easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use

• K Number: K181657
• Device Name: easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
• Manufacturer: Ezisurg Medical Co., Ltd.
• Date Cleared: 2019-02-01 ( 224 days)
• Product Code: GDW GAG
• Regulation Number: 878.4750

Intended Use

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses. The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.

Device Description

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure. The easyCS™ Circular Stapler for Single Use 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 resect by the circular knife, and then a circular anastomosis is created. The stapler is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

Predicate Devices

K020779, K983536, K100723

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

Yes.
The device is used for surgical procedures involving tissue transection, resection, and creation of anastomoses in the gastrointestinal tract, which are therapeutic medical interventions.

Diagnostic

No

This device is a surgical stapler used for cutting and joining tissue, not for diagnosis. Its intended use is for transection, resection, and/or creation of anastomoses in gastrointestinal and alimentary applications.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components (staplers, loading units, staples, circular knife) and performance studies involve bench testing on physical tissue, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the devices are for "transection, resection, and/or creation of anastomoses" and "end to side and side to side anastomoses" in the gastrointestinal and alimentary tracts. These are surgical procedures performed on the patient's body.
• Device Description: The description details mechanical devices that place staples and cut tissue. This is consistent with surgical instruments, not devices used to test samples outside the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.

Product codes

GDW, GAG

Device Description

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.

The easyCS™ Circular Stapler for Single Use 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 resect by the circular knife, and then a circular anastomosis is created. The stapler is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Gastrointestinal, alimentary

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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-NF 34 Pyrogen

Bench test was conducted on porcine stomach and intestine for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests

• Pressure Resistance Test
• Closed Staple Dimension Test
• Staple Formation Test
• Force Required to Fire Stapler Test

Biocompatibility test was conducted on the proposed device, the test include cytotoxicity, irritation, skin sensitization and pyrogenicity.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K020779, K983536, K100723

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 1, 2019

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

Re: K181657

Trade/Device Name: easyLCTM Linear Cutter Staplers and Loading Units for Single Use; easyCS™ Circular Stapler for Single Use

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: June 12, 2018 Received: June 22, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

$$\textbf{David }\textbf{Krausse}\text{-}\textbf{S}{\begin{subarray}{c}\textbf{S}{\begin{subarray}{c}\textbf{Diag}\0\le\textbf{W}\end{subarray}}\text{-}\textbf{S}{\begin{subarray}{c}\textbf{S}{\begin{subarray}{c}\textbf{Diag}\0\le\textbf{W}\end{subarray}}\text{-}\textbf{M}\end{subarray}}$$

• 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) K181657

Device Name

easyLCTM Linear Cutter Staplers and Loading Units for Single Use, easyCSTM Circular Stapler for Single Use

Indications for Use (Describe)

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.

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)

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See PRA Statement below.

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Exhibit #2 510(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: K181657

• 1. Date of Preparation: 12/29/2018
• 2. Sponsor Identification

Ezisurg Medical Co., Ltd.

Rm.103, Bldg.2,No.1690 Cailun Road, China (Shanghai) Pilot Free Trade Zone, 201203 Shanghai, China.

Establishment Registration Number: Not yet registered.

Contact Person: Liang Xia Position: Non-active Device Senior Regulatory Affairs Supervisor Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. 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: [phone], Fax: [phone] Email: [e-mail]

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• Identification of Proposed Device 4.
  Trade Name: easyLCTM Linear Cutter Staplers and Loading Units for Single Use easyCSTM Circular Stapler 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:

The easyLC™ Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The easyCS™ Circular Stapler for Single Use has applications throughout the alimentary for end to end, end to side and side to side anastomoses.

Device Description

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.

The easyCS™ Circular Stapler for Single Use 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 resect by the circular knife, and then a circular anastomosis is created. The stapler is available in 21mm, 29mm, 31mm and 33mm

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five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

• ર . Identification of Predicate Devices
  Predicate Device 1 510(k) Number: K020779 Product Name: ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers

Predicate Device 2 510(k) Number: K983536 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers

Predicate Device 3 510(k) Number: K100723 Device Name: PROXIMATE Curved and Straight Intraluminal 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 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-NF 34 Pyrogen

Bench test was conducted on porcine stomach and intestine for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests

• Pressure Resistance Test

• Closed Staple Dimension Test

• Staple Formation Test

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Force Required to Fire Stapler Test

Biocompatibility test was conducted on the proposed device, the test include cytotoxicity, irritation, skin sensitization and pyrogenicity.

• 7. Clinical Test Conclusion
     No clinical study is included in this submission.
• 8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device 1
Product Code	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750
Intended Use	The easyLCTM Linear Cutter Staplers
and Loading Units for Single Use have
application in gastrointestinal for
transection, resection, and/or creation of
anastomoses.	The PROXIMATE Linear and Vascular
Linear Cutters with Safety Lockout
have application in gastrointestinal,
gynecologic, thoracic and pediatric
surgery for transection, resection, and/or
creation of anastomoses and can be used
with staple line or tissue buttressing
materials, such as bovine pericardium
Cutting Mechanism	Linear	Linear
Operation Principle	Manual	Manual
Safety Mechanism	Safety release for prevent from
mis-firing	Safety release for prevent from
mis-firing
Suture Length	60mm, 80mm, 100mm	55, 75mm
Closed Staple Height	1.0mm, 1.5mm, 2.0mm	1.0mm, 1.5mm, 1.8mm, 2.0mm
Closed staple form	Image: staple form	Image: staple form
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801

Table 1 Comparison for easyLC™ Linear Cutter Staplers and Loading Units for Single Use

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| Item | Proposed Device | Predicate Device 2
K983536 | Predicate Device 3
K100723 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GDW | GDW | GDW |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Intended Use | The easyCSTM Circular Stapler for
Single Use has applications throughout
the alimentary for end to end, end to
side and side to side anastomoses. | The PROXIMATER Curved and
Straight Intraluminal Staplers have
application throughout the alimentary
for end to end, end to side and side to
side anastomoses. | The Disposable Circular Stapler has
application throughout the alimentary
tract for end-to-end, end-to-side anc
side-to-side anastomoses. |
| Cutting Mechanism | Circular Knife | Circular Knife | Circular Knife |
| Operation Principle | Manual | Manual | Manual |
| Safety Mechanism | Safety Release is used for preventing
from mis-firing. | Safety Release is used for preventing
from mis-firing. | Safety Release is used for preventing
from mis-firing. |
| Diameter | 21mm, 25mm, 29mm, 31mm, 33mm | 21mm, 25mm, 29mm, 33mm | 25.5mm, 29.5mm |
| Closed Staple Height | 1.02.5mm | 1.02.5mm | 1.5~2.0mm |
| Closed staple form | Image: staple form | Image: staple form | Image: staple form |
| Endotoxin Limit | 20 EU | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |

	Table 2 Comparison for easy CSTM Circular Stapler for Single Use
--	------------------------------------------------------------------

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• 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.