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 jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.

The main component of the proposed device is jaws, spring sheath and handle.

The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 to the power of -6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

AI/ML Overview

The provided FDA 510(k) summary (K180018) for the "Disposable Hot Biopsy Forceps" describes the acceptance criteria and the studies performed to demonstrate that the device meets those criteria.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document states that "Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion with a corresponding reported performance outcome. Instead, it lists the standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.

Acceptance Criteria (Implied by Standards Met)	Reported Device Performance (Implied by Compliance)
Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15)	Complies with standard
Detecting Seal Leaks in Porous Medical Packaging By Dye Penetration (ASTM F1929-15)	Complies with standard
Internal Pressurization Failure Resistance Of Unrestrained Packages (ASTM F1140/F1140M-13)	Complies with standard
Integrity of Seals for Flexible Packaging by Visual Inspection (ASTM F1886/F1886M–16)	Complies with standard
Sterility (USP 40 - NF35:2017 <71>)	Complies with standard (Sterility Assurance Level: $10^{-6}$)
Accelerated Aging of Sterile Barrier Systems for Medical Devices (ASTM F1980-16)	Complies with standard
Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process (ISO 10993-1:2009)	Complies with standard
Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity (ISO 10993-5: 2009)	Complies with standard
Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10: 2010)	Complies with standard
Biological evaluation of medical devices-Part 11: Tests for systemic toxicity (ISO 10993-11: 2006)	Complies with standard
Pyrogen Test (USP 40 NF 35:2017 <151>)	Complies with standard
Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135 Second Edition 2014)	Complies with standard

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the non-clinical tests listed. It also does not explicitly state the provenance (country of origin, retrospective/prospective) of the data beyond the fact that Micro-Tech (Nanjing) Co., Ltd. is located in Nanjing, Jiangsu, China. The tests are described as "Non-Clinical Tests," implying laboratory or bench testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The studies conducted are non-clinical (bench/laboratory tests) and do not involve human subject interpretation or expert ground truth establishment in the medical sense (e.g., radiologists interpreting images).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the studies are non-clinical and do not involve human interpretation or 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

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

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 medical instrument (Disposable Hot Biopsy Forceps), not a software algorithm, so the concept of standalone performance for an algorithm does not apply. The "performance" here refers to the physical and biological properties of the device meeting established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is established by the specifications and measurement techniques outlined in the referenced international and national standards (e.g., ASTM, ISO, USP). For example, a "sealed" package must pass specific dye penetration or burst strength tests as defined by the ASTM standards, and "sterility" is defined by the absence of microbial growth as per USP <71> criteria.

8. The sample size for the training set

This is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no "training set" for this type of medical device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and is stacked in two lines.

July 5, 2018

Micro-Tech (Nanjing) CO., Ltd. Becky Li Ouality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K180018

Trade/Device Name: Disposable Hot Biopsy Forceps Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KGE Dated: May 18, 2018 Received: May 21, 2018

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 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.

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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); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for 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)

K180018

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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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 words "MICRO-TECH" to the right of the letters. Below the words "MICRO-TECH" are two Chinese characters. The logo is blue and white.

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: K180018

1. Date of Preparation: 05/08/2018

1. 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 and Regulatory Affairs Director Tel: +86-25-58646378 Fax: +86-25-58350006 Email: In@micro-tech.com.cn

3. Identification of Proposed Device

Trade Name: Disposable Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric Classification Name: Endoscopic electrosurgical unit and accessories Classification: 2 Product Code: KGE Requlation Number: 876.4300 Review Panel: Gastroenterology/Urology

4. ldentification of Predicate Device

510(k) Number: K160625 Trade Name: Disposable Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric

5. Indications for Use

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510K Summary

Device Description 6.

The main component of the proposed device is jaws, spring sheath and handle.

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.

7. Comparison of Technological Characteristics

The Disposable Hot Biopsy Forceps incorporates substantially equivalent device materials, design, configuration, manufacturing processes, sterilization process and intended use as those featured in.

Item	Proposed DeviceDisposable Hot BiopsyForceps	Predicate DeviceDisposable Hot BiopsyForceps (K160625)	Comparisonto PredicateDevice
Product Code	KGE	KGE	Same
Regulation No.	876.4300	876.4300	Same
Class	2	2	Same
Supplied Sterile	Yes	Yes	Same
Jaws Shape	Oval JawsAlligator Jaws	Oval Jaws	Similar
Outer TubeDiameter	2.3mm	2.3mm	Same
Minimal WorkingChannel	2.8mm	2.8mm	Same
Working Length	1800mm, 2300mm	1800mm, 2300mm	Same
Indications for Use	The device is intended tobe used for endoscopichistological sampling orelectrocoagulation ofvarious tissues, within the	The device is intended tobe used for endoscopichistological sampling orelectrocoagulation ofvarious tissues, within the	Same

Comparison to predicate Device:

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Image /page/5/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the word "MICRO-TECH" in a similar blue font. Below the word "MICRO-TECH" are two Chinese characters.

Item	Proposed DeviceDisposable Hot BiopsyForceps	Predicate DeviceDisposable Hot BiopsyForceps (K160625)	510K SummaryComparisonto PredicateDevice
	the gastrointestinal andbronchial tracts, via theoperating channel ofendoscopic instruments.	gastrointestinal andbronchial tracts, via theoperating channel ofendoscopic instruments.
Configuration	Jaws, Spring Sheath,High-Frequency, andHandle	Jaws, Spring Sheath,High-Frequency, andHandle	Same
Single Use	Yes	Yes	Same
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1	Same
Sterility	Sterility Assurance Level:$10^{-6}$ .	Sterility Assurance Level:$10^{-6}$ .	Same
Packaging	Single-use EO sterilizedpouch with one device perpouch	Single-use EO sterilizedpouch with one device perpouch	Same
Shelf Life	Three years	Four years	Different

Compared to the predicate device, the proposed device is different from the predicate device in the following:

1. Add two new models that the Jaws shape is Alligator;
1. Change the color of spring tube from blue to Red and add mark;
1. Change the packaging, delete the inner plate and add the Jaws protective cap and Fixed Tape.
Shelf life Change 4)

8. Non-Clinical Test

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.

ASTM F1929-15 Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration

ASTM F1140/F1140M-13 Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages

ASTM F1886/F1886M–16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

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Image /page/6/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 in blue and white. To the right of the letters is the text "MICRO-TECH" in blue, with a horizontal line underneath. Below the line is some Chinese text.

510K Summary

USP 40 - NF35:2017 <71> Sterility Tests

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ISO 10993-1:2009 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process

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: Tests for irritation and delayed-type hypersensitivity

ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity

ISO 10993-11: 2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity USP 40 NF 35:2017 <151> Pyrogen Test

ISO 11135 Second Edition 2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices

9. Clinical Test Conclusion

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 Disposable Hot Biopsy Forceps cleared under K160625.

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).