(91 days)
Olympus Light Guide Cable A3908 is intended for use in conjunction with Olympus OTV-SSC Video System and accessories with optical endoscopes for observation and recording during diagnostic and therapeutic applications requiring Type CF equipment.
Olympus OTV-S5C Video System, its associated accessories and ancillary equipment for CF application.
This documentdoes not contain information related to acceptance criteria or a study proving device performance for the Olympus OTV-S5C Video System or the A3908 Light Guide Cable.
The provided text is a 510(k) summary and an FDA clearance letter for a medical device. These documents primarily focus on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study.
- Intended Use and Indications: Defining how the device is meant to be used.
- Regulatory Classification: Placing the device within the FDA's regulatory framework.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth.
This information would typically be found in detailed pre-clinical or clinical study reports, which are usually referenced or summarized within a 510(k) submission but not fully contained in the public summary.
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510 (k) SUMMARY JUL 16 1997 OLYMPUS OTV-S5C VIDEO SYSTEM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus OTV-S5C Video System, its associatedaccessories and ancillary equipment for CF application. |
|---|---|
| Common/Usual Name: | Video Camera System |
| Classification Name: | 21 CFR 876.1500, Class IIEndoscope and Accessories |
| Predicate Devices: | Olympus OTV-S5 Video System, its associated accessoriesand ancillary equipment (BF Type).Cleared in 510(k) # K955404. |
| Prepared & Submitted By: Mr. Subhash Patel(Contact Person) | Olympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5481 |
| Summary PreparationDate: | 4/10/97 [Revised - 7/15/97] |
Statement of Intended Use:
A3908 Light Guide Cable
Olympus Light Guide Cable A3908 is intended for use in conjunction with Olympus OTV-SSC Video System and accessories with optical endoscopes for observation and recording during diagnostic and therapeutic applications requiring Type CF equipment.
ED
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 1997
Re: K971416
Olympus Light Cable Guide A3098 for use with OES OTV-S5C Video System Dated: April 10, 1997 Received: April 16, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG, GCJ
Mr. Subhash R. Patel Regulatory*Affairs Associate Endoscope Division Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157
Dear Mr. Patel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls: Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 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 regulations.
This letter will allow you to begine 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
htliau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name:
Olympus OES OTV-S5C Video System, its associated accessories and ancillary equipment for CF applications.
Indications for Use:
A3908 Light Guide Cable
Olympus Light Guide Cable A3908 is intended for use in conjunction with Olympus OTV-SSC Video System and accessories with optical endoscopes for observation and recording during diagnostic and therapeutic applications requiring Type CF equipment.
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Concurrence of CDRH, Office of Device Evaluation (ODE) but no no (Division Sign-Off) Division of Reproductive, Abdominal, ENT.
and Rediological Sevices Prescription Use and Radiological Devices (Optional Format 1-2-96) (per 21CFR 801.109) 1416 510(k) Number
§ 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.