(195 days)
Not Found
No
The description focuses on the mechanical components and materials of a disposable endoscopic device, with no mention of AI or ML capabilities.
Yes
The device is used for transendoscopic sphincterotomy, which is a therapeutic procedure involving the cutting of the sphincter to treat conditions. It also directly interacts with and acts upon tissue (Papilla of Vater and/or the Sphincter of Oddi) to achieve a therapeutic outcome.
No
The device is indicated for sphincterotomy and cannulation/contrast injection, which are interventional and imaging preparation procedures, respectively, not diagnostic procedures.
No
The device description clearly outlines physical components such as a cutting wire, sheath, handle, etc., indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for transendoscopic sphincterotomy and cannulation/injection of contrast medium. These are surgical and interventional procedures performed directly on the patient's body, not tests performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a physical device used for cutting and manipulating tissue within the body. This aligns with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Disposable Sphincterotome is a medical device used for surgical/interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.
Product codes
KNS
Device Description
The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome.
The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring.
The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel.
The subject device 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 3 years.
The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Papilla of Vater and/or the 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)
Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 10993-1, ISO 10993-7, ISO 11607-1, and Technical Requirements of "Disposable Sphincterotome" provided by Beijing ZKSK Technology Co., Ltd. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Disposable Sphincterotome is delivered sterile and have successfully been tested according to ISO 11135 and ASTM 1980. The label shelf life is 3 vears.
7.2 Biocompatibility testing of Disposable Sphincterotome has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Sphincterotome is non-toxic and biocompatible.
7.3 Performance testing - Bench: The following bench tests were performed on Disposable Sphincterotome:
-- Appearance,
-- Dimension,
-- Operational Performance,
-- Tensile Performance,
-- Hydraulic Leak Resistance,
-- Injection Connector (Luer connectors) performance,
-- Conduction resistance,
-- Contrast Agent Injection Function
-- Cutting Line Function
-- Radiopacity
-- Compatible endoscopes tests
-- Thermal effect test
The results of all testing of Disposable Sphincterotome have been verified.
7.4 Electromagnetic Compatibility and Electrical Safety: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-18:2009 and IEC 60601-2-2:2017.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2025
Beijing ZKSK Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Re: K242192
Trade/Device Name: Disposable Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: January 6, 2025 Received: January 7, 2025
Dear Boyle 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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,
Anthony Lee -S
Anthony Lee, 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
3
Indications for Use
510(k) Number (if known) K242192
Device Name Disposable Sphincterotome
Indications for Use (Describe)
The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 K242192
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Beijing ZKSK Technology Co., Ltd. |
|---|---|
| Address: | Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle |
| Economic Development Zone, Tongzhou District,Beijing 101105, | |
| China | |
| Tel: | +86 -13811778090 |
| Contact: | Ma Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Jan.14th, 2025
2.0 Device Information
| Trade name: | Disposable Sphincterotome |
|---|---|
| Common name: | Sphincterotome |
| Regulation name: | Endoscopic electrosurgical unit and accessories |
3.0 Classification
| Product code: | KNS |
|---|---|
| Regulation number: | 21 CFR 876.4300 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
4.0 Predicate Device Information
5
| Manufacturer: | Boston Scientific Corporation (BSC) |
|---|---|
| Trade/Device Name: | Autotome™ RX |
| 510(k) number: | K013153 |
5.0 Device Description
The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome.
The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring.
The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel.
The subject device 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 3 years.
The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.
6.0 Indication for Use Statement
Sphincterotome is indicated for use in transendoscopic The Disposable sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.
7.0 Summary of Non-Clinical Testing
Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 10993-1, ISO 10993-7, ISO 11607-1, and Technical Requirements of "Disposable Sphincterotome" provided by Beijing ZKSK Technology Co., Ltd. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Disposable Sphincterotome is delivered sterile and have successfully been tested according to ISO 11135 and ASTM 1980. The label shelf life is 3 vears.
7.2 Biocompatibility testing of Disposable Sphincterotome has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Sphincterotome is non-toxic and biocompatible.
