EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I

K001241 · The Olympus Optical Co. · FDF · May 9, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K001241
• Device Name: EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
• Applicant: The Olympus Optical Co.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: May 9, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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).

Device Story

EVIS EXERA Colonovideoscopes (CF-Q160 AL/I and PCF-160 AL/I) are flexible endoscopes used for visualization and surgery in the lower digestive tract. The device integrates with an Olympus video system center, light source, and documentation equipment. A key modification is the addition of a control mechanism allowing the physician to vary the stiffness of the insertion tube to facilitate navigation through the colon. The device is operated by physicians in clinical settings. Output is provided via a video monitor for real-time visualization, aiding in diagnostic and therapeutic procedures. The stiffness control mechanism assists in insertion, potentially improving procedural efficiency and patient comfort.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Flexible colonovideoscopes with integrated stiffness control mechanism for the insertion tube. Designed for use with Olympus video system centers, light sources, and endo-therapy accessories. Class II device (21 CFR 876.1500).

Indications for Use

Indicated for endoscopy and endoscopic surgery within the lower digestive tract, including the anus, rectum, sigmoid colon, colon, and ileocecal valve.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Submission Summary (Full Text)

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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 [phone] 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 [phone] Facsimile [phone]

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<br>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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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).

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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)