(265 days)
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 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.
The provided text describes a 510(k) premarket notification for a medical device called "Sphincterotome." This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and does not include a study with explicit acceptance criteria and device performance results in the format requested.
Here's an analysis of what is available and what is missing, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria and corresponding reported device performance values. Instead, it states broadly that "The Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."
The comparison tables (Table 5.6-1 and Table 5.6-2) highlight similarities and differences between the proposed device and predicate devices for various characteristics but do not present acceptance criteria or quantitative performance data. For example, under "Performance," it lists several performance aspects like "Injection performance, Compatibility with traction guide wire, Compatibility with endoscope, Ray detectability, Visibility under endoscopy, Electric performance, Operation flexibility, Connected firmly, Rotation performance, Force to Bow, Orientation of Cutting Wire and Visualization of Cutting Wire, Ink Validation; Cutting rate; Energy dose analyses;" and states "Unknown" for predicate device K013153 and provides a similar list for predicate K201121. For the proposed device, it states that "Bench test has been conducted to demonstrate substantial equivalence," but the specific results of these tests against predefined acceptance criteria are not presented in the provided text.
2. Sample Size for Test Set and Data Provenance
Not applicable. The document explicitly states: "No Clinical test is included in this submission." The performance data mentioned are non-clinical bench tests. The sample size for these bench tests is not provided, and the data provenance, beyond being "non-clinical," is not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device submission relies on non-clinical bench testing to demonstrate substantial equivalence, not on human expert assessments of medical images or diagnoses. Therefore, there is no mention of experts establishing ground truth.
4. Adjudication Method for Test Set
Not applicable. As no clinical test involving human readers and ground truth establishment was conducted, no adjudication method is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. The document states "No Clinical test is included in this submission." An MRMC study would be a type of clinical study involving human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (Sphincterotome), not an AI algorithm. Its performance is assessed through bench testing, not an algorithm-only study.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for this device would be established through engineering specifications, recognized medical device standards (e.g., IEC 60601, ISO 10993, ISO 11135), and results from non-clinical bench tests. These tests confirm that the device performs as intended and is comparable to predicate devices in terms of mechanical, electrical, and biological safety and performance. No pathology, outcomes data, or expert consensus (in the typical sense of diagnostic accuracy studies) were used as ground truth for this submission.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable. As above, this is a physical medical device, not an AI model.
Summary of what is missing/not applicable based on the provided text:
- Specific, quantifiable acceptance criteria and device performance results in a table.
- Sample sizes for the "test set" (as this was non-clinical bench testing, not a clinical test set).
- Data provenance for any performance testing.
- Information on experts for ground truth or adjudication methods.
- Any multi-reader multi-case or standalone AI performance studies.
- Information on training sets or how their ground truth was established.
The document is a 510(k) summary focused on demonstrating substantial equivalence to previously cleared devices through comparison of technical characteristics and compliance with recognized standards via non-clinical testing. It explicitly states that no clinical tests were included.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
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."
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
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 YuhangDistrict, 311106 Hangzhou, Zhejiang, China |
| EstablishmentRegistration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Jiayuan ZhangPhone: 0086-18668235131Fax: 0086-0571-87671225Email: zhangjy@bioags.com |
| 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) |
{4}------------------------------------------------
| 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.
{5}------------------------------------------------
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}------------------------------------------------
| Item | Proposed deviceSphincterotome | Predicate device(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 thecannulation of the biliary ducts and the transendoscopicsphincterotomy of the Papilla of Vater and/or the Spincterof Oddi. The device is supplied sterile and intended forsingle use only. | The Sphincterotome is indicated for use in theselective cannulation of the Common Bile Ducts(CBD) and the transendoscopic sphincterotomy of thePapilla of Vater and/or the Sphincter of Oddi. TheSphincterotome can also be used to inject contrastmedium. | Similar.The equivalent device has a widerrange of intended use than theproposed device. |
| Technical | Principles ofoperation | Monopolar Sphincterotome manufactured is an appliedpart of electrosurgical generator, using monopolarhigh-frequency current delivered by the electrosurgicalgenerator for sphincterotomy with the electrode. Thehigh-frequency electricity flows from the active electrodeto the neutral electrode placed on patient skin. | Sphincterotome is an applied part of electrosurgicalgenerator, using monopolar high-frequency currentdelivered by the electrosurgical generator forsphincterotomy with the electrode. Thehigh-frequency electricity flows from the activeelectrode to the neutral electrode placed on patientskin. | |
| Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same | |
| Sheath tube | 2.4mm | 2.4mm | Same | |
| Item | Proposed deviceSphincterotome | Predicate device(K013153) | Comparison | |
| Wire Guide Diameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| Insulation protected | With/without | Without | Similar.This difference wouldn't influencethe safety or performance if thedevice. | |
