K Number

Device Name

Disposable Endoscopic Cutter Stapler and Cartridge

Manufacturer

Changzhou Waston Medical Appliance Co., Ltd

Date Cleared

2023-01-19

(638 days)

Product Code

GDW GAG

Regulation Number

878.4750

Intended Use

The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.

Device Description

Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161757

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical function (stapling and cutting) and does not mention any computational or data-driven features indicative of AI/ML.

Therapeutic

No
The device is described as a surgical stapler used for resection and anastomosis, which is a tool for performing surgery rather than a device intended to treat a disease or condition.

Diagnostic

No
The device description and intended use indicate it is a surgical stapler for cutting and anastomosing tissue, which is a therapeutic function rather than a diagnostic one. The performance studies focus on mechanical and biocompatibility properties, not diagnostic accuracy.

SaMD (Software as a Medical Device)

The device description clearly details a physical, disposable surgical instrument (cutter stapler and cartridge) made of titanium staples, with various lengths and staple sizes. The performance studies involve bench testing on animal tissue and biocompatibility testing, which are characteristic of hardware devices, not software. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
Device Function: The description clearly states that this device is a "Disposable Endoscopic Cutter Stapler and Cartridge" used for "resection and creation of anastomosis" in surgical procedures. It physically cuts and staples tissue within the body.
Lack of Specimen Examination: There is no mention of this device being used to examine specimens outside of the body. Its function is entirely focused on manipulating tissue during surgery.

The information provided describes a surgical instrument, not a diagnostic test performed on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GDW

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal, gynecologic, pediatric and thoracic

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 10993-1:2018 Biological evaluation of medical device- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Test for in vitro cytotoxicity.
ISO10993-10:2010 Biological evaluation of medical devices-Part10: Test for irritation and delayed-type hypersensitivity.
ISO 10993-11:2017 Biological evaluation of medical Devices-Part 11: Tests for systemic toxicity
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
USP 43-NF 38 Bacterial Endotoxins Tests
USP 43-NF 38 Pyrogen
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials;

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 Height Test
Staple Formation Test
Force Required to Fire Stapler Test

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

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K161757

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

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.

January19, 2023

Changzhou Waston Medical Appliance Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K211197

Trade/Device Name: Disposable Endoscopic Cutter Stapler and Cartridge Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: January 6, 2023 Received: January 6, 2023

Dear Diana 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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.01.19
09:24:35 -05'00' |

---------------------	---------------------------------------------------------------------------------

Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K211197

Device Name

Disposable Endoscopic Cutter Stapler and Cartridge

Indications for Use (Describe)

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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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: K211197

1. Date of Preparation: 01/19/2023
1. Sponsor Identification

Changzhou Waston Medical Appliance Co., Ltd 9 Xihu Road, Wujin Hi-Tech Industry Zone, Jiangsu Province, China

Establishment Registration Number: 3006717850

Contact Person: Ning Mao Position: Marketing Manager Tel: +86-13776866021 Email: paris.mao@wastonmed.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)

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

Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net

Identification of Proposed Device 4.

Trade Name: Disposable Endoscopic Cutter Stapler and Cartridge

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 Product Code: GAG; Regulation Number: 21 CFR 878.4800 Review Panel: General & Plastic Surgery

Indications for Use:

Device Description:

న. Identification of Predicate Device
Predicate Device 510(k) Number: K161757 Product Name: Single Use Endoscopic Linear Cutters and Reloads

Manufacturer: Victor Medical Instruments Co., Ltd.

