This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

Device Description

The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

It consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current to cut polyp with the loop.

The main component of the proposed device is jaws, spring sheath and handle. The proposed device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

The proposed device has two (2) specifications, HBF55-11023180 and HBF55-11023230. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

AI/ML Overview

The provided document is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Disposable Hot Biopsy Forceps. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria in the context of a new, innovative medical device relying on clinical performance metrics.

Instead, the document details physical and performance characteristics to argue that the proposed device is similar enough to an already approved device. Therefore, a direct answer to the request regarding acceptance criteria and a study that proves the device meets the acceptance criteria as would be typical for a clinical trial or performance study of a diagnostic or treatment effectiveness device, cannot be fully provided from this document.

Here's an analysis based on the information available:

The core "acceptance criteria" here are that the proposed device performs as well as the predicate and is substantially equivalent. The "study" is a series of bench tests comparing the proposed device against established performance benchmarks or implicitly, the performance of the predicate device (though explicit comparative data is not provided in detail).

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Device performs "as well as the predicate"	"The Disposable Hot Biopsy Forceps performs as well as the predicate and is substantially equivalent to the predicate devices."
Meets standards for Dimensions	"Dimension Testing Report" completed
Meets standards for Cutting Performance	"Cutting Performance Testing" completed
Meets standards for Tensile Strength	"Tensile Strength Testing" completed
Meets standards for Package Integrity	"Package Integrity" testing completed
Meets standards for Electrode Contact Impedance	"Electrode Contact Impedance Testing" completed
Meets standards for Pushability	"Pushability Testing" completed
Meets standards for Jaws Misalignment	"Jaws Misalignment Testing" completed
Maintains sterility and function for specified shelf life (3 years)	"Shelf Life Testing" completed; "shelf life of 3 years" mentioned in Device Description.
Sterility Assurance Level (SAL) of 10^-6	"EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6"

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the bench tests (e.g., how many forceps were tested for cutting performance). The data provenance is implied to be from in-vitro bench testing conducted by Micro-Tech (Nanjing) Co., Ltd. There is no mention of country of origin of data in a patient context, as no clinical data was used. All testing appears to be prospective testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is not applicable to the provided document. The "ground truth" for these bench tests would be engineering specifications and validated test methods, not expert clinical consensus or interpretation for a diagnostic device.

4. Adjudication method for the test set:
This is not applicable as the testing performed was bench testing against engineering specifications, not clinical outcomes requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a physical surgical instrument (hot biopsy forceps), not an AI-powered diagnostic or treatment assistance tool. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:
For the bench testing, the "ground truth" would be engineering specifications, material properties, and performance standards relevant to medical devices of this type, likely derived from recognized consensus standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.

8. The sample size for the training set:
This is not applicable. There is no machine learning or AI algorithm being developed; therefore, there is no "training set."

9. How the ground truth for the training set was established:
This is not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2016

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality Director No. 10 Gaoke Third Road National Hi-Tech Industrial Development Zone Nanjing, 210032, Jiangsu Province China

Re: K160625 Trade/Device Name: Disposable Hot Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: May 13, 2016 Received: May 17, 2016

Dear Becky Li.

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. 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 mav 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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)

K160625

Device Name

Disposable Hot Biopsy Forceps

Indications for Use (Describe)

☒ 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 the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the letters colored in blue. To the right of the letters, the words "MICRO-TECH" are written in a simple, sans-serif font, also in blue. Below the words "MICRO-TECH", there are two Chinese characters, also in blue.

Tab 7

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:

1. Date of Preparation:01/08/2016

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC

Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality Director

Tel: +86-25-58646378

Fax: +86-25-58744269

Email: In@micro-tech.com.cn

3. Identification of Proposed Device

Trade Name: Disposable Hot Biopsy Forceps Common Name: Disposable Hot Biopsy Forceps Classification Name: Forceps, Biopsy, Electric Classification: 2 Product Code: KGE Regulation Number: 876.4300 Review Panel: Gastroenterology/Urology

4. Identification of Predicate Device

510(k) Number: K953355 Trade Name: GIP/Medi-Globe Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric

5. Indications for Use

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Device Description 6.

Comparison of Technological Characteristics 7.

The Disposable Hot Biopsy Forceps incorporates substantially equivalent device materials, design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Medi-Globe predicate devices.

Item	Proposed Device	Comparison toPredicate Devices
	Disposable Hot Biopsy Forceps	Same
Product Code	KGE	Same
Regulation No.	876.4300	Same
Class	2	Same
Supplied Sterile	Yes	Same
Jaws Shape	Oval Jaws	Same
Outer Tube Diameter	2.3mm	Similar
Minimal Working Channel	2.8mm	Same
Working Length	1800mm, 2300mm	Same
Indications for Use	The device is intended to be used forendoscopic histological sampling orelectrocoagulation of various tissues,within the gastrointestinal and bronchialtracts, via the operating channel ofendoscopic instruments.	Similar
Configuration	Jaws, Spring Sheath, High-Frequency,	Same

Comparison to predicate Devices:

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Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the letters overlapping each other. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font. Below the text "MICRO-TECH" are two Chinese characters.

Item	Proposed DeviceDisposable Hot Biopsy Forcepsand Handle	510K SummaryComparison toPredicate Devices
Single Use	Yes	Same
Packaging	Single-use EO sterilized pouch with onedevice per pouch	Similar
Shelf Life	Four years	Similar

8. Performance Data

Bench testing was performed to support a determination of substantial equivalence. The Disposable Hot Biopsy Forceps performs as well as the predicate and is substantially equivalent to the predicate devices.

The following in-vitro performance tests were completed on the Disposable Hot Biopsy Forceps:

Dimension Testing Report	Electrode Contact Impedance Testing
Cutting Performance Testing	Pushability Testing
Tensile Strength Testing	Jaws Misalignment Testing
Package Integrity	Shelf Life Testing

Clinical Test Conclusion 9.

No clinical study is included in this submission.

10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Disposable Hot Biopsy Forceps has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the GIP/Medi-Globe Hot Biopsy Forceps.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).