(247 days)
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.
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 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.
This document describes the premarket notification (510(k)) for the Micro-Tech (Nanjing) Co., Ltd. Sphincterotome. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical studies or specific device performance acceptance criteria against which a study directly proves the device meets. Therefore, some of the requested information, particularly regarding specific acceptance criteria metrics, will not be directly available.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance values for clinical metrics. Instead, it lists various performance tests conducted to demonstrate essential performance and confirm that the proposed device works as intended and is substantially equivalent to the predicate device. The conclusion states that "the test results meet the requirement," implying that the device passed the internal acceptance criteria for each test.
Key Performance Tests Conducted (without specific numerical acceptance criteria or reported values in this document):
| Test Category | Description of Test (from document) | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Operational & Functional | Operation Testing | Device operates as intended. | Confirmed to operate as intended. |
| Endoscope Compatibility Testing | Compatible with specified endoscopes (e.g., working channel ≥3.2mm, ≥2.8mm). | Confirmed compatibility with specified endoscopes. (Document states "Compatible endoscopy working channel: ≥3.2mm, ≥2.8mm" for proposed device vs. "≥2.8mm" for predicate). | |
| Head Preflexed Testing | Device maintains structural integrity and function after preflexion. | Test results met requirements. | |
| Conductivity Testing | Electrical conductivity meets specifications for electrosurgical function. | Test results met requirements. | |
| Connection Strength Testing | Connections (e.g., handle to outer tube) are secure and maintain integrity. | Test results met requirements. | |
| Injection Luer Port Testing | Luer port for injection is functional and leak-free. | Test results met requirements. | |
| Infusion Patency Testing | Contrast medium can be infused freely through the device. | Test results met requirements. | |
| Energy Delivery and Cutting Testing | Device effectively delivers electrosurgical energy and performs cutting as intended. | The HF Generator supplies high frequency energy through the Cutting Wire of the proposed device to cut the tissue at the appropriate power and voltage. Test results met requirements. (Maximum rated accessory voltage: 1200Vp (2400Vp-p) for proposed vs. 750Vp (1500Vp-p) for predicate - difference noted but implied acceptable based on comparison with reference devices and performance testing). | |
| Cutting Rate Testing | Device cuts within acceptable timeframes and with appropriate efficiency. | Test results met requirements. | |
| Cannulation Performance Testing | Device enables successful cannulation. | Test results met requirements. | |
| Safety & Durability | Endoscopy Visualization Testing | Clear visualization through or around the device maintained during endoscopy. | Test results met requirements. |
| Shelf-life testing (Accelerated aging based on ASTM F1980-16; 1-year aging test) | Device maintains sterility and functional integrity for its claimed shelf-life. | Demonstrated 1-year shelf life. | |
| Sterilization validation (ISO 11135:2014) | Achieves Sterility Assurance Level (SAL) of 10^-6. | EO sterilized, SAL: 10^-6 achieved. | |
| Biocompatibility testing (ISO 10993) | Device materials are biocompatible and do not pose unacceptable biological risks. | Complies with ISO10993-1. | |
| Electromagnetic compatibility, electric safety, and thermal safety (IEC 60601-1, -1-2, -2-2, -2-18) | Device meets relevant electrical, electromagnetic, and thermal safety standards. | Conforms to IEC60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (number of devices) used for each of the performance tests listed. Since this is a submission based on physical and functional performance testing of the device itself rather than patient data, there is no information on data provenance in terms of country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The performance tests described are laboratory-based and do not involve human interpretation against a "ground truth" established by medical experts.
4. Adjudication method for the test set
This information is not applicable as the tests are objective performance measurements, not subjective evaluations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study, as this device is not an AI-powered diagnostic or assistive tool. It is a medical instrument (sphincterotome).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical instrument, not an algorithm.
7. The type of ground truth used
This information is not applicable in the context of device performance testing for a physical instrument. The "ground truth" in this context would be engineering specifications and validated test methods for physical, electrical, and functional performance.
8. The sample size for the training set
This information is not applicable as this is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/algorithm device.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |||
|---|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
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 DeviceSphincterotome | Predicate DeviceSphincterotome(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,Outer tube assembly and Handleassembly | Consists of Cutting wire assembly,Outer tube assembly and Handleassembly | 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 DeviceSphincterotome | Predicate DeviceSphincterotome(K013153) | Remark |
| Cutting Wire Type | Single, Weave | Single | Different |
| Insulation Tube | With, Without | Without | Different |
| Compatibleendoscopy workingchannel | ≥3.2mm≥2.8mm | ≥2.8mm | Different |
| Compatibleguidewire diameter | ≤0.03 inch | ≤ 0.035 inch | Same |
| Energy source | HF generator | HF generator | Same |
| Maximum ratedaccessory voltage | 1200Vp (2400Vp-p) | 750Vp (1500Vp-p) | Different |
| Indications for use | The Sphincterotome is intended tobe used in the selective cannulationof the biliary ducts and thetransendoscopic sphincterotomy ofthe Papilla of Vater and/or theSphincter of Oddi. The device canalso be used to inject contrastmedium. | The Sphincterotome is indicatedfor use in the selective cannulationof the Common Bile Ducts (CBD)and the transendoscopicsphincterotomy of the Papilla ofVater and/or the Sphincter of Oddi.The Sphincterotome can also beused 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 DeviceSphincterotome | Predicate DeviceSphincterotome(K013153) | Remark |
| Electrical SafetyandElectromagneticcompatibility | Conform to:IEC60601-1IEC 60601-1-2IEC 60601-2-2IEC 60601-2-18 | Conform to:IEC60601-1IEC 60601-1-2IEC 60601-2-2IEC 60601-2-18 | Same |
Comparison between the proposed device and predicate device:
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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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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).
§ 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).