Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures.

Device Description

The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments are packaged with a primary lithium battery pack which must be installed prior to use. The powered stapler and cartridges are sterilized by EO sterilization, and battery pack is sterilized by Gamma irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The staplers are available in three shaft lengths: compact (Model DCE46 and DCE46, 280±10mm), regular (Model DSE46 and DSE60, 340±10mm) and long (Model DLE46 and DLE60. 440±10mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. According to the length of the anastomosis, the cartridges (DCR series) can be divided into two specifications of 46mm and 60mm; the staples inside the cartridges can be divided into 2.5mm, 3.5mm, 4.1mm according to the nail height, and they are distinguished by color. The color codes are white (W), blue (B), yellow (Y), and green (G). There are total 8 models of cartridges within the proposed device: two stapler line length: 46mm and 60mm, each length of the cartridges has four colors which stand for different staple heights: Green (4.1mm), Yellow (3.8mm), Blue (3.5mm), White (2.5mm). The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are powered by the internal lithium battery, which has the rated specifications of DC voltage 12V and capability 1400mAh. Battery package model is BP813, composed of four lithium battery cells. The proposed device is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device: "Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states in section 8, "Substantial equivalence does not depend on clinical test data."

Given this, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of human clinical performance or AI/algorithm performance. The information requested in points 1-9 (e.g., sample size for test set, adjudication method, MRMC study, standalone performance, ground truth establishment) is typically associated with studies evaluating the clinical performance or diagnostic accuracy of a device, especially those involving AI or human interpretation, which is not the subject of this 510(k) submission.

The "Performance testing" section (page 7) describes non-clinical bench tests and an animal study, but these are to demonstrate the device's functional integrity and safety characteristics (e.g., staple height, integrity, reliability, electrical safety, biological compatibility, hemostasis, anastomotic pressure resistance) rather than a comparative effectiveness or diagnostic accuracy study in humans.

Therefore, for the prompt's specific request for a study proving the device meets acceptance criteria, and details like MRMC, human reader improvement, ground truth, and training data, the provided document does not contain this type of information.

Summary

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May 18, 2021

Ningbo Verykind Medical Device Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K202709

Trade/Device Name: Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 30, 2020 Received: September 16, 2020

Dear James Tsai:

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

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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 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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202709

Device Name

Disposable powered endoscopic linear cutting staplers and cartridges

Indications for Use (Describe)

Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K202709

1. Administrative Information

Date of Summary prepared	April 9, 2021
Manufacturer information	Company: Ningbo Verykind Medical Device Co., Ltd.
	Company address:
	#100 Jinghua Road, Hi-tech industrial developmentzone, Ningbo, Zhejiang 315040, China
	Contact person: Hong Pengfei
	Phone: +86-574-87910279
	Fax: +86-574-87910279
	E-mail: pfhong@nbverykind.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
	Address: 1713A, 17th Floor, Block A, ZhongguanTimes Square, Nanshan District, Shenzhen
	Contact person: James Tsai
	E-Mail: james_tsai@cefda.com; field@cefda.com
Establishment registration number

2. Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Disposable Powered Endoscopic Linear CuttingStaplers and Cartridges
Classification name:	Implantable Staple
Review Panel:	General and plastic surgery devices
Product Code:	GDW
Device Class:	II
Regulation Number:	878.4750

3. Predicate Device Information

Manufacturer:	Ethicon Endo-Surgery, LLC
Trade Device:	Echelon Flex Powered Articulating EndoscopicLinear Cutters

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K130653 510(K) Number: Staple, Implantable; Stapler, Surgical Classification name: GDW Product Code: Device Class: ll Regulation Number: 878.4750

4. Device Descriptions

The staplers are available in three shaft lengths: compact (Model DCE46 and DCE46, 280±10mm), regular (Model DSE46 and DSE60, 340±10mm) and long (Model DLE46 and DLE60. 440±10mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

According to the length of the anastomosis, the cartridges (DCR series) can be divided into two specifications of 46mm and 60mm; the staples inside the cartridges can be divided into 2.5mm, 3.5mm, 4.1mm according to the nail height, and they are distinguished by color. The color codes are white (W), blue (B), yellow (Y), and green (G). There are total 8 models of cartridges within the proposed device: two stapler line length: 46mm and 60mm, each length of the cartridges has four colors which stand for different staple heights: Green (4.1mm), Yellow (3.8mm), Blue (3.5mm), White (2.5mm).

The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are powered by the internal lithium battery, which has the rated specifications of DC voltage 12V and capability 1400mAh. Battery package model is BP813, composed of four lithium battery cells. The proposed device is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.

