PENTAX VIDEO COLONOSCOPES (EC FAMILY)

K131855 · Pentax Medical Company · FDF · Apr 9, 2014 · Gastroenterology, Urology

Device Facts

Record IDK131855
Device NamePENTAX VIDEO COLONOSCOPES (EC FAMILY)
ApplicantPentax Medical Company
Product CodeFDF · Gastroenterology, Urology
Decision DateApr 9, 2014
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

PENTAX Video Colonoscopes (EC Family) are flexible endoscopes designed for lower gastrointestinal tract visualization and surgery. The device consists of an insertion portion (with distal end, bending section, objective lens, light guide, instrument channel, and air/water/water-jet nozzles) and a control body (with angulation knobs, suction/irrigation valves, and remote buttons). The device connects to a PENTAX Video Processor and light source. A CCD at the distal end captures reflected light from the body cavity, converting it into image data transmitted to the processor for display on a monitor. Clinicians operate the device to navigate the colon, perform suction/irrigation, and insert endotherapy devices (e.g., biopsy forceps) through the instrument channel. The device facilitates real-time visualization to assist in clinical decision-making during diagnostic or therapeutic procedures, potentially benefiting patients by enabling minimally invasive examination and intervention.

Clinical Evidence

Bench testing only. Performance evaluated via design verification and validation in accordance with 21 CFR 820.30, including electrical safety (IEC 60601-1 series), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, 5, 10), and reprocessing validation (AAMI TIR12, TIR30, TIR79).

Technological Characteristics

Flexible video colonoscope; insertion portion with CCD sensor, light guide, and instrument channels. Materials evaluated per ISO 10993. Connectivity via PVE connector to PENTAX Video Processor. Standards: IEC 60601-1, IEC 60601-2-18, ISO 8600-1/3/4, ISO 10993, ISO 14971, IEC 62304. Reprocessing: Manual cleaning and high-level disinfection.

Indications for Use

Indicated for endoscopic visualization and surgery within the lower digestive tract, including the anus, rectum, sigmoid colon, colon, and ileocecal valve, in patients requiring diagnostic or therapeutic colonoscopy.

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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,<br>HOYA Corporation PENTAX Division<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782 | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Krishna Govindarajan<br>Regulatory Manager<br>PENTAX Medical Company,<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782<br>Phone: 800-431-5880 x 2125, 201-251-2300 x 2125<br>Fax: 201-799-4117<br>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,<br>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<br>(K001241; dated May 9 2000)<br>OLYMPUS Colonovideoscope CF TYPE Q180AL<br>(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. 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the words "PENTAX MEDICAL" in bold, with a line separating the two words. Below the words, there is the text "K131855 Page 3 of 5". The text appears to be part of a document or report. # Intended 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. # Summary of Technology Characteristics 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 has the same fundamental technology and operating principles in comparison to those of the predicate devices, including same intended use, design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination. The minor differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device. # Safety and Performance Data (Non-clinical tests) 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the words "PENTAX MEDICAL" in bold, black letters. Below the word "MEDICAL" is the alphanumeric code "K131855" and the text "Page 4 of 5". The text is arranged in a way that suggests it is part of a document or report. - 10. ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion - 11. AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers - 12. 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 - 22. IEC 60878:2003 Graphical symbols for electrical equipment in medical practice 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, Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards. # 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 {4}------------------------------------------------ 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. # Substantial Equivalence discussion: 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 has the same intended use, fundamental technology and operating principles including design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination in comparison to those of the predicate device. The minor dimensional differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device. ### Conclusion: The PENTAX Medical Company believes 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-i10L, as indicated in this 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 9, 2014 PENTAX Medical Krishna Govindarajan Regulatory Affairs, Americas 3 Paragon Drive Montvale, NJ 07645 Re: K131855 Trade/Device Name: PENTAX Video Colonoscopes (EC Family) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: March 28, 2014 Received: March 31, 2014 Dear Krishna Govindarajan, 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 cnactment 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {6}------------------------------------------------ Page 2 - Krishna Govindarajan 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Image /page/6/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a name or title. The letters are clearly legible, with varying degrees of boldness. Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. #### 510(k) Number (if known) K131855 #### Device Name PENTAX Video Colonoscopes (EC Family) #### Indications for Use (Describe) 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 endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) : ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY ... ... Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Benjamin R. Fisher 2014.04.08 22:15 :: FORM FDA 3881 (1/14) ::
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