Who is the manufacturer of Sphincterotome?

Hangzhou AGS MedTech Co., Ltd. filed the 510(k) submission for Sphincterotome (K201121).

What is the FDA product code for Sphincterotome?

KNS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Sphincterotome?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sphincterotome?

Sphincterotome with DomeTip (K172665); Huibregtse Needle knife (K040981).

Who can help prepare an FDA 510(k) submission like Sphincterotome?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sphincterotome

K201121 · Hangzhou AGS MedTech Co., Ltd. · KNS · Feb 5, 2021 · Gastroenterology, Urology

Device Facts

Record ID	K201121
Device Name	Sphincterotome
Applicant	Hangzhou AGS MedTech Co., Ltd.
Product Code	KNS · Gastroenterology, Urology
Decision Date	Feb 5, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Indications for 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 sphincterotome for endoscopic use; compatible with endoscope working channels. Device consists of long plastic tube with internal wire; distal end features exposed wire segment. Operated by physician during ERCP; device functions as applied part of electrosurgical generator. High-frequency monopolar current delivered through wire to open papilla roof, exposing biliary or pancreatic orifices for cannulation. Some models include preloaded guidewire. Output is mechanical incision via electrosurgical energy. Benefits include facilitated ductal access and sphincterotomy.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10, -11), electrosurgical safety (IEC 60601), and performance testing (injection, compatibility, visibility, electrical performance, mechanical integrity).

Technological Characteristics

Materials: PTFE, Stainless Steel 304, PET, silicone oil, polyurethane, hydrophilic coating. Energy: Monopolar radio frequency current. Form factor: Long tube (1800mm) for 2.8mm accessory channels. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Connectivity: None (standalone accessory).