5. Intended Use/ Indications for Use

6. Comparison to predicate device

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Item	Disposable Powered EndoscopicLinear Cutting Staplers andCartridges (Proposed device)	Echelon Flex Powered ArticulatingEndoscopic Linear Cutters(Predicate device, K130653)
Manufacturer	Ningbo Verykind Medical Device Co.,Ltd.	Ethicon Endo-Surgery, LLC
Product Code	GDW	GDW
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)
Intended use/Indications forUse	Disposable Powered EndoscopicLinear Cutting Staplers andcartridges are intended fortransection, resection, and/orcreation of anastomoses.The instruments have application inmultiple open or minimally invasivegeneral, gynecologic, abdominal,thoracic, and pediatric surgicalprocedures.	The Echelon families of endoscopiclinear cutters (articulating andstraight) are intended for transection,resection, and/or creation ofanastomoses.The instruments have application inmultiple open or minimally invasivegeneral, gynecologic, urologic,thoracic, and pediatric surgicalprocedures.They can be used with staple line ortissue buttressing materials.The instruments may also be used fortransection and resection of liverparenchyma (hepatic vasculature andbiliary structures), pancreas, kidneyand spleen.
Safety feature	Power stapler has empty-reloadsafety protection mechanism	Power stapler has empty-reloadsafety protection mechanism
Cuttingmechanism	Stapler places two, triple staggeredrows of staples and simultaneouslycuts and divides the tissue betweenthe two rows	Stapler places two, triple staggeredrows of staples and simultaneouslycuts and divides the tissue betweenthe two rows
Cuttingmechanism	Linear	Linear
Stapling power	Powered (Lithium Battery)	Powered
Suture Length	46mm, 60mm	45mm, 60mm
Stapleheight	2.5mm, 3.5mm, 3.8mm, 4.1mm	2.0mm, 2.5mm, 3.5mm, 3.8mm,4.1mm, 4.4mm
	1.0mm, 1.5mm, 1.8mm, 2.0mm	0.75mm, 1.0mm, 1.5mm, 1.8mm,2.0mm, 2.3mm
Closed stapleform	Image: staple	Image: staple
Number ofstaples	70, 88	70, 88
Articulationangle	15°-60°	15°-45°
Rows of StapleLine	Six staggered rows of staples, threeon either side of the cut line	Six staggered rows of staples, threeon either side of the cut line
ImplantableMaterial	Unalloyed Titanium conforms toASTM F67-13	Unalloyed Titanium conforms toASTM F67-13
Structures(main	It consists of Shell, Adjusting knob,Adjusting shell, Knife reverse button	It consists of Shell, Adjusting knob,Adjusting shell, Knife reverse button
components)	Firing safety, Battery pack, Manualoverride, Firing trigger, Close handle,Shaft, Anvil jaw, Reload jaw,Articulation protective sleeve, Cuttingknife, Staple, Staple holder, Staplerholder cover	Firing safety, Battery pack, Manualoverride, Firing trigger, Close handle,Shaft, Anvil jaw, Reload jaw,Articulation protective sleeve, Cuttingknife, Staple, Staple holder, Staplerholder cover
	Reload jaw:06Cr19Ni10(SUS304),05Cr17Ni4Cu4Nb(SUS630)	Not publicly available
Body materialpatient short-time contact	Anvil jaw:06Cr19Ni10(SUS304),05Cr17Ni4Cu4Nb(SUS630)	Not publicly available
	Articulation protective sleeve:TPU	Not publicly available
	Shaft:06Cr19Ni10(SUS304)	Not publicly available
	Cutting Knife:20Cr13 (SUS420J1),30Cr13 (SUS420J2)	Not publicly available
	Staple:Ti (TA1G)	Not publicly available
	Stapler holder & cover:PC, ABS(PA757), PEI	Not publicly available
Biocompatibility	All components of the proposeddevice are composed of materials,which are in accordance withrelevant parts of ISO Standard10993	Conform to relevant parts of ISOstandard 10993
SterilizationSterilityAssuranceLevel	Stapler andcartridges	Ethylene Oxide(EO) sterilizationSAL 10-6
	Battery	Gamma IrradiationSAL 10-6
Labeling	Conforms to 21 CFR part 801 and830	Conforms to 21 CFR part 801 and830

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The proposed device and the predicate device have the same indications for use and similar technological characteristics. The differences in the materials, articulation angle and sterilization method do not raise additional questions for safety and effectiveness based on series tests, trials and validations.

7. Brief discussions of the nonclinical tests

All nonclinical tests performed on new devices are to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards.

Biocompatibility testing

The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The biocompatibility testing includes the following:

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Cytotoxicity
Sensitization & irritation
Acute systemic toxicity ●
. Pvrogen test

The staplers are considered tissue contacting for duration less than 24 hours, while the staples are considered permanent implants. The titanium material of implantable staples conforms to ASTM F67-13.

Sterilization validation

Ethylene oxide and Gamma Irradiation are used to sterilize the proposed device, and the standards below are followed:

ISO 11135: 2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11737-1:2018 Sterilization of health care products Microbiological ● methods - Part 1: Determination of a population of microorganisms on product
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene ● oxide sterilization residuals
. ASTM F88:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
. ASTM F1929:2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
. Endotoxin Test

Performance testing

The following nonclinical tests were conducted with Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges to verify that the proposed device is as safe and as effective as the predicate device, performs as intended, and meets all design specifications:

Form staple height
Stable line integrity ●
Reliability testing ●
Angle of articulation testing for the articulation connector change ●
. Safety system tests
. Reliability test for knife reverse button
Appearance, Dimension and Surface roughness ●

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the proposed device complies with the following standards:

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) . Medical electrical equipment - Part 1: General requirements for basic safety

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and essential performance for safety

. IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC
IEC 60086-4:2014 Primary batteries Part 4: Safety of lithium batteries ●

Animal studv

To demonstrate the operation performance is as safe and as effective as the predicate device, the animal study was carried out to assess the following safety and performance criteria:

Success rate of anastomosis ●
Hemostasis evaluation test ●
Anastomotic pressure resistance
Anastomotic healing ●
Staple forming ●
Tensile strength & Burst pressure

MR Compatibility Information

Non-clinical testing demonstrated the staples in the device are MR conditional.

Summarv

All the testing results, including bench tests, sterilization, biocompatibility tests and animal study, demonstrate that the Disposable powered endoscopic linear cutting staplers and cartridges manufactured by Verykind Company meet the requirements of its pre-defined acceptance criteria and intended use, and it has a safety and effectiveness profile that is similar to the predicate device.

8. Clinical Testing

Substantial equivalence does not depend on clinical test data.

9. Conclusions

Based on device comparison information and performance data, the proposed device is as safety and effectiveness as predicate device, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.

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.