(83 days)
The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.
The Disposable 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. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission. The proposed devices are 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 3 years.
This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for novel acceptance criteria.
Based on the provided text, the "acceptance criteria" for the Disposable Sphincterotome are primarily established by its similarity to the predicate device (Hangzhou AGS MedTech Co., Ltd.'s Sphincterotome, K201121) and compliance with relevant consensus standards.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the way one might see for a novel AI algorithm or a device with new performance claims. Instead, the performance is demonstrated by showing the proposed device is substantially equivalent to the predicate device and meets established safety and performance standards.
| Acceptance Criteria Category (Implied) | Reported Device Performance (vs. Predicate/Standards) |
|---|---|
| Indications for Use | Same as predicate: "The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only." |
| Product Code | Same as predicate: KNS |
| Regulation Number | Same as predicate: 878.4300 |
| Regulatory Class | Same as predicate: Class II |
| Sterility | Same as predicate: Supplied sterile, EO sterilized to achieve SAL of 10-6. |
| Principles of Operation | Same as predicate: Uses thermal effect from high-frequency current for incision, Monopolar Radio Frequency Current from an electrosurgical generator. |
| Injection Capability | Same as predicate: Can inject Contrast Medium (for models with injection). |
| Packaging | Same as predicate: Single-use EO sterilized pouch with one device per pouch. |
| Biocompatibility | Conform to ISO 10993-1 (Same as predicate). |
| Sterilization Residuals | Conform to ISO 10993-7. |
| Physical Properties | Passing results for Appearance and Physical properties bench tests. |
| Wire Guide Diameter | Proposed: 0.89mm; Predicate: 0.63mm, 0.89mm. Similar; the proposed device's diameter is within the range of the predicate, and this difference is explicitly stated not to raise safety/effectiveness concerns. |
| Minimum Accessory Channel | Proposed: 2.4mm; Predicate: 2.8mm. Similar; the proposed device has a smaller requirement, which is unlikely to raise safety/effectiveness concerns related to the endoscopic channel. |
| Working Length | Proposed: 2000mm; Predicate: 1800mm. Similar; a longer length may offer more reach but doesn't fundamentally change the device's function or safety as long as it handles appropriately. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document describes bench testing for physical properties ("Appearance, Physical properties") and compliance with standards (e.g., sterilization, biocompatibility). It does not specify the exact number of units tested for these bench tests.
- Data Provenance: The tests are non-clinical (bench tests) conducted by the manufacturer, Zhejiang Soudon Medical Technology Co.,Ltd. The country of origin of the device is China. The data is prospective in the sense that the manufacturer performed these tests specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as this submission relies on engineering and manufacturing standards verification as opposed to clinical expert assessment of a diagnostic outcome. For bench testing, ground truth is typically defined by engineering specifications and standard test methods.
4. Adjudication method for the test set:
- This is not applicable as the document describes bench testing against predefined engineering specifications and compliance with international standards, rather than expert-adjudicated clinical outcomes.
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:
- No, an MRMC study was not done. This device is a Disposable Sphincterotome, which is an electrosurgical accessory used by a clinician, not an AI-assisted diagnostic tool for "human readers." Therefore, this type of study is irrelevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is an electrosurgical medical device, not an algorithm or software requiring standalone performance testing in that context.
7. The type of ground truth used:
- For the non-clinical performance data, the ground truth is based on:
- Engineering specifications and design requirements for "Appearance" and "Physical properties."
- International Consensus Standards such as ISO 10993-1 (Biocompatibility), ISO 11135-1 (EO Sterilization), and ISO 10993-7 (Ethylene Oxide Sterilization Residuals).
- Substantial Equivalence to the legally marketed predicate device (K201121) in terms of indications for use, technological characteristics, and safety/performance profiles.
