Sphincterotome

K222421 · Hangzhou AGS MedTech Co., Ltd. · KNS · May 3, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222421
• Device Name: Sphincterotome
• Applicant: Hangzhou AGS MedTech Co., Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

Device Story

Sterile, single-use endoscopic accessory; consists of long plastic tube with internal wire; distal end features exposed wire segment. Operated by physician during endoscopic procedures; device inserted through endoscope working channel. High-frequency monopolar electrosurgical current delivered from external generator through wire to open papilla roof; facilitates access to biliary or pancreatic orifices for cannulation. Enables therapeutic sphincterotomy; benefits patient by allowing minimally invasive access to biliary/pancreatic ducts for diagnostic or therapeutic intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrosurgical safety (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135). Performance metrics verified include injection performance, compatibility with guide wires/endoscopes, visibility, and cutting rate.

Technological Characteristics

Monopolar electrosurgical accessory. Materials: PTFE, Stainless Steel 304, Polyurethane, silicone oil, medical grade hydrophilic coating. Energy: Monopolar Radio Frequency. Dimensions: 2.4mm sheath, 1800mm working length. Compatibility: 2.8mm or 3.7mm endoscope channels. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients requiring cannulation of biliary ducts and transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.

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

• Autotome™ RX (K013153)
• Sphincterotome (K201121)

Submission Summary (Full Text)

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May 3, 2023

Hangzhou AGS MedTech Co., Ltd. Jiayuan Zhang RA Specialist Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA

Re: K222421

> Trade/Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: April 4, 2023 Received: April 4, 2023

Dear Jiayuan Zhang:

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

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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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-devices/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-devices/device-advicecomprehensive-regulatory-assistance/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,

# Glenn B. Bell -S

Glenn B. Bell, Ph.D. 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 Ouality 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) K222421

Device Name Sphincterotome

Indications for Use (Describe)

The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

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

IZ] Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Summary

We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.

#### 5.1 Submitter

| | Hangzhou AGS MedTech Co., Ltd. |
|---------------------------------------|--------------------------------------------------------------------------------------------------|
| Submitted by/Owner: | Building 5, Building 6, No.597 Kangxin Road Yuhang<br>District, 311106 Hangzhou, Zhejiang, China |
| Establishment<br>Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Jiayuan Zhang<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | May 2, 2023 |

### 5.2 Device Identification

| Trade Name: | Sphincterotome |
|--------------------|-----------------------------------------------------------------|
| Device Name: | Sphincterotome |
| Common Name: | Sphincterotome |
| Regulation Class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |

#### 5.3.1 Primary Predicate Device

| Trade Name: | Autotome™ RX |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | Autotome RX Cannulating Sphincterotome |
| Common Name: | Sphincterotome |
| 510(k) Number: | K013153 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |

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| Trade Name: | Sphincterotome |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | Sphincterotome |
| Common Name: | Sphincterotome |
| 510(k) Number: | K201121 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |

#### 5.3.2 Secondary Predicate Device

#### 5.4 Device Description

The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.

#### 5.5 Indication for use statement

The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

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## 5.6 Comparison of Technology Characteristics

Our proposed device Sphincterotome is substantially equivalent to the predicate devices. The differences between the Sphincterotome and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

