OCCLUSION CLAMP** DEVICE by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.

Device Description

The AUTO SUTURE* Occluding Clamp** device is a vascular clamp applier.

AI/ML Overview

The provided documents for the AUTO SUTURE* Occluding Clamp** device (K964251) offer limited details regarding specific acceptance criteria and the comprehensive study that proves the device meets these criteria. The submission states that the device "was tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective." However, it does not provide the detailed information requested in the prompt.

Therefore, much of the requested information cannot be extracted from the given text.

Here is what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The general claim is "safe and effective."	"The results of the testing demonstrate the subject device to be safe and effective." (No specific metrics or quantitative results provided for performance.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not provided.
Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as this is a medical device (vascular clamp applier) rather than an AI/diagnostic imaging device. No mention of experts establishing a "ground truth" for diagnostic purposes. The evaluation would likely involve surgeons or clinical professionals observing the device's mechanical performance and clinical outcome.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. The type of device and the information given do not suggest a need for an adjudication method as would be used for subjective interpretations in diagnostic studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies that "safety and effectiveness" were evaluated through "in-vitro and in-vivo" testing. For a vascular clamp, "ground truth" would likely be established through:
- In-vitro: Mechanical testing (e.g., clamp force, durability, material compatibility, sealing capabilities) against engineering specifications.
- In-vivo: Clinical outcomes data from animal or human studies (e.g., successful temporary occlusion of coronary arteries without damage, ease of use, absence of complications).
- However, the specific metrics and how ground truth was established are not detailed.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set mentioned or implied.

In summary, the provided 510(k) premarket notification is a high-level summary that confirms the device underwent testing and was found to be safe and effective, leading to substantial equivalence with a predicate device. It does not contain the detailed study protocols, specific acceptance criteria, or performance metrics that would typically be found in a comprehensive clinical or engineering report.

Summary

{0}------------------------------------------------

UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device

K964251

MAY 23 1997

SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856(203) 845-1000
------------	------------------------------------------------------------------------------------------------

Victor Clavelli CONTACT PERSON: (203) 845-4543

October 16, 1996 DATE PREPARED:

Vascular Clamp CLASSIFICATION NAME:

AUTO SUTURE* Occluding Clamp** device COMMON NAME:

PROPRIETARY NAME: Trademark name not yet determined

PREDICATE DEVICE: RMITM YACOUBIANTM Clamp, K920936

The AUTO SUTURE* Occluding Clamp** device is a DEVICE DESCRIPTION: vascular clamp applier.

INTENDED USE: The device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.
The AUTO SUTURE* Occluding Clamp** device is MATERIALS: comprised of materials which are in accordance with ISO Standard # 10993-1.

THE AUTO SUTURE* Occluding Clamp** device was PERFORMANCE: tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective.

Trademark of United States Surgical Corporation ** Trademark name not yet determined

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its wings or body. The text "SERVICES - USA" is arranged in an arc above the bird figure, and the text "DEPARTMENT OF HEALTH & HUM" is arranged in an arc below the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 1997

Mr. Victor Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re: K964251 AUTO SUTURE* Occluding Clamp** Device Regulatory Class: II (two) Product Code: DXC Dated: February 21, 1997 February 24, 1997 Received:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

{2}------------------------------------------------

requlatory 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.

This letter will allow you to begin marketing your device as described to a m 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 at (301) 443-6597.

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device

INDICATIONS FOR USE: ll.

510(k) Number (if known):

AUTO SUTURE* Occluding Clamp** device Device Name:

Indications for use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K964251

Prescription Use:	✓	OR	Over-The-Counter Use:
-------------------	-------------------------------------------------------------------	----	-----------------------

Trademark of United States Surgical Corporation ** Trademark name not yet determined

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).