The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.

Device Description

The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.

The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip.

The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.

AI/ML Overview

The provided text describes the Micro-Tech (Nanjing) Co., Ltd. Elastic Traction System, an endoscopic traction device. The information details the device's characteristics, its comparison to a predicate device, and the non-clinical performance data used to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria appear to be framed around demonstrating substantial equivalence to the predicate device, ProdiGI Traction Wire (DEN220006), across various performance aspects that confirm safety and effectiveness for its intended use. While explicit numerical acceptance criteria values are not given in this summary, the document states that tests were performed to demonstrate that the device performs as intended under anticipated conditions of use and is considered safe and effective for its intended use.

Acceptance Criteria Category	Reported Device Performance
Bench Tests	Performed as intended under anticipated conditions of use for:
Dimension	✓
Release Force	✓
Clamping Strength	✓
Tensile Strength	✓
Elastic Performance	✓
Rotation Performance	✓
Repeated Opening/Closing	✓
Clip Opening/Closing Forces	✓
Endoscope Compatibility	✓
Endoscope Damage	✓
Usability	Intended user can safely and correctly use the proposed device.
Shelf-Life	Demonstrated 2-years aging stability (according to ASTM F1980-16).
Sterilization	Validated according to ISO 11135:2014+A1:2019.
Biocompatibility	Complies with ISO 10993-1.
Animal Study	Performs as intended under anticipated conditions of use.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual bench test. It mentions that "bench tests below were tested and evaluated." For the animal study, it states an "animal test" was conducted, implying one study, but the number of animals or procedures is not specified.
Data Provenance: The data provenance is from non-clinical studies (bench tests, animal study, usability assessment, shelf-life, sterilization, biocompatibility testing) conducted by Micro-Tech (Nanjing) Co., Ltd. The animal study was conducted according to 21 CFR §58 (GLP Regulations), suggesting it was a prospective study. The bench tests are laboratory-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the performance data is derived from objective, replicable tests (bench, animal, etc.) rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device (an endoscopic traction system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data presented refers to the device's physical and functional characteristics.

7. Type of Ground Truth Used

For the non-clinical performance tests (bench tests), the ground truth is based on engineering specifications, established test methods, and compliance with relevant international standards (e.g., ASTM F1980, ISO 11135, ISO 10993-1).
For the animal study, the ground truth for safety and effectiveness would be established through direct observation of the device's performance in vivo and histological examination or other relevant biological assessments, evaluated against pre-defined success criteria.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical medical device.

Summary

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

October 3, 2022

Micro-Tech (Nanjing) Co., Ltd. Sally He. RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA

K222354 Re: Trade/Device Name: Elastic Traction System Regulation Number: 21 CFR 876.4410 Regulation Name: Endoscopic traction device Regulatory Class: Class II Product Code: QSW Dated: July 29, 2022 Received: August 4, 2022

Dear Sally He:

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

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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 medical devices and radiation-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,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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)

K222354

Device Name Elastic Traction System

Indications for Use (Describe)

The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissus resection, exposure, and removal of tissue within the stomach and colon.

☑ 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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Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

510K 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: K222354

1. Date of Preparation: 2022-09-30

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Sally He

Position: RA Engineer

Tel: +86-25-58646395

Fax: +86-25-58350006

Email: ra.micro-tech@outlook.com

3. Identification of Proposed Device

Trade Name: Elastic Traction System

Common Name: Endoscopic Traction Device

Regulatory Information

Device Classification Name: Endoscopic Traction Device

Classification: 2

Product Code: OSW

Regulation Number: 21 CFR 876.4410

Review Panel: Gastroenterology/Urology

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K222354 Page 2 of 6

Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly to the right, creating a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

4. Identification of Predicate Device

De Novo Number: DEN220006 Product Name: ProdiGI Traction Wire Manufacturer: Covidien LLC.

5. Indications for Use

Device Description 6.

The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.

7. Comparison of Technological Characteristics

The Elastic Traction System substantially equivalent device materials, design, configuration, packaging, sterilization process and intended use as those featured in the predicate device ProdiGI Traction Wire

(DEN220006).

