The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Device Description

The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures. It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure. The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Endoscopic Linear Cutting Staplers with Single Use Loading Units:

This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It is not a clinical study report that would typically describe detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies as you requested. The "study" here refers to non-clinical bench testing for substantial equivalence, not a clinical trial or AI algorithm validation.

Therefore, many of your requested items are not applicable (NA) or not explicitly stated in this type of regulatory submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

The provided text describes a "Substantial Equivalence (SE) Conclusion" based on a comparison to a predicate device, rather than explicit numerical acceptance criteria for a new clinical performance study. The reported performance is that the proposed device is "Substantially Equivalent" to the predicate device in terms of safety and effectiveness, based on meeting similar technological characteristics and passing non-clinical tests.

Item	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Proposed Device Performance
Intended Use	Must be same as predicate.	Applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. May be used for transection and resection of liver substance, hepatic vasculature and biliary structures. (Same as Predicate)
Product Code	Must be same as predicate (GDW).	GDW (Same as Predicate)
Regulation Number	Must be same as predicate (21 CFR 878.4750).	21 CFR 878.4750 (Same as Predicate)
Class	Must be same as predicate (II).	II (Same as Predicate)
Cutting Mechanism	Must be same as predicate (Linear).	Linear (Same as Predicate)
Operation Principle	Must be same as predicate (Manual).	Manual (Same as Predicate)
Safety Mechanism	Must be same as predicate.	Green button for preventing from mis-firing. (Same as Predicate)
Suture Length	Must be similar to predicate.	46, 61 mm (Similar to Predicate)
Closed Staples Height	Must be same as predicate.	0.75, 1.0, 1.5, 2.0 mm (Same as Predicate)
Closed Staples Form	Must be same as predicate.	Image: staple form (Same as Predicate)
Staple Material	Must be same as predicate (Unalloyed Titanium conforms to ASTM F 67-06).	Unalloyed Titanium conforms to ASTM F 67-06 (Same as Predicate)
Stapler Materials	Must be same as predicate (Stainless Steel).	Stainless Steel (Same as Predicate)
Sterilization	Must be similar to predicate.	Irradiation Sterilized, SAL: 10-6 (Similar to Predicate)
Overall Safety & Effectiveness	Must be demonstrably equivalent to predicate.	Determined to be Substantially Equivalent to predicate (K120179). (Meets Criteria)
Non-Clinical Design Specifications	All design specifications must be met.	All design specifications met through Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing. (Meets Criteria)

Study Details (as inferable from the provided text)

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

Sample Size for Test Set: Not specified. The "test set" here refers to units of the device subjected to non-clinical bench testing. The number of devices tested for "Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing" is not detailed.
Data Provenance: Not specified. These are non-clinical bench tests; geographical origin of data is typically less relevant than for clinical studies. The manufacturer is Nanjing Maidixin Medical Device Company, LTD (China), suggesting the testing likely occurred there or through a contract lab.
Retrospective/Prospective: NA. This classification typically applies to clinical studies.

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)

NA. This document describes non-clinical engineering and performance testing, not evaluation by medical experts to establish a "ground truth" for diagnostic or clinical outcome data. The "ground truth" here is objective measurement results from bench tests compared to design specifications or predicate device characteristics.

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

NA. Adjudication methods are relevant for clinical studies or image interpretation, not for bench testing of a stapler.

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

NA. This type of study is for AI-powered diagnostic or assistive devices, which this stapler is not.

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

NA. This device does not involve an algorithm.

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

The "ground truth" for this submission is based on objective engineering and laboratory measurements (e.g., staple height, material composition, sterilization levels, physical performance metrics like cutting force or staple formation) and the established characteristics of the legally marketed predicate device.

8. The sample size for the training set

NA. This device does not use machine learning, so there is no training set. The "design specifications" could be considered the "training" for the device's manufacturing and testing.

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

NA. Not applicable as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the device's design and manufacturing standards would have been established through engineering principles, regulatory standards (e.g., ASTM F67-06 for titanium), and comparison to existing, proven devices (the predicate).

Summary

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Section III 510(k) Summary

Project #: M0032012Aa

DEC 1 3 2013

Proposed Device Identification 4.

Proposed Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Device Common Name: Stapler

Regulatory Information: Classification Name: Staple, Implantable; Classification: II; Product Code: GDW: Regulation Number: 21 CFR 878.4750; Review Panel: General & Plastic Surgery;

Intended Use Statement:

The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

Predicate Device Identification 5.

510(k) Number:K 120179

Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Manufacturer: Reach Surgical, Inc.

6. Device Description

It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure.

The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.

Non-Clinical Test Conclusion 7.
111-2

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Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.

1. Substantially Equivalent (SE) Conclusion
  The following table compares the proposed device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation Number	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Endoscopic Linear Cutting Staplers with SingleUse Loading Units have applications in general,gynecologic, pediatric and thoracic surgery forresection, transection, and creation of anastomoses.They may be used for transection and resection ofliver substance, hepatic vasculature and biliarystructures.	Same
Cutting Mechanism	Linear	Same
Operation Principle	Manual	Same
Safety Mechanism	Green button for preventing from mis-firing.	Same
Suture Length	46, 61 mm	Similar
Closed Staples Height	0.75, 1.0, 1.5, 2.0 mm	Same
Closed Staples Form	Image: staple form	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar

.Table 111-1 Comparison of Technology Characteristics

The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.

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Image /page/2/Picture/0 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 that resembles a human figure embracing or supporting another, representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Nanjing Maidixin Medical Device Company, LTD % Ms. Diana Hong Mid-Link Consulting Company LTD P.O. Box 120-119 Shanghai, China 200120

December 13, 2013

Re: K130738

Trade/Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 7, 2013 Received: November 12, 2013

Dear Ms. Hong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Ms. Diana Hong

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

For

Sincerely vours.

Joshua

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Section II Indications for Use

510(k) Number: K130738 Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units

Indications for Use:

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

David Krause SS

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130738

II-I

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.