Indications for Use

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

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 with DomeTip (K172665)
Huibregtse Needle knife (K040981)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 8, 2021 Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA Re: K201121 Trade/Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dear Chunqi Han: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 5, 2021. Specifically, FDA is updating this SE Letter with a signature as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thelma Valdes, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-9621, Thelma.valdes@fda.hhs.gov. Sincerely, Date: 2021.02.08 Thelma I. Valdes -S 12:47:14 -05'00' Thelma Valdes, Ph.D. Acting 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. February 5, 2021 Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA Re: K201121 > 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 22, 2020 Received: April 27, 2020 Dear Chungi Han: 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 {2}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Thelma Valdes, PhD Acting Assistant Director Obesity and Hepatobiliary Devices Team 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 {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) K201121 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection. including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue circular design with a green center, resembling a stylized medical symbol. To the right of the symbol, the text "AGS MEDTECH" is written in a simple, sans-serif font, with the Chinese characters for "Anjie Si Medical" appearing below it. # 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 | Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, NO.597 Kangxin Road Yuhang District, Hangzhou, Zhejiang 311106 China | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3010288205 | | Registration Status: | Active | | Contact Person: | Yanping Fu Phone: 0086-15958493282 Fax: 0086-0571-87671225 Email: fuyp@bioags.com | | Date Prepared: | Apr. 22, 2020 | # 5.2 Proposed Device | Trade Name: | Sphincterotome | |-------------------------|-----------------------------------------------------------------| | Device Name: | Sphincterotome | | Common Name: | Sphincterotome | | 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 Predicate Device | Trade Name: | Howell D.A.S.H.® | |-------------------------|-----------------------------------------------------------------| | Device Name: | Sphincterotome with DomeTip | | Common Name: | Sphincterotome with DomeTip | | 510(k) Number: | K172665 | | 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}------------------------------------------------ Image /page/5/Picture/1 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The text is in a simple, sans-serif font. | Trade Name: | Huibregtse® | |-------------------------|-----------------------------------------------------------------| | Device Name: | Needle knife | | Common Name: | Needle knife | | 510(k) Number: | K040981 | | 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) | ### 5.4 Device Description The sphincterotome described in this submission are a sterile, single use devices 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 the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For 50910 series, there's preloaded guide wire. ### 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. ### 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 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains a logo with the text "AGS MEDTECH" and "安杰思医学". The logo consists of a circular design with three curved shapes in blue and green. The text "AGS MEDTECH" is in a smaller font size and is positioned above the Chinese characters "安杰思医学", which are in a larger font size. The overall design is clean and professional, suggesting a company in the medical technology field. | Item | Proposed device | Predicate device | Comparison | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Common name | Sphincterotome | Sphincterotome with DomeTip | Similar | | | Trade name | Sphincterotome | D.A.S.H | / | | | Model number | 5096, 5098, 50910 | DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO- 25-450, DASH-35, DASH- ACRO-35-260, DASH-35- 480, DASHACRO-35-450 | / | | | 510(k) submitter | Hangzhou AGS MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | / | | | 510(k) number | / | K172665 | / | | | Clinical 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. | Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO- 25-450, DASH-35, DASH- ACRO-35-260, DASH-35- 480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. | Same | | | Technical Principles of operation | Monopolar Sphincterotome manufactured is an applied part of electrosurgical generator, using monopolar high- frequency current delivered by the | Monopolar Sphincterotome manufactured is an applied part of electrosurgical generator, using monopolar high-frequency current delivered by the electrosurgical generator for sphincterotomy with the electrode. The high- | Same | | | | Item | Proposed device | Predicate device | Comparison | | | | electrosurgical generator for sphincterotomy with the electrode. The high-frequency electricity flows from the active electrode to the neutral electrode placed on patient skin. | frequency electricity flows from the active electrode to the neutral electrode placed on patient skin. | | | | Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same | | | Preloaded Wire Guide or not | Preloaded Wire Guide: 50910 Not preloaded Wire Guide: 5096, 5098; | Preloaded Wire Guide: DASH-21-480, DASH- ACRO-25-450, DASH-480, DASH-260, DASH-ACRO- 35-260, DASH-35-480, DASHACRO-35-450; Not preloaded Wire Guide: DASH-21, DASH-1, DASH-35; | / | | | Sheath tube | 2.4mm | Catheter Size: 5.5Fr (≈1.8mm), 6Fr (≈2mm), 6.5Fr (≈2.1mm) | Similar | | | Wire Guide Diameter | 0.63mm, 0.89mm | Wire Guide Diameter inch: 0.021 (≈0.53mm), 0.025 (≈0.58mm), 0.035 (≈0.89mm); | Similar | | | Minimum Accessory Channel: | 2.8mm | 2.8mm | Same | | | Working length | 1800mm | 1960mm; | Similar | | | Performance | (1)Injection performance; (2)Compatibility with traction guide wire; (3)Compatibility with Endoscope; (4)X-ray detectability, | No information | Substantial equivalence. We conducted all the