Characteristics	Proposed DeviceElastic Traction System	Predicated DeviceProdiGI Traction Wire(DEN220006)	Remark
Product Code	QSW	QSW	Same
Class	II	II	Same
Regulation	Endoscopic Traction Device	Endoscopic Traction Device	Same
Characteristics	Proposed DeviceElastic Traction System	Predicated DeviceProdiGI Traction Wire(DEN220006)	Remark
Description
Regulationnumber	876.4410	876.4410	Same
Indications forUse	The Elastic Traction System isindicated for adult only for use inflexible Endoscopy to provideretraction to assist in tissue resection,exposure, and removal of tissue withinthe stomach and colon.	The Medtronic ProdiGI TractionWire is indicated to grasp tissuewithin the esophagus, stomach, andcolon of adults during anEndoscopic Submucosal Dissection(ESD) procedure.	Similar
Target population	Adults	Adults	Same
Use Condition	Endoscopy suite, used with acompatible Endoscope	Endoscopy suite, used with acompatible Endoscope	Same
Mechanics ofAction	Manual	Manual	Same
Operation Principle	Anchor the edge of tissue on thesilicone band with endoscopic clipsand retract the tissue through ownelastic force of the silicone band.	Anchor the edge of tissue on thewire with endoscopic clips andretract the tissue through restoringforce of the wire .	Similar
GeneralConfiguration	2 ClipsSilicone band	2 ClipsMetal Wire band	Similar
Compatibleendoscopy workingchannel	2.8 mmor larger	2.8 mmor larger	Same
Working length	1650 mm, 2350 mm	2300 mm	Similar
Siliconeband/Traction wirelength	The longest distance of the rings centeris 7.1 mm	20 mm, 35mm	Similar
Main Patient-contact Material	Silicone rubber	Metal	Different
Single Use	Yes	Yes	Same
Supplied in Sterile	Yes	Yes	Same
Characteristics	Proposed DeviceElastic Traction System	Predicated DeviceProdiGI Traction Wire(DEN220006)	Remark
Rx-only	Yes	Yes	Same
Non-clinicalPerformance	Performs as intended underanticipated conditions of use	Performs as intended underanticipated conditions of use	SE
Usability	The intended user can safely andcorrectly use the proposed device.	The intended user can safely andcorrectly use the proposed device.	SE
In vivo study	Animal study performs as intendedunder anticipated conditions of use	In vivo performance testingperforms as intended underanticipated conditions of use	SE
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Shelf Life	Comply with ASTM F1980	Comply with ASTM F1980	SE
Labeling	Conforms to 21 CFR part 801	Conforms to 21 CFR part 801	SE

Comparison to predicate Devices:

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small registered trademark symbol is located in the upper right corner of the logo.

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Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and connected, with the "M" slightly overlapping the "T". A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a simple, modern design.

The proposed device and the predicate device both used the two clips to anchor the edge of the tissue and lift the mucosal to provide the visualization with a connecting band during the ESD procedure. The main difference between the two devices is the material of the connecting band, the proposed device used the silicon rubber which provides retraction with elastic force of deforming, while the predicate device used the metal wire with restoring force of memory function.

8. Performance Data

Performance testing was conducted to demonstrate the essential performance of the proposed device Elastic Traction System and confirmed that the proposed device works as intended.

The bench tests below were tested and evaluated as substantially equivalent to the predicate device.

Dimension
Release Force
Clamping Strength
Tensile strength
Elastic Performance
Rotation Performance
Repeated Opening and Closing Performance

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

Clip Opening and Closing Forces A
Endoscope Compatibility
A Endoscope Damage

Usability assessment was performed to demonstrate that the intended user can safely and correctly use the proposed device.

Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Two-years aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.

Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2019 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The results of performance testing demonstrate that the proposed device Elastic Traction System is considered safe and effective for its intended use.

9. Animal Study

The proposed device Elastic Traction System has conducted animal test according to 21 CFR §58 (GLP Regulations) to demonstrate the safety and effectiveness.

10. Clinical Study

No clinical study is included in this submission.

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small registered trademark symbol is located in the upper right corner of the logo.

11. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Elastic Traction System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device the ProdiGI approved under DEN220006.

Regulation Number and Section

N/A