(21 days)
The CF-Q160 AL/I and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
The EVIS EXERA Colonovideoscopes CF-Q160 AL/1 and PCF-160 AL/1 have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment. The modifications to these devices is to provide a control mechanism to the endoscopes which allows the user the ability to vary the stiffness of the insertion tube, as a means of aiding the physician in inserting the colonoscope into the human colon.
The provided text is a 510(k) submission for the Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "When compared to similar devices, the EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I do not incorporate any significant changes in intended use, material or design that could affect safety or efficacy." This indicates that a formal clinical study with performance metrics against pre-defined acceptance criteria was not deemed necessary for this 510(k) submission, as the device's modifications primarily involve a control mechanism for insertion tube stiffness, not core imaging or diagnostic capabilities. The submission focuses on comparing the new device's design and intended use to existing predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No clinical test set and thus no ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This document predates widespread AI integration in medical devices and does not describe any MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This document describes a physical endoscope, not an algorithm, and does not mention standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical test set requiring ground truth is described.
8. The sample size for the training set
- Cannot be provided. As there's no mention of an algorithm or AI, there is no training set.
9. How the ground truth for the training set was established
- Cannot be provided. As there's no mention of an algorithm or AI, there is no training set ground truth to establish.
Summary of the study/submission:
The submission for the Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I is a 510(k) premarket notification based on substantial equivalence. It asserts that the modified devices (with a control mechanism to vary insertion tube stiffness) do not significantly alter the safety or efficacy compared to legally marketed predicate devices. The review by the FDA confirmed this substantial equivalence, allowing the devices to be marketed without requiring new clinical trials that would establish specific acceptance criteria and performance against a ground truth dataset. The focus of the submission is a comparison of design and intended use, not clinical efficacy metrics.
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510(k) Summary EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of subject device
Name & Address of manufacturer:
Registration number: Address, Phone and Fax numbers of R&D department, Endoscope division:
Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho Hachioji-shi, Tokyo 192-8507 telephone (426) 42-5101 Facsimile (426) 46-2786
B. Name of Contact Person
Name: Address, Phone and Fax numbers:
Laura Storms-Tyler Olympus America Inc. Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157 Telephone (516) 844-5688 Facsimile (516) 844-5416
C. Device Name, Common Name, Classification Name and Predicate Devices
| Device Name: | Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I |
|---|---|
| Common Name: | Endoscopic Video Information System |
| Classification Name: | Endoscope and accessories21 CFR 876.1500, Class II |
Summary Preparation Date: April 17, 2000
D. Device Description:
The EVIS EXERA Colonovideoscopes CF-Q160 AL/1 and PCF-160 AL/1 have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment.
The modifications to these devices is to provide a control mechanism to the endoscopes which allows the user the ability to vary the stiffness of the insertion tube, as a means of aiding the physician in inserting the colonoscope into the human colon.
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E. Statement of Intended Use
The CF-Q160 AL/I and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). -
F. Summary including Conclusions drawn from Non-Clinical Tests
When compared to similar devices, the EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I do not incorporate any significant changes in intended use, material or design that could affect safety or efficacy.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2000
Olympus Optical Co., LTD c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America Inc. Two Corporate Center Drive Melville, NY 11747
Re: K001241 EVIS EXERA Colonovideoendoscopes Dated: April 17, 2000 Received: April 18, 2000 Requiatory Class: II. 21 CFR §876.1500/ Procode: 78 FDF
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have detemned the device is substantially equivalent (for the including for use stated in the enclosure) to legally marketed predicate devices marketed in Interstate commerce pror 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 Cosmelic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing proctice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematiet Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Oode of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Reculation (QS) for Medical Devices: General requiration (21 CFR Part 820) and that, It rough periodic QS inspections, the Food and Drug Admisistation (FDA) will verify such assumptions. Fallure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or requiations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general Information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 636-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html",
Sincerely yours.
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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| 510(k) Number (If known): | K001241 |
|---|---|
| Device Name: | EVIS EXERA Colonovideo endoscopes |
Indications for Use:
The EVIS EXERA Colonovideoscopes CF-Q160 AL/I and the PCF-160 AL/I are intended for THE LYN LABO Popic surgery within the lower digestive tract (including the anus, sigmoid colon, colon and ileocecal valve).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over the Counter Use __
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K001241
(Optional Format 1-2-96)
§ 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.