(42 days)
This instrument has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).
The subject devices, EVIS EXERA Colonovideoscope XCF-Q160W1L/I are identical to the predicate device, CF-Q160AL/I, in intended use. These instrument 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 for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). As for the device specifications, they are basically identical to the predicate devices, the CF-Q160AL/I, with the exception that the subject devices have wider field of views compared to the CF-Q160AL/I/. With this field of view, the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time.
I am sorry, but based on the provided text, there is no study described that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for the EVIS EXERA Colonovideoscope XCF-Q160W1L/I. The core assertion within this 510(k) is that the device is substantially equivalent to a predicate device (EVIS EXERA Colonovideoscope CF-Q160AL/I). This means that instead of conducting new clinical trials to prove safety and effectiveness against specific acceptance criteria, the manufacturer is arguing that the new device is so similar to an already approved device that it can be presumed safe and effective.
Here's a breakdown of why the requested information cannot be provided from this text:
-
No Acceptance Criteria or Reported Performance: The document does not list any specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, or procedure time reduction targets) for the new colonovideoscope. Consequently, it also doesn't report any performance metrics against such criteria. The "Comparison of Technological Characteristics" table only compares physical specifications (Field of View, Diameter).
-
No Study Described: The document explicitly states: "Therefore, clinical data is not necessary for its evaluation of safety and efficacy." This indicates that a study demonstrating performance against acceptance criteria was not conducted or submitted for this 510(k) pathway. The basis for approval here is substantial equivalence.
Therefore, for your specific questions:
- Table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not applicable, as no such study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a hardware device, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The closest thing to a "performance claim" is the statement that "the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time" due to its wider field of view. However, this is presented as a potential benefit and an observation, not as a result of a formal study demonstrating it meets predefined acceptance criteria for these outcomes.
{0}------------------------------------------------
SMDA 510(k) SUMMARY EVIS EXERA Colonovidoscope XCF Q160W1L/I
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
1. GENERAL INFORMATION
| Applicant | Aizu Olympus Co., Ltd500 Aza Muranishi OoazaNiidera, Monden-machiAizuwakamatsu-shi, Fukushima, JAPAN 965-8520Establishment Registration No.: 9610595 |
|---|---|
| Submission Correspondent | Akiko FukagawaOlympus Medical Systems Corp.(Former name: Olympus Corporation)2951 Ishikawa-cho,Hachioji-shi, Tokyo, 192-8507, JapanPhone: +81-426-2891Fax: +81-426-3174E-mail: akiko_fukagawa@ot.olympus.co.jpEstablishment Registration No.: 8010047 |
| Official Correspondent | Laura Storms-TylerDirector, Regulatory Affairs and Quality AssuranceOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-9058Phone: 631-844-5688Fax: 631-844-5554Establishment Registration No.: 2429304 |
2. Device Identification
| Trade Name: | EVIS EXERA Colonovideoscope XCF-Q160W1L/I |
|---|---|
| Common Name: | Gastrointestinalvideoscope/Colonovideoscope |
| Regulation Number: | 21CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Class: | II |
| Product Code: | 78 FDF |
{1}------------------------------------------------
3. Predicate Device
Predicate Device Name: EVIS EXERA Colonovideoscope CF-Q160AL/I Manufacturer: Olympus Corporation 510(k) Number: K001241
4. Device Description
The subject devices, EVIS EXERA Colonovideoscope XCF-Q160W1L/I are identical to the predicate device, CF-Q160AL/I, in intended use. These instrument 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 for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). As for the device specifications, they are basically identical to the predicate devices, the CF-Q160AL/I, with the exception that the subject devices have wider field of views compared to the CF-Q160AL/I/. With this field of view, the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time.
5. Intended Use of the device
This instrument has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).
6. Comparison of Technological Characteristics
| Specifications | Subject DeviceXCF-Q160W1L/I | Predicate DeviceCF-Q160AL/I |
|---|---|---|
| Field of View | 170° | 140° |
| Distal end OuterDiameter | $\phi$ 13.2 mm | $\phi$ 12.8 mm |
| Insertion Tube OuterDiameter | $\phi$ 12.8 mm | $\phi$ 12.8 mm |
| Inner Channel Diameter | $\phi$ 3.7 mm | $\phi$ 3.7 mm |
Below is the comparison table between the subject devices and predicate device.
{2}------------------------------------------------
7. Materials
Some of the patient contact materials used in the subject devices are identical to those used in the devices cleared in the past 510(k) submissions. As the others are not identical to the predicate devices, biocompatibility testing was performed in accordance with Japan's Ministry of Health and Welfare notification "GUIDELINES FOR BASIC BIOLOGICAL EVALUATION OF MEDICAL DEVICES" (issued on June 27, 1995), YAKKI No.99.
8. Conclusion
When compared to the predicate device, XCF-Q160W1L/I do not incorporate any significant when compared to the progration, material, or design that could affect the safety and effectiveness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2005
OLYMPUS AMERICA INC. c/o Mr. Ned E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Avenue, SE GRAND RAPIDS MI 49548
Re: K043487
K043487
Trade/Device Name: EVIS EXERA Colonovideoscope XCF-Q160WIL/I Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDF Dated: January 12, 2005 Received: January 13, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the enclosine) to regally manctment date of the Medical Device American of Read Drug commerce prior to May 20, 1776, are enalerations of the Federal Food, Drug, devices mat have occh reclassino in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, basjon to the ments for annual registration, listing of general controls provisions of the frectiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (IPMA), If your device is classified (sec above) into existing major regulations affecting your device can be it may be suoject to additional controls. Entraling migres 800 to 898. In addition, FDA may loudia in the Code of I odelar is concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of our device complies with other requirements of the Act that FDA has made a decermination an administered by other Federal agencies. You must of ally rederal statues and roganients including, but not limited to: registration and listing Comply with an the Act 3 requirements, as a manufacturing practice requirements as set (21 CFR Part 807), laboring (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (QD) roganitimes 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
The station of the support of a final four of substantial equivalence of your de This letter will allow you to begin marketing your acvice of your device of your device to a legally
premarket notification. The FDA inding of substantial equivalence of you premarket notification. The FDA finding of substantial equivatelies of 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), please
r many of the filler of the fillering pumbers, hased on the regulation nu If you desire specific advice for your device on our labeling regaration (e virus).
contact the Office of Compliance at one of the following numbers, based on the regulation the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general Infornation on your resposistences at its toll-free number (800)
Division of Small Manufacturers, International (1) var the sounder (80 Division of Small Manufacturers, International and Consultor Institution of the comments.
638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edrh/dsmarl
Sincerely yours,
Nancy C. Brogdon
Nancy C. È rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number(if known):
Device Name: EVIS EXERA Colonovideoscope XCF-Q160W1L/l
Indications for Use:
Indications for Osc.
This instrument has been designed to be used with the Olympus Video System Center, This Instrument nation Equipment, Video Monitor, Electrosurgical Unit, Endo-Light Ooulos, Documents a Biopsy Forceps and other ancillary equipment for therapy 1 loosconos vithin the lower digestive tract (including the anus, rectum, and sigmoid colon, and ileocecal valve).
Prescription Use_**_
(21 CFR 801 Subpart D)
OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
David h. Severson
(Division Sign-Off)
Page 1 of __ 1
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043487
§ 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.