Ensure Single-Use Coagulation Forceps

K202438 · Micro-Tech (Nanjing) Co., Ltd. · KGE · Mar 15, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202438
• Device Name: Ensure Single-Use Coagulation Forceps
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Mar 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

Device Story

Ensure Single-Use Coagulation Forceps are sterile, single-use endoscopic instruments; used by clinicians to achieve hemostasis in the digestive tract. Device consists of jaw, coated spring sheath, high-frequency electrical interface, and handle. Clinician advances device through endoscope channel; manipulates finger ring to open/close jaws; clamps bleeding site. High-frequency, high-voltage current is delivered via external electrosurgical generator to the target tissue to induce coagulation. Device provides mechanical clamping and electrical energy delivery; aids in managing gastrointestinal bleeding. Benefits include effective, localized hemostasis during endoscopic procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via dimension, rotatable, pushability, actuation, HF plug removal, electrode contact impedance, hemostatic performance, and tensile strength testing. Biocompatibility per ISO 10993-1; sterilization per ISO 11135; electrical safety/EMC per IEC 60601-1, 60601-1-2, 60601-2-2, and 60601-2-18. Shelf-life validated via accelerated aging per ASTM F1980-16.

Technological Characteristics

Materials: 17-4ph, SUS303F, SUS304, HDPE, FEP. Energy: Monopolar Radio Frequency. Configuration: Jaws, tube, plug, slider. Dimensions: Max diameter ≤2.7 mm; lengths 1650mm/2300mm. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None (manual endoscopic accessory). Standards: ISO 10993, ISO 11135, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ASTM F1980-16.

Indications for Use

Indicated for adult patients requiring cauterization, coagulation, or hemostasis via high-frequency current during endoscopic procedures in the digestive tract.

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

• Single-Use Electrosurgical Hemostatic Forceps (K062517)

Submission Summary (Full Text)

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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 FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 15, 2021

Micro-Tech (Nanjing) Co., Ltd. Cecilia Sun RA Engineer No. 10 Gaoke Third Road Nanjing, Jiangsu Province 210032 CHINA

Re: K202438

> Trade/Device Name: Ensure Single-Use Coagulation Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: February 9, 2021 Received: February 12, 2021

Dear Cecilia Sun:

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

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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) 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] 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) K202438

Device Name

Ensure(TM) Single-Use Coagulation Forceps

Indications for Use (Describe)

These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect height="16" style="fill:lightgray;stroke:black;stroke-width:1px" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect height="16" style="fill:lightgray;stroke:black;stroke-width:1px" width="16"></rect> </svg> Over The Counter Use (21 CFR 801 Subpart </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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K202438 Page 1 of 6

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 made of solid blocks, giving them a bold and modern look. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

## Section 5 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: _

# 1. Date of Preparation: 2020-05-27

- 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: Cecilia Sun

Position: RA Engineer

Tel: [phone]

Fax: [phone]

Email: [e-mail]

## 3. Identification of Proposed Device

Trade Name: Ensure™ Single-Use Coagulation Forceps

Common Name: Electrosurgical Hemostatic Forceps

## Regulatory Information

Classification Name: Endoscopic electrosurgical unit and accessories Classification: 2 Product Code: KGE Regulation Number: 876.4300 Review Panel: Gastroenterology and urology

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K202438 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 made of solid blocks, giving them a bold and modern look. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

Section 5 510k summary

### 4. Identification of Predicate Device

510(k) Number: K062517

Product Name: Single-Use Electrosurgical Hemostatic Forceps Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION

### 5. Indications for Use

These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

## 6. Device Description

The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients.

The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

## 7. Comparison of Technological Characteristics

The Ensure™ Single-Use Coagulation Forceps incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology,

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K202438 Page 3 of 6

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 made of solid blocks. A small registered trademark symbol is located in the upper right corner of the logo.

Section 5 510k summary

sterilization process and intended use as those featured in the predicate device -

# Single-Use Electrosurgical Hemostatic Forceps.

## Comparison to predicate Devices:

| | Proposed Device | Predicate Device | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Item | Ensure™ Single-Use Coagulation<br>Forceps | Single-Use Electrosurgical<br>Hemostatic Forceps (K062517) | Remark |
| Product Code | KGE | KGE | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied in<br>Sterile | Yes | Yes | Same |
| Main Material | 17-4ph, SUS303F, SUS304, HDPE, FEP | Stainless steel, Polyethylene | Similar |
| Configuration | Jaws, Tube, Plug, Slider | Forceps, Tube, Plug, Slider | Same |
| Working length | 1650mm and 2300mm. | 1650mm, 1950mm and 2300mm | Similar |
| Jaws Type | Image: Type A, Type B, Type C | Image: Type A, Type B, Type C | Same |
| Maximum<br>Diameter | ≤2.7 mm | ≤2.75 mm / ≤3.1 mm | Similar |
| Energy<br>Used/Delivered | Monopolar Radio Frequency Current. | Monopolar Radio Frequency<br>Current. | Same |
| Rated<br>High-Frequency<br>Voltage | COAG: 2300 Vp (4600 Vp-p) | COAG: 2900 Vp (5800 Vp-p) | Different |
| Biological<br>Performance | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same |
| Electrical Safety<br>and<br>Electromagnetic<br>Compatibility | Conform to:<br>IEC60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2<br>IEC 60601-2-18 | Conform to:<br>IEC60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2<br>IEC 60601-2-18 | Same |
| Indications for | These instruments have been designed | These instruments have been | Same |
| | Section 5 510k summary | | |
| Item | Proposed Device | Predicate Device | Remark |
| | Ensure™ Single-Use Coagulation | Single-Use Electrosurgical | |
| | Forceps | Hemostatic Forceps (K062517) | |
| Use | to be used with endoscopes to cauterize<br>and coagulate or to perform hemostasis<br>using high-frequency current within the<br>digestive tract. | designed to be used with<br>Olympus endoscopes to<br>cauterize and coagulate or to<br>perform hemostasis using<br>high-frequency current within the<br>digestive tract. Do not use this<br>instrument for any purpose other<br>than its intended use | |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized pouch with one<br>device per pouch | Single-use EO sterilized pouch<br>with one device per pouch | Same |
| Shelf Life | Two years | Three years | Different |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same |

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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 connected and appear to be angled slightly, giving the logo a dynamic look. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

## 8. Performance Data

The proposed device the Ensure™ Single-Use Coagulation Forceps meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process", ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals",

The following bench tests were performed on the Ensure™ Single-Use Coagulation Forceps

- > Dimension Testing
- > Rotatable Performance Testing
- > Pushability Testing
- > Actuation Testing
- > The Removal of HF Plug Testing

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K202438 Page 5 of 6

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 registered trademark symbol is located in the upper right corner of the logo.

Section 5 510k summary

- A Electrode Contact Impedance Testing
- A Hemostatic Performance Testing
- > Tensile Strength Testing

The tests performed demonstrated that the proposed device and predicate device are substantially equivalent.

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-year aging test will be 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 "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 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16,2016.

Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:

IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment - general requirements for the basic safety and essential performance IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic

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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 blocky and appear to be constructed from multiple layers, giving them a sense of depth. A small registered trademark symbol is located in the upper right corner of the logo. The logo is simple, bold, and easily recognizable.

Section 5 510k summary

disturbances - Requirements and tests

# 9. Animal Study

No animal study is included in this submission.

#### 10. Clinical Study

No clinical study is included in this submission.

#### 11. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Ensure™ Single-Use Coagulation Forceps has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Single-Use Electrosurgical Hemostatic Forceps (K062517).