6
7.3 Performance testing - Bench: The following bench tests were performed on Disposable Sphincterotome:
- -- Appearance,
- -- Dimension,
- -- Operational Performance,
- -- Tensile Performance,
- -- Hydraulic Leak Resistance,
- -- Injection Connector (Luer connectors) performance,
- -- Conduction resistance,
- -- Contrast Agent Injection Function
- -- Cutting Line Function
- -- Radiopacity
- -- Compatible endoscopes tests
- -- Thermal effect test
The results of all testing of Disposable Sphincterotome have been verified.
7.4 Electromagnetic Compatibility and Electrical Safety: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-18:2009 and IEC 60601-2-2:2017.
8.0 _Summary of Clinical Testing
No clinical study is included in this submission.
9.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) No. | K242192 | K013153 | / |
| Product Code | KNS | KNS | Same |
| Regulation No. | 21 CFR 876.4300 | 21 CFR 876.4300 | Same |
| Class | II | II | Same |
| Intended | |||
| Use/Indication for | |||
| Use | The Disposable Sphincterotome | ||
| is indicated for use in | |||
| transendoscopic sphincterotomy | |||
| of the Papilla of Vater and/or the | |||
| Sphincter of Oddi. This device | |||
| can also be used to cannulate | |||
| and inject contrast medium. | The Autotome™ RX is indicated | ||
| for use in transendoscopic | |||
| sphincterotomy of the Papilla of | |||
| Vater and/or the Sphincter of | |||
| Oddi. This device can also be | |||
| used to cannulate and inject | |||
| contrast medium. | Same | ||
| Injection | Contrast Medium | Contrast Medium | Same |
Table 2- Comparison of Technology Characteristics
7
| Cutting Wire Length | 10/20/25/30mm | 20/30mm | Different |
|---|---|---|---|
| Compatible | |||
| endoscopy working | |||
| channel | ≥2.8mm | ≥2.8mm | Same |
| Compatible guidewire | |||
| diameter | ≤0.035 inch (Ø0.89mm) | ≤0.035 inch (Ø0.89mm) | Same |
| Energy source | HF generator | HF generator | Same |
| Working Length | 1800/2000/2300mm | 2000mm | Different |
| Tip length | 5/10/15mm | 5mm | Different |
| Rated High- | |||
| Frequency Voltage | 1600 Vp (3200 Vp-p) | 750Vp (1500Vp-p) | Different |
| Operation Output | |||
| Power | 30-40W | 30-70W | Different |
| Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide, SAL: 10-6 | Same |
| Single Use | Single Use | Single Use | Same |
| Biocompatibility | Conform with ISO 10993 -1 | Conform with ISO 10993 -1 | Same |
| Electromagnetic | |||
| Compatibility and | |||
| Electrical Safety | Conform with IEC 60601-1; | ||
| IEC 60601-1-2; | |||
| IEC 60601-2-2; | |||
| IEC 60601-2-18 | Conform with IEC 60601-1; | ||
| IEC 60601-1-2; | |||
| IEC 60601-2-2; | |||
| IEC 60601-2-18 | Same |
The technological characteristics of the subject device are identical to those of predicate device. The subject device has the similar basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
- · Same intended use
- · Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology/principal of operation/user interface
1)The Cutting Wire Length, Working Length and Tip length range of the subject device are different from those of the predicate device. Performance testing was performed on the representative specifications that represent the worst-case design. The performance comparison testing was conducted with the predicate device and the candidate device to compare their physical performance. The test results showed that the differences don't affect the substantial equivalence. These differences will have no effect on the safety and effectiveness.
- The Rated High-Frequency Voltage is different from the predicate device, and both devices had passed the safety and EMC testing.
3)Recommendations on Operation Output Power for the subject device is different from the predicate device. Performance comparison testing on Cutting Line Function under 30W, 40W, and 70W was performed and the test results showed that the subject device is as safe and effective as the predicate device.
Therefore, the differences between the proposed device and the predicated device are considered not to affect the Substantially Equivalency between the proposed and predicate devices concerning the safety and effectiveness.
8
Conclusion 10.0
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device K013153 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.