The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.

Device Description

SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows of titanium staples and the blade, contained in the reload, simultaneously divides the tissue between the two rows. These devices allow for a maximum of 8 reloads in a single surgical procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based upon clinical input, the procedures these devices are used for and the maximum allowable firings for similar devices of other manufactures. Note: Only the stapler is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.

AI/ML Overview

The provided document describes a 510(k) premarket notification for Reprocessed AutoSuture GIA Endoscopic Staplers. This is a submission for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) product. Therefore, the information requested in the prompt, such as AI model performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment, is not applicable to this type of submission.

The acceptance criteria and supporting study for a reprocessed device primarily focus on demonstrating that the reprocessed device performs substantially equivalently to the original (predicate) device and that the reprocessing methods (cleaning, sterilization, functional testing) are validated and effective.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for Reprocessed AutoSuture GIA Endoscopic Staplers

Acceptance Criteria Category	Description	Reported Device Performance
Functional Characteristics	The reprocessed staplers must demonstrate appropriate functional characteristics, performing in a manner substantially equivalent to the original, new AutoSuture GIA Endoscopic Stapler. This includes:	Representative samples of reprocessed staplers are confirmed to meet the functional performance of the predicate device (AutoSuture GIA Endoscopic Stapler K061095). Specific metrics are not detailed but would typically include:
Cleaning Validation	The reprocessing methods must effectively clean the used devices to remove biological contaminants and particulates.	Process validation testing was performed to validate the cleaning procedures. The specific metrics for cleanliness (e.g., residual protein, hemoglobin, TOC) and the acceptance limits would have been established and met during this validation.
Sterilization Validation	The reprocessing methods must effectively sterilize the cleaned devices, rendering them free of viable microorganisms.	Process validation testing was performed to validate the sterilization procedures. This typically involves demonstrating a sterility assurance level (SAL) of 10^-6 or better for a terminal sterilization process, using biological indicators and validated cycles.
Packaging Validation	The packaging used for the reprocessed devices must maintain sterility and product integrity until the point of use.	Process validation testing was performed to validate device packaging. This typically involves accelerated and real-time aging studies, as well as package integrity tests (e.g., peel strength, burst tests).
Manufacturing Process Control	The manufacturing process for reprocessing must include robust controls to ensure consistent quality and performance of all produced devices.	The manufacturing process includes visual and validated functional testing of all products produced. This implies a quality management system with in-process and final product inspections and tests to ensure conformity to specifications.
Maximum Firings Allowed	The reprocessed device must be safe for use for a specified maximum number of firings within a single surgical procedure. The OEM allows up to 25 firings for new devices. SterilMed aimed to lower this number based on clinical input and comparison with similar devices, demonstrating safety for the proposed use.	SterilMed lowered the number of firings allowed to 8 based on clinical input, procedures used, and maximum allowable firings for similar devices of other manufacturers. This implies testing was conducted to support the safety and efficacy of the device for at least 8 firings after reprocessing.
Material Equivalence	The reprocessed device, post-reprocessing, must maintain material properties that are substantially equivalent to the predicate device and suitable for its intended use. (Not explicitly stated as an "acceptance criteria" but implied by substantial equivalence claim).	The conclusion of substantial equivalence is based on the devices' similarities in functional design (principle of operation), materials, indications for use, and methods of construction. This suggests that materials are not significantly degraded or altered by the reprocessing such that they compromise safety or performance.
Indications for Use	The reprocessed device must be suitable for the same indications for use as the predicate device.	The reprocessed reloadable AutoSuture GIA staplers are intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection of tissue and anastomosis. Additionally, the AutoSuture ENDO GIA Staplers may be used for transection of liver tissue, hepatic vasculature, and biliary structures, which aligns with the typical indications for the new predicate device.

Regarding the AI/SaMD specific questions from the prompt:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a reprocessed physical device. Testing would involve a sample of reprocessed devices from the production line, not a data test set.
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. Clinical input informed the "8 firings" decision, but this isn't ground truth for an algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a reprocessed device, "ground truth" would relate to objective measurements of functionality, safety (e.g., sterility, cleanliness, burst strength for staple lines), and material integrity compared to the new device specifications and regulatory standards. It doesn't involve clinical "ground truth" in the diagnostic sense.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence for a reprocessed stapler through bench testing and process validation for cleaning, sterilization, packaging, and functional performance, rather than clinical studies or AI algorithm validation.

Summary

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070930 pg 1 of 1

RILMED INC

510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007

For Reprocessed Autosuture Gia Endoscopic Staplers

II. SUMMARY AND CERTIFICATION

0CT 1 8 2007

A. 510(k) Summary

Submitter:	SterilMed, Inc.
Contact Person:	Caroline Butterfield11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 888-856-4870Fax: 763-488-3350
Date Prepared:	March 30, 2007
Trade Name:	Reprocessed AutoSuture GIA Endoscopic Staplers
Classification Name:	Staple, Implantable
Classification Number:	Class II, 21 CFR 878.4750
Product Code:	NLL

PredicateDevices:	The reprocessed AutoSuture GIA Endoscopic Staplers are substantially equivalent to theAutoSuture GIA Endoscopic Stapler (K061095).
DeviceDescription:	SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rowsof titanium staples and the blade, contained in the reload, simultaneously divides the tissuebetween the two rows. These devices allow for a maximum of 8 reloads in a single surgicalprocedure. The OEM has specified that the subject staplers may be fired up to 25 times in asingle surgical procedure. SterilMed has lowered the number of firings allowed to 8 basedupon clinical input, the procedures these devices are used for and the maximum allowablefirings for similar devices of other manufactures.Note: Only the stapler is the subject of this submission, the implantable staple and the staplecartridge are not reprocessed and therefore are not included.
Intended Use:
Functional andSafety Testing:	Representative samples of reprocessed staplers are tested to demonstrate appropriate functionalcharacteristics. Process validation testing is performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturing process includes visualand validated functional testing of all products produced.
Conclusion:	The reprocessed endoscopic staplers are substantially equivalent to the GIA Endoscopic Stapler(K061095) manufactured by AutoSuture.This conclusion is based upon the devices' similarities in functional design (principle ofoperation), materials, indications for use and methods of construction.

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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 stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

SterilMed, Inc. % Mr. Dennis J. Toussaint Director, Regulatory Affairs 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369

Re: K070930

Trade/Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: October 10, 2007 Received: October 11, 2007

Dear Mr. Toussaint:

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 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, 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 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. Dennis J. Toussaint

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson De
Director
10
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
17

Center for Devices and Radiological Health

Enclosure

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topsiof

Devices Included in this Submission List of

OEM	Model	Description	A MILL CLASS AND ALL ALL ALL PLAN A BLACK A STATUS A STATUS A FLA PARTY A BELL A FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FReprocesso	SterilMed Part

	030403	GIA Universal 12mm dia., 63		Number AUT030403
		mm long shaft Endo GIA Universal 12mm dia.,
AutoSuture	030449		SterilMed, Inc.	AUT030449
		155 mm long shaft
	EGIAUNIVXL	Endo GIA Universal XL – Long		AUTEGIAUNIVXI
		12 mm dia., 255mm long shaft------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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070930 pg 1 of 1

510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007

For Reprocessed Autosuture Gia Endoscopic Staplers

Indications for Use

510(k) Number (if known):

Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers

Indications For Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
-------------------------------------------------	---	--------	------------------------------------------------

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Signature
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	14070930
---------------	----------

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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.