(32 days)
Not Found
No
The summary describes an over-tube accessory for an endoscope and does not mention any AI/ML capabilities or image processing.
No
The device is an accessory (over-tube) used to assist with endoscopic insertion. Its function is primarily mechanical, facilitating the procedure rather than providing direct therapy or treatment.
No
The intended use states that the product is "intended to be used in combination with an endoscope to assist endoscopic insertion into the body." It does not mention diagnosing conditions or interpreting patient data.
No
The summary describes an "Over-tube model" and mentions performance testing related to physical characteristics like "Insertion Force, Working length, Flexibility, Maximum diameter of insertion portion, Outer diameter of insertion portion." These are characteristics of a physical device, not software. The predicate device is also an "Over-tube," which is a physical accessory for an endoscope.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is an accessory used in combination with an endoscope to assist with insertion into the body. This is a mechanical/procedural function, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No mention of diagnostic testing: The purpose is to facilitate a procedure (endoscopic insertion), not to diagnose a disease or condition.
In summary, this device is an accessory for an endoscopic procedure, not a diagnostic tool that analyzes samples in vitro.
N/A
Intended Use / Indications for Use
"This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments."
Product codes
FED
Device Description
Not Found
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
"medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments." / "medical facilities"
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)
"To determine if the changes would affect the safety or efficacy of the subject device, performance testing was conducted, and the subject device passed all test objectives. It was determined that the new Over-tube model is substantially equivalent to the predicate devices. The subject device met performance specifications in the following additional testing:
- Insertion Force
- Working length
- Flexibility
- Maximum diameter of insertion portion
- Outer diameter of insertion portion"
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.
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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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 1, 2024
Fujifilm Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave. Suite 300 Lexington, Massachusetts 02421
Re: K243091
Trade/Device Name: Over-tube (TR-1108A) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FED Dated: September 30, 2024 Received: September 30, 2024
Dear Chaitrali Kulkarni:
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"
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(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-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-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).
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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
3
Indications for Use
Submission Number (if known)
Device Name
Over-tube (TR-1108A)
Indications for Use (Describe)
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
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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| 510(k) Summary | Prepared on: 2024-09-27 | |||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Fujifilm Corporation | |||
| Applicant Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN KANAGAWA | |||
| 258-8538 Japan | ||||
| Applicant Contact Telephone | 704-517-4886 | |||
| Applicant Contact | Ms. Chaitrali Kulkarni | |||
| Applicant Contact Email | hcusregulatoryaffairs@fujifilm.com | |||
| Correspondent Name | FUJIFILM Healthcare Americas Corporation | |||
| Correspondent Address | 81 Hartwell Ave. Suite 300 Lexington MA 02421 United States | |||
| Correspondent Contact Telephone | 704-517-4886 | |||
| Correspondent Contact | Ms. Chaitrali Kulkarni | |||
| Correspondent Contact Email | hcusregulatoryaffairs@fujifilm.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Over-tube (TR-1108A) | |||
| Common Name | Endoscope and accessories | |||
| Classification Name | Endoscopic Access Overtube, Gastroenterology-Urology | |||
| Regulation Number | 876.1500 | |||
| Product Code(s) | FED | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K230752 | Over-tube (TR-1208A) | FED | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
A. Intended Use/indications for Use This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
5
This product is intended to be used in combination with an endoscopic insertion into the body. Never use this product for any other purpose. This product is intended facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
Indications for Use Comparison
The indication for use for the proposed device and the predicate devices are same.
Technological Comparison
There are size differences in the outer diameter, and maximum outer diameter. The differences in size do not affect the safety or efficacy of the device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The changes in the subject device from the predicate device are changed in outer diameter, Maximum outer diameter, insertion route, and combination endoscope. There were no changes to material, sterilization, or intended use. To determine if the changes would affect the safety or efficacy of the subject device, performance testing was conducted, and the subject device passed all test objectives. It was determined that the new Over-tube model is substantially equivalent to the predicate devices.
The subject device met performance specifications in the following additional testing:
- Insertion Force
- Working length
- · Flexibility
- Maximum diameter of insertion portion
- · Outer diameter of insertion portion
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
K243091 Page 2 of 2
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)