Sphincterotome / short-wire compatible, Sterile Sphincterotome

K210934 · Micro-Tech (Nanjing) Co., Ltd. · KNS · Dec 1, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210934
• Device Name: Sphincterotome / short-wire compatible, Sterile Sphincterotome
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Dec 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.

Device Story

Electrosurgical accessory for ERCP procedures; used for selective cannulation of biliary ducts and sphincterotomy. Device comprises cutting wire, outer tube, and handle assembly. Operated by physician during endoscopic procedures; connects to high-frequency (HF) generator to deliver energy through cutting wire for tissue incision. Enables contrast medium injection. Available in multiple specifications (cutting wire types/lengths, insulation, guidewire compatibility). Used in clinical settings; facilitates biliary access and therapeutic intervention. Benefits include rapid exchange capability (short-wire compatible models) and precise tissue cutting.

Clinical Evidence

No clinical data. Bench testing only: operation, endoscope compatibility, preflexed testing, conductivity, connection strength, injection port/infusion patency, energy delivery/cutting performance, cannulation performance, and visualization. Biocompatibility per ISO 10993-1; sterilization per ISO 11135; electrical/thermal safety per IEC 60601 series.

Technological Characteristics

Materials: PTFE, ABS, SUS304. Energy: HF generator (max 1200Vp). Configuration: Cutting wire, outer tube, handle. Sterilization: EO (SAL 10^-6). Standards: ISO 10993-1, ISO 11135, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ASTM F1980-16. Connectivity: None (mechanical/electrosurgical accessory).

Indications for Use

Indicated for selective cannulation of biliary ducts and transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi; includes contrast medium injection capability.

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

• Sphincterotome (K013153)

Reference Devices

• Olympus KD Sphincterotome (K955247)
• Rotatable Sphincterotome (K061684)

Submission Summary (Full Text)

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December 1, 2021

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

Re: K210934

Trade/Device Name: Sphincterotome / short-wire compatible, Sterile Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: October 27, 2021 Received: November 1, 2021

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,

Je Hi An, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K210934

### Device Name

Sphincterotome (Sphincterotome / short-wire compatible and Sterile Sphincterotome)

Indications for Use (Describe)

The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.

| Type of Use (Select one or both, as applicable) | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span style="font-size: 12pt;"><b></b></span></td><td><span style="font-size: 12pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span></td><td><span style="font-size: 12pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span></td></tr></table> | <span style="font-size: 12pt;"><b></b></span> | <span style="font-size: 12pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 12pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| <span style="font-size: 12pt;"><b></b></span> | <span style="font-size: 12pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 12pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |

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Image /page/3/Picture/0 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 angled slightly, giving them a sense of depth. A small registered trademark symbol is visible in the upper right corner of the logo. The logo is simple and bold, with a clean design.

Section 5

# 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: K210934

#### 1. Date of Preparation: 2021-12-01

#### 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

Trade Name: Sphincterotome / short-wire compatible, Sterile Sphincterotome

Common Name: Sphincterotome

## Regulatory Information

Classification Name: Endoscopic electrosurgical unit and accessories.

Classification: 2

Product Code: KNS

Regulation Number: 876.4300

Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/0 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 them a sense of depth. A registered trademark symbol (®) is positioned in the upper right corner of the logo.

# 4. Identification of Predicate Device/Reference Device Predicate Device 510(k) Number: K013153 Product Name: Sphincterotome Manufacturer: Boston Scientific Corporation (BSC) Reference Devices: 510(k) Number: K955247 Product Name: Olympus KD Sphincterotome Manufacturer: Olympus America, Inc. Reference Devices: 510(k) Number: K061684 Product Name: Rotatable Sphincterotome Manufacturer: Medi-Globe GmbH

#### Indications for Use ട്.

The device is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.

#### Device Description 6.

The proposed device has two types: Sphincterotome / short-wire compatible and Sterile Sphincterotome. Sterile commonly traditional Endoscopic Retrograde Sphincterotome used in Cholangiopancreatography (Hereinafter referred to ERCP) surgery need to be used with a long guidewire, while Sphincterotome / short-wire compatible with short-wire techniques to compatible with a short guidewire to achieve rapid exchange between ERCP devices.

