The CSC Series Intraluminal Stapler for Single Use 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 PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.

The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Device Description

The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be used 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. It places a double staggered, circular row of titanium staples upon activation, which was achieved 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 proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.

The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.

AI/ML Overview

This document describes the 510(k) summary for three intraluminal stapler devices. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about clinical studies with human participants, expert review of data, or AI performance metrics.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table for each proposed device against its predicate device, outlining various specifications which act as acceptance criteria. The "Proposed Device" column lists the performance or specifications of the new device, which are implicitly understood to meet the stated criteria by being "Same" or "Similar" to the predicate, with differences not affecting safety or effectiveness.

For all three devices (CSC Series, PPHplus Series, TST Series):

Item	Acceptance Criteria (Implied by Predicate/Device Spec)	Reported Device Performance (Proposed Device)
Product Code	GDW	GDW
Regulation No.	21 CFR 878.4750	21 CFR 878.4750
Class	Class II	Class II
Intended Use	Specific to each device	Same as predicate (details in tables 3-1, 3-2, 3-3)
Operation Principle	Manual	Manual
Cutting Mechanism	Circular Knife	Circular Knife
Safety Mechanism	Indicator for appropriate closed staple height, Safety Release for preventing mis-firing	Indicator for appropriate closed staple height, Safety Release for preventing mis-firing
Hardness (Circular knife)	≥380HV0.2	≥380HV0.2
Pressure Resistance after Suturing	≥3.6kPa	≥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	Irradiation Sterilized, SAL: 10-6	Irradiation Sterilized, SAL: 10-6
Endotoxin Limit	20 EU per Product	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

Device-Specific Performance (Examples from tables):

CSC Series Intraluminal Stapler (Table 3-1):
- Outsider Diameter: 21, 25, 29, 33 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 12.7, 16.4, 20.0, 24.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 16, 20, 24, 28 (Proposed); Similar (Predicate)
- Closed Staple Height: 2.0 mm (Proposed); Similar (Predicate)
- Closed Staple Form: Image (Proposed); Same (Predicate)
PPHplus Series PPH Stapler (Table 3-2):
- Outsider Diameter: 33.5 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 24.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 32 (Proposed); Same (Predicate)
- Closed Staple Height: 1.3, 1.6 mm (Proposed); Similar (Predicate)
TST Series Tissue-Selecting Therapy Stapler (Table 3-3):
- Outsider Diameter: 31.5, 33.5, 36.5 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 22.4, 24.4, 26.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 30, 32, 34 (Proposed); Similar (Predicate)
- Closed Staple Height: 1.3, 1.6, 2.0 mm (Proposed); Similar (Predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document states that "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 non-clinical tests include Performance Testing (Physical Specification, Closed Staple Height, Pressure Resistance, Tensile Strength, Force to Fire), Endotoxin Limit, Package Integrity, and Shelf Life.

Sample Size for Test Set: Not explicitly stated. The tests are described generally, without specific numbers of devices or samples tested.
Data Provenance: The tests are non-clinical (laboratory/bench testing) and do not involve human or animal subjects in the sense of clinical trials. The country of origin for the data is implicitly the country where Touchstone International Medical Science Co., Ltd. conducts its testing, which is P.R. CHINA. The data is prospective in the sense that these tests were conducted on the newly manufactured devices to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This document describes non-clinical engineering and performance testing of a medical stapler. There is no "ground truth" established by experts in the context of diagnoses or interpretations of medical images/data, as there would be for an AI device. The "ground truth" here refers to the actual measured physical properties and performance characteristics of the device during bench testing, compared against predetermined engineering specifications or predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical bench testing. There is no adjudication method in the context of expert review or consensus for patient-related outcomes. The judgment is based on objective measurements and adherence to specifications.

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

Not applicable. This document is for a surgical stapler, not an AI or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document is for a surgical stapler, not an AI or algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests can be considered the objectively measured performance characteristics of the device itself (e.g., measured closed staple height, actual pressure resistance, force to fire, endotoxin levels). These measurements are then compared against established engineering specifications, regulatory standards (like ASTM F 67-06 for Titanium), and the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms a wing-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

December 12, 2014

Touchstone International Medical Science Company, Ltd. Mr. Jo Qiao Management Representative 21A Science Plaza, International Science Park No. 1355 Jinjihu Avenue Suzhou, 215021 P.R. CHINA

Re: K141097

Trade/Device Name: CSC Series Intraluminal Stapler for Single Use, PPHplus Series PPH Stapler, and TST Series Tissue-Selecting Therapy Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: August 26, 2014 Received: August 29, 2014

Dear Mr. Qiao:

This letter corrects our substantially equivalent letter of September 26, 2014.

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.

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Page 2 - Mr. Jo Qiao

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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091 ); 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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)

Device Name

CSC Series Intraluminal Stapler for Single Use

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

PPHplus Series PPH Stapler and Purse Sets for Single Use

Indications for Use (Describe)

The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.

Type of Use (Select one or both, as applicable)

즈 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

TST Series Tissue-Selecting Therapy Stapler

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

즈 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{5}------------------------------------------------

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:

Submission Date: 04/18/2014 1.
Sponsor Identification 2.

