(83 days)
Not Found
No
The device description and intended use focus on mechanical and electrical functions for a surgical procedure, with no mention of data processing, algorithms, or learning capabilities.
Yes.
The device is used to perform a transendoscopic sphincterotomy, a surgical procedure to incise the sphincter of Oddi, which is a therapeutic intervention.
No
The device is described as a surgical tool used for sphincterotomy and cannulation, not for diagnosing conditions.
No
The device description clearly outlines physical components (plastic tube, wire, materials like PTFE, ABS, SUS304) and a physical mechanism of action (passing high-frequency current through a wire). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (cannulation and sphincterotomy) performed on the patient's body, not for testing samples from the patient's body to diagnose a condition.
- Device Description: The device is a surgical tool used to cut tissue and inject contrast medium, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing diagnostic information based on the analysis of such samples.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic/surgical device used to perform a procedure directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data was submitted. 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.
No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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"
1
(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.
2
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
3
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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4
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.,Ltd
Address:Room 302-1,Floor 3, Building 4, No.1 Nangonghe
Road, Donghu Street, Linping District, Hangzhou 311100
Zhejiang, China |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nick Wang
RA Specialist
Shanghai Vanhe Consulting Co., Ltd
Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu
District, Shanghai, China.
Phone: 0086-13585860297
Email: 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
5
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 | Disposable
Sphincterotome(Proposed
Device) | Sphincterotome,
K201121 | Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | 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 Sphincter of Oddi.
The device is supplied
sterile and intended for
single use only. | Same |
| Product Code | KNS | KNS | |
| Regulation
Number | 878.4300 | 878.4300 | Same |
| Class | 2 | 2 | Same |
| Supplied in | Yes | Yes | Same |
| Item | Disposable
Sphincterotome(Proposed
Device) | Sphincterotome,
K201121 | Discussion |
| Sterile | | | |
| Principles of
Operation | The product reaches the
duodenal papilla through
the working channel of the
duodenoscope, and the
cutting wire of the product
uses the thermal effect
produced by
high-frequency current to
dehydrate and proteinize
the tissue at the duodenal
papilla to achieve the
purpose of incision of the
tissue. | Sphincterotome
manufactured is an
applied part of
electrosurgical
generator,
using monopolar high
frequency current
delivered by the
electrosurgical
generator
for sphincterotomy
with
the electrode. The high
frequency electricity
flows from the active
electrode to the neutral
electrode placed on
patient skin. | Same |
| Injection | Contrast Medium | Contrast Medium | Same |
| Wire Guide
Diameter | 0.89mm | 0.63mm, 0.89mm | Similar |
| Minimum
Accessory
Channel | 2.4mm | 2.8mm | Similar |
| Working
Length | 2000mm | 1800mm | Similar |
| Energy
Used/Delivered | Monopolar Radio
Frequency Current | Monopolar Radio
Frequency Current | Same |
| Packaging | Single-use EO sterilized
pouch with one device per
pouch | Single-use EO
sterilized pouch with
one device per pouch | Same |
| SAL | 10-6 | 10-6 | Same |
| Sterilization
Method | EO Sterilization | EO Sterilization | Same |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO
10993-1 | Same |
6
5. Non-clinical Performance Data
7
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.