The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.

The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.

AI/ML Overview

The provided document is a 510(k) summary for the Micro-Tech Grasping Forceps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it explicitly states:

"8. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria for a clinical study and the study proving the device meets those criteria, as requested, cannot be provided because no clinical study was conducted or presented in this document.

The document does include a "Non-Clinical Test Conclusion" which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."

Here's the relevant information about the acceptance criteria and non-clinical testing from the document:

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

The document does not provide a table with explicit acceptance criteria for performance in a clinical setting. Instead, it relies on non-clinical tests to demonstrate that the device complies with various standards, thereby showing it meets design specifications and is substantially equivalent to a predicate device.

Test Category	Acceptance Criteria (Implied by standard compliance)	Reported Device Performance
Material/Packaging Integrity	Compliance with:	Met all design specifications and standards.
	- ASTM F88/F88M-09 (Seal Strength)
	- ASTM F1929-12 (Seal Leaks by Dye Penetration)
	- ASTM F1140/F1140M-13 (Internal Pressurization Failure Resistance)
	- ASTM F1886/F1886M-09 (Integrity of Seals by Visual Inspection)
Sterility & Biocompatibility	Compliance with:	Met all design specifications and standards.
	- ISO 11737-1 (Microorganisms on products)
	- AAMI ANSI ST72 (Bacterial Endotoxins)
	- ISO 10993-5 (In Vitro Cytotoxicity)
	- ISO 10993-7 (Ethylene Oxide Sterilization Residuals)
	- ISO 10993-10 (Irritation And Skin Sensitization)
	- USP 37 NF 32 <71> (Sterility Tests)
	- USP 37-NF 32 <85> (Bacterial Endotoxins Test)
	- ISO 11135 (Ethylene Oxide Sterilization)
Shelf Life	Compliance with ASTM F1980-07:2011 (Accelerated Aging of Sterile Barrier Systems)	Achieved a shelf life of 5 years.

2. Sample sized 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 sample sizes for each non-clinical test. The provenance of the data is implicitly from Micro-Tech (Nanjing) Co., Ltd. in Jiangsu Province, PRC, as they are the submitter of the 510(k). The tests are non-clinical (laboratory/bench tests), not human clinical data, so the retrospective/prospective and country of origin for patients are not applicable.

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 "ground truth" for non-clinical tests is compliance with published international and national standards, not expert consensus interpreting clinical data. Therefore, no experts for establishing ground truth in the context of clinical performance are mentioned.

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

Not applicable, as this refers to clinical data adjudication, which was not performed.

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

Not applicable. No clinical studies, MRMC studies, or AI components are mentioned in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. No algorithm or AI component is mentioned.

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

For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., ASTM, ISO, USP). For the claim of Substantial Equivalence, the "ground truth" is that the device's technical characteristics, intended use, and performance (as shown through non-clinical testing) are sufficiently similar to the predicate device, and it raises no new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI or machine learning component.

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

Not applicable. No training set or ground truth for a training set is mentioned.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.

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

January 21, 2016

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

Re: K152802 Trade/Device Name: Grasping Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCZ Dated: December 18, 2015 Received: December 21, 2015

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. 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.

Herbert P. Lerner -S

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) K152802

Device Name

Grasping Forceps

Indications for Use (Describe)

Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

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Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue stylized "MT" on the left, followed by the text "MICRO-TECH" in blue. Below "MICRO-TECH" are two Chinese characters, also in blue.

Tab7

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: 11/25/2015

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: Manager of Quality Department Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn

3. Identification of Proposed Device

Product Name: Grasping Forceps Common Name: Grasping Forceps Requlatory Information Classification Name: endoscopic grasping/cutting instrument, non-powered Classification: 2 Product Code: OCZ Regulation Number: 876.1500 Review Panel: Gastroenterology/Urology

4. Indications for Use

Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.

5. Device Description

The proposed device Grasping Forceps is a sterile, single-use device,

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Image /page/4/Picture/1 description: The image contains a logo for Micro-Tech. The logo consists of a blue stylized letter "M" and "T" on the left side. To the right of the letters, the text "MICRO-TECH" is written in blue, with a line underneath it. Below the line, there are two Chinese characters.

designed to pass through a 2.8 mm or greater working channel of an endoscope.

The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.

6. Identification of Predicate Device

510(k) Number: K120084

Trade Name: The US Endoscopy Endoscopic Retrieval Device Regulation Name: Endoscope and accessories

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications 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-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.

ASTM F1929-12, 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.

ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices -Microbiological methods-Part 1: Determination of a population of

microorganisms on products

ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

AAMI ANSI ST72:2011 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing.

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Image /page/5/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue stylized letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue. Below the text is the Chinese translation of the company name.

ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-7:2008(R) 2012, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. USP 37 NF 32: 2014 <71> Sterility Tests USP 37-NF 32: 2014 <85> BACTERIAL ENDOTOXINS 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

8. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

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Image /page/6/Picture/4 description: The image shows the logo for MICRO-TECH. The text "MICRO-TECH" is written vertically in blue, with a curved line above it. To the right of the text are two Chinese characters, also in blue. Below the text is a blue geometric shape.

510K Summary

		Table 1 Comparison of Technology Characteristics
Item	Proposed DeviceGrasping Forceps	Predicate Device (K120084)The US Endoscopy Endoscopic Retrieval Device	Substantial Equivalence
Product Code	OCZ	OCZ	Same
Regulation No.	876.1500	876.1500	Same
Class	2	2	Same
Supplied Sterile	Yes	Yes	Same
Indications for Use	Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.	The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.	Similar
Jaws open wide (mm)	6.3mm, 8.1mm	10mm	Similar
Working Length	1800mm, 2300mm	2300mm	Similar
Configuration	Jaws, Spring sheath, Finger ring	Jaws, Spring sheath, Finger ring	Same
Single Use	Yes	Yes	Same
Packaging	Single-use EO sterilized pouch with one device per pouch	Single-use EO sterilized pouch with one device per pouch	Same
Image: MICRO-TECH logo		510K Summary
Item	Proposed Device	Predicate Device (K120084)	SubstantialEquivalence
	Grasping Forceps	The US Endoscopy Endoscopic RetrievalDevice
Shelf Life	Five years	Three years	Similar

4/5

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10.

as Substantialy Equivalent (SE) Conclusion
Based on the comparison and analysis from the nondinical tests, the proposed devices in affective, performances are
well as the pred

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.