(24 days)
The Modified Auto Suture* VCS** Anastomotic** clip cartridge is intended for use in the anastomosis of vascular structures and in the attachment of synthetic vascular prosthesis.
The Modified Auto Suture* VCS** Anastomotic** clip cartridge uses titanium implantable clips to hold everted tissue edges together for the creation of vascular anastomosis.
The provided text does not contain information about acceptance criteria, device performance, or studies in the context of a medical device's analytical or clinical validation, especially not in a way that aligns with the requested format (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details). Instead, the document describes a 510(k) submission for a Modified Auto Suture* VCS** Anastomotic** Clip Cartridge, focusing on its regulatory approval process, intended use, and substantial equivalence to predicate devices.
Therefore, I cannot fulfill your request for an acceptance criteria table and study details based on the provided text. The information required for such a response (like performance metrics, study designs, and data characteristics) is simply not present in the given document.
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Modified Auto Suture* VCS** Anastomotic** Clip Cartridge K984438
IX. 510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856 |
|---|---|
| ------------ | ------------------------------------------------------------------------------ |
CONTACT PERSON: Christopher A. Graham
DATE PREPARED: December 11, 1998
CLASSIFICATION NAME: Implantable Clip
COMMON NAME: Implantable Clip
PROPRIETARY NAME: Modified Auto Suture* VCS** Anastomotic** clip cartridge
Auto Suture* VCS* Clip Applier (K970793) and Sutures PREDICATE DEVICES:
The Modified Auto Suture* VCS** Anastomotic** clip DEVICE DESCRIPTION: cartridge uses titanium implantable clips to hold everted tissue edges together for the creation of vascular anastomosis.
INTENDED USE:
MATERIALS:
structures and in the attachment of synthetic vascular prosthesis. All component materials of the Modified Auto Suture* VCS**
The Modified Auto Suture* VCS** Anastomotic** clip cartridge is intended for use in the anastomosis of vascular
Anastomotic ** clip cartridge are comprised of materials which are in accordance with ISO Standard # 10993-1.
510(k) Premarket Notification
United States Surgical Corporation *Trademark of United States Surgical Corporation
12/11/98 Page 28
** Trademark name not you determined
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 JAN
Mr. Christopher A. Graham Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K984438
Trade Name: Modified Auto Suture VCS Anastomotic Clip Cartridge Regulatory Class: II Product Code: FZP Dated: December 11, 1998 Received: December 14, 1998
Dear Mr. Graham:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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. Christopher A. Graham
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Modified Auto Suture* VCS** Anastomotic** Clip Cartridge
IV. Indications For Use:
510(k) Number (if known): K984438
Name: Modified Auto Suture* VCS** Anastomotic** clip cartridge
Indications For Use:
The Modified Auto Suture* VCS** Anastomotic** clip cartridge has indications for use in the creation of vascular anastomoses and in the attachment of synthetic vascular prosthesis.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use:
OR Over-The-Counter Use:
(Per 21 CFR §801.109)
sion Sign-Off)
Division of General Restorati 510(k) Number
United States Surgical Corporation *Trademark of United States Surgical Corporation
** Trademark name not yet determined
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.