Guidewire Locking Device

K220247 · Micro-Tech (Nanjing) Co., Ltd. · ODC · Mar 29, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220247
• Device Name: Guidewire Locking Device
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Mar 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

Device Story

Guidewire Locking Device is a sterile, single-use accessory for ERCP procedures; fits onto duodenoscope to lock guidewires and plug working channel access. Device consists of guidewire locking assembly and clamp seal assembly; allows locking of up to two guidewires simultaneously. Operated manually by trained healthcare professionals in endoscopic clinics. During device insertion and exchange, locking mechanism prevents guidewire movement, improving procedural convenience. Benefits include enhanced stability of guidewires during biliary interventions.

Clinical Evidence

Bench testing only. No clinical or animal studies were performed. Performance testing included slide block flexibility, locking retention, friction resistance, instrument insertion smoothness, sealability, wire locking force, brush/squeegee performance, and connection force. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) and sterilization validation (ISO 11135) were completed. Shelf-life validated via accelerated aging (ASTM F1980-16).

Technological Characteristics

Materials: ABS, Silicone rubber, SUS304, Polyurethane sponge. Manual operation. Single-use. EO sterilized (SAL 10^-6). Compatible with Olympus/Fujinon or Pentax duodenoscopes. Biocompatibility per ISO 10993-1. Shelf life: 6 months.

Indications for Use

Indicated for use by healthcare professionals trained in ERCP to lock up to two guidewires in place during endoscopic biliary procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fusion Wire Guide Locking Device (K040137)

Submission Summary (Full Text)

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March 29, 2022

Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu Province 210032 CHINA

Re: K220247

> Trade/Device Name: Guidewire Locking Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: January 20, 2022 Received: January 28, 2022

Dear Sally He:

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

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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 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 (QS) 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 medical devices and radiation-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) K220247

Device Name Guidewire Locking Device

Indications for Use (Describe)

The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------|-----------------------------------------------|
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K220247 Page 1 of 5

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

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: K220247

## 1. Date of Preparation: 2022-1-20

## 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: Sally He

Position: RA Engineer

Tel: [phone]

Fax: [phone]

Email: [e-mail]

## 3. Identification of Proposed Device

Product Name: Guidewire Locking Device

Common Name: Locking Device

## Regulatory Information

Classification Name: Endoscope and accessories.

Classification: 2

Product Code: ODC

Regulation Number: 876.1500

Review Panel: Gastroenterology/Urology

Confidential: This document contains information that is confidential and proprietary property of Micro-Tech (Naging) CO., Ltd. Neither this document nor the information therein may be reproduced to or for the benefit of any third party without prior written consent of Micro-Tech.

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K220247 Page 2 of 5

Image /page/4/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional font. The "M" is white and appears to be in front of the blue "T", creating a sense of depth. A registered trademark symbol is located in the upper right corner of the logo.

510k summary

#### 4. Identification of Predicate Device

510(k) Number: K040137

Product Name in Original 510(k) Submission: Wilson-Cook USW Cap and Wire Lock

Current Trade Name in Market: Fusion Wire Guide Locking Device

Manufacturer: Wilson-Cook Medical Inc

#### 5. Indications for Use

The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

### Device Description 6.

The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures.

The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidewire can be locked and will not be moved, so the convenience of the operation can be improved.

The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge.

This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy.

There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope.

The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 6 months.

Confidential:This document contains information that is confidential and proprietary property of Micro-Tech (Naging) CO., Ltd. Neither this document nor the information therein may be reproduced, used or for the benefit of any third party without prior written consent of Micro-Tech.

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K220247 Page 3 of 5

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 stacked on top of each other, creating a block-like shape. A registered trademark symbol is located in the upper right corner of the logo.

510k summary

## 7. Comparison of Technological Characteristics

The proposed device Guidewire Locking Device incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Fusion Wire Guide Locking Device.

Comparison between the proposed device and predicate device:

| Item | Proposed Device<br>Guidewire Locking Device | Predicate Device<br>Fusion Wire Guide Locking<br>Device (K040137) | Remark |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Supplied in sterile | YES | YES | SE |
| Configuration | The guidewire locking assembly<br>and the clamp seal assembly | The guidewire locking assembly<br>and the clamp seal assembly | SE |
| Main Material | Main body: ABS<br>Seal Cap :Silicone rubber | Plastic, unknown formulation<br>Rubber, unknown formulation | Similar |
| Using Environment | Endoscopic Clinic | Endoscopic Clinic | SE |
| Compatible<br>Endoscopy | Olympus/ Fujinon, Pentax | Olympus/ Fujinon, Pentax | SE |
| Indications for Use | The Guidewire Locking Device<br>is an accessory to be used with<br>endoscopic biliary devices to<br>lock the guidewire(s) in place<br>during ERCP procedures. | The Wilson-Cook USW Cap and<br>Wire Lock Device is an accessory<br>to be used with endoscopic biliary<br>devices to lock the wire guide(s) in<br>place during ERCP procedures. | SE |
| Mechanics of Action | Manual | Manual | SE |
| Multiple Locking<br>Positions | Yes | Yes | SE |
| Single Use | Yes | Yes | SE |
| Packaging | Single-use EO sterilized pouch<br>with one device per pouch | Single-use EO sterilized pouch<br>with one device per pouch | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | SE |
| Item | Proposed Device<br>Guidewire Locking Device | Predicate Device<br>Fusion Wire Guide Locking<br>Device (K040137) | Remark |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | SE |

Confidential: This document contains information that is confidential and proprietary property of Micro-Fech (Nanjing) CO., Ltd. Neither this document nor the information therein may be reproduced to or for the benefit of any third party without prior written consent of Micro-Tech.

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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 constructed from blocks, giving them a solid, geometric appearance. A registered trademark symbol (®) is positioned in the upper right corner of the logo.

## 8. Performance Data

Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device.

- A Slide Block Flexibility Test
- A Locking Retention Performance Test
- > Friction Resistance Test
- A Smoothness of Instrument Insertion Test
- > Sealability Test
- > Wire Locking Force Test
- > Brush and Squeegee Performance Test
- A Connection Force Test

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. 6 months aging test was 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+A1:2018 "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

Confidential:This document contains information that is confidential and proprietary property of Micro-Fech (Nanjing) CO, Ltd. Neither this document nor the information therein may be reproduced, used or for the benefit of any third party without prior written consent of Micro-Tech.

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K220247 Page 5 of 5

Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are connected and appear to be three-dimensional, with shading that suggests a light source from above. A registered trademark symbol (®) is located in the upper right corner of the logo.

510k summary

risk management process" issued on September 4, 2020. Biocompatibility testing included the following tests:

- > ISO 10993-5: 2009 Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity
- > ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for irritation and sensitization
- ≫ ISO 10993-11: 2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

## 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 proposed device Guidewire Locking Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Fusion Wire Guide Locking Device (K040137).