The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Device Description

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

AI/ML Overview

This document is a 510(k) Premarket Notification from Ezisurg (Suzhou) Medical Co., Ltd. for their Endoscopic Linear Cutting Staplers and Loading Units for Single Use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding ground truth, expert opinions, and multi-reader studies is not applicable or available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests conducted, but it does not explicitly state specific numerical acceptance criteria or quantitatively report the device's performance against them in a tabular format. Instead, it makes a general statement that "The test results demonstrated that the proposed device complies with the following standards" and were performed "to determine substantial equivalence."

Performance Test Category	Implicit Acceptance Criteria (based on "substantial equivalence" to predicate devices, and compliance with standards)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, 10993-5, 10993-10; USP 38-NF 33 <85>; USP 39-NF34:2016 <151>	Met the standards
Device Performance	Equivalent to predicate devices (K111825 and K061156) in:	Achieved substantial equivalence to predicate devices
- Firing Force Test	- Satisfactory firing force	Not quantitatively reported
- Staple Formation Test	- Proper staple formation (Image: staple, as shown for predicate devices)	Not quantitatively reported
- Staple Line Pressure Test	- Acceptable staple line pressure	Not quantitatively reported
- Staple Line Tensile Test	- Acceptable staple line tensile strength	Not quantitatively reported
- Hemostasis Evaluation Test	- Satisfactory hemostasis	Not quantitatively reported
- Close Staple Height Test	- Achieved specified closed staple heights (2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.8mm)	Not quantitatively reported
Sterilization	Compliance with ISO 11137-2:2013	Met the standard
Package Integrity	Compliance with ASTM F 88/F88M-09	Met the standard
Shelf Life	Maintained package integrity and performance over time	Achieved satisfactory shelf life
Endotoxin Limit	≤ 20 EU (same as predicate devices)	Met the limit (≤ 20 EU)

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

This information is not provided in the document. The document only mentions that "Non clinical tests were conducted," but does not specify the sample sizes for these tests or the origin of any data used.

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)

This information is not applicable/not provided. The document describes a pre-market notification process for a surgical stapler, which relies on physical and mechanical performance testing, not on interpretation of medical images or expert consensus for diagnosis. Therefore, there is no "ground truth" established by experts in this context.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation), which this submission does not describe. The tests mentioned are non-clinical, mechanical, and biological evaluations.

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

This information is not applicable/not provided. The device is an endoscopic linear cutting stapler, a physical surgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable/not provided. As explained above, the device is a mechanical surgical instrument, not an algorithm.

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

For the non-clinical tests described, the "ground truth" would be established by objective measurements and adherence to international standards and internal design specifications. For example, the "Staple Formation Test" would have an objective standard for what constitutes a properly formed staple, likely visually assessed and measured against specifications. "Biocompatibility" is assessed against specific ISO standards. "Endotoxin Limit" is measured quantitatively against a defined limit. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of engineering and biological performance tests.

8. The sample size for the training set

This information is not applicable/not provided. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 18, 2018

Ezisurg (Suzhou) Medical Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 Cn

Re: K181620

Trade/Device Name: Endoscopic Linear Cutting Staplers and Loading Units for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 7, 2018 Received: June 20, 2018

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

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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 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/Resourcesfor You/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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K181620

Device Name

Endoscopic Linear Cutting Staplers and Loading Units for Single Use

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: __K181620

1. Date of Preparation: 04/16/2018
1. Sponsor Identification

Ezisurg (Suzhou) Medical Co., Ltd.

Building 16, No.8 Jinfeng Rd., Suzhou National Hi-Tech District, Suzhou 215163 Jiangsu, China

Establishment Registration Number: Not yet registered.

Contact Person: Jingtian Ren Position: VP Quality& Registration Tel: 021-50456176-8026 Fax: 021-50676156 Email: renjingtian@ezisurg.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net

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Identification of Proposed Device 4.

Trade Name: Endoscopic Linear Cutting Staplers and Loading Units for Single Use Common Name: Stapler and Reload

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

Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery

Intended Use Statement:

Device Description

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ડ. Identification of Predicate Device

Predicate Device 1 510(k) Number: K111825 Product Name: Endo GIATM Staplers

Predicate Device 2 510(k) Number: K061156 Device Name: ENDOPATH Linear Cutters and Staplers

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
USP 38-NF 33 <85> Bacterial Endotoxins Tests
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
USP 39-NF34:2016 <151> Pyrogen Test

The tests provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility test, shelf life test and performance test were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items

Firing Force Test
Staple Formation Test
Staple Line Pressure Test
Staple Line Tensile Test
Hemostasis Evaluation Test
Close Staple Height Test

Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.

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Shelf life testing which included package integrity and performance evaluations were performed.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison for Endoscopic Linear Cutting Staplers and Loading Units for Single Use
Item	Proposed Device	Predicate Device 1	Predicate Device 2
		K111825	K061156
Product Code	GDW	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750	21 CFR 878.4750
Intended Use	The device are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.	The Endo GIATM Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.	The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
Cutting Mechanism	Linear	Linear	Linear
Operation Principle	Manual	Manual	Manual
Safety Mechanism	Green button is used for preventing from mis-firing.	Green button is used for preventing from mis-firing.	Green button is used for preventing from mis-firing.
Suture Length	30mm, 45mm, 60mm	30mm, 45mm, 60mm	60mm
Staple height	2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.8mm	2.0mm, 2.5mm, 3.5mm, 4.8mm	2.5mm, 3.5mm, 3.8mm, 4.1mm
Closed staple form	Image: staple	Image: staple	Image: staple
Endotoxin Limit	20 EU	20EU	20EU
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801	Conforms with 21 CFR 801

Table 1 Comparison for Endoscopic Linear Cutting Staplers and Loading Units for Single Use

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1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.