The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.

Device Description

The proposed devices, easyEndo® Linear Cutting Stapler and Loading Unit for Single Use, are sterilized and disposable surgical instruments, which have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.

It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The easyEndo® Linear Cutting Stapler may be reloaded and fired no more than 25 times in a single procedure.

AI/ML Overview

This document does not describe a study proving the device meets acceptance criteria. Instead, it is an FDA 510(k) Premarket Notification summary for the "easyEndo® Linear Cutting Stapler and Loading Unit for Single Use."

The document focuses on establishing substantial equivalence to a predicate device (Endo GIA™ Universal Staplers with Duet TRS™ reloads) rather than detailing performance acceptance criteria and a study to prove they are met in the traditional sense of a clinical trial or performance study against specific metrics.

Here's a breakdown of the information requested, based on the provided text, and highlighting what is not present:

1. A table of acceptance criteria and the reported device performance

The provided document does not present a table of acceptance criteria with corresponding device performance results in a quantitative manner as typically found in a device performance study. Instead, it lists non-clinical tests conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device.

Acceptance Criteria (Stated as conformance to standards/design)	Reported Device Performance (Implied by "met" or "complies with")
Seal strength of flexible barrier materials (ASTM F88/F88M-09)	Complies with standard
Detecting seal leaks in porous medical packaging (ASTM 1929-12)	Complies with standard
Bacterial Endotoxins Test (USP 37-NF32:2014, <85>)	Complies with standard
Pyrogen Test (USP Rabbit Test) (USP 37-NF32 <151>)	Complies with standard
Biocompatibility (Cytotoxicity, ISO 10993-5)	Complies with standard
Biocompatibility (Irritation and skin sensitization, ISO 10993-10)	Complies with standard

The document also offers a "Substantially Equivalent (SE) Comparison" (Table 1) which compares technological characteristics between the proposed and predicate device. This table does not list acceptance criteria but rather features of the device.

2. Sample sized 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. The document states that "Non clinical tests were conducted," but does not specify sample sizes for these tests or the provenance of the data.

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 provided. The non-clinical tests described do not involve human expert ground truth establishment; they refer to standard testing protocols.

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

This information is not provided. As the tests are non-clinical, an adjudication method for ground truth would not be applicable in the same way it would for a clinical study involving subjective assessments.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a surgical stapler, not an AI-assisted diagnostic or treatment device, so such a study would not be applicable. The document explicitly states: "No clinical study is included in this submission."

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

This question is not applicable as the device is a mechanical surgical stapler, not an algorithm or AI system.

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

For the non-clinical tests mentioned, the "ground truth" is established by the specifications and standardized methods of the referenced ASTM, USP, and ISO standards (e.g., a seal passes if it meets the strength requirement of ASTM F88, a material is biocompatible if it passes the ISO 10993 tests for cytotoxicity, etc.). There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical tests.

8. The sample size for the training set

This question is not applicable as the device is a mechanical surgical stapler, not an AI/ML algorithm that requires training data.

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

This question is not applicable as the device is a mechanical surgical stapler, not an AI/ML algorithm that requires training data.

Summary

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Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.

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

January 29, 2015

EziSurgMedical Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd. P.O. Box 120-119 200120 Shanghai China

Re: K143129

Trade/Device Name: easyEndo® Linear Cutting Stapler and Loading Unit for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 29, 2014 Received: October 31, 2014

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

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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 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

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143129

Device Name

easyEndo® Linear Cutting Stapler and Loading Unit for Single Use

Indications for Use (Describe)

The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.

	Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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Tab #7 510(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: ________

1. Date of Preparation: 10/24/2014
1. Sponsor Identification

EziSurg Medical Co., Ltd.

Room 312, Bldg. 2, No. 1690, Cailun Road Zhangjiang High-Tech Park Pudong, Shanghai, 201203, P.R. China

Establishment Registration Number: Not yet registered

Contact Person: Johnny Yan Position: System Submission Specialist Tel: 86-21-50456156 Fax: 86-21-50456176 Email: johnnyyan@ezisurg.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

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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4. Identification of Proposed Device

Trade Name: easyEndo® Linear Cutting Stapler and Loading Unit for Single Use Common Name: Stapler Model: Stapler F12S, F12M, F12L Loading Unit FDU 45W, FDU 45B, FDU 45G, FDU 60B, FDU 60G

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 easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, and creation, and creation of anastomoses.

Device Description

5. Identification of Predicate Device

510(k) Number: K120258 Product Name: Endo GIA™ Universal Staplers with Duet TRS™ reloads

6. 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. The test results demonstrated that the proposed device complies with the following standards:

ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials. >

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ASTM 1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
USP 37-NF32:2014, <85> Bacterial Endotoxins Test
USP 37-NF32 <151> Pyrogen Test (USP Rabbit Test)
ISO 10993-5,2009/(R) 2014:Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device
Product Code	GDW	Same
Regulation No.	21 CFR 878.4750	Same
Class	II	Same
Intended Use	The easyEndo® Linear Cutting Stapler andLoading Unit for Single Use haveapplications in abdominal, gynecologic andpediatric surgery for resection, transection,and creation of anastomoses.	Similar
Cutting Mechanism	Linear	Same
Operation Principle	Manual	Same
Safety Machanism	Green button for preventing from mis-firing.	Same
Suture Length	45,60 mm	Same
Closed StaplesHeight	1.0, 1.5, 2.0 mm	Same
Closed StaplesForm	Image: Staples Form	Same
Patient-contactMaterial	Unalloyed Titanium conforms to ASTM F67, Polyamide resin	Similar
Sterilization	Irradiation Sterilized, SAL: 10-6	Similar
Endotoxin Limit	20 EU per Product	Same
Labeling	Conforms to 21 CFR part 801	Same

Table 1 Comparison of Technology Characteristics

9. 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.