate. | Same as predicate. |
| Fundamental
Scientific
Technology | Laser speckle imaging, wherein
changes in the contrast of a laser
speckle pattern are caused by
the movement of blood within
tissue, which is captured using a
camera sensor. | Same as predicate. |
| Type of Use | Reusable | Single-use |
| Light Source | Infra-red Laser Light,
785 nm,
Class 1 per IEC 60825-1:2014 | Same as predicate |
| Detector | Digital CMOS camera for laser
speckle imaging. | Same as predicate |
| Biocompatibility | Material intended to contact skin
(silicone rubber) tested for
biocompatibility per ISO-10993. | Materials intended to contact skin
(silicone and acrylic adhesives)
tested for biocompatibility per
ISO-10993. |
| Physical Structure | Light source (laser diode) and
detector (CMOS camera)
secured in clip-on ABS/PC
housing. Light source and
detector are oriented to allow
transillumination of digit. | Light source (laser diode) and
detector (CMOS camera)
secured in ABS/PC housings
which are affixed to the digit
using medical tape. Light source
and detector are oriented to allow
transillumination of digit. |
Summary
The FlowMet™ and the FlowMet-R™ both use the same fundamental scientific technology for the measurement of blood flow rate and both devices share the same indications for use. The primary change from the predicate to the FlowMet™ is the transition from a spring-loaded clip to medical tape for attachment of the digit. This change results in the FlowMet™ probe becoming single use.