(90 days)
Not Found
No.
The device is described as a "short transparent plastic tube" that attaches to an endoscope, indicating a purely mechanical function with no mention of AI, DNN, ML, or image processing capabilities.
No
The device is described as an attachment for an endoscope designed to maintain a suitable depth of view during endoscopic procedures, facilitating observation of tissues. It does not provide any therapeutic function.
No
The device is a distal attachment for an endoscope, designed to maintain the field of view and facilitate observation during endoscopic procedures. Its function is to aid in visualization, not to diagnose a condition itself.
No
The device is a physical, sterile, single-use, transparent plastic tube designed to be attached to the distal end of an endoscope. Its description and the performance studies clearly indicate it is a hardware component with physical and material properties, not software.
No.
This device is an accessory to an endoscope, designed to facilitate observation of tissues during endoscopic procedures by maintaining a suitable depth of view. It does not perform any in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.
Product codes
FDS, FDF
Device Description
The Disposable Distal Attachment D-201 Series is comprised of seven (7), sterile, single-use, distal attachments of varying diameters. Each distal attachment is a short transparent plastic tube which is attached to the distal end of an endoscope to facilitate observation of tissues during endoscopic procedures. A subset of the models includes a drainage side hole that allows egress of water and blood during use. The Disposable Distal Attachment D-201 Series is to be used with compatible endoscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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
Bench testing, biological safety evaluation, sterilization validation, and shelf-life studies were undertaken on the subject device and predicate device to demonstrate substantial equivalence.
The following performance data were provided to demonstrate substantial equivalence:
• Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), and material mediated pyrogenicity (USP )
• Sterilization validation per ISO 11135:2014
• Ethylene oxide residuals per ISO 10993-7:2008
• Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ASTM F1980-21
• Mechanical testing and comparative testing to verify device performance
• Human Factors Testing
Key Metrics
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 Attachment D-201 Series
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
May 1, 2025
Olympus Medical Systems Corp.
℅ Roshana Ahmed
Program Manager, Regulatory Affairs
Olympus Corporation of the Americas
800 West Park Drive
Westborough, Massachusetts 01581
Re: K250296
Trade/Device Name: Disposable Distal Attachment D-201 Series
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDS, FDF
Dated: January 31, 2025
Received: January 31, 2025
Dear Roshana Ahmed:
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"
Page 2
K250296 - Roshana Ahmed Page 2
(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-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 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-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-devices/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-devices/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).
Page 3
K250296 - Roshana Ahmed Page 3
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, PhD
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
Submission Number (if known)
K250296
Device Name
Disposable Distal Attachment D-201 Series
Indications for Use (Describe)
The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.
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."
Page 5
Traditional 510(k)
Disposable Distal Attachment D-201 Series
Page 1 of 4
510(k) Summary
I. Submitter
Olympus Medical Systems Corporation
2951 Ishikawa-cho
Hachioji-shi
Tokyo 192-8507
Japan
Contact Person: Seiko Yunoki
Phone: +81 42-642-2111
Date Prepared: January 20, 2025
II. Device
| Device Proprietary Name | Disposable Distal Attachment D-201 Series |
|---|---|
| Common or Usual Name | Distal Attachment |
| Classification Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Product Code | FDS/FDF |
| Device Classification | Class II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
• Olympus Distal Attachment, MODELS MH-462, -463, -464, -465, -466, -483, -587, -588, -589, -590, -591, -592, -593, -594, -595, -596, -597, -598, K984358, Olympus America, Inc.
IV. Device Description
The Disposable Distal Attachment D-201 Series is comprised of seven (7), sterile, single-use, distal attachments of varying diameters. Each distal attachment is a short transparent
Page 6
Traditional 510(k)
Disposable Distal Attachment D-201 Series
Page 2 of 4
plastic tube which is attached to the distal end of an endoscope to facilitate observation of tissues during endoscopic procedures. A subset of the models includes a drainage side hole that allows egress of water and blood during use.
The Disposable Distal Attachment D-201 Series is to be used with compatible endoscopes.
V. Indications for Use
The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.
VI. Comparison of Technological Characteristics
The subject device has the same intended use as the predicate device. The devices are intended to be attached to compatible endoscopes to keep the suitable depth of endoscope's view field within the gastrointestinal tract.
The subject device and predicate device are straight transparent tubes which are attached to the distal end of endoscopes using medical tape to maintain a suitable depth of the field of view during endoscopic procedures. Except for variant D-201-11802, the subject device includes a side drainage hole to facilitate egress of fluids during endoscopic procedures. Furthermore, the subject device is provided sterile (via EtO) and is intended for single use. The subject and predicate device are offered in similar outer diameters; however, the subject device features a shorter length from the distal end of the endoscope than the predicate device.
Bench testing, biological safety evaluation, sterilization validation, and shelf-life studies were undertaken on the subject device and predicate device to demonstrate substantial equivalence. A comparison of the subject and predicate device technological characteristics is provided below.
Page 7
Traditional 510(k)
Disposable Distal Attachment D-201 Series
Page 3 of 4
| | Subject Device
Disposable Distal Attachment D-201 Series | Predicate Device
Distal attachment MH series | Analysis |
|---|---|---|---|
| Manufacturer | Olympus Medical Systems Corp. | Olympus Medical Systems Corp. | - |
| Indications for use | The Disposable Distal Attachment D-201 series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract. | Olympus Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. Olympus Distal Attachment is used for the followings
1.Gastrointestinal mucosal resection (endoscopic mucosal resection)
2.Keeping the suitable depth of endoscope's view field
3.Helping the endoscope with being inserted into the gastrointestinal tract | Substantially equivalent |
| Models | D-201-10704
D-201-11304
D-201-11804
D-201-12704
D-201-14304
D-201-15004
D-201-11802 | MH-463
MH-598 | Substantially equivalent |
| Type | Straight | MH-463: Straight
MH-598: Straight with rim | Substantially equivalent |
| Outer diameter | Ø 11.35 – 15.7 mm | MH-463: Ø 13.5 mm
MH-598: Ø 19.2 mm | Substantially equivalent |
| Drainage Side Holes | Yes
D-201-10704
D-201-11304
D-201-11804
D-201-12704
D-201-14304
D-201-15004
No
D-201-11802 | - | Different
No | Identical |
| Attachment to endoscope | Medical tape | Medical tape | Identical |
Page 8
Traditional 510(k)
Disposable Distal Attachment D-201 Series
Page 4 of 4
| | Subject Device
Disposable Distal Attachment D-201 Series | Predicate Device
Distal attachment MH series | Analysis |
|---|---|---|---|
| Single use/Reusable | Single use | Reusable | Different |
| Sterile/nonsterile | Sterile | Non-sterile | Different |
| Sterilization method | ETO | Non sterilized
(Autoclave by the user before use) | Different |
| Transparent | Yes | Yes | Identical |
| Biocompatible | Yes
ISO 10993-1:2018 | Yes
ISO 10993-1 | Identical |
VII. Performance Data
The following performance data were provided to demonstrate substantial equivalence:
• Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), and material mediated pyrogenicity (USP )
• Sterilization validation per ISO 11135:2014
• Ethylene oxide residuals per ISO 10993-7:2008
• Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ASTM F1980-21
• Mechanical testing and comparative testing to verify device performance
• Human Factors Testing
Clinical data is not required to demonstrate substantial equivalence.
VIII. Conclusion
The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device. Therefore, it is concluded that the Disposable Distal Attachment D-201 Series is substantially equivalent to the identified predicate device.