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| Item | | Proposed device<br>Sphincterotome | Predicate device<br>(K013153) | Comparison |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | | Sphincterotome | Sphincterotome | / |
| Trade name | | Sphincterotome | Autotome™ RX | / |
| Model number | | 50912, 50913, 50917 series | M00545150, M00545160, M00545170, M00545180, M00545190, M00545200 | / |
| 510(k) submitter | | Hangzhou AGS MedTech Co., Ltd. | Boston Scientific Corporation | / |
| 510(k) number | | / | K013153 | / |
| Clinical | Intended use | The Sphincterotome is indicated for use in the<br>cannulation of the biliary ducts and the transendoscopic<br>sphincterotomy of the Papilla of Vater and/or the Spincter<br>of Oddi. The device is supplied sterile and intended for<br>single use only. | The Sphincterotome is indicated for use in the<br>selective cannulation of the Common Bile Ducts<br>(CBD) and the transendoscopic sphincterotomy of the<br>Papilla of Vater and/or the Sphincter of Oddi. The<br>Sphincterotome can also be used to inject contrast<br>medium. | Similar.<br>The equivalent device has a wider<br>range of intended use than the<br>proposed device. |
| | Technical | Principles of<br>operation | Monopolar Sphincterotome manufactured is an applied<br>part of electrosurgical generator, using monopolar<br>high-frequency current delivered by the electrosurgical<br>generator for sphincterotomy with the electrode. The<br>high-frequency electricity flows from the active electrode<br>to the neutral electrode placed on patient skin. | Sphincterotome is an applied part of electrosurgical<br>generator, using monopolar high-frequency current<br>delivered by the electrosurgical generator for<br>sphincterotomy with the electrode. The<br>high-frequency electricity flows from the active<br>electrode to the neutral electrode placed on patient<br>skin. |
| Energy Use | | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| | Sheath tube | 2.4mm | 2.4mm | Same |
| Item | Proposed device<br>Sphincterotome | Predicate device<br>(K013153) | Comparison | |
| Wire Guide Diameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| Insulation protected | With/without | Without | Similar.<br>This difference wouldn't influence<br>the safety or performance if the<br>device. | |
| Preloaded Wire Guide<br>or not | Preloaded Wire Guide: 50913, 50917;<br>Not preloaded Wire Guide: 50912; | No | Similar.<br>Bench test has been conducted to<br>demonstrate substantial equivalence,<br>please refer to Section 18 bench<br>performance testing. | |
| Compatible Minimum<br>Accessory Channel | 3.7mm | 3.7mm | Same | |
| Working length | 1800mm | 2000mm | Different.<br>Bench test has been conducted to<br>demonstrate substantial equivalence,<br>please refer to Section 18 bench<br>performance testing. | |
| Performance | Injection performance,<br>Compatibility with traction guide wire,<br>Compatibility with endoscope,<br>Ray detectability,<br>Visibility under endoscopy,<br>Electric performance, | Unknown | Same.<br>Bench test has been conducted to<br>demonstrate substantial equivalence,<br>please refer to Section 18 bench<br>performance testing. | |
| Item | | Proposed device<br>Sphincterotome | Predicate device<br>(K013153) | Comparison |
| | | Operation flexibility,<br>Connected firmly,<br>Rotation performance,<br>Force to Bow,<br>Orientation of Cutting Wire and Visualization of Cutting<br>Wire,<br>Ink Validation;<br>Cutting rate;<br>Energy dose analyses; | | |
| Biological | Materials or<br>substances in contact<br>with the same human<br>tissue or body fluids | Plastic PTFE, Stainless Steel 304, PTFE;<br>Silicone oil, PTFE, Polyurethane, Medical grade<br>hydrophilic coating; | Unknown | Different.<br>Biocompatibility tests have been<br>done. Biological risks are<br>acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;<br>Skin sensitization Test: ISO 10993-10: 2010;<br>Intracutaneous Reactivity Test: ISO 10993-10: 2010;<br>Acute Systemic Toxicity Test: ISO 10993-11:2017;<br>Pyrogenicity: ISO 10993-11:2017; | Unknown | |
| Single Use | | Yes | Yes | Same |
| Shelf life and sterilization | | Shelf life: 18 months;<br>Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;<br>Sterilization: EO Sterilization; | Different.<br>Accelerated aging tests have been<br>done. The proposed device can<br>support the claimed shelf life. |
| Item | Proposed device<br>Sphincterotome | Predicate device<br>(K201121) | Comparison | |
| Common name | Sphincterotome | Sphincterotome | / | |
