(148 days)
The AUTO SUTURE* VCS* Anastomotic** clip cartridge is intended to apply titanium clips for use in the creation of vascular anastomoses and in the attachment of synthetic vascular prosthesis.
The AUTO SUTURE* VCS*Anastomotic** clip cartridge fires multiple titanium clips simultaneously around the junction of 2 vessels to create a vascular anastomosis.
The provided document is a 510(k) premarket notification for a medical device (Auto Suture VCS Anastomotic Clip Cartridge). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a study proving the device meets those criteria in a typical AI/software context.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria because the document does not contain this type of information.
The document is a regulatory approval letter and a summary of information for a medical device that uses pre-formed titanium clips for vascular anastomoses. This is a physical, mechanical device, not a software-based AI device. The regulatory pathway for such devices typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria in the manner one would see for AI/ML algorithms.
Here's why the requested information isn't present in this document:
- Acceptance Criteria & Reported Performance: The document states, "The AUTO SUTURE* VCS* Anastomotic**clip cartridge has been subjected to substantial safety and effectiveness testing." However, it does not detail specific quantitative acceptance criteria (e.g., success rates, force thresholds, leakage rates) or the reported performance outcomes against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth Establishment: These categories are typically relevant for AI/Machine Learning algorithms or diagnostic devices where performance is measured against a "ground truth" derived from expert interpretation, pathology, or outcomes. The Auto Suture Clip Cartridge is a surgical instrument. Its "performance" would be assessed through preclinical (e.g., in vitro, animal studies) and potentially clinical studies focusing on aspects like clip integrity, vessel occlusion, patency, and absence of adverse events, not through the metrics typically used for AI.
In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specific type of information requested regarding acceptance criteria and performance studies commonly found in evaluations of AI-powered devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Victor Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
JUL 30 1997
Re: K970793
Trade Name: Auto Suture* VCS* Anastomotic** Clip Cartridge Regulatory Class: II Product Code: FZP Dated: July 1, 1997 Received: July 7, 1997
Dear Mr. Clavelli:
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 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 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. Victor Clavelli
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.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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UNITED STATES SURGICAL CORPORATION 510(k) PRE MARKET NOTIFICATION AUTO SUTURE* VCS* ANASTOMOTIC** CLIP CARTRIDGE
510(K) SUMMARY OF INFORMATION SUPPORTING SAFETY AND SUMMARY EFFECTIVENESS
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SUBMITTER: United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
JUL 30 1997 -
CONTACT PERSON: Victor Clavelli
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DATE PREPARED: February 28, 1997
CLASSIFICATION NAME: Implantable Clip
- COMMON NAME: Implantable Clip
- PROPRIETARY NAME: The trademark name of this device has not yet been determined.
- PREDICATE DEVICE: AUTO SUTURE* Vascular Anastomosis** clip cartridge
DEVICE DESCRIPTION: The AUTO SUTURE* VCS*Anastomotic** clip cartridge fires multiple titanium clips simultaneously around the junction of 2 vessels to create a vascular anastomosis.
INTENDED USE: The AUTO SUTURE* VCS* Anastomotic** clip cartridge is indicated for the creation of vascular anastomoses.
- MATERIALS: The AUTO SUTURE* VCS* Anastomotic** clip cartridge is comprised of materials which are in accordance with ISO Standard #10993-1 for their intended patient contact profile.
- PERFORMANCE: The AUTO SUTURE* VCS* Anastomotic**clip cartridge has been subjected to substantial safety and effectiveness testing.
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INDICATIONS FOR USE
510(k) Number (if known): K970793
AUTO SUTURE* VCS* Anastomotic ** clip cartridge Device Name:
Indications for use:
The AUTO SUTURE* VCS* Anastomotic** clip cartridge is intended to apply titanium clips 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 Device Evaluation
scotty
(Division Sign-Off) Division of General Restorative Der 510(k) Number _
Prescription Use: √
OR
Over-The-Counter Use:
§ 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.