The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

Device Description

The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.

AI/ML Overview

This submission pertains to the Auto Suture TA & GIA Staplers. However, the provided document does not contain information about acceptance criteria or a study demonstrating device performance. Instead, it is a 510(k) summary and FDA clearance letter primarily focused on establishing substantial equivalence to predicate devices based on identical technological characteristics and changes only in the indication for use statement.

Therefore, the requested information cannot be extracted from the provided text. The document states: "The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement." This implies that performance data proving the device meets acceptance criteria would likely be covered by the predicate device's clearance and not explicitly re-stated or re-generated for this particular submission, as the device itself is considered identical.

To address the prompt fully, if such a study were present in alternative documentation (not provided here), the sections would be populated as follows:

1. Table of acceptance criteria and the reported device performance: This table would list specific quantitative or qualitative criteria that the device's performance needed to achieve (e.g., staple formation strength, leakage rates, successful tissue transection in a certain percentage of cases) and then show the results from the study, demonstrating how the device met or exceeded those criteria.

2. Sample size used for the test set and the data provenance: This would state the number of devices or procedures included in the test phase of the study and describe if the data was collected retrospectively (from existing records) or prospectively (specifically for the study), along with the geographic origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many medical professionals (e.g., surgeons, pathologists) reviewed the outcomes of the test procedures and their expertise (e.g., Board-certified surgeon with 20 years of experience in abdominal surgery).

4. Adjudication method for the test set: If multiple experts were used, this would describe how disagreements were resolved (e.g., "2+1" meaning if two out of three experts agreed, that was the final decision; "3+1" might imply a tie-breaking fourth expert, or simply all three must agree).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is specific to AI/software-assisted diagnostic devices. For a surgical stapler, an MRMC study comparing human performance with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is relevant for AI/software devices. For a surgical stapler, this concept does not apply.

7. The type of ground truth used: This would specify the definitive standard against which the device's performance was measured (e.g., pathology reports confirming successful tissue approximation, outcomes data like absence of anastomotic leaks, expert consensus on visual inspection of stapled lines).

8. The sample size for the training set: If a learning algorithm was involved (not applicable here), this would be the number of cases or data points used to train the algorithm.

9. How the ground truth for the training set was established: Again, if applicable, this would describe the process of labeling or categorizing the training data.

Summary

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DEC - 1 2003

K03 2696

IX. 510(k) Summary of Safety and Effectiveness

SUBMITTER:	United States Surgical150 Glover AvenueNorwalk, CT 06856
CONTACT PERSON:	Chester McCoy
DATE PREPARED:	November 14, 2003
CLASSIFICATION NAME:	Staple, Implantable
COMMON NAME:	Staple, Implantable
PROPRIETARY NAME:	Auto Suture* TA* & GIA* Staplers
PREDICATE DEVICES:	Auto Suture* TA* & GIA* Staplers
TECHNOLOGICAL CHARACTERISTICS:	The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement.
DEVICE DESCRIPTION:	The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.
INTENDED USE:	The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.
MATERIALS:	All component materials of the Auto Suture TA* & GIA* staplers are comprised of materials which are in accordance with ISO Standard #10993-1

United States Surgical *Trademark of United States Surgical

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Image /page/1/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 symbol of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2003

Mr. Chester McCoy Director of Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K032696

Trade/Device Name: Auto Suture TA Surgical Staplers Auto Suture Knifeless GIA Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 29, 2003 Received: September 2, 2003

Dear Mr. McCoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Insting 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 (PMA). 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 898. In addition. FIDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Chester McCoy

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 032696

IV. Indications For Use:

510(k) Number (if known): K032696

Name: Auto Suture* TA* Surgical Staplers Auto Suture* Knifeless GIA* Surgical Staplers

Indications For Use:

(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use:(Per 21 CFR §801.109)	OR Over-The-Counter Use:
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Miriam C. Provost

Restorative al Devic

510(k) Number K032696

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.