(89 days)
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.
The PVR-100 / Vasogram is a noninvasive medical device.
This looks like a 510(k) submission summary for a medical device (PVR-100/Vasogram II). The provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets them.
Specifically, the text is a letter from the FDA acknowledging receipt and review of the 510(k) submission and stating that the device is substantially equivalent to legally marketed predicate devices. It also outlines the intended use of the device.
To answer your request, I would need to find sections of the 510(k) submission itself that describe:
- The specific performance characteristics tested.
- The acceptance criteria for those characteristics.
- Details of the study (clinical or bench) conducted to demonstrate performance.
- The statistical methods used, sample sizes, ground truth establishment, etc.
Therefore, based solely on the provided text, I cannot complete your request.
If you have access to the full 510(k) submission for the PVR-100/Vasogram II, please provide the relevant sections describing the performance data and acceptance criteria.
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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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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
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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
§ 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).