(21 days)
Not Found
Not Found
No
The summary describes a mechanical modification to the endoscope's insertion tube stiffness and does not mention any AI/ML components or image processing capabilities.
No
The device is used for endoscopy and endoscopic surgery, and aids in the insertion of the colonoscope. While it is used in medical procedures, its primary function is diagnostic and interventional (surgical guidance) rather than directly therapeutic in itself. It is explicitly mentioned to be used with "endo-therapy accessories such as biopsy forceps," suggesting those accessories, not the device itself, perform therapeutic actions.
Yes
Explanation: The device is described as a "Colonovideoscopes" intended for "endoscopy and endoscopic surgery," which are procedures used to visualize internal body structures and diagnose conditions.
No
The device description clearly states it is a colonovideoscope, which is a physical medical device with an insertion tube and control mechanisms, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endoscopy and endoscopic surgery within the lower digestive tract. This is a procedure performed directly on the patient's body for visualization and intervention, not for testing samples in vitro (outside the body).
- Device Description: The device is a colonovideoscope, which is a medical instrument used for direct visualization and manipulation within the body. It's designed to be used with other equipment for performing endoscopic procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for performing a medical procedure.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
78 FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Koo1241
pg 1 of 2
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 accessories |
| 21 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.
1
Koo1241
pg 2 of 2
-
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.
2
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)
3
| 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)