(91 days)
No
The summary describes a light guide cable and video system, with no mention of AI, ML, or advanced image processing beyond basic video display.
No.
The device is a light guide cable used for observation and recording during diagnostic and therapeutic applications, not for delivering therapy itself.
No
The A3908 Light Guide Cable is an accessory used with an imaging system for observation and recording, but it is not itself a diagnostic device. The diagnostic function would be attributed to the overall system and the interpretation of the images by a clinician.
No
The device description explicitly states it is a "Light Guide Cable" and part of a "Video System," indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "observation and recording during diagnostic and therapeutic applications requiring Type CF equipment" in conjunction with optical endoscopes. This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: It describes a "Video System, its associated accessories and ancillary equipment for CF application." This further reinforces its role in a clinical setting during procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
Therefore, the Olympus Light Guide Cable A3908 is a component of a medical device system used for visualization during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
78 KOG, GCJ
Device Description
Olympus OTV-S5C Video System, its associated accessories and ancillary equipment for CF application.
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)
Not Found
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.
0
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 associated
accessories and ancillary equipment for CF application. |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Video Camera System |
| Classification Name: | 21 CFR 876.1500, Class II
Endoscope and Accessories |
| Predicate Devices: | Olympus OTV-S5 Video System, its associated accessories
and ancillary equipment (BF Type).
Cleared in 510(k) # K955404. |
| Prepared & Submitted By: Mr. Subhash Patel
(Contact Person) | Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5481 |
| Summary Preparation
Date: | 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
1
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
2
ED
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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