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 10993-1:2018 Biological evaluation of medical device- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Test for in vitro cytotoxicity.
ISO10993-10:2010 Biological evaluation of medical devices-Part10: Test for irritation and delayed-type hypersensitivity.
ISO 10993-11:2017 Biological evaluation of medical Devices-Part 11: Tests for systemic toxicity
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
USP 43-NF 38 Bacterial Endotoxins Tests
USP 43-NF 38 Pyrogen
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials;

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
A Closed Staple Height Test
Staple Formation Test
Force Required to Fire Stapler Test

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

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

8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device K161757	Remark
Product Code	GDW	GDW	SE
Regulation No.	21 CFR 878.4750	21 CFR 878.4750	SE
Class	II	II	SE
Indication for Use	The Disposable Endoscopic
Cutter Stapler and Cartridge
has applications in abdominal,
gynecologic, pediatric and
thoracic surgery for resection,
transection and creation of
anastomosis.
The Disposable Endoscopic
Cutter Stapler and Cartridge is
not to be used in the
transection and resection of
solid organs.	The Single Use Endoscopic
Linear Cutters and Reloads 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.	SE
Analysis 1
Configuration	Pin
Shaft
Articulation Lever
Rotation Collar
Green Firing Button
Black Return Knob
Light Blue Unload Button
Loop Handle
Anvil
Lower Clamp Cover
Staple Cartridge	Instrument Shaft
Rotation Collar
Rotation Knob
Shell
Black Return Knob
Insurance
Green Button
Free Handle
Staple Cartridge
Anvil
Cutting Knife
Reload Shell	SE
Analysis 2
Operation Principle	Manual	Manual	SE
Cutting Mechanism	Linear Knife	Linear Knife	SE
Safety Mechanism	Green button for preventing
from mis-firing	Green button for preventing
from
mis-firing	SE
Suture Length	30mm,45mm,60mm	30mm,45mm,60mm	SE
Staple Height	2.0~~3.0mm, 3.0~~4.0mm,
4.0~5.0mm	2.0~~3.0mm, 3.0~~4.0mm,
4.0~5.0mm	SE
	0.88~~1.22mm, 1.54~~2.14mm,	0.8-1.5mm, 1.5-2.25mm,	SE
Closed staple height	1.92~2.28mm	2.25-3.0mm	Analysis 3
Row Number of
Staples	6	6	SE
Staple Counts for
Each Row	8, 11,15	7, 11,15	SE
Analysis 4
Closed staple form	Image: Closed staple form	Image: Closed staple form	SE
Patient-contact
material	Unalloyed Titanium
Stainless Steel
Polyamide	Unalloyed Titanium
Acrylonitrile-Butadiene-Styrene
Stainless Steel	SE
Analysis 5
Sterilization	EO Sterilization	Irradiation Sterilization	SE
Analysis 6
Endotoxin Limit	20EU	20EU	SE
Labeling	Conforms with 21CFR 801	Conforms with 21CFR 801	SE

Table 1 Comparison for the Disposable Endoscopic Cutter Stapler and Cartridge

SE Analysis 1 Indication for Use

The indication for use of proposed device is different from predicate device. The proposed device does not have the additional indication of transection of liver substance, hepatic vasculature, biliary structures, and pancreas. However, the indication for use of proposed device can be covered by the predicate device. Therefore, this difference is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

SE Analysis 2 Configuration

The configuration for proposed device is different from predicate device. By the proposed device and predicate device's performance test reports (Firing Force, Closed Staple Height, Pressure Resistance, Staple Formation), it proves that this difference is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

SE Analysis 3 Closed staple height

The closed staple height for proposed device is different from predicate device. By the proposed device and predicate device's performance test reports (Closed Staple Height), it proves that this difference is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

SE Analysis 4 Staple Counts for Each Row

The staple counts for proposed device are different from predicate device. By the proposed device and

predicate device's performance test reports (Firing Force, Closed Staple Height, Pressure Resistance, Staple Formation), it proves that this difference is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

SE Analysis 5 Patient-contact material

The patient-contact material of proposed device is different from predicate device. However, the biocompatibility tests were performed on proposed device and the test result can meet the requirements of ISO 10993 series standards. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

SE Analysis 6 Sterilization

The sterilization method for proposed device is different from predicate device. However, the sterilization parameter for proposed device was established per ISO ISO11135 to achieve the SAL of 106. Therefore, this difference is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

9. Substantially Equivalent (SE) Conclusion

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