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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PENTAX Video Colonoscopes (EC Family):

This document describes the safety and performance testing for a traditional medical device (colonoscope), not an AI/ML-enabled device. Therefore, many of the requested fields pertinent to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not applicable or explicitly mentioned in the provided text.

The acceptance criteria are primarily related to general safety and performance standards for endoscopes and medical electrical equipment.

Acceptance Criteria and Device Performance for PENTAX Video Colonoscopes (EC Family)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Design Control	21 CFR Part 820.30 (Design Verification and Validation testing)	"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."
Basic Safety & Essential Performance	IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for basic safety and essential performance)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Safety - Medical Electrical Systems	IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2001+A1:2004 (Electromagnetic compatibility - Requirements and tests)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the IEC 60601-1-2..."
Biocompatibility	ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process) ISO 10993-5:2009 (Tests for in vitro cytotoxicity) ISO 10993-10:2010 (Tests for irritation and skin sensitization) FDA's guidance 'Use of International Standard ISO-10993, Part 1'	"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	FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2, 2011) AAMITIR12:2010 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities) AAMITIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) ANSI/AAMI TIR79:2010 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)	"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... AAMI TIR 12:2010... AAMI TIR 30:2011... and AAMI TIR79:2010..." "All the study results satisfy the acceptance criteria specified by the above applicable standards." "The validation confirmed that the PENTAX Video Colonoscopes (EC Family)... Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user."
Endoscopic Equipment Specific	IEC 60601-2-18:1996+A1:2000 (Particular requirements for the basic safety and essential performance of endoscopic equipment) ISO 8600-1:2005 (Optics and photonics Medical endoscopes and endotherapy devices - Part 1: General requirements) ISO 8600-3:1997+A1:2003 (Determination of field of view and direction of view of endoscopes with optics) ISO 8600-4:1997 (Determination of maximum width of insertion portion)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the... IEC 60601-2-18..."
Quality Management Systems	ISO13485:2003 (Medical devices Quality management systems Requirements for regulatory purposes)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Risk Management	ISO 14971:2007 (corrected version) (Medical devices -Application of risk management to medical devices)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Programmable Electrical Medical Systems	IEC 60601-1-4:2000 Ed. 1.1 (General requirements for safety- Collateral Standard: Programmable electrical medical systems)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the... IEC 60601-1-4..."
Usability	IEC 60601-1-6:2010 (General requirements for basic safety and essential performance - Collateral standard: Usability) IEC 62366:2007 (Medical devices -Application of usability engineering to medical devices)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Software Life Cycle Processes	IEC 62304:2006 (Medical device software- Software life cycle processes)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Graphical Symbols	IEC 60417ISO 7000-DB-12M:2004 (Graphical symbols for use on equipment) ISO 15223-1:2012 (Medical devices Symbols to be used with medical device labels, labeling and information) IEC 60878:2003 (Graphical symbols for electrical equipment in medical practice)	"Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards."
Electrical Safety	IEC 60601-1 (General requirements for basic safety and essential performance)	"The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... 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."

Regarding AI/ML-Specific Information:

The provided text details the submission for PENTAX Video Colonoscopes (EC Family), which are traditional endoscopy devices. The safety and performance data presented are for the physical device itself (electrical safety, biocompatibility, reprocessing, etc.) as per various international standards. There is no mention of artificial intelligence (AI) or machine learning (ML) within this document. Therefore, the following AI/ML-specific points cannot be addressed from the given text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device submission, not an AI/ML algorithm. Testing was on the physical device and its components.
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. Ground truth for AI/ML is usually related to disease presence/absence or other assessments by human experts. For this device, "ground truth" refers to compliance with engineering and biological standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as there is no AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or acceptance criteria are defined by recognized consensus standards (e.g., IEC, ISO, AAMI) regarding safety, performance, and functionality.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

Summary of the Study for PENTAX Video Colonoscopes (EC Family):

The study was a comprehensive non-clinical design verification and validation testing program focused on ensuring the device meets established safety and performance standards for endoscopes. The testing confirmed:

Design Compliance: Adherence to 21 CFR Part 820.30 (Design Control).
Safety (Electrical & Mechanical): Compliance with IEC 60601 series for basic safety, essential performance, and specific requirements for endoscopic equipment (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-4).
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.
Biocompatibility: Confirmation that materials are safe for patient contact, tested according to ISO 10993 series for cytotoxicity, sensitization, and intracutaneous reactivity.
Reprocessing Validation: Validation of cleaning and high-level disinfection procedures through simulated use conditioned test samples, adhering to FDA draft guidance and AAMI TIR standards to ensure the device can be effectively reprocessed for reuse. User comprehensibility of reprocessing instructions was also validated.
Usability: Compliance with IEC 60601-1-6 and IEC 62366.
Software Life Cycle: Compliance with IEC 62304 (if applicable to the device's embedded software).
Optical Characteristics: Compliance with ISO 8600 series for field of view, direction of view, and insertion portion dimensions.
Quality Management and Risk Management: Compliance with ISO 13485 and ISO 14971.
Labeling and Symbols: Compliance with relevant IEC and ISO standards for graphical symbols.

The "Master Device (EC-3890TLK)" was used for testing, and its results were stated to satisfy the acceptance criteria of all applicable standards, indicating the entire EC Family is substantially equivalent and safe/effective.

Summary

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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 Division3 Paragon DriveMontvale, New Jersey 07645-1782
Contact:	Krishna GovindarajanRegulatory ManagerPENTAX Medical Company,3 Paragon DriveMontvale, New Jersey 07645-1782Phone: 800-431-5880 x 2125, 201-251-2300 x 2125Fax: 201-799-4117Email: 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

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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 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.

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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:

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

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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.

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

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

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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.

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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.

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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

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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)

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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)

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.