8. The sample size for the training set:
- This is not applicable. This submission is for a physical medical device, not an AI algorithm, and therefore there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
November 7, 2023
Zhejiang Soudon Medical Technology Co.,Ltd % Nick Wang RA Specialist Shanghai Vanhe Consulting Co., Ltd Shanghai, 201703 CHINA
Re: K232476
Trade/Device Name: Disposable Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: July 18, 2023 Received: August 16, 2023
Dear Nick Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232476
Device Name Disposable Sphincterotome
Indications for Use (Describe)
The Disposable Sphincterotome is indicated for use in the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Submitter
| Submitted by: | Zhejiang Soudon Medical Technology Co.,LtdAddress:Room 302-1,Floor 3, Building 4, No.1 NangongheRoad, Donghu Street, Linping District, Hangzhou 311100Zhejiang, China |
|---|---|
| Contact Person: | Nick WangRA SpecialistShanghai Vanhe Consulting Co., LtdAddress: 2F, Building No.1, 3938 Huqingping Road, QingpuDistrict, Shanghai, China.Phone: 0086-13585860297Email: vanheconsulting@126.com |
| Date Prepared: | July 24, 2023 |
Device
| Device Name: | Disposable Sphincterotome |
|---|---|
| Classification Name: | unit, electrosurgical, endoscopic (with or without accessories) |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Product Code: | KNS |
Predicate Device
| Device Name: | Sphincterotome, K201121 |
|---|---|
| Manufacturer: | Hangzhou AGS MedTech Co., Ltd. |
| Classification Name: | unit, electrosurgical, endoscopic (with or without accessories) |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Product Code: | KNS |
2. Device Description
The Disposable Sphincterotome described in this submission are a sterile, single use
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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.
The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
3. Indication for Use:
The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.
4. Comparison of Technological Characteristics
The Disposable Sphincterotome has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS MedTech Co., Ltd.'s Sphincterotome, K201121. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | DisposableSphincterotome(ProposedDevice) | Sphincterotome,K201121 | Discussion |
|---|---|---|---|
| Indication forUse | The DisposableSphincterotome isindicated for use in thecannulation of the biliaryducts and thetransendoscopicsphincterotomy of thePapilla of Vater and/or theSphincter of Oddi. Thedevice is supplied sterileand intended for single useonly. | The Sphincterotome isindicated for use in thecannulation of thebiliary ducts and thetransendoscopicsphincterotomy of thePapilla of Vater and/orthe Sphincter of Oddi.The device is suppliedsterile and intended forsingle use only. | Same |
| Product Code | KNS | KNS | |
| RegulationNumber | 878.4300 | 878.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied in | Yes | Yes | Same |
| Item | DisposableSphincterotome(ProposedDevice) | Sphincterotome,K201121 | Discussion |
| Sterile | |||
| Principles ofOperation | The product reaches theduodenal papilla throughthe working channel of theduodenoscope, and thecutting wire of the productuses the thermal effectproduced byhigh-frequency current todehydrate and proteinizethe tissue at the duodenalpapilla to achieve thepurpose of incision of thetissue. | Sphincterotomemanufactured is anapplied part ofelectrosurgicalgenerator,using monopolar highfrequency currentdelivered by theelectrosurgicalgeneratorfor sphincterotomywiththe electrode. The highfrequency electricityflows from the activeelectrode to the neutralelectrode placed onpatient skin. | Same |
| Injection | Contrast Medium | Contrast Medium | Same |
| Wire GuideDiameter | 0.89mm | 0.63mm, 0.89mm | Similar |
| MinimumAccessoryChannel | 2.4mm | 2.8mm | Similar |
| WorkingLength | 2000mm | 1800mm | Similar |
| EnergyUsed/Delivered | Monopolar RadioFrequency Current | Monopolar RadioFrequency Current | Same |
| Packaging | Single-use EO sterilizedpouch with one device perpouch | Single-use EOsterilized pouch withone device per pouch | Same |
| SAL | 10-6 | 10-6 | Same |
| SterilizationMethod | EO Sterilization | EO Sterilization | Same |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO10993-1 | Same |
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5. Non-clinical Performance Data
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The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following bench tests were performed on Disposable Sphincterotome: Appearance, Physical properties. The results of all testing were passing.
6. Clinical Test Data
No Clinical Study is included in this submission.
7. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Zhejiang Soudon Medical Technology Co.,Ltd has demonstrated that proposed device Disposable Sphincterotome is substantially equivalent to Hangzhou AGS MedTech Co., Ltd.'s currently marketed Sphincterotome, K201121.
§ 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).