| Trade name | Sphincterotome | Sphincterotome | / | |
| Model number | 5091, 5093, 5094, 5096, 5098, 5099, 50910, 50912,<br>50913, 50916, 50917 series | 5096, 5098, 5099, 50910 series | / | |
| 510(k) submitter | Hangzhou AGS MedTech Co., Ltd. | Hangzhou AGS MedTech Co., Ltd. | / | |
| 510(k) number | / | K201121 | / | |
| Clinical<br> | Intended use | The Sphincterotome is indicated for use in the<br>cannulation of the biliary ducts and the transendoscopic<br>sphincterotomy of the Papilla of Vater and/or the Spincter<br>of Oddi. The device is supplied sterile and intended for<br>single use only. | The Sphincterotome is indicated for use in the<br>cannulation of the biliary ducts and the transendoscopic<br>sphincterotomy of the Papilla of Vater and/or the<br>Spincter of Oddi. The device is supplied sterile and<br>intended for single use only. | Same |
| Technical | Principles of<br>operation | Monopolar Sphincterotome manufactured is an applied<br>part of electrosurgical generator, using monopolar<br>high-frequency current delivered by the electrosurgical<br>generator for sphincterotomy with the electrode. The<br>high-frequency electricity flows from the active electrode<br>to the neutral electrode placed on patient skin. | Monopolar Sphincterotome manufactured is an applied<br>part of electrosurgical generator, using monopolar<br>high-frequency current delivered by the electrosurgical<br>generator for sphincterotomy with the electrode. The<br>high-frequency electricity flows from the active<br>electrode to the neutral electrode placed on patient skin. | Same |
| | Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| | Preloaded Wire<br>Guide or Not | Preloaded Wire Guide: 50910, 50913, 50916, 50917;<br>Not preloaded Wire Guide: 5091, 5093, 5094, 5096, | Preloaded Wire Guide: 50910<br>Not preloaded Wire Guide: 5096, 5098, 5099; | Same |
| Item | Proposed device<br>Sphincterotome | Predicate device<br>(K201121) | Comparison | |
| | 5098, 5099, 50912; | | | |
| Sheath tube | 2.4mm | 2.4mm | Same | |
| Wire Guide<br>Diameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| Compatible<br>Minimum<br>Accessory Channel | 5091, 5094, 5096, 5099: 2.8mm;<br>5093, 5098, 50910, 50912, 50913, 50916, 50917: 3.7mm; | 5096, 5099: 2.8mm;<br>5098, 50910: 3.7mm; | Same | |
| Working Length | 1800mm | 1800mm | Same | |
| Performance | Injection performance,<br>Compatibility with traction guide wire,<br>Compatibility with endoscope,<br>Ray detectability,<br>Visibility under endoscopy,<br>Electric performance,<br>Operation flexibility,<br>Connected firmly,<br>Rotation performance,<br>Force to Bow,<br>Orientation of Cutting Wire and Visualization of Cutting<br>Wire,<br>Ink Validation;<br>Cutting rate;<br>Energy dose analyses; | Injection performance,<br>Compatibility with traction guide wire,<br>Compatibility with Endoscope,<br>Ray detectability,<br>Visibility under endoscopy,<br>Electric performance,<br>Operation flexibility,<br>Connected firmly,<br>Rotation performance;<br>Force to Bow,<br>Orientation of Cutting Wire and Visualization of<br>Cutting Wire,<br>Ink Validation; | Same.<br>Bench test has been conducted to<br>demonstrate substantial<br>equivalence, please refer to<br>Section 18 bench performance<br>testing. | |
| Item | Proposed device<br>Sphincterotome | Predicate device<br>(K201121) | Comparison | |
| Biological | Materials or<br>substances in<br>contact with the<br>same human tissue<br>or body fluids | Plastic PTFE, Stainless Steel 304, PTFE;<br>Silicone oil, PTFE, Polyurethane, Medical grade<br>hydrophilic coating; | Plastic PTFE, Stainless Steel 304, PET;<br>Silicone oil, PTFE, Polyurethane, Medical grade<br>hydrophilic coating; | Same.<br>Biocompatibility tests have been<br>done. Biological risks are<br>acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;<br>Skin sensitization Test: ISO 10993-10: 2010;<br>Intracutaneous Reactivity Test: ISO 10993-10: 2010;<br>Acute Systemic Toxicity Test: ISO 10993-11:2017;<br>Pyrogenicity: ISO 10993-11:2017; | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;<br>Skin sensitization Test: ISO 10993-10: 2010;<br>Intracutaneous Reactivity Test: ISO 10993-10: 2010;<br>Acute Systemic Toxicity Test: ISO 10993-11:2017;<br>Pyrogenicity: ISO 10993-11:2017; | |
| Single Use | | Yes | Yes | Same |
| Shelf life and sterilization | | Shelf life: 18 months;<br>Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;<br>Sterilization: EO Sterilization, SAL of 10-6; | Different.<br>Accelerated aging tests have been<br>done. The proposed device can<br…