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 Medical Video Colonoscope EC34-i10T Series is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727). They scopes are composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion Portion. The Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. The Bending Section of the Insertion Body is used to operate the endoscope angulation and is bent by the Angulation Control Knob on the Control Body. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, and Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor. The EC34-i10T series includes three models: EC34-i10TF, and EC34-i10TF, and EC34-i10TM. These models are identical in all parameters and only differ in length of the insertion of the scopes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a new medical device, the PENTAX Medical Video Colonoscope EC34-i10T Series. The document focuses on demonstrating that this new device is substantially equivalent to a previously cleared predicate device (PENTAX Medical EC34-i10L Video Colonoscope).

The nature of this submission (demonstrating substantial equivalence to a predicate device) means that the testing performed largely confirms that the new device maintains the safety and effectiveness characteristics of the predicate, despite minor dimensional and material changes. It does not involve a study to "prove the device meets the acceptance criteria" in the way one might for a novel diagnostic algorithm or a therapy with specific performance metrics against a defined standard. Instead, the acceptance criteria are largely met by demonstrating performance comparable to the predicate and compliance with relevant safety and reprocessing standards.

Therefore, the requested information, particularly regarding "device performance," "sample sizes," "ground truth," "experts," and "MRMC comparative effectiveness study," is not directly applicable in the context of this 510(k) submission, as it relates to a colonoscope, not an AI/ML-based diagnostic tool. The document primarily focuses on validation of reprocessing, biocompatibility, electrical safety, EMC, software, and optical/usability performance against established standards or the predicate device.

However, I can extract the relevant information that is present in the document related to acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Reprocessing	All acceptance criteria were satisfied for Soil Accumulation, Cleaning Efficacy, High-Level Disinfection (HLD) Efficacy, Rinsing Validation, and Sterilization Validation.	"All acceptance criteria were satisfied." (Implies successful completion and meeting of predefined thresholds for each reprocessing step).
Biocompatibility	Compliance with "Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (June 16, 2016)" with passing results.	"The biocompatibility evaluation of the patient contacting materials... was conducted in accordance with... ISO 10993-1... with passing results."
Electrical Safety	Compliance with IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, IEC 60601-2-18:2009, and ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012.	"The PENTAX Medical Video Colonoscope EC34-i10T Series was tested and comply with the following standards for electrical safety..." (Implies successful compliance with all listed standards).
EMC	Compliance with IEC 60601-1-2:2007/EN 60601-1-2:2007.	"... and EMC. The PENTAX Medical Video Colonoscope EC34-i10T Series was tested and comply with the following standards for... EMC... IEC 60601-1-2:2007/EN 60601-1-2:2007." (Implies successful compliance).
Software V&V	Same software as the predicate device, implying that the predicate's validated software is used.	"The subject devices utilize the same software as the predicate device."
Optical - Light Distribution, Spectral Distribution, Total Luminous Flux	Comparable to the predicate device (PENTAX Medical Video Colonoscope EC34-i10L).	"The results of the testing indicate that the light distributions, intensity and wavelength, and total luminous flux of the EC34-i10TL were comparable to the EC34-i10L."
Optical - Photobiological Safety	IEC 62471 evaluation values of Risk Group 2 or lower, and equivalent safety to the predicate device combinations.	"Testing revealed that IEC 62471 evaluation values of all subject and predicate device combinations are risk group 2 or lower, and the safety of the subject device combinations are considered to be equivalent to the predicate device combinations."
Usability	No difference in all operations compared to PENTAX Medical i10 and k10 series of scopes (including the predicate device), and equivalent usability.	"Usability testing of various operating conditions was analyzed, which demonstrated that there is no difference in all operations, and their usability is equivalent." (Compared to PENTAX Medical i10 and k10 series of scopes, of which the i10 series includes the predicate device).

2. Sample size used for the test set and the data provenance:

Reprocessing Validation: The document states that "The following testing has been performed for the PENTAX Medical Video Colonoscope EC34-i10T Series." This implies specific units of the device were tested. Sample sizes are not explicitly provided (e.g., how many colonoscopes were subjected to cleaning or HLD efficacy testing), but it would typically involve a statistically relevant number of units as per reprocessing validation standards. Data provenance is not mentioned, but these types of studies are typically conducted by the manufacturer or accredited testing labs.
Biocompatibility: Involves testing of patient-contacting materials. Sample sizes are not specified but would be dictated by ISO 10993-1.
Electrical Safety and EMC: Involves testing of device units. Sample sizes are not specified but are typically one or a few units for compliance testing.
Optical Testing: The document states "PENTAX Medical completed optical testing of the PENTAX Medical Video Colonoscope EC34-i10T compared to the predicate, PENTAX Medical Video Colonoscope EC34-i10L." This indicates at least one unit of each (subject and predicate) was used for comparison.
Usability Testing: The document states "A comparison of the usability of the PENTAX Medical Video Colonoscope EC34-i10T to PENTAX Medical i10 and k10 series of scopes was conducted." Sample sizes for the tested scopes are not mentioned, nor are the number of users involved in the usability assessment.

All these studies appear to be prospective (conducted specifically for this submission) in nature, performed by the manufacturer or their designated testing facilities. No country of origin for the data is specified, but given the manufacturer's location (Montvale, New Jersey, USA) and the submission to the FDA, it's reasonable to infer a U.S. or international standard-compliant testing environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device and submission. Colonoscopes are physical instruments, and their performance is evaluated through engineering and biological testing, not by establishing "ground truth" through expert clinical interpretation in the context of a diagnostic AI.

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

This is not applicable as there is no "ground truth" adjudication process involving experts for a physical device like a colonoscope.

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

This is not applicable. The device is a video colonoscope, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance were conducted or reported.

