(138 days)
This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.
The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.
The provided text is a 510(k) summary for a medical device called "Locking device." It describes the device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA. However, the document does not contain information about acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.
Instead, it focuses on bench testing and biocompatibility for a physical medical accessory. Therefore, I cannot extract the requested information as it is not present in the provided text.
The information that is available includes:
- Device Name: Locking device
- Intended Use: An accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. Supplied sterile and intended for single use only.
- Predicate Device: Wilson-Cook USW Cap and Wire Lock (K040137)
- Performance Testing Mentioned:
- Guidewire fixing force performance (for 0.025inch, 0.035inch, 0.038inch diameter guidewires)
- Biocompatibility tests (In Vitro Cytotoxicity Test: ISO 10993-5:2009; Skin sensitization Test: ISO 10993-10:2010; Intracutaneous Reactivity Test: ISO 10993-10: 2010)
- Manufacturing process for sterility (ISO 11135)
The document explicitly states: "No Clinical test is included in this submission."
Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation as the document describes a purely mechanical medical device accessory.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
December 23, 2020
Hangzhou AGS MedTech Co., Ltd. Yanping Fu RA Supervisor Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 China
Re: K202237
Trade/Device Name: Locking device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: November 17, 2020 Received: December 21, 2020
Dear Yanping Fu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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,
Shanil P. Haugen, 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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Indications for Use
510(k) Number (if known) K202237
Device Name Locking Device
Indications for Use (Describe)
This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.
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) |
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Image /page/3/Picture/0 description: The image contains a logo with a symbol and text. The symbol is on the left and appears to be three curved shapes in blue and green, intertwined to form a circular design. To the right of the symbol, there is text in two lines. The first line reads "AGS MEDTECH" in a sans-serif font, and the second line is in Chinese characters, which translates to "An Jie Si Medical".
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
| 5.1 Submitter | |
|---|---|
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.Building 5, Building 6, NO.597 Kangxin Road YuhangDistrict, Hangzhou, Zhejiang 311106 China |
| EstablishmentRegistration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671225Email: fuyp@bioags.com |
| Date Prepared: | July 30, 2019 |
5.2 Proposed Device
| Trade Name: | Locking device |
|---|---|
| Device Name: | Locking device |
| Common Name: | Locking device |
| Regulation class: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Description: | Endoscope and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | ODC |
| Product Code Name: | Endoscope Channel Accessory |
5.3 Predicate Device
| Trade Name: | Wilson-Cook USW Cap and Wire Lock |
|---|---|
| Device Name: | Wilson-Cook USW Cap and Wire Lock |
| Common Name: | Cap and Wire Lock |
| 510(k) Number: | K040137 |
| Regulation class: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Description: | Endoscope and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | OCY |
| Product Code Name: | Endoscopic Guidewire, Gastroenterology-Urology |
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Image /page/4/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle around a green center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters below it. The logo appears to be for a medical technology company.
K202237 Page 2 of 3
5.4 Device Description
The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.
5.5 Indication for use statement
This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.
5.6 Comparison of Technology Characteristics
Our proposed device Locking Device is substantially equivalent to the predicate devices. The differences between the Locking Device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Proposed device | Predicate device | Comparison |
|---|---|---|---|
| Recommended Wire GuideDiameter inch | 0.025inch0.035inch0.038inch | Unknown | Different.We have conducted guide wirefixing force performance for ourproposed device, demonstrate thatour Locking device is suitable forguide wire with0.025inch/0.035inch/0.038inchdiameter. For details, please referto Appendix 18-1 Benchperformance Testing report. |
| BiologicalMaterials orsubstances incontact with thesame humantissue or bodyfluids | ABS, Silica gel | Unknown | Different.Biocompatibility tests have beendone for the difference. Biologicalrisks are acceptable. |
| Biocompatibility | In Vitro CytotoxicityTest: ISO 10993-5:2009;Skin sensitizationTest: ISO 10993-10:2010;IntracutaneousReactivity Test: ISO | Unknown |
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Image /page/5/Picture/0 description: The image contains a logo with a circular design on the left and text on the right. The circular design features three curved shapes in blue, forming a triangle in the center, which is filled with green. To the right of the logo, the text "AGS MEDTECH" is written in a smaller, sans-serif font, followed by Chinese characters in a larger font size. The overall design appears to represent a medical technology company.
| Item | Proposed device | Predicate device | Comparison |
|---|---|---|---|
| 10993-10: 2010; |
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Locking Device meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
5.9 Clinical Test
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Locking Device is substantially equivalent to the predicate devices.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.