performance testing on our proposed device in comparison with our chosen | | Item | Proposed device | Predicate device | Comparison | | | | ⑤Visibility under endoscopy, ⑥Electric performance, ⑦Operation flexibility, ⑧Rotation performance; | | predicate. All the test results show that the proposed device is substantial equivalence with the predicate. For bench tests reports, please refer to Section 18 of this submission. | | | | Connected firmly: ensure the device does not cause device breakage or detachment between joints. | Connected firmly: ensure the device does not cause device breakage or detachment between joints. | Substantial equivalence. We conducted Connected firmly on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is safer than our predicate device. For bench tests reports, please refer to Section 18 of this submission. | | | | Force to Bow | Force to Bow | Substantial equivalence. We conducted Force to Bow on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is as safe | | | Item | Proposed device | Predicate device | Comparison | | | | | | and effective as our predicate device. For bench tests reports, please refer to Section 18 of this submission. | | | | Orientation of Cutting Wire and Visualization of Cutting Wire testing: ensure for orientation and visualization of the cutting wire when endoscopically viewed. | Orientation of Cutting Wire and Visualization of Cutting Wire: ensure for orientation and visualization of the cutting wire when endoscopically viewed. | Substantial equivalence. We conducted Orientation of Cutting Wire and Visualization of Cutting Wire on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is as safe and effective as our predicate device. For bench tests reports, please refer to Section 18 of this submission. | | | | Ink Validation testing: ensure for ink marking visualization when endoscopically viewed. | Ink visualization: ensure for ink marking visualization when endoscopically viewed. | Substantial equivalence. We conducted Ink visualization on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is as safe | | | Item | Proposed device | Predicate device | Comparison | | | | | | and effective as our predicate device. For bench tests reports, please refer to Section 18 of this submission. | | | | Fluoroscopic Visibility testing: ensure the end user is able to fluoroscopically visualize the location of the sphincterotome. | Fluoroscopic Visibility: ensure the end user is able to fluoroscopically visualize the location of the sphincterotome. | Substantial equivalence. We conducted Fluoroscopic Visibility on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is as safe and effective as our predicate device. For bench tests reports, please refer to Section 18 of this submission. | | | Biolo- gical | Materials or substances in contact with the same human tissue or body fluids | Plastic PTFE, Stainless Steel 304, PET; Silicone oil, PTFE, Polyurethane, Medical grade hydrophilic coating; | No exact information. | Different. Biocompatibility tests have been done for the difference. Biological risks are acceptable. | | | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009; Skin sensitization Test: ISO 10993-10: 2010; Intracutaneous Reactivity Test: ISO | No exact information. | | | Item | Proposed device | Predicate device | Comparison | | | | 10993-10: 2010; Acute Systemic Toxicity Test: ISO 10993-11:2017; Pyrogenicity: ISO 10993-11:2017; | | | | | Single / Use | Yes | Yes | Same | | | Shelf / life and sterili- zation | Shelf life: 3 years Sterilization: EO Sterilization, SAL OF 10-6 | Shelf life: 3 years Sterilization: EO Sterilization | Same | | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in a sans-serif font, followed by Chinese characters below it. {8}------------------------------------------------ K201121 Page 5 of 11 Image /page/8/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the text 'K201121' on the first line and 'Page 6 of 11' on the second line. The text is in a simple, sans-serif font and is horizontally aligned. The text likely indicates a document identifier and page number within a larger document. Image /page/9/Picture/1 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The Chinese characters are likely the Chinese translation of "AGS MEDTECH". {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue teardrop shapes arranged in a triangle, with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the Chinese characters "安杰思医学". {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with three curved shapes inside, one of which is green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. # Table 5.6-2 Comparison of technical characteristics | Item | Proposed device | Predicate device | Comparison | | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common name | Sphincterotome | Needle knife | Similar | | | Trade name | Sphincterotome | Huibregtse® | / | | | Model number | 5099 | G24885/HPC-3 | / | | | 510(k) submitter | Hangzhou AGS MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | Same | | | 510(k) number | K201121 | K040981 | / | | | Clinical 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. | The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only. | Same | | | Item | Proposed device | Predicate device | Comparison | | | Technical | Principles of operation | Monopolar Sphincterotome manufactured is an applied part of electrosurgical generator, using monopolar high- frequency current delivered by the electrosurgical generator for sphincterotomy with the electrode. The high- frequency electricity flows from the active electrode to the neutral electrode placed on patient skin. | Monopolar Sphincterotome manufactured is an applied part of electrosurgical generator, using monopolar high- frequency current delivered by the electrosurgical generator for sphincterotomy with the electrode. The high-frequency electricity flows from the active electrode to the neutral electrode placed on patient skin. | Same | | | Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same | | | Catheter Size | 2.4mm-1.8mm | 7Fr(2.33mm)-5Fr(1.67mm) | Same | | | Wire Guide Diameter | 0.63mm, 0.89mm | 0.035 (~0.89mm); | Similar | | | Minimum Accessory Channel | 2.8mm | 2.8mm | Same | | | Working length | 1800mm | 2000mm | Similar | | | Perform…

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