The EC-3870CILK, Confocal Video Colonoscope, is intended to provide optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor), and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Device Description

The EC-3870CILK, Confocal Video Colonoscope, must be used with a Pentax Video Processor (software controlled device) and with Pentax Confocal Laser System (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Confocal Electrical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, forward water jet tube, and a confocal scanner. The instrument contains a working channel through legally marketed endoscopic accessories may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects color image data. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display on the endoscopic image monitor. The endoscope confocal scanner contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal electrical connected to the confocal laser system. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitty to transmit/ receive the light signals through the endoscope confocal imaging module. The detected signal is sent to the system computer. The System Computer processes the confocal image information for display on the confocal monitor, controls the laser light source, and acts as an image storage device for still frame images. The endoscope is immersable (with the use of supplied cleaning accessories).

AI/ML Overview

The provided text is a 510(k) summary for the Pentax EC-3870CILK Confocal Video Colonoscope.

Based on the information provided, no clinical performance study demonstrating the device meets specific acceptance criteria was conducted or is documented in this summary.

Here's why and what can be extracted:

The critical statement is: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly states that clinical studies for the device's performance against acceptance criteria were not part of this submission.

Therefore, most of the requested information cannot be provided from this document.

However, I can still address the relevant points based on what is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in this document as part of a formal performance study for substantial equivalence.
Reported Device Performance: Not reported in this document as it explicitly states clinical performance data was not assessed for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical performance study was conducted or reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical performance study was conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical performance study was conducted or reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was mentioned. This device is a colonoscope, not an AI-assisted diagnostic tool in the context described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (colonoscope), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical performance study was conducted or reported.

8. The sample size for the training set

Not applicable. This relates to machine learning models, which are not the subject of the performance assessment in this document.

9. How the ground truth for the training set was established

Not applicable. This relates to machine learning models, which are not the subject of the performance assessment in this document.

Summary of what was used for substantial equivalence:

The submission for substantial equivalence was based on:

Literature including specifications of the EC-3870CILK.
Identification of standard set components.
Identification of optional accessories.
Comparison tables illustrating similarities to the predicate devices (EC-3800L, Video Colonoscope, and Zeiss CLSO Confocal Laser Scanner Ophthalmoscope).

This 510(k) relies on the device being substantially equivalent to existing legally marketed predicate devices, meaning it shares similar technological characteristics and is intended for the same use, rather than requiring new clinical performance data to establish safety and effectiveness.

Summary

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OCT 1 9 2004

510(k )Summary EC-3870CILK, Confocal Video Colonoscope

Submitter Information:

Pentax Medical Company 102 Chestnut Ridge Road Montvale. New Jersey 07645-1856 Tel: (201)-391-0932

Name Of Device:

Trade Name:	EC-3870CILK, Confocal Video Colonoscope
Classification Name:	Colonoscope, Gastro- Urology (78FDF) (876.1500) [Class II]

Predicated Device(s) Information:

Model, Description	Manufacturer	PMN#
EC-3800L, Video Colonoscope	Pentax Corporation	K951574
Zeiss CLSO Confocal Laser Scanner Ophthalmoscope	Carl Zeiss, Inc.	K912581

Device Description:

Intended Use:

The EC-3870CILK, Confocal Video Colonoscope, is intended to provide optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor), and therapeutic access to, the Lower Gastrointestinal Tract The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Comparison To Predicated Device(s):

The submission for substantial equivalence included EC-3870CILK literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.

Prepared By:

Paul Silva

Paul Silva, Regulatory Affairs Coordinator

09-09-2004 Date

Control Number: PS-726.EC-3870CILK.510KS page 1 of 1

Revision: a

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Pentax Medical Company c/o Mr. Tamas Borsai Division Manager, Medical Division, and Program Manager, Third Party Review Program TÜV Rheinland of North America 12 Commerce Road Newtown, Connecticut 06470

Re: K042741

Trade/Device Name: EC-3870CILK, Confocal Video Colonoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, KOG Dated: September 30, 2004 Received: October 4, 2004

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21-CFR 1000-1050.

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Page 2 - Mr. Tamas Borsai

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
C.C.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EC-3870CILK, Confocal Video Colonoscope

Intended Use Statement:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number K042771

Regulation Number and Section

§ 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.