Touchstone International Medical Science Co., Ltd. 21A Science Plaza, International Science Park, No.1355 Jinjihu Avenue, Suzhou, 215021 P.R.CHINA

Establishment Registration Number:

Contact Person: Jo.Qiao Position: Management Representative Tel: +86 512 62991985 Fax: +86 512 62991998 Email: tsmo@touchstone.hk

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Proposed Device Identification 3.

Proposed Device for CSC Series 3.1

Proposed Device Name: CSC Series Intraluminal Stapler for Single Use 3.1.1
3.1.2 Proposed Device Common Name: Stapler

3.1.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery

3.1.4 Intended Use Statement

3.1.5 Device Description

It places a double staggered, circular row of titanium staples upon activation, which was achieved 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.

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3.2 Proposed Device for PPHplus Series

3.2.1 Proposed Device Name: PPHplus Series PPH Stapler and Purse Sets for Single Use
3.2.2 Proposed Device Common Name: Stapler

3.2.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery

3.2.4 Intended Use Statement

The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.

3.2.5 Device Description

The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids.

It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.

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

3.3 Proposed Device for TST Series

3.3.1 Proposed Device Name: TST Series Tissue-Selecting Therapy Stapler
3.3.2 Proposed Device Common Name: Stapler

3.3.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery

3.3.4 Intended Use Statement

3.3.5 Device Description

It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.

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

1. Predicate Device Identification
- Predicate Device for Disposable Circular Stapler 4.1

510(k) Number: K131511

Product Name: Disposable Circular Stapler

Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.

4.2 Predicate Device for Disposable Hemorrhoidal Stapler

510(k) Number: K131511

Product Name: Disposable Hemorrhoidal Stapler

Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.

4.3 Predicate Device for PROXIMATE® HCS

510(k) Number: K030925

Product Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories(PPH01) Manufacturer: Ethicon Endo-Surgery, Inc.

1. 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 Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler.

Endotoxin Limit

Package Integrity, including dye penetration tests and seal strength test.

Shelf Life

1. Substantially Equivalent (SE) Conclusion
  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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Item	Proposed Device	PredicateDevice
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The CSC Series Intraluminal Stapler for Single Use haveapplications throughout the alimentary tract for the creationof end-to-end, end-to-side and side-to-side anastomoses inboth open and laparoscopic surgeries.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Indicator for appropriate range of desired closed stapleheight.Safety Release for preventing from mis-firing	Same
Outsider Diameter	21, 25, 29, 33 mm	Similar
Cutting Diameter	12.7, 16.4, 20.0, 24.4, mm	Similar
Number of Staples	16, 20, 24, 28	Similar
Closed Staple Height	2.0 mm	Similar
Closed Staple Form	Image: staple form	Same
Hardness (Circular knife)	$≥380HV0.2$	Same
Pressure Resistance after 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	Same
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-1 CSC Series Intraluminal Stapler for Single Use

Difference in Outsider Diameter, Cutting Diameter, Number of Staples, Closed Staple Height. Between the proposed and the 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, CSC Series Intraluminal Stapler for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Circular Stapler (K131511), in respect of safety and effectiveness.

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

Item	Proposed Device	PredicateDevice
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The PPHplus Series PPH Stapler and Purse Sets for SingleUse have application for general surgical treatment ofhemorrhoids.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Indicator for appropriate range of desired closed stapleheight.	Same
	Safety Release for preventing from mis-firing	Same
Outsider Diameter	33.5 mm	Similar
Cutting Diameter	24.4 mm	Similar
Number of Staples	32	Same
Closed Staple Height	1.3, 1.6 mm	Similar
Closed Staple Form	UD	Same
Hardness (Circular knife)	≥380HV0.2	Same
Pressure Resistance after 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	Same
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-2 PPHplus Series PPH Stapler and Purse Sets for Single Use

Difference in Outsider Diameter, Cutting Diameter, Closed Staples Height. 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, PPHplus Series PPH Stapler and Purse Sets for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Hemorrhoidal Stapler(K131511), in respect of safety and effectiveness.

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

Item	Proposed Device	PredicateDevice
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The TST Series Tissue-Selecting Therapy Stapler haveapplication for general surgical treatment of anorectal walldefects by means of transanal stapling and resection ofmucosal and musculomucosal tissue.	Same
Operation Principle	Manual	Same
Cutting Mechanism	Circular Knife	Same
Safety Mechanism	Indicator for appropriate range of desired closed stapleheight.	Same
	Safety Release for preventing from mis-firing	Same
Outsider Diameter	31.5, 33.5, 36.5 mm	Similar
Cutting Diameter	22.4, 24.4, 26.4 mm	Similar
Number of Staple	30, 32, 34	Similar
Closed Staple Height	1.3, 1.6, 2.0 mm	Similar
Closed Staple Form	Image: Closed Staple Form	Same
Hardness (Circular knife)	$\ge$ 380HV0.2	Same
Pressure Resistance after 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	Same
Endotoxin Limit	20 EU per Product	Same
Package	Tray with Tyvek Paper	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 3-3 TST Series Tissue-Selecting Therapy Stapler

Difference in Outsider Diameter, Cutting Diameter, Number of Staple, Closed Staple Height. 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, TST Series Tissue-Selecting Therapy Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories(K030925), in respect of safety and effectiveness.

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.