(247 days)
No
The description focuses on the mechanical and electrical components of a surgical tool and does not mention any AI/ML capabilities.
Yes.
The device is used for transendoscopic sphincterotomy, which is a therapeutic procedure involving the cutting of tissue to treat conditions related to the Papilla of Vater and/or the Sphincter of Oddi.
No
The device is primarily used for therapeutic procedures (selective cannulation and sphincterotomy) and for injecting contrast medium, which aids in visualization but is not a diagnostic function of the device itself. While contrast injection can support diagnosis, the device's main role is interventional.
No
The device description clearly outlines physical components (Cutting Wire, Outer Tube, Handle Assembly) made of materials like PTFE, ABS, and SUS304. It also describes sterilization and packaging, indicating a physical medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (cannulation and sphincterotomy) and injecting contrast medium within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to diagnose or monitor conditions.
- Device Description: The description details a physical device with a cutting wire, outer tube, and handle assembly, used with a high-frequency generator for cutting tissue. This is consistent with a surgical instrument, not an IVD.
- Anatomical Site: The device is used directly on anatomical sites within the body (biliary ducts, Papilla of Vater, Sphincter of Oddi).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device described is a surgical instrument used in endoscopic procedures.
N/A
Intended Use / Indications for Use
The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.
Product codes
KNS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts, Papilla of Vater, Sphincter of Oddi
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
- Endoscope Compatibility Testing
- 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
- Endoscopy Visualization Testing
- 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, IEC 60601-2-2:2017, IEC 60601-2-18:2009, IEC 60601-1-2:2014.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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December 1, 2021
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA
Re: K210934
Trade/Device Name: Sphincterotome / short-wire compatible, Sterile Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: October 27, 2021 Received: November 1, 2021
Dear Sally He:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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
5
Image /page/5/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional design. The letters are primarily in a dark blue color, with the "M" on the left and the "T" on the right, slightly overlapping each other. A registered trademark symbol (®) is visible in the upper right corner of the logo. The logo has a modern and corporate appearance.
the tissue at the appropriate power and voltage. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304.
The proposed device has 52 specifications, which mainly differ in cutting wire type, cutting wire length, preloaded guidewire length and with insulation tube or not.
The proposed device Sphincterotome is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 1 year.
7. Comparison of Technological Characteristics
The proposed device Sphincterotome incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Sphincterotome.
| Item | Proposed Device
Sphincterotome | Predicate Device
Sphincterotome
(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 Handle
assembly | Consists of Cutting wire assembly,
Outer tube assembly and Handle
assembly | Same |
| Injection | Contrast medium | Contrast medium | Same |
| Cutting wire length | 5mm, 20mm, 25mm, 30mm | 20mm, 30mm | Different |
| Working length | 2000mm | 2000mm | Same |
| Tip length | 5mm | 5mm | Same |
| Tip Type | Cone Knife, Needle Knife | Cone Knife | Different |
| Item | Proposed Device
Sphincterotome | Predicate Device
Sphincterotome
(K013153) | Remark |
| Cutting Wire Type | Single, Weave | Single | Different |
| Insulation Tube | With, Without | Without | Different |
| Compatible
endoscopy working
channel | ≥3.2mm
≥2.8mm | ≥2.8mm | Different |
| Compatible
guidewire diameter | ≤0.03 inch | ≤ 0.035 inch | Same |
| Energy source | HF generator | HF generator | Same |
| Maximum rated
accessory voltage | 1200Vp (2400Vp-p) | 750Vp (1500Vp-p) | Different |
| Indications for use | The Sphincterotome is intended to
be used in the selective cannulation
of the biliary ducts and the
transendoscopic sphincterotomy of
the Papilla of Vater and/or the
Sphincter of Oddi. The device can
also be used to inject contrast
medium. | The Sphincterotome is indicated
for use in the selective cannulation
of the Common Bile Ducts (CBD)
and the transendoscopic
sphincterotomy of the Papilla of
Vater and/or the Sphincter of Oddi.
The Sphincterotome can also be
used to inject contrast medium. | Same |
| Single use | Yes | Yes | Same |
| Packaging | 1 Piece/Pouch | 1 Piece/Pouch | Same |
| Shelf life | One year | Three years | Different |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | Same |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | Same |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
| Item | Proposed Device
Sphincterotome | Predicate Device
Sphincterotome
(K013153) | Remark |
| Electrical Safety
and
Electromagnetic
compatibility | Conform to:
IEC60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-18 | Conform to:
IEC60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-18 | Same |
Comparison between the proposed device and predicate device:
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Image /page/6/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
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Image /page/7/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol is located in the upper right corner of the logo.
The proposed device is similar in design and technological characteristics to the predicate device, although there are some differences, those differences have been compared with the reference device legally marketed in the U.S. market, and conduct the performance testing, the test results meet the requirement. Therefore, the difference between proposed device and predicated device is considered not to affect the Substantially Equivalency between the proposed and predicate devices concerning the safety and effectiveness.
Performance Data 8.
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device.
-
Operation Testing
- A Endoscope Compatibility Testing
- A Head Preflexed Testing
-
Conductivity Testing
-
Connection Strength Testing
-
Injection Luer Port Testing
-
Infusion Patency Testing
-
Energy Delivery and Cutting Testing
-
Cutting Rate Testing
-
Cannulation Performance Testing
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Image /page/8/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be stacked on top of each other, creating a block-like shape. A registered trademark symbol is located in the upper right corner of the logo.
Endoscopy Visualization Testing A
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. One-year aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed according to the following standards:
IEC60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: Medical electrical equipment general requirements for the basic safety and essential performance
IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
9. Animal Study
No animal study is included in this submission.
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Image /page/9/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are connected and appear to be in a three-dimensional perspective. A registered trademark symbol is located in the upper right corner of the logo.
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).