(29 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical devices like image analysis or automated interpretation.
No
The device is intended for the evaluation of blood flow, not for treating a condition or disease.
Yes
The device is intended for "evaluation of blood flow," which is a diagnostic purpose to assess a physiological state.
No
The description explicitly mentions "VTI Intraoperative Doppler Systems" and "VTI Doppler Probes," which are hardware components used for evaluating blood flow. The summary does not indicate that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intraoperative and transcutaneous evaluation of blood flow." This involves directly interacting with the patient's body to measure a physiological parameter (blood flow).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living body (in vitro).
- Lack of IVD Characteristics: The description does not mention analyzing samples taken from the body, nor does it describe a laboratory-based test.
Therefore, the VTI Intraoperative Doppler Systems, as described, fall under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Product codes
DPW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an eagle or bird-like figure, composed of three curved, parallel lines that create a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 2008
Vascular Technology, Inc. c/o Mr. David L. Regan Vice President - Sales 12 Murphy Drive Nashua, NH 03062
Re: K082870
VTI Intraoperative Doppler Systems Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood Cardiovascular Regulatory Class: Class II (two) Product Code: DPW Dated: September 22, 2008 Received: September 29, 2008
Dear Mr. Regan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. David L. Regan
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
V
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2 - Indications for Use
510(k) Number (if known): K082870
Device Name: VTI Intraoperative Doppler Systems
Indications for Use:
The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Prescription Use
OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21CFR 801.109)
(Division/Sign-OfM
Division of Cardiovascular Devices
510(k) Number K082870