| Preloaded Wire Guideor not | Preloaded Wire Guide: 50913, 50917;Not preloaded Wire Guide: 50912; | No | Similar.Bench test has been conducted todemonstrate substantial equivalence,please refer to Section 18 benchperformance testing. | |
| Compatible MinimumAccessory Channel | 3.7mm | 3.7mm | Same | |
| Working length | 1800mm | 2000mm | Different.Bench test has been conducted todemonstrate substantial equivalence,please refer to Section 18 benchperformance testing. | |
| Performance | Injection performance,Compatibility with traction guide wire,Compatibility with endoscope,Ray detectability,Visibility under endoscopy,Electric performance, | Unknown | Same.Bench test has been conducted todemonstrate substantial equivalence,please refer to Section 18 benchperformance testing. | |
| Item | Proposed deviceSphincterotome | Predicate device(K013153) | Comparison | |
| Operation flexibility,Connected firmly,Rotation performance,Force to Bow,Orientation of Cutting Wire and Visualization of CuttingWire,Ink Validation;Cutting rate;Energy dose analyses; | ||||
| Biological | Materials orsubstances in contactwith the same humantissue or body fluids | Plastic PTFE, Stainless Steel 304, PTFE;Silicone oil, PTFE, Polyurethane, Medical gradehydrophilic coating; | Unknown | Different.Biocompatibility tests have beendone. Biological risks areacceptable. |
| Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;Skin sensitization Test: ISO 10993-10: 2010;Intracutaneous Reactivity Test: ISO 10993-10: 2010;Acute Systemic Toxicity Test: ISO 10993-11:2017;Pyrogenicity: ISO 10993-11:2017; | Unknown | ||
| Single Use | Yes | Yes | Same | |
| Shelf life and sterilization | Shelf life: 18 months;Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;Sterilization: EO Sterilization; | Different.Accelerated aging tests have beendone. The proposed device cansupport the claimed shelf life. | |
| Item | Proposed deviceSphincterotome | Predicate device(K201121) | Comparison | |
| Common name | Sphincterotome | Sphincterotome | / | |
| Trade name | Sphincterotome | Sphincterotome | / | |
| Model number | 5091, 5093, 5094, 5096, 5098, 5099, 50910, 50912,50913, 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 | Intended use | The Sphincterotome is indicated for use in thecannulation of the biliary ducts and the transendoscopicsphincterotomy of the Papilla of Vater and/or the Spincterof Oddi. The device is supplied sterile and intended forsingle use only. | The Sphincterotome is indicated for use in thecannulation of the biliary ducts and the transendoscopicsphincterotomy of the Papilla of Vater and/or theSpincter of Oddi. The device is supplied sterile andintended for single use only. | Same |
| Technical | Principles ofoperation | Monopolar Sphincterotome manufactured is an appliedpart of electrosurgical generator, using monopolarhigh-frequency current delivered by the electrosurgicalgenerator for sphincterotomy with the electrode. Thehigh-frequency electricity flows from the active electrodeto the neutral electrode placed on patient skin. | Monopolar Sphincterotome manufactured is an appliedpart of electrosurgical generator, using monopolarhigh-frequency current delivered by the electrosurgicalgenerator for sphincterotomy with the electrode. Thehigh-frequency electricity flows from the activeelectrode to the neutral electrode placed on patient skin. | Same |
| Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same | |
| Preloaded WireGuide or Not | Preloaded Wire Guide: 50910, 50913, 50916, 50917;Not preloaded Wire Guide: 5091, 5093, 5094, 5096, | Preloaded Wire Guide: 50910Not preloaded Wire Guide: 5096, 5098, 5099; | Same | |
| Item | Proposed deviceSphincterotome | Predicate device(K201121) | Comparison | |
| 5098, 5099, 50912; | ||||
| Sheath tube | 2.4mm | 2.4mm | Same | |
| Wire GuideDiameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| CompatibleMinimumAccessory Channel | 5091, 5094, 5096, 5099: 2.8mm;5093, 5098, 50910, 50912, 50913, 50916, 50917: 3.7mm; | 5096, 5099: 2.8mm;5098, 50910: 3.7mm; | Same | |
| Working Length | 1800mm | 1800mm | Same | |
| Performance | Injection performance,Compatibility with traction guide wire,Compatibility with endoscope,Ray detectability,Visibility under endoscopy,Electric performance,Operation flexibility,Connected firmly,Rotation performance,Force to Bow,Orientation of Cutting Wire and Visualization of CuttingWire,Ink Validation;Cutting rate;Energy dose analyses; | Injection performance,Compatibility with traction guide wire,Compatibility with Endoscope,Ray detectability,Visibility under endoscopy,Electric performance,Operation flexibility,Connected firmly,Rotation performance;Force to Bow,Orientation of Cutting Wire and Visualization ofCutting Wire,Ink Validation; | Same.Bench test has been conducted todemonstrate substantialequivalence, please refer toSection 18 bench performancetesting. | |
| Item | Proposed deviceSphincterotome | Predicate device(K201121) | Comparison | |
| Biological | Materials orsubstances incontact with thesame human tissueor body fluids | Plastic PTFE, Stainless Steel 304, PTFE;Silicone oil, PTFE, Polyurethane, Medical gradehydrophilic coating; | Plastic PTFE, Stainless Steel 304, PET;Silicone oil, PTFE, Polyurethane, Medical gradehydrophilic coating; | Same.Biocompatibility tests have beendone. Biological risks areacceptable. |
| Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;Skin sensitization Test: ISO 10993-10: 2010;Intracutaneous Reactivity Test: ISO 10993-10: 2010;Acute Systemic Toxicity Test: ISO 10993-11:2017;Pyrogenicity: ISO 10993-11:2017; | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;Skin sensitization Test: ISO 10993-10: 2010;Intracutaneous Reactivity Test: ISO 10993-10: 2010;Acute Systemic Toxicity Test: ISO 10993-11:2017;Pyrogenicity: ISO 10993-11:2017; | ||
| Single Use | Yes | Yes | Same | |
| Shelf life and sterilization | Shelf life: 18 months;Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;Sterilization: EO Sterilization, SAL of 10-6; | Different.Accelerated aging tests have beendone. The proposed device cansupport the claimed shelf life. |
Table 5.6-1 Comparison of technical characteristics
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Table 5.6-2 Comparison of technical characteristics
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
5.9 Clinical Test
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Sphincterotome is substantially equivalent to the predicate devices.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
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.(b)
Classification. Class II (performance standards).