(485 days)
Not Found
No
The document describes a tissue perfusion monitor that measures flow, mass, or velocity using laser Doppler technology. It does not mention any AI or ML capabilities, data processing beyond basic measurement and display, or any training/test sets typically associated with AI/ML development. The device's functionality is based on direct measurement and a simple low-flow indicator tone.
No.
The device is a monitor intended for measurement of microvascular perfusion, not for treatment.
Yes
Explanation: The device is intended for "measurement of microvascular perfusion," which is a diagnostic purpose to assess the state of tissue health.
No
The device description explicitly states it is housed in a "small metal case" and has physical components like a digital display, analog outputs, and a USB interface, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "measurement of microvascular perfusion" in tissue. This is a measurement taken directly from living tissue, not from a sample of bodily fluid or tissue that has been removed from the body.
- Device Description: The device is a "Tissue Perfusion Monitor" that uses Laser Doppler technology. This technology is used for in vivo (within the living body) measurements.
- Anatomical Site: The anatomical site is "tissue," which further supports the in vivo nature of the measurement.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnostic purposes. This device operates in vivo to measure perfusion directly in the tissue.
N/A
Intended Use / Indications for Use
Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.
Product codes
DPW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
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
1
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 Road
Ithaca, NY 14850 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person & Telephone: | Leah Van De Water
607-257-5300 |
| Date Summary Prepared: | March 24, 2014 (Revised July 17, 2015) |
| Device Name: | Proprietary Name – Transonic Tissue Perfusion Monitor
Common/Usual Name – Laser Doppler Meter
Classification Name – Cardiovascular Blood Flowmeter
(21 CFR 870.2100)
Product Code: DPW
Regulatory Class: II |
| Predicate Device: | K903633 ALF21 Laser Flow Meter |
Device Description:
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.
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.