The BLF22 (single-channel) Tissue Perfusion Monitor reports Flow, Mass or Velocity on its front panel digital display. Housed in a small metal case, the Monitor is equipped with a convenient multi-position handle/stand. It also features: rear panel analog outputs for Flow/Mass/Velocity in 0 - 10 Volts DC; and a USB computer interface.

The BLF22A (single-channel + Indicator Tone) Tissue Perfusion Monitor incorporates all the functionality of the BLF22, plus adjustable Low Flow Indicator Tone circuitry. This will sound an audio signal when tissue perfusion flow drops below a preset level.

AI/ML Overview

The provided document is a 510(k) summary for the Transonic Tissue Perfusion Monitors (Models BLF22 and BLF22A). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and electrical safety testing.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they relate to studies for AI/ML device performance validation.

Here's a summary of the information that can be extracted, and an explanation for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner. The performance testing is described qualitatively as demonstrating "functional requirement specifications" and meeting "all required release specifications."

Acceptance Criteria (Implied)	Reported Device Performance
Functional requirement specifications (including flow values and user messages)	Demonstrated
Compliance with electrical safety standard IEC 60601-1	Complied
Measurement of volume flow within specified full range and accuracy (for probe/monitor combination)	Tested and met

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

Not applicable. The document describes "bench studies" and "testing" but does not specify a "test set" in the context of an AI/ML model or a sample size of patient data. The testing appears to be hardware-focused, evaluating the device's functional and electrical properties.

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

Not applicable. Ground truth establishment by experts is not described, as the performance testing focused on the device's physical and electrical functioning, not diagnostic accuracy based on expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through bench and electrical safety testing, not assessing human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a monitor measuring microvascular perfusion, not an AI algorithm, so the concept of "standalone performance" for an algorithm is not relevant here. The device itself is standalone in its function as a measurement tool.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing would be the true physical measurements of flow, mass, and velocity under controlled conditions, and compliance with electrical safety standards. This is inherent in bench testing and refers to accurately calibrated equipment and established safety protocols.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Transonic Systems Incorporated Ms. Leah Van De Water Senior Regulatory Affairs Manager 34 Dutch Mill Road Ithaca, New York 14850

July 23, 2015

Re: K140740

Trade/Device Name: Transonic Tissue Perfusion Monitors Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW Dated: June 8, 2015 Received: June 9, 2015

Dear Mr. Klementowski:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerelv vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140740

Device Name

Transonic Tissue Perfusion Monitors Model numbers: BLF22 and BLF22A.

Indications for Use (Describe)

Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K140740

510(k) SUMMARY

Summary of Safety & Effectiveness

Submitter's Name & Address:	Transonic Systems, Inc.34 Dutch Mill RoadIthaca, NY 14850
Contact Person & Telephone:	Leah Van De Water607-257-5300
Date Summary Prepared:	March 24, 2014 (Revised July 17, 2015)
Device Name:	Proprietary Name – Transonic Tissue Perfusion MonitorCommon/Usual Name – Laser Doppler MeterClassification Name – Cardiovascular Blood Flowmeter(21 CFR 870.2100)Product Code: DPWRegulatory Class: II
Predicate Device:	K903633 ALF21 Laser Flow Meter

Device Description:

Models:

Transonic Systems Laser Doppler BLF22 Series monitors consist of the following model numbers: BLF22 and BLF22A.

Indications for Use (Prescription Device):

Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.

Substantial Equivalence:

The Transonic BLF22 and BLF22A Monitors are similar in materials, form, and operating principle to the ALF21 Laser Flowmeter in K903633. The BLF22 and BLF22A monitors have

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K140740

the same principle of operation and electronics design. The case and circuit has been updated to utilize alarm electronics, clinical power supply, and poser entry module inside the case.

Performance Testing:

Bench studies demonstrated the functional requirement specifications of the BLF22A including flow values and messages to user.

Electrical safety testing was conducted and the BLF22/ BLF22A comply with IEC 60601-1.

The product is tested and must meet all required release specifications before distribution. Testing is completed for the tissue perfusion probe/monitor combination demonstrating the volume flow is measured within the specified full range and accuracy.

Animal and clinical testing was not required to support substantial equivalence.

The successful testing demonstrates the safety and effectiveness of the BLF22 and BLF22A Tissue Perfusion Monitors when used for the defined indications for use.

Conclusion:

The sponsor believes that the BLF22 and BLF22A tissue perfusion monitoring systems utilize similar technology as the predicate K903633 device. The sponsor has provided technical performance specifications and testing data. This information demonstrates that the devices do not raise new types of questions regarding safety or effectiveness when compared to the K903633 device and when used for the indications for use provided above. The sponsor thus concludes that the BLF22 and BLF22A devices are substantially equivalent to the predicate K903633 ALF21 device.

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).