Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard video colonoscope and its components. There is no mention of AI, ML, or any advanced image analysis beyond basic image processing for display. The performance studies focus on compliance with electrical, mechanical, and biocompatibility standards, not algorithmic performance.

Therapeutic

No.
The device is an endoscope used for visualization and to facilitate endoscopic surgery, but it does not directly provide therapy.

Diagnostic

Yes

The device is a PENTAX Video Colonoscope, which is used to visually examine the lower digestive tract. The "Intended Use" states it's for endoscopy, which is a diagnostic procedure, and it captures image data used to display the "image inside the body cavity" on a monitor, enabling visual diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical medical device (colonoscope) with various hardware components (insertion portion, control body, lenses, channels, etc.) and mentions its use with other physical equipment like a video processor and monitor. While it processes image data, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the instrument is for endoscopy and endoscopic surgery within the lower digestive tract. This involves direct visualization and intervention within the body, not the examination of specimens in vitro (outside the body).
Device Description: The description details a device designed for insertion into the body, with components for visualization, illumination, manipulation (bending section), and access for surgical tools (instrument channel). This is characteristic of an endoscopic device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.

While the device involves image processing, which is common in some IVDs that analyze images of samples (like digital pathology), the context here is processing images from within the body for direct visualization and guidance during a procedure.

Therefore, this device falls under the category of an endoscopic instrument for in-vivo procedures, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

Product codes

FDF

Device Description

The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38i10L are used with a Video Processor.

The EC-3890TLK is composed of the following main parts: an Insertion Portion, Control Body and PVE Connector.

The Insertion Portion is inserted into the body cavity of patient. The Insertion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The AirMater Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The PVE Connector is connected to the Video Processor via an Electrical Contacts.

The Bending Section is bent by the Angulation Control Knob to operate the endoscope anqulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the AirMater Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The EC-3890TLK has two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.

Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.

The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle.

The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug which is connected to the Light Source inside the Video Processor.

The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is " displayed on the Monitor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

Mentions image processing

The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is " displayed on the Monitor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Reflected light (image data) captured by CCD

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

Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the PENTAX Video Colonoscopes (EC Family) were evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our in-house test protocols and use of external testing laboratories:

Medical electrical equipment Part 1: 1. IEC 60601-1:1988+A1:1991+A2:1995 General requirements for basic safety and essential performance
Medical electrical equipment- Part 1-1: General requirements IEC 60601-1-1:2000 2. for safety- Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General 3. requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and 4. testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro ട. cvtotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10:Tests for ട. irritation and skin sensitization
IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular 7. requirements for the basic safety and essential performance of endoscopic equipment
ISO 8600-1:2005 Optics and photonics Medical endoscopes and endotherapy 8. devices - Part 1: General requirements
ISO 8600-3:1997+A1:2003 Optics and optical instruments -Medical endoscopes and ത endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
1. ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
1. AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers
1. AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
ANSI/AAMI TIR79:2010 Comprehensive quide to steam sterilization and sterility 13. assurance in health care facilities
IS013485:2003 Medical devices Quality management systems Requirements for 14. requiatory purposes
ISO 14971:2007 (corrected version): Medical devices -Application of risk 15. management to medical devices
Medical electrical equipment- Part 1-4: General 16. IEC 60601-1-4:2000 Ed. 1.1 requirements for safety- Collateral Standard: Programmable electricalmedical systems
IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements 17. for basic safety and essential performance - Collateral standard: Usability
IEC 62366:2007 Medical devices -Application of usability engineering to medical 18. devices
IEC 62304:2006 Medical device software- Software life cycle processes 19.
IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment- 12-20. month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000
Medical devices Symbols to be used with medical device labels, 21. ISO 15223-1:2012 labeling and information to be supplied - Part 1: General requirements
1. IEC 60878:2003 Graphical symbols for electrical equipment in medical practice

Biocompatibility Test: Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1, 5, and 10 Biological evaluation of medical devices standard and the FDA's guidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.

Reprocessing Validation: Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Colonoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011, AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A quide for device manufacturers. AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. All the study results satisfy the acceptance criteria specified by the above applicable standards. In addition, the Reprocessing Instructions (Manual) were validated based on the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011. The validation confirmed that the PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li. EC-3890Li. EC-3490TLi. EC-3490LK, EC-3890LK, EC-3890LZi, EC34-110L, Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user.

EMC and Electrical Safety: The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LZi, EC-3890LZi, EC34-i10L were confirmed by testing in accordance with the IEC 60601-1-2; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Safety requirements for medical electrical systems, Electromagnetic compatibility - Requirements and tests; and IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

OLYMPUS Colonovideoscope CF TYPE Q160AL (K001241), OLYMPUS Colonovideoscope CF TYPE Q180AL (K100584)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

510(k) Summary

The following summary is provided in accordance with 21 CFR 807.92:

APR 0 9 2014

K131855 Page 1 of 5

Date: 19 Jun 2013

| Submitter: | PENTAX Medical Company,
HOYA Corporation PENTAX Division
3 Paragon Drive
Montvale, New Jersey 07645-1782 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Krishna Govindarajan
Regulatory Manager
PENTAX Medical Company,
3 Paragon Drive
Montvale, New Jersey 07645-1782
Phone: 800-431-5880 x 2125, 201-251-2300 x 2125
Fax: 201-799-4117
Email: Krishna.govindarajan@pentaxmedical.com |
| Trade/Device Name: | PENTAX Video Colonoscopes (EC Family) |
| Model Numbers: | EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi,
EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38-i10L |
| Common/Usual Name: | Colonoscope and Accessories, Flexible/Rigid |
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Product Code: | FDF |
| Predicate Device: | OLYMPUS Colonovideoscope CF TYPE Q160AL
(K001241; dated May 9 2000)
OLYMPUS Colonovideoscope CF TYPE Q180AL
(K100584; dated Jul 2 2010) |
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Product Code: | FDF |

PENTAX Video Colonoscopes (EC Family) 510(k) Summary

1

Device Description:

Image /page/1/Picture/1 description: The image shows the words "PENTAX MEDICAL" in bold, black letters. Below that, the text "K131855 Page 2 of 5" is printed in a smaller font size. The text appears to be part of a document or report, possibly indicating a page number and a reference number.