(624 days)
INTENDED USE. The VariSoft Guide Wire is intended to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. The VariSoft Guide Wire is not intended for use in the cerebral vasculature.
INTENDED USE. The ABD VariSoft Guide Wire Extension is intended to provide the necessary length to allow the exchange of one dilatation catheter for another while maintaining the position of the ABD VariSoft Steerable Guide Wire in the coronary artery. After the dilatation catheter exchange has been completed, the ABD VariSoft Guide Wire Extension can be detached and the ABD VariSoft Steerable Guide Wire can be used as a conventional steerable guide wire.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device: the ABD-VariSoft Guide Wire and Extension. This document does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The letter explicitly states: "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..."
This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than a clinical study proving its performance against acceptance criteria in the manner requested. Clinical study data, if any, would have been part of the 510(k) submission, but is not included in this letter.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Mr. R. Edward Winters Advanced Biomedical Devices, Inc. 3 Dundee Park P.O. Box 2087 Andover, MA 01810
Re : K981936 ABD-VariSoft Guide Wire and Extension Requlatory Class: II (two) Product Code: DQX November 13, 1999 Dated: Received: November 18, 1999
Dear Mr. Winters:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 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.
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Page 2 - Mr. R. Edward Winters
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, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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,
Chistopher
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510 (k) NUMBER (IF KNOWN) : K981936
DEVICE NAME: ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
INDICATIONS FOR USE:
INTENDED USE. The VariSoft Guide Wire is intended to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. The VariSoft Guide Wire is not intended for use in the cerebral vasculature.
INTENDED USE. The ABD VariSoft Guide Wire Extension is intended to provide the necessary length to allow the exchange of one dilatation catheter for another while maintaining the position of the ABD VariSoft Steerable Guide Wire in the coronary artery. After the dilatation catheter exchange has been completed, the ABD VariSoft Guide Wire Extension can be detached and the ABD VariSoft Steerable Guide Wire can be used as a conventional steerable guide wire.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(per 21 CFR 80-1.109) | X |
|---|---|
| OR Over-The-Counter-Use |
(optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K98 1936 |
|---|---|
| --------------- | ---------- |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.