(15 days)
Not Found
No
The description details standard endoscopic and confocal imaging technology and image processing for display and storage. There is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access to, the Lower Gastrointestinal Tract." Additionally, the "Device Description" mentions that "the instrument contains a working channel through legally marketed endoscopic accessories may be introduced (the instrument is supplied with two biopsy forceps)," which facilitates therapeutic interventions.
Yes
The "Intended Use" section states that the device is for "optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor)" of the Lower Gastrointestinal Tract. This involves the active collection of images of the body's internal structures to aid in diagnosis.
No
The device description clearly details hardware components such as a flexible insertion tube, control body, light carrying bundles, CCD, confocal scanner, and a working channel. While it mentions software-controlled components (Video Processor and Confocal Laser System), the device itself is a physical instrument with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EC-3870CILK, Confocal Video Colonoscope, is a medical device used for direct visualization of the lower gastrointestinal tract. It provides optical and confocal microscopic images of the internal anatomy. It also allows for therapeutic access.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly images the tissue within the body.
Therefore, while it is a diagnostic tool used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, KOG
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization, Confocal microscopic visualization
Anatomical Site
Lower Gastrointestinal Tract (Large Bowel)
Indicated Patient Age Range
adult and pediatric patient populations
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)
The submission for substantial equivalence was not based on an assessment of clinical performance data.
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.
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
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:
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).
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
1
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.
2
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
3
EC-3870CILK, Confocal Video Colonoscope
Intended Use Statement:
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.
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