The proposed device consists of Cutting Wire, Outer Tube and Handle Assembly. It is used with the High Frequency Generator (Hereinafter referred to HF Generator) and the endoscopic procedures. The HF Generator supplies high frequency energy through the Cutting Wire of the proposed device to cut

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Image /page/5/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional design. The letters are primarily in a dark blue color, with the "M" on the left and the "T" on the right, slightly overlapping each other. A registered trademark symbol (®) is visible in the upper right corner of the logo. The logo has a modern and corporate appearance.

the tissue at the appropriate power and voltage. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304.

The proposed device has 52 specifications, which mainly differ in cutting wire type, cutting wire length, preloaded guidewire length and with insulation tube or not.

The proposed device Sphincterotome is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 1 year.

#### 7. Comparison of Technological Characteristics

The proposed device Sphincterotome incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Sphincterotome.

| Item | Proposed Device<br>Sphincterotome | Predicate Device<br>Sphincterotome<br>(K013153) | Remark |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product code | KNS | KNS | Same |
| Regulation No. | 876.4300 | 876.4300 | Same |
| Class | II | II | Same |
| Supplied in sterile | YES | YES | Same |
| Main material | PTFE, SUS304, ABS | Polymer materials, Stainless Steel | Different |
| Configuration | Consists of Cutting wire assembly,<br>Outer tube assembly and Handle<br>assembly | Consists of Cutting wire assembly,<br>Outer tube assembly and Handle<br>assembly | Same |
| Injection | Contrast medium | Contrast medium | Same |
| Cutting wire length | 5mm, 20mm, 25mm, 30mm | 20mm, 30mm | Different |
| Working length | 2000mm | 2000mm | Same |
| Tip length | 5mm | 5mm | Same |
| Tip Type | Cone Knife, Needle Knife | Cone Knife | Different |
| Item | Proposed Device<br>Sphincterotome | Predicate Device<br>Sphincterotome<br>(K013153) | Remark |
| Cutting Wire Type | Single, Weave | Single | Different |
| Insulation Tube | With, Without | Without | Different |
| Compatible<br>endoscopy working<br>channel | ≥3.2mm<br>≥2.8mm | ≥2.8mm | Different |
| Compatible<br>guidewire diameter | ≤0.03 inch | ≤ 0.035 inch | Same |
| Energy source | HF generator | HF generator | Same |
| Maximum rated<br>accessory voltage | 1200Vp (2400Vp-p) | 750Vp (1500Vp-p) | Different |
| Indications for use | The Sphincterotome is intended to<br>be used in the selective cannulation<br>of the biliary ducts and the<br>transendoscopic sphincterotomy of<br>the Papilla of Vater and/or the<br>Sphincter of Oddi. The device can<br>also be used to inject contrast<br>medium. | The Sphincterotome is indicated<br>for use in the selective cannulation<br>of the Common Bile Ducts (CBD)<br>and the transendoscopic<br>sphincterotomy of the Papilla of<br>Vater and/or the Sphincter of Oddi.<br>The Sphincterotome can also be<br>used to inject contrast medium. | Same |
| Single use | Yes | Yes | Same |
| Packaging | 1 Piece/Pouch | 1 Piece/Pouch | Same |
| Shelf life | One year | Three years | Different |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | Same |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | Same |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
| Item | Proposed Device<br>Sphincterotome | Predicate Device<br>Sphincterotome<br>(K013153) | Remark |
| 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 |

Comparison between the proposed device and predicate device:

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Image /page/6/Picture/0 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 sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

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Image /page/7/Picture/0 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.

The proposed device is similar in design and technological characteristics to the predicate device, although there are some differences, those differences have been compared with the reference device legally marketed in the U.S. market, and conduct the performance testing, the test results meet the requirement. Therefore, the difference between proposed device and predicated device is considered not to affect the Substantially Equivalency between the proposed and predicate devices concerning the safety and effectiveness.

#### Performance Data 8.

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.

- > Operation Testing
- A Endoscope Compatibility Testing
- A Head Preflexed Testing
- > Conductivity Testing
- > Connection Strength Testing
- > Injection Luer Port Testing
- > Infusion Patency Testing
- > Energy Delivery and Cutting Testing
- > Cutting Rate Testing
- > Cannulation Performance Testing

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Image /page/8/Picture/0 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.

#### Endoscopy Visualization Testing A

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. One-year 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 "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 September 4, 2020.

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 disturbances - Requirements and tests

#### 9. Animal Study

No animal study is included in this submission.

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# 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 Sphincterotome has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Sphincterotome (K013153).