Disposable Hot Biopsy Forceps

K180018 · Micro-Tech (Nanjing) Co., Ltd. · KGE · Jul 5, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180018
• Device Name: Disposable Hot Biopsy Forceps
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Jul 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Disposable Hot Biopsy Forceps; sterile, single-use endoscopic instrument. Consists of flexible wire cable, handle, and jaws (oval or alligator). Operated by physician via endoscope working channel. Delivers monopolar electrical current for tissue sampling or electrocoagulation. Used in gastrointestinal and bronchial tracts. Provides tissue samples for biopsy or achieves hemostasis/tissue destruction via electrocoagulation. Benefits patient by enabling minimally invasive diagnostic and therapeutic procedures.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10993 (biocompatibility), ISO 11135 (sterilization), and various ASTM standards for packaging integrity (F88, F1929, F1140, F1886) and accelerated aging (F1980).

Technological Characteristics

Monopolar electrosurgical accessory. Components: jaws, spring sheath, handle. Outer diameter 2.3mm; compatible with 2.8mm working channels. Lengths: 1800mm, 2300mm. EO sterilized (SAL 10^-6). Biocompatibility per ISO 10993-1. Packaging integrity per ASTM F88, F1929, F1140, F1886.

Indications for Use

Indicated for endoscopic histological sampling or electrocoagulation of tissues within the gastrointestinal and bronchial tracts. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Disposable Hot Biopsy Forceps (K160625)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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

### 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

- 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 and Regulatory Affairs Director Tel: [phone] Fax: [phone] Email: [e-mail]

#### 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

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.

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### 510K Summary

#### Device Description 6.

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 ° 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 Device<br>Disposable Hot Biopsy<br>Forceps | Predicate Device<br>Disposable Hot Biopsy<br>Forceps (K160625) | Comparison<br>to Predicate<br>Device |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Code | KGE | KGE | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied Sterile | Yes | Yes | Same |
| Jaws Shape | Oval Jaws<br>Alligator Jaws | Oval Jaws | Similar |
| Outer Tube<br>Diameter | 2.3mm | 2.3mm | Same |
| Minimal Working<br>Channel | 2.8mm | 2.8mm | Same |
| Working Length | 1800mm, 2300mm | 1800mm, 2300mm | Same |
| Indications for Use | The device is intended to<br>be used for endoscopic<br>histological sampling or<br>electrocoagulation of<br>various tissues, within the | The device is intended to<br>be used for endoscopic<br>histological sampling or<br>electrocoagulation of<br>various 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 Device<br>Disposable Hot Biopsy<br>Forceps | Predicate Device<br>Disposable Hot Biopsy<br>Forceps (K160625) | 510K Summary<br>Comparison<br>to Predicate<br>Device |
|------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | the gastrointestinal and<br>bronchial tracts, via the<br>operating channel of<br>endoscopic instruments. | gastrointestinal and<br>bronchial tracts, via the<br>operating channel of<br>endoscopic instruments. | |
| Configuration | Jaws, Spring Sheath,<br>High-Frequency, and<br>Handle | Jaws, Spring Sheath,<br>High-Frequency, and<br>Handle | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | Same |
| Sterility | Sterility Assurance Level:<br>$10^{-6}$ . | Sterility Assurance Level:<br>$10^{-6}$ . | Same |
| Packaging | Single-use EO sterilized<br>pouch with one device per<br>pouch | Single-use EO sterilized<br>pouch with one device per<br>pouch | 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;
- 2) Change the color of spring tube from blue to Red and add mark;
- 3) 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.