(239 days)
Not Found
No
The device description, performance studies, and lack of mentions of AI, DNN, or ML indicate it is a passive physical accessory for an endoscope, not a software-driven device with an AI model.
No
The device is described as a "Disposable Distal Cap" used to maintain an appropriate endoscopic field of view, which is a diagnostic or procedural aid, not a therapeutic intervention.
No
The device description clearly states its purpose: "to keep appropriate endoscopic field of view." It does not mention any function related to diagnosing diseases or conditions. The performance studies focus on biocompatibility, physical dimensions, compatibility with endoscopes, and connection force, which are all related to the device's function as an accessory for maintaining view during endoscopy, not for diagnostic interpretation.
No
The device is a physical, disposable cap for endoscopes. Its description
details physical attributes, sterilization, and material compatibility
tests, rather than software functions.
No.
The device is an accessory for an endoscope to improve the field of view, which is not a diagnostic function performed on in vitro samples.
N/A
Intended Use / Indications for Use
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.
Product codes
FDS
Device Description
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. 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 one year.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The biocompatibility evaluation for proposed device was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
a) Cytotoxicity
b) Sensitization
c) Irritation
d) Acute Systemic Toxicity
e) Material Mediated Pyrogenicity
The following performances were conducted and evaluated for proposed device for all specifications:
• Dimension Test
• Endoscope Compatibility Test
• Endoscopic Field of view Test
• Connection Force Test
Side-by-side comparison testing have been conducted on the predicate device.
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Three-year accelerated aging test was performed to demonstrate the three-year stability in the shelf life.
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".
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
§ 876.1500 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.
FDA 510(k) Clearance Letter - Disposable Distal Cap
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 27, 2025
Micro-Tech (Nanjing) Co., Ltd.
℅ Sally He
Regional RA Manager
Mirco-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Rd
Nanjing National Hi-Tech, Industrial Development Zone
Nanjing, Jiangsu 210032
China
Re: K243388
Trade/Device Name: Disposable Distal Cap
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDS
Dated: May 30, 2025
Received: May 30, 2025
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 (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.
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K243388 - Sally He
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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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243388 - Sally He
Page 3
assistance/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 -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
510(k) Number (if known): K243388
Device Name: Disposable Distal Cap
Indications for Use (Describe)
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K243388
Page 1 of 4
510(k) 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: K243388
1. Date of Preparation: 2025-05-22
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: Regional RA Manager
Tel: +86-25-58646378
Email: ra.micro-tech@outlook.com
3. Identification of Proposed Device
Trade Name: Disposable Distal Cap
Regulatory Information
Classification Name: Gastroscope And Accessories, Flexible/Rigid
Classification: 2
Product Code: FDS
Regulation Number: 876.1500
Review Panel: Gastroenterology/Urology
4. Identification of Predicate Device
510(k) Number: K984358
Product Name: Disposable Distal Attachment
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
5. Indications for Use
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.
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K243388
Page 2 of 4
6. Device Description
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. 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 one year.
7. Comparison of Technological Characteristics
The proposed device incorporates substantially equivalent device's intended use, using environment, design, packaging fundamental technology, principles of operation, manufacturing processes including sterilization process, configuration, as those featured in the predicate device Disposable Distal Attachment cleared under K984358.
| ITEM | Proposed Device Disposable Distal Cap | Predicate Device Disposable Distal Attachment (K984358) | Remark |
|---|---|---|---|
| Product Code | FDS | FDS | SE |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | SE |
| Class | II | II | SE |
| Indications for Use | The Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view | These instruments have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field. Do not use these instruments for any purpose other than their intended uses. | SE |
| Configuration | Single structure, a component is a product | Single structure, a component is a product | SE |
| Supplied in Sterile | Sterile | Sterile | SE |
| Sterilization method | EO | EO | SE |
| Maximum diameter | 11.35, 11.8, 12.4, 13.4, 14, 15, 15.7 | 11.35, 11.8, 12.4, 13.4, 14, 15, 15.7 | SE |
| Compatibility | Compatible with different diameters of endoscopy | Compatible with different diameters of Olympus endoscopy | Similar |
| Single Use | Yes | Yes | SE |
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K243388
Page 3 of 4
| ITEM | Proposed Device Disposable Distal Cap | Predicate Device Disposable Distal Attachment (K984358) | Remark |
|---|---|---|---|
| Packaging | One product is housed in a protective cover and packaged in a sealed pouched | One product is housed in a protective cover and packaged in a sealed pouched | SE |
| Shelf Life | One year | Three years | Similar |
| Patient-Contact Material | Silicone + Ink | TPES | Similar |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO10993-1 | SE |
| Sterilization | EO Sterilized, SAL: 10⁻⁶ | EO Sterilized, SAL: 10⁻⁶ | SE |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | SE |
8. Performance Data
The biocompatibility evaluation for proposed device was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
a) Cytotoxicity
b) Sensitization
c) Irritation
d) Acute Systemic Toxicity
e) Material Mediated Pyrogenicity
The following performances were conducted and evaluated for proposed device for all specifications:
• Dimension Test
• Endoscope Compatibility Test
• Endoscopic Field of view Test
• Connection Force Test
Side-by-side comparison testing have been conducted on the predicate device.
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming,
Page 8
K243388
Page 4 of 4
sealing and assembly processes. Three-year accelerated aging test was performed to demonstrate the three-year stability in the shelf life.
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".
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, safety and performance testing, Disposable Distal Cap has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device cleared under K984358.