The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Disposable Hemorrhoidal Staple has application for general surgical treatment of hemorrhoids.

The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

The Disposable Curved Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.

Device Description

The proposed device, Disposable Circular Stapler is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created. The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue.

The proposed device, Disposable Linear Staplers and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications.

The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them. Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required.

The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads is a sterilized and I ile proposed unstrument, which has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for thoracter bargery 200 on of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available. The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description.

The proposed device, Disposable Linear Cutter Staplers and Reloads is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate उन्द various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm. The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications.

The proposed device, Disposable Curved Cutter Stapler is a sterilized and disposable surgical instrument, which is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.

AI/ML Overview

The provided document is a 510(k) Summary for various surgical staplers. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study report with detailed acceptance criteria and performance data for a new AI/ML device.

Therefore, the requested information, particularly regarding specifics of a study proving device performance against acceptance criteria, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or specific AI algorithm performance metrics, is not present in this document.

This document outlines the intended use, technological characteristics, and comparison to predicate devices for a suite of surgical staplers. The "Non-Clinical Test Conclusion" section {4} states that tests were conducted to verify the device met all design specifications and was substantially equivalent to the predicate device. These tests primarily cover physical performance, material properties, and packaging integrity.

Here's a table summarizing the acceptance criteria and reported device performance for one of the devices (Disposable Circular Stapler) as presented in the document:

Table of Acceptance Criteria and Reported Device Performance (Disposable Circular Stapler)

Acceptance Criteria (Item)	Unit	Acceptance Range / Predicate Value (Implicitly the criterion)	Reported Device Performance (Proposed Device)
Product Code	-	GDW	GDW
Regulation No.	-	21 CFR 878.4750	21 CFR 878.4750
Class	-	II	II
Intended Use	-	Creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.	Same
Operation Principle	-	Manual	Manual
Cutting Mechanism	-	Circular Knife	Circular Knife
Safety Mechanism	-	Indicator for appropriate range of desired closed staple height. Safety Release for preventing from mis-firing.	Same
Outsider Diameter	mm	Similar to predicate	21, 23, 25, 27, 29, 31, 33 mm
Cutting Diameter	mm	Similar to predicate	12.4, 15, 17, 18.5, 20, 22.2, 24 mm
Number of Staples	-	Similar to predicate	18, 20, 22, 24, 28, 30
Closed Staples Height	mm	Similar to predicate	2.0, 2.2 mm
Closed Staples Form	-	Two staples connected at the top	Image: Two staples connected at the top
Hardness (Circular knife)	HV0.2	≥ 380	≥ 380HV0.2
Pressure Resistance after Suturing	kPa	≥ 3.6	≥ 3.6kPa
Staple Material	-	Unalloyed Titanium conforms to ASTM F 67-06	Unalloyed Titanium conforms to ASTM F 67-06
Stapler Materials	-	Stainless Steel, Polycarbonate	Stainless Steel, Polycarbonate
Sterilization	-	Similar to predicate	Irradiation Sterilized, SAL: 10-6
Endotoxin Limit	EU per Product	20	20 EU per Product
Package	-	Tray with Tyvek Paper	Tray with Tyvek Paper
Labeling	-	Conforms to 21 CFR part 801	Conforms to 21 CFR part 801

Regarding the other requested information:

Sample size used for the test set and the data provenance: This document does not specify sample sizes for specific tests or the provenance of any "data provenance" (e.g., country of origin, retrospective/prospective clinical data) as it's a submission for a medical device (surgical staplers) based on non-clinical performance and substantial equivalence to existing predicate devices, not an AI/ML diagnostic or prognostic tool. The tests mentioned are "Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Perforrnality Tisting, Mercums Tensile Strength of Staple Line Repair and Force Required to Fire Stapler" {4}.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for surgical staplers like this would typically be established through engineering specifications, material standards, and performance testing against those standards, not expert consensus on interpretations of data.
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: No, an MRMC study was not done as this is not an AI/ML-driven diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device would be its adherence to established engineering specifications, material standards (e.g., ASTM F 67-06 for titanium), and performance thresholds (e.g., pressure resistance, hardness) determined through non-clinical testing.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence of a physical medical device (surgical staplers) to previously cleared devices based on non-clinical performance testing and design specifications, rather than clinical studies or AI/ML algorithm evaluations which would require the detailed information requested.

Summary

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JUL 5 2013

3-1

Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _ K31511

1. Date of Submission: 04/07/2013
1. Sponsor Identification

Changzhou Sinolinks Medical Innovation Co., Ltd NO. 10 Ziwei Road, Zhonglou Zone, Changzhou, Jiangsu, 213023,China

Establishment Registration Number: 3008383115

Contact Person: Junchang Yue Position: Quality Department Manager Tel: +86-519-88021676 Fax: +86-519-88021698 Email: junchang.yue@gmail.com

Submission Correspondent 3.

Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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K131511 page 2/11

Project #: M0172013Aa

Proposed Device Identification 4.

Proposed Device Name: Disposable Circular Stapler

Disposable Linear Staplers and Reloads

Disposable Hemorrhoidal Stapler

Disposable Endoscopic Linear Cutter Staplers and Reloads

Disposable Linear Cutter Staplers and Reloads

Disposable Curved Cutter Stapler

Proposed Device Common Name: Staplers

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 Disposable Circular Stapler have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Staplers and Reloads have application in the resection of transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Disposable Hemorrhoidal Staple have application for general surgical treatment of hemorrhoids.

The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatic and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynesological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

The Disposable Curved Cutter Stapler is intended for transection, and/or creation of In answere of the instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

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Project #: M0172013Aa

Predicate Device Identification 5.

510(k) Number: K120179

Product Name: REACHTM Surgical Staplers, including:

Circular Staplers with Staples,

Linear Staplers with Single Use Loading Units,

Procedure Sets for Prolapse and Hemorrhoids,

Endoscopic Linear Cutting Staplers with Single Use Loading Units,

Linear Cutting Staplers with Single Use Loading Units

Manufacturer: Reach Surgical, Inc.

510(k) Number: K091322

Predicate Device Name: CONTOURTH Curved Cutter Stapler and Reloads Manufacturer: Ethicon Endo-Surgery, LLC

Device Description 6.

6.1 Disposable Circular Stapler

It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.

The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue.

6.2 Disposable Linear Staplers and Reloads

It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings.

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Project #: M0172013Aa

The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications.

6.3 Disposable Hemorrhoidal Stapler

The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids.

It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them.
Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required.

6.4 Disposable Endoscopic Linear Cutter Staplers and Reloads

It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available.

The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description.

6.5 Disposable Linear Cutter Staplers and Reloads

It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate उन्द

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Project #: M017

various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm.

The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers
Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications.

6.6 Disposable Curved Cutter Stapler

It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.

7. Non-Clinical Test Conclusion

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:

Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Periormality Tisting, Mercums Tensile Strength of Staple Line Repair and Force Required to Fire Stapler

Endotoxin Limit

Package Integrity, including internal pressure test, dye penetration tests and seal strength test Shelf Lift

Substantially Equivalent (SE) Conclusion 8.

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

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Project #: M0172013A

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Circular Stapler have applicationsthroughout the alimentary tract for the creation ofend-to-end, end-to-side and side-to-side anastomosesin both open and laparoscopic surgeries.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Indicator for appropriate range of desired closedstaple height.Safety Release for preventing from mis-firing.	Same
Outsider Diameter	21, 23, 25, 27, 29, 31, 33 mm	Similar
Cutting Diameter	12.4, 15, 17, 18.5, 20, 22.2, 24, mm	Similar
Number of Staples	18, 20, 22, 24, 28, 30	Similar
Closed Staples Height	2.0, 2.2 mm	Similar
Closed Staples Form	Image: Two staples connected at the top	Same
Hardness (Circularknife)	$\ge$ 380HV0.2	Same
Pressure Resistanceafter Suturing	$\ge$ 3.6kPa	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-1 Comparison of Disposable Circular Stapler

Difference in Outsider Diameter, Cutting Diameter, Number of Staples and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

The proposed device, Disposable Circular Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, Circular Staplers with Staples (K120179), in respect of safety and effectiveness.

રેન્ડર્

{6}------------------------------------------------

Section 3 510 (k) Summary

Project #: MOI 72013Aa

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Linear Staplers and Reloads haveapplication in the resection or transection of tissue forabdominal, gynecological, pediatric and thoracicsurgical procedures.	Same
Operation Principle	Manual	Same
Safety Mechanism	Safety Release for preventing from mis-firing.	Same
Suture Line Length	30, 45, 60, 94 mm	Similar
Number of Staples	11, 15, 21, 33	Same
Closed Staples Height	1.5, 1.8 mm	Similar
Closed Staples Form	Image: Two staples connected at the top	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-2 Comparison of Disposable Linear Staplers and Reloads

Difference in Suture Line Length, Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

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

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Section 3 510 (k) Summary

Project #: M0172013Aa

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Hemorrhoidal Staple haveapplication for general surgical treatment ofhemorrhoids.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Indicator for appropriate range of desired closedstaple height.Safety Release for preventing from mis-firing.	Same
Outsider Diameter	32, 34 mm	Same
Cutting Diameter	23, 25 mm	Same
Number of Staples	32	Same
Closed Staples Height	1.9 mm	Similar
Closed Staples Form	Image: [staples]	Same
Hardness (Circularknife)	≥380HV0.2	Same
Pressure Resistanceafter Suturing	>3.6kPa	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-3 Disposable Hemorrhoidal Stapler

Difference in Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

The proposed device, Disposable Hemorhoidal Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, Procedure Sets for Prolapse and Hemorrhoids (K120179), in respect of safety and effectiveness.

