easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

K210909 · Ezisurg Medical Co., Ltd. · GDW · Jun 24, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210909
• Device Name: easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
• Applicant: Ezisurg Medical Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The easyEndo™ Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Device Story

Manual surgical instrument; places two, triple-staggered rows of titanium staples while simultaneously dividing tissue along a central line. Used in open or minimally invasive abdominal, gynecologic, thoracic, and pediatric surgeries. Operated by surgeons. Device available in 260mm, 350mm, and 440mm lengths; accommodates tissue thicknesses of 2.0mm, 2.5mm, 3.5mm, 3.8mm, and 4.1mm. Reloadable up to 13 times per procedure. Provides secure tissue closure and transection; benefits patient by facilitating surgical access and tissue management during complex procedures.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including biocompatibility (ISO 10993-5, -10, -11), pyrogen/endotoxin testing (USP <151>, <85>), seal strength (ASTM F88), and ex-vivo porcine tissue testing (stomach, intestine, and jugular vein) to evaluate burst pressure, staple formation, and firing force.

Technological Characteristics

Manual linear cutting stapler. Materials: Stainless steel (SUS304, SUS420, 17-4PH, SUS301), Polyamide, Unalloyed Titanium. Staple configuration: 6 rows, triple-staggered. Sterilization: Irradiation (ISO 11137-2). Connectivity: None. Dimensions: 260mm-440mm lengths; 2.0mm-4.1mm staple heights.

Indications for Use

Indicated for patients undergoing open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures requiring transection, resection, or creation of anastomoses.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use (K172960)
• ECHELON GRAY CARTRIDGE, MODEL ERC45M (K080839)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 24, 2021

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

Re: K210909

Trade/Device Name: easyEndo Lite 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: March 18, 2021 Received: March 29, 2021

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K210909

### Device Name

easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Indications for Use (Describe)

The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

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

| <div><span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-----------------------------------------------------------------------------------------------|
| <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# Tab #6 510(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: K210909

- 1. Date of Preparation: 06/22/2021
- 2. Sponsor Identification

### Ezisurg Medical Co., Ltd.

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

Establishment Registration Number: Not registered yet

Contact Person: Jingtian Ren Position: Senior RA Engineer Tel: [phone]-8026 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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#### 4. Identification of Proposed Device

Trade Name: easyEndoTM Lite Linear Cutting Stapler and Loading Unit 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

Indication for Use Statement:

The easyEndo™ Lite Linear Cutting Stapler and Loading Units for Single Use 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.

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 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.

- ર. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K172960 Product Name: easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use

Predicate Device 2 510(k) Number: K080839 Product Name: ECHELON GRAY CARTRIDGE, MODEL ERC45M

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#### 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:

- > 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
- > ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicitv
- > USP 43-NF38:2020 <151> Pyrogen Test
- USP 42-NF 37<85> Bacterial Endotoxins Tests >
- > ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
- A ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose

Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for less than 2.5mm staple height. Burst pressure, closed staple formation were evaluated in jugular vein test.

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

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Ref.:M10692020

### 8. Summary of Technological characteristics

| Item | Proposed Device | Predicate Device 1<br>K172960 | Predicate Device 2<br>K080839 | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | GDW&GAG | GDW&GAG | GDW | SE |
| Regulation Number | 21 CFR 878.4750&21CFR 878.4800 | 21 CFR 878.4750&21CFR 878.4800 | 21 CFR 878.4750 | SE |
| Intended Use | The easyEndo™ Lite Linear Cutting<br>Stapler and Loading Units for Single<br>Use are intended for transection,<br>resection, and/or creation of<br>anastomoses. The instruments have<br>application in multiple open or<br>minimally invasive general abdominal,<br>gynecologic, thoracic, and pediatric<br>surgical procedures. | The devices are intended for<br>transection, resection, and/or creation<br>of anastomoses. The instruments have<br>application in multiple open or<br>minimally invasive general abdominal,<br>gynecologic, thoracic, and pediatric<br>surgical procedures. | The Echelon Endoscopic Linear<br>Cutters, Staplers and Reloads are<br>intended for transection, resection,<br>and/or anastomoses. The instruments<br>have application in multiple open or<br>minimally invasive general,<br>gynecologic, urologic, thoracic, and<br>pediatric surgical procedures. They<br>can be used with staple line or tissue<br>buttressing materials. The instruments<br>may also be used for transection and<br>resection of liver parenchyma (hepatic<br>vasculature and biliary structures),<br>pancreas, kidney and spleen. | Similar |
| Main Configuration | Stapler<br>Knife<br>Staple | Stapler<br>Knife<br>Staple | Knife<br>Staple | Similar |
| Operate Principle | Manual | Manual | Manual | SE |
| Cutting mechanism | Linear | Linear | Linear | SE |
| Safety mechanism | Safety release for preventing from | Safety release for preventing from | Safety release for preventing from | SE |
| | mis-firing | mis-firing | mis-firing | |
| Suture Length | 45mm, 60mm | 45mm, 60mm | 45mm | Similar |
| Staple Height | 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm | 2.5mm, 3.5mm, 3.8mm, 4.1mm | 2.0mm | Similar |
| Row Number of Staples | 6 | 6 | 6 | SE |
| Closed Staple Form | Image: staple form | Image: staple form | Image: staple form | SE |
| Staple Material | Unalloyed Titanium | Unalloyed Titanium | Unalloyed Titanium | SE |
| Patient-contact material | Stainless steel (SUS304)<br>Stainless steel (SUS420, 20Cr13)<br>Stainless steel (17-4PH)<br>Stainless steel (SUS301)<br>Polyamide<br>Unalloyed Titanium | Unalloyed Titanium<br>Polyphthalamide + Glass Fiber Stainless<br>Steel | Unalloyed Titanium | Different |
| Sterilization | Irradiation Sterilization | Irradiation Sterilization | EO sterilization | Different |
| Endotoxin Limit | 20 EU | 20 EU | 20 EU | SE |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | SE |

# Table 1 Comparison of Technology Characteristics

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## Similar-Indication for use

The indication for use for proposed device is different from proposed device does not have the indication for using with buttessing material or organ transection. However, the indication for use for proposed device can be covered by the predicate device 2. In addition, the indications for use for the proposed device is same as the predicate device 1. Therefore, is not considered to affect substantially equivalence.

## Similar-Structure

The structure for the proposed device is different from the predicate device 2 is a cartridge. However, the structure for proposed device is same as the predicate device 1. Therefore, this difference is not considered to affect substantially equivalence. Similar-Suture length

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The proposed device has the additional suture levice. However, this suture length specification can be overed by the predicate device 1. Therefore, this difference is not considered to affect substantially equivalence.

## Similar- Staple Height

The staple height of the proposed device is different from the predicate device 2. However, the staple height of the proposed device (2.5mm~4.1mm) can be covered by the proposed stable height 2.0mm is same as predicate device 2. Therefore, this difference is not considered to affect substantially equivalence.

## Different- Patient-contact material

The patient-contact material of the proposed device. However, the biocompatbility test has been performed on the material of the proposed device and the test result show that the proposed device will not affect adverse effect on the patient. Therefore, this difference is not considered to affect substantially equivalence.

## Different-Sterilization

The sterlization method for the proposed device. However, the sterlization process has been validated per ISO 11137 and the validation result can demonstrate the sterilization which can maintain the declared sterilization assurance level, In addition, the irradiation sterilization method is also used for the 1. Therefore, this difference is not considered to affect substantially equivalence.

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#### Substantially Equivalent (SE) Conclusion 9.

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K172960 and K080839.