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

This is not applicable. The device is a video colonoscope, not an algorithm.

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

This is not applicable for the reasons outlined above. The "ground truth" for colonoscope performance is adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, demonstrated through direct physical and electrical testing.

8. The sample size for the training set:

This is not applicable. This is a hardware device, not a machine learning algorithm requiring a training set. The device does utilize software, but it is explicitly stated that "The subject devices utilize the same software as the predicate device," implying the software was previously
validated and no new training was performed for this submission.

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

This is not applicable. See points 7 and 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 26, 2018

PENTAX of America, Inc. James W. Monroe Director, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782

Re: K180285

Trade/Device Name: PENTAX Medical Video Colonoscope EC34-i10T Series Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: September 21, 2018 Received: September 27, 2018

Dear James W. Monroe:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (see 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image contains the name "Glenn B. Bell -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are bold and easily readable, with a clear distinction between each character.

for 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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Indications for Use

510(k) Number (if known)

K180285

Device Name

PENTAX Medical Video Colonoscope EC34-i10T Series

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

SUBMITTER 1.

PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 800-431-5880 Ext 2129 Fax: 201-571-2340

Contact: James Monroe Date Prepared: January 31, 2018

II. DEVICE

The purpose of this 510(k) is to obtain clearance of the PENTAX Medical Video Colonoscope EC34-i10T Series (EC34-i10T family of scopes).

Device Name	PENTAX Medical Video Colonoscope EC34-i10T Series
Common Name	Colonoscope And Accessories, Flexible/Rigid
Classification Name	Endoscope and accessories
Regulation No.	876.1500
Device Class	2
Product Code	FDF
Classification Panel	Gastroenterology/ Urology

Table 5.1: Regulatory Classification of PENTAX Medical Video Colonoscopes EC34-i10T Series.

III. PREDICATE DEVICES

The predicate device for this submission, PENTAX Medical EC34-i10L Video Colonoscope (K131855), is virtually identical to the EC34-i10T family of scopes. The subject and predicate devices differ slightly with regard to dimensional specifications and materials.

IV. DEVICE DESCRIPTION

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Body is used to operate the endoscope angulation and is bent by the Angulation Control Knob on the Control Body.

The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, and Instrument Channel Inlet.

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

The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

The EC34-i10T series includes three models: EC34-i10TF, and EC34-i10TF, and EC34-i10TM. These models are identical in all parameters and only differ in length of the insertion of the scopes. The differences are outlined below:

EC34-i10TL: Insertion portion length - 1700 mm; Total length - 2016 mm
EC34-i10TF: Insertion portion length - 1500 mm; Total length - 1816 mm
EC34-i10TM: Insertion portion length 1300 mm; Total length 1616 mm ●

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

The subject devices are virtually identical to the predicate device. The subject devices have the same fundamental technology and operating principles of the predicate device, including the same intended use and design technological characteristics, such as Insertion Portion, Control Body and optical characteristics. The minor differences between the subject and predicate devices exist with regard to dimensional specifications and materials. These modifications do not impact the intended use and do not raise different questions of safety and effectiveness.

VII. PERFORMANCE DATA

a. Reprocessing Validation

The PENTAX Medical Video Colonoscope EC34-i10T Series are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before

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initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.

The following testing has been performed for the PENTAX Medical Video Colonoscope EC34-i10T Series:

Soil Accumulation Study
Cleaning Efficacy Study
High Level Disinfection (HLD) Efficacy Study
Rinsing Validation
Sterilization Validation

All acceptance criteria were satisfied.

b. Biocompatibility

The biocompatibility evaluation of the patient contacting materials of the PENTAX Medical Video Colonoscope EC34-i10T Series was conducted in accordance with "Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (June 16, 2016)" with passing results.

c. Electrical Safety and Electromagnetic Compatibility (EMC)

The PENTAX Medical Video Colonoscope EC34-i10T Series was tested and comply with the following standards for electrical safety and EMC.

Electrical Safety

IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 .
IEC 60601-2-18:2009
ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012

Electromagnetic Capability

IEC 60601-1-2:2007/EN 60601-1-2:2007

d. Software Verification and Validation

The subject devices utilize the same software as the predicate device.

e. Performance Testing

Optical Testing

PENTAX Medical completed optical testing of the PENTAX Medical Video Colonoscope EC34-i10T compared to the predicate, PENTAX Medical Video Colonoscope EC34-i10L. The scopes were evaluated for Light Distribution, Spectral Distribution, Total Luminous Flux, and Photobiological Safety. Testing was conducted using both the PENTAX Medical EPK-i5010 and EPK-i7010 Video Processors. The results of the testing indicate that the light distributions, intensity and wavelength, and total luminous flux of the EC34-i10TL were comparable to the EC34-i10L.

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The photobiological safety of the lamps and lamp systems was evaluated in accordance with IEC 62471, Photobiological safety of lamps and lamp systems. Testing revealed that IEC 62471 evaluation values of all subject and predicate device combinations are risk group 2 or lower, and the safety of the subject device combinations are considered to be equivalent to the predicate device combinations.

Usability Testing

A comparison of the usability of the PENTAX Medical Video Colonoscope EC34-i10T to PENTAX Medical i10 and k10 series of scopes was conducted. The i10 series of scopes include the predicate device, EC34-i10L. Usability testing of various operating conditions was analyzed, which demonstrated that there is no difference in all operations, and their usability is equivalent.

VIII. CONCLUSION

The subject device is virtually identical to the predicate device with only minor changes to materials and dimensional specifications. The intended use of the subject and predicate devices are identical. Any differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

The data submitted support the performance and reprocessing for the PENTAX Medical Video Colonoscope EC34-i10T Series demonstrate that the scopes perform as intended and can be reprocessed in a safe and effective manner. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.

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.