AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY by SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE

The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Device Description

This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Autosuture™ Endo GIA™ Stapler as described in the predicate submission K083519. The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue. The black Reloads shall be made available in 45 mm and 60 mm lengths.

AI/ML Overview

The provided text describes a 510(k) submission for a surgical stapler reload, the "Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology." The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested elements for AI model evaluation are not present in this document.

However, I can extract information related to the acceptance criteria and the general study type from the provided text for this medical device (not an AI device).

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format common for AI models (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, for this surgical device, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices and acceptable performance in bench and in-vivo evaluations. The primary performance goals are safety and effectiveness when used as intended, and functional equivalence to the predicate.

The table below summarizes the closest information available regarding acceptance aspects and reported performance, framed within the context of a medical device submission:

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence: The new Reload should exhibit identical design characteristics to predicate Reloads with Tri-Staple™ Technology, with specified staple sizes.	"The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue." "The Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology for use in extra thick tissue is substantially equivalent to the predicate Reload cartridges with regard to the stapling technologies employed."
Material Biocompatibility: Materials used should be in accordance with ISO Standard 10993-1.	"All components of the Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology are comprised of materials that are in accordance with ISO Standard 10993-1."
Safety and Effectiveness: When used with the Autosuture™ Endo GIA™ Stapler, the device must be safe and effective and perform as intended.	"Bench and in-vivo performance evaluations were conducted to demonstrate that the new Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology when used with the Autosuture™ Endo GIA™ Stapler is safe and effective and performs as intended."

Study Information (Based on provided text)

Given that this is a 510(k) summary for a surgical stapler reload and not an AI device, the following points address the requested information as much as possible, or explain why it is not applicable or available in the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Bench and in-vivo performance evaluations were conducted."
- Bench Test Sample Size: Not specified in the summary document. Bench tests typically involve a controlled number of samples to assess mechanical properties and function.
- In-vivo Test Sample Size: Not specified in the summary document. In-vivo studies typically involve animal models or, less commonly for 510(k)s, human subjects. The details of these studies are not provided.
- Data Provenance: Not specified in the summary document. Such details (country, retrospective/prospective) are not typically included in a 510(k) summary for bench or in-vivo non-human studies.
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):
- N/A. For this type of surgical device performance study, "ground truth" is typically established through direct measurement (e.g., staple formation, tissue integrity) in bench testing and observational outcomes in in-vivo studies, rather than expert consensus on diagnostic images. No information on experts establishing ground truth is provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiology reads) where disagreements need resolution. It is not applicable to the bench and in-vivo performance evaluations described for this surgical stapler reload.
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:
- N/A. This is a medical device, not an AI device. No MRMC study was conducted, as there is no AI component or human reader interpretation involved in its intended use.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical surgical device, not an algorithm. Its performance is inherent to its mechanical function, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Bench Tests: Ground truth would likely be based on engineering specifications, mechanical measurements (e.g., staple leg formation, closure height, bursting pressure for anastomoses), and visual inspection for proper function.
- For In-vivo Tests: Ground truth would include direct observation of surgical outcomes, tissue healing, absence of leaks or bleeding, and potentially histological analysis of stapled tissue, as applicable to animal models.
- The document does not detail the specific ground truth metrics beyond generally stating "safe and effective and performs as intended."
The sample size for the training set:
- N/A. This is a medical device, not an AI model. There is no concept of a "training set" in the context of this 510(k) submission.
How the ground truth for the training set was established:
- N/A. Not an AI model; thus, no training set or associated ground truth establishment process for a training set.

Summary

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510(k) Summary of Safety and Effectiveness

SUBMITTER:	Surgical Devices, a global business unitof Tyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473Tel. No.: (203) 492-5352	K093410
CONTACT PERSON:	Frank GianelliSenior Associate, Regulatory Affairs
DATE PREPARED:	October 29, 2009	NOV 12 2009
TRADE/PROPRIETARY NAME:	Autosuture™ Endo GIA™ Staplers
COMMON/USUAL NAME:	Surgical Stapler with Implantable Staples
CLASSIFICATION NAME:	Staples, Implantable
PREDICATE DEVICE(S):	Autosuture™ Endo GIA™ Stapler (K083519; K061095)
DEVICE DESCRIPTION:	This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketedAutosuture™ Endo GIA™ Stapler as described in the predicatesubmission K083519. The black Reload bears the identical designcharacteristics as the Reloads with Tri-Staple™ Technologydescribed in the predicate submission with the exception that thestaples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thicktissue. The black Reloads shall be made available in 45 mm and60 mm lengths.
INTENDED USE:	The Autosuture™ Endo GIA™ Staplers have applications inabdominal, gynecologic, pediatric and thoracic surgery forresection, transection, and creation of anastomoses. They maybe used for transection and resection of liver substance, hepaticvasculature and biliary structures.
	Note: The Autosuture™ Endo GIA™ Single Use Black Reloadwith Tri-Staple™ Technology is intended for use with theAutosuture™ Endo GIA™ Stapler and does not carry a separateindication from the stapling device.
TECHNOLOGICALCHARACTERISTICS:	The Endo GIA™ Single Use Black Reload with Tri-Staple™Technology for use in extra thick tissue is substantially equivalentto the predicate Reload cartridges with regard to the staplingtechnologies employed. The addition of the Single Use BlackReload with Tri-Staple™ Technology provides an additionaloffering to the surgeon where thick tissue must be transected orresected.
MATERIALS:	All components of the Autosuture™ Endo GIA™ Single UseBlack Reload with Tri-Staple™ Technology are comprised ofmaterials that are in accordance with ISO Standard 10993-1.
PERFORMANCE DATA:	Bench and in-vivo performance evaluations were conducted todemonstrate that the new Endo GIA™ Single Use Black Reloadwith Tri-Staple™ Technology when used with the Autosuture™Endo GIA™ Stapler is safe and effective and performs asintended

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Surgical Devices Tyco Healthcare Group LP (d/b/a Covidien) % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K093410

Trade/Device Name: Autosuture™ Endo GIA™Single Use Black Reload with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 30, 2009 Received: November 2, 2009

NOV 12 2009

Dear Mr. Gianelli:

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, 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 (PMA), it may be subject to 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, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Frank Gianelli

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

K09340 510(k) Number (if known):

Device Name: Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM

(Division Sign-Of) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093410

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.