(89 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or processes that are characteristic of AI/ML applications in medical devices (e.g., image analysis, pattern recognition, predictive modeling based on complex algorithms). The device description and intended use are consistent with traditional non-invasive vascular assessment methods.
No.
The device is used for diagnosis and recording and displaying arterial compliance, not for treating any condition.
Yes
The device is described as being used to "noninvasively diagnosis extremity arterial and venous disorders".
No
The device description and intended use clearly state it is a "noninvasive medical device" used "in conjunction with other devices" like Doppler ultrasound and ultrasonic imaging. This implies a hardware component is involved in acquiring the physiological data, which the software then likely processes or displays. The predicate device is also a "Pulse Volume Recorder," which is typically a hardware device.
Based on the provided information, the PVR-100 / Vasogram is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- PVR-100 / Vasogram's function: The description clearly states that the PVR-100 / Vasogram is a noninvasive device used in conjunction with other noninvasive techniques (Doppler ultrasound, treadmill testing, ultrasonic imaging) to assess vascular conditions in the limbs and digits. It does not involve the analysis of specimens taken from the body.
Therefore, the PVR-100 / Vasogram falls under the category of a noninvasive diagnostic device used for physiological measurements, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.
Product codes
JOM
Device Description
The PVR-100 is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic imaging techniques
Anatomical Site
limbs and digits (extremity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1998
Jeff Raines Ph.D. Vasocor, Inc. Corporate Park of Miami 7705 N.W. 48th Street, Suite 120 Miami, FL 33166
K990123 Re: PVR-100/Vasogram II Requlatory Class: Product Code: JOM Dated: January 13, 1999 Received: January 13, 1999
Dear Dr. Raines:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Edward F. Waddell
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely, yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
8.0 Intended Use
In 510(k) K973659 for the Vasocor PVR-100 (Pulse Volume Recorder), the indications for use statement is as follows:
The PVR-100 is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders.
The addition of the Vasogram to the PVR-100 expands the indications for use statement for the PVR-100 / Vasogram is given in its entirety as follows:
The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.
Wolf Scupstein MD
ision of Cardiovascular, Respira and Neurological Devices 510(k) Number
Vasocor, Inc. PVR-100 / Vasogram January 13, 1999