(60 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI, ML, or image processing.
No.
The device is an accessory to endoscopic biliary devices, intended to lock guidewires in place during ERCP procedures. It does not directly treat a disease or condition.
No
The Guidewire Locking Device is an accessory designed to lock guidewires in place during ERCP procedures, acting as a tool to facilitate the procedure rather than providing diagnostic information or the ability to identify a disease or condition.
No
The device description explicitly states it is composed of physical materials (ABS, Silicone rubber, SUS304, Polyurethane sponge) and is a sterile, single-use accessory that is fitted onto a duodenoscope. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lock the guidewire(s) in place during ERCP procedures." This is a mechanical function performed during a medical procedure on a patient.
- Device Description: The description details a physical accessory that attaches to an endoscope to manipulate and secure guidewires. It describes its components and materials.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these purposes.
The device is clearly an accessory used in an interventional procedure (ERCP) and does not perform any diagnostic testing in vitro.
N/A
Intended Use / Indications for Use
The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures.
The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidewire can be locked and will not be moved, so the convenience of the operation can be improved.
The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge.
This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy.
There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope.
The proposed 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 6 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional trained in ERCP / Endoscopic Clinic
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)
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.
- A Slide Block Flexibility Test
- A Locking Retention Performance Test
- Friction Resistance Test
- A Smoothness of Instrument Insertion Test
- Sealability Test
- Wire Locking Force Test
- Brush and Squeegee Performance Test
- A Connection Force Test
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. 6 months 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+A1:2018 "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. Biocompatibility testing included the following tests:
- ISO 10993-5: 2009 Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for irritation and sensitization
- ISO 10993-11: 2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
Animal study: No animal study is included in this submission.
Clinical study: 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
§ 876.1500 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2022
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu Province 210032 CHINA
Re: K220247
Trade/Device Name: Guidewire Locking Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: January 20, 2022 Received: January 28, 2022
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,
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
2
Indications for Use
510(k) Number (if known) K220247
Device Name Guidewire Locking Device
Indications for Use (Describe)
The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
K220247 Page 1 of 5
Image /page/3/Picture/1 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.
510k summary
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: K220247
1. Date of Preparation: 2022-1-20
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
Product Name: Guidewire Locking Device
Common Name: Locking Device
Regulatory Information
Classification Name: Endoscope and accessories.
Classification: 2
Product Code: ODC
Regulation Number: 876.1500
Review Panel: Gastroenterology/Urology
Confidential: This document contains information that is confidential and proprietary property of Micro-Tech (Naging) CO., Ltd. Neither this document nor the information therein may be reproduced to or for the benefit of any third party without prior written consent of Micro-Tech.
4
K220247 Page 2 of 5
Image /page/4/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional font. The "M" is white and appears to be in front of the blue "T", creating a sense of depth. A registered trademark symbol is located in the upper right corner of the logo.
510k summary
4. Identification of Predicate Device
510(k) Number: K040137
Product Name in Original 510(k) Submission: Wilson-Cook USW Cap and Wire Lock
Current Trade Name in Market: Fusion Wire Guide Locking Device
Manufacturer: Wilson-Cook Medical Inc
5. Indications for Use
The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.
Device Description 6.
The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures.
The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidewire can be locked and will not be moved, so the convenience of the operation can be improved.
The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge.
This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy.
There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope.
The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 6 months.
Confidential:This document contains information that is confidential and proprietary property of Micro-Tech (Naging) CO., Ltd. Neither this document nor the information therein may be reproduced, used or for the benefit of any third party without prior written consent of Micro-Tech.
5
K220247 Page 3 of 5
Image /page/5/Picture/1 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.
510k summary
7. Comparison of Technological Characteristics
The proposed device Guidewire Locking Device incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Fusion Wire Guide Locking Device.
Comparison between the proposed device and predicate device:
| Item | Proposed Device
Guidewire Locking Device | Predicate Device
Fusion Wire Guide Locking
Device (K040137) | Remark |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Supplied in sterile | YES | YES | SE |
| Configuration | The guidewire locking assembly
and the clamp seal assembly | The guidewire locking assembly
and the clamp seal assembly | SE |
| Main Material | Main body: ABS
Seal Cap :Silicone rubber | Plastic, unknown formulation
Rubber, unknown formulation | Similar |
| Using Environment | Endoscopic Clinic | Endoscopic Clinic | SE |
| Compatible
Endoscopy | Olympus/ Fujinon, Pentax | Olympus/ Fujinon, Pentax | SE |
| Indications for Use | The Guidewire Locking Device
is an accessory to be used with
endoscopic biliary devices to
lock the guidewire(s) in place
during ERCP procedures. | The Wilson-Cook USW Cap and
Wire Lock Device is an accessory
to be used with endoscopic biliary
devices to lock the wire guide(s) in
place during ERCP procedures. | SE |
| Mechanics of Action | Manual | Manual | SE |
| Multiple Locking
Positions | Yes | Yes | SE |
| Single Use | Yes | Yes | SE |
| Packaging | Single-use EO sterilized pouch
with one device per pouch | Single-use EO sterilized pouch
with one device per pouch | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | SE |
| Item | Proposed Device
Guidewire Locking Device | Predicate Device
Fusion Wire Guide Locking
Device (K040137) | Remark |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | SE |
Confidential: This document contains information that is confidential and proprietary property of Micro-Fech (Nanjing) CO., Ltd. Neither this document nor the information therein may be reproduced to or for the benefit of any third party without prior written consent of Micro-Tech.
6
Image /page/6/Picture/1 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 constructed from blocks, giving them a solid, geometric appearance. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
8. Performance Data
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.
- A Slide Block Flexibility Test
- A Locking Retention Performance Test
-
Friction Resistance Test
- A Smoothness of Instrument Insertion Test
-
Sealability Test
-
Wire Locking Force Test
-
Brush and Squeegee Performance Test
- A Connection Force Test
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. 6 months 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+A1:2018 "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
Confidential:This document contains information that is confidential and proprietary property of Micro-Fech (Nanjing) CO, Ltd. Neither this document nor the information therein may be reproduced, used or for the benefit of any third party without prior written consent of Micro-Tech.
7
K220247 Page 5 of 5
Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are connected and appear to be three-dimensional, with shading that suggests a light source from above. A registered trademark symbol (®) is located in the upper right corner of the logo.
510k summary
risk management process" issued on September 4, 2020. Biocompatibility testing included the following tests:
-
ISO 10993-5: 2009 Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for irritation and sensitization
- ≫ ISO 10993-11: 2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
9. Animal Study
No animal study is included in this submission.
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 Guidewire Locking Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Fusion Wire Guide Locking Device (K040137).