{8}------------------------------------------------

K131511
page 9/11

Section 3 510 (k) Summary

Project #: M0172013AB

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Endoscopic Linear Cutter Staplersand Reloads 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
Operation Principle	Manual	Same
Cutting Mechanism	Linear	Same
Safety Mechanism	Green button for preventing from mis-firing.	Same
Suture Length	30, 45, 60 mm	Same
Cutting Length	26, 41, 58 mm	Similar
Closed Staples Height	1.5, 1.9 mm	Similar
Closed Staples Form		Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-4 Disposable Endoscopic Linear Cutter Staplers and Reloads

Difference in Cutting Length, Closed Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads, is determined to be The propose 2011.05, Days to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.

{9}------------------------------------------------

K131511
page 10/11

Section 3 510 (k) Summary

Project #: M0172013Aa

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Linear Cutter Staplers and Reloadshave application in abdominal, gynecological,thoracic and pediatric surgery transection, resection,and the creation of anastomoses.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Linear	Same
Safety Mechanism	Safety Release for preventing from mis-firing.	Same
Suture Length	56, 76, 81, 101 mm	Similar
Cutting Length	55, 75, 80, 100 mm	Similar
Number of Staples	32, 38, 42, 52	Similar
Closed Staples Height	1.5, 1.8 mm	Similar
Closed Staples Form	Image: Two circles connected by a line	Same
Knife Hardness	$≥$ 380HV0.2	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-5 Disposable Linear Cutter Staplers and Reloads

Difference in Suture Length, Cutting Length, Number of Staples Height and Sterilization between the proposed and predicate device are discussed in the 510(k) submission documents, it is between the proposed and proposed will not affectiveness and safety of the proposed device.

The proposed device, Disposable Linear Cutter Staplers and Reloads, is determined to be Substantially File proposed arries, Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.

{10}------------------------------------------------

K131511
page 11/11

Section 3 510 (k) Summary

Project #: M0172013Aa

Item	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The Disposable Curved Cutter Stapler is intended fortransection, resection, and/or creation ofanastomoses. The instrument has application inmultiple open or minimally invasive general(gastrointestinal and skeletal muscle), gynecologic,urologic, and thoracic surgical procedures.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Safety Release for preventing from mis-firing.	Same
Cutting Diameter	40 mm	Same
Row Number ofStaples	4	Same
Closed Staples Height	1.9 mm	Similar
Closed Staples Form	Image: Staples Form	Same
Knife Hardness	≥380HV0.2	Same
Staple Materiel	Unalloyed Titanium conforms to ASTM F 67-06	Same
Stapler Materials	Stainless Steel, Polycarbonate	Same
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

sable Curved Cutter Stapler 2 4 Dies

The proposed device, Disposable Curved Cutter Stapler, is determined to be Substantially Equivalent (SE) I he proposed device, Disposable OLI 100 Cutter Stapler and Reloads (K091322), in respect of safety and effectiveness.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 5, 2013 Changzhou Sinolinks Medical Innovation Co., Ltd. % Mid-Link Consulting Co., Ltd. Ms. Diana Hong P.O. Box 120-119 Shanghai, 200120, China

Re: K131511

Trade/Device Name: Disposable Circular Stapler, Disposable Curved Cutter Stapler Disposable Linear Staplers and Reloads, Disposable Hemorrhoidal Stapler, Disposable Endoscopic Linear Cutter Staplers and Reloads, Disposable Linear Cutter Staplers and Reloads

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW " Dated: May 21, 2013 Received: May 28, 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

{12}------------------------------------------------

Page 2 - Ms. Diana Hong

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.fdg.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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131511

Device Name: Disposable Circular Stapler / Disposable Linear Staplers and Reloads / Disposable Hemormoidal Stapler / Disposable Endoscopic Linear Cutter Staplers and Reloads / Disposable Linear Cutter Staplers and Reloads / Disposable Curved Cutter Stapler

Indications For Use:

The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Disposable Hemorrhoidal Staple has application for general surgical treatment of hemorrhoids.

The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

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

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)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131511

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.