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 upper digestive tract including the esophagus, stomach, and duodenum.

Device Description

The subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes as described in K131902. The PENTAX Medical Video Upper G.I. scopes (EG Family) are used with Video Processors. They are composed of three main components: 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, 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. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens. The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity. The GI Family of scopes also contains a Magnification Control Lever used to magnify the image on the video monitor, as necessary. As this magnification is performed electrically, focus and depth of field are not changed. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. 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. 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 PENTAX Medical Video Upper G.I. scopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.

AI/ML Overview

This document is a 510(k) Premarket Notification for the PENTAX Medical Video Upper GI Scopes (EG Family), primarily seeking clearance for revised reprocessing instructions. It is not an AI/ML device, and as such, the typical acceptance criteria and study designs for such devices (e.g., accuracy, sensitivity, specificity, reader studies, etc.) are not applicable here.

The "study" in this context is a reprocessing validation study to demonstrate that the revised cleaning instructions maintain the safety and effectiveness of the endoscopes.

Here's how the provided information relates to acceptance criteria and the "study":

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device or a device with performance metrics like sensitivity/specificity, the acceptance criteria are related to the effectiveness of the reprocessing instructions in ensuring the device remains safe for reuse.

Acceptance Criteria (for reprocessing)	Reported Device Performance (as implied by the submission)
Effectiveness of cleaning: The revised manual pre-cleaning and cleaning instructions must be effective in removing soil and biological burden from the endoscope channels and surfaces.	Reprocessing validation data, including "soil accumulation and cleaning efficiency studies," were provided. The conclusion states that the scopes "can be reprocessed in a safe and effective manner."
Maintenance of device function/integrity: The revised instructions should not negatively impact the design, specifications, or technological characteristics of the endoscope.	The submission explicitly states "There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes." The focus of the 510(k) is solely on the instructions.
Clinical Equivalence: The reprocessed device must remain substantially equivalent to the legally marketed predicate device.	The submission argues substantial equivalence by stating the device is identical to the predicate device and the only change is to reprocessing instructions, which "does not impact the intended use and does not raise different questions of safety and effectiveness."

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

Sample Size for Test Set: The document does not specify the exact number of endoscopes or cleaning cycles used in the reprocessing validation study. It only mentions "reprocessing validation data" and "soil accumulation and cleaning efficiency studies." For medical device reprocessing validation, this typically involves a defined number of cycles on a set of devices to demonstrate reproducibility and effectiveness.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by or for PENTAX. It would be prospective (purpose-designed experiments) to validate the new instructions. The country of origin is not specified but would likely be where the manufacturing or R&D validation takes place.

3. 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):

This isn't applicable. For reprocessing validation, "ground truth" is established through standardized laboratory methods (e.g., measuring residual protein, hemoglobin, or other markers after cleaning; visual inspection; microbial load testing). It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. Experts in this context would be reprocessing validation engineers and microbiologists, adhering to relevant standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in reader studies for diagnostic performance where human interpretation is the primary outcome. Here, the "outcomes" are quantitative measurements of cleaning effectiveness. Quality control and statistical analysis methods would be used to ensure the validity of the reprocessing study results.

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:

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases.

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

Not applicable. This is a medical device (endoscope) with revised instructions for use, not an algorithm.

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

The "ground truth" (or more accurately, the validation methodology) for reprocessing effectiveness is based on scientific and regulatory standards for cleaning validation. This typically involves:

Quantitative analytical methods: Measuring the removal of simulated soil (e.g., protein, hemoglobin, carbohydrates) using validated assays.
Microbiological methods: Demonstrating reduction of microbial burden to acceptable levels, often involving inoculation of devices with specific microorganisms and subsequent recovery and enumeration after cleaning and disinfection.
Visual inspection: Ensuring macroscopic cleanliness.

8. The sample size for the training set:

Not applicable. This section pertains to AI/ML models that require training data. For a hardware device with revised reprocessing instructions, there is no "training set" in this sense. The initial design and testing of the endoscope itself formed the basis for its predicate clearance. The current submission focuses on validating the reprocessing instructions.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "data" used for this submission is the reprocessing validation study data, as described in point 7.

Summary

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November 12, 2019

PENTAX of America, Inc. William Goeller Vice President. Quality and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782

K190799 Re: Trade/Device Name: PENTAX Medical Video Upper GI Scopes (EG Family) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS Dated: October 23, 2019 Received: October 24, 2019

Dear William Goeller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware 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. 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190799

Device Name

PENTAX Medical Video Upper GI Scopes (EG Family)

Indications for Use (Describe)

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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PENTAX Medical Video Upper G.I. (EG Family) Optimized IFU Traditional 510(k) Submission

510(k) Summary

SUBMITTER l.

PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340

Contact: William Goeller Date Prepared: March 14, 2019

II. DEVICE

The purpose of this 510(k) is to obtain clearance for revised reprocessing instructions which include optimized manual pre-cleaning instructions for the PENTAX Medical Video Upper GI Scopes (EG Family), its components, and its accessories. There are no other changes to the reprocessing instructions for use, nor are there any changes to the design, intended use, or indications for use of the EG Family of endoscopes.

Device Name	PENTAX Medical Video Upper GI Scopes (EG Family)
510(k) Number	K190799
Common Name	Gastroscope And Accessories, Flexible/Rigid
Classification Name	Endoscope and accessories
Regulation No.	21 CFR 876.1500
Device Class	2
Product Code	FDS
Classification Panel	Gastroenterology/ Urology

Table 5.1: Regulatory Classification of PENTAX Medical Video Upper GI Scopes.

III. PREDICATE DEVICES

The predicate device for this submission is also the subject of this submission, the PENTAX Medical Video Upper G.I. scopes (EG Family) (K131902). The predicate device is identical to the device subject to this 510(k); the only change relates to the manual pre-cleaning and cleaning portions of the reprocessing instructions to streamline the instructions and improve clarity. No changes are being made to the high-level disinfection or any other portion of the instructions for use.

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IV. REFERENCE DEVICES

The PENTAX Video Colonoscopes (EC Family) K181084 have recently obtained clearance for the similarly revised reprocessing instructions which include the optimized manual pre-cleaning and cleaning instructions for the PENTAX Medical Video Colonoscopes (EC Family), its components, and its accessories. Because of the similarities in design and reprocessing instructions between the cleared EC family (K181084) and the subject EG family of scopes, and the fact that EC master scopes as well as accessories apply to EG reprocessing validation process, the former will be used as the reference device for the EG family of scopes with revised reprocessing instructions. The rationale for the selection of master scopes is documented in the Reprocessing validation plan for 90i/90K/i10 series EG family (EX-062-0139).

V. DEVICE DESCRIPTION

PENTAX Video Upper G.I. scopes (EG Family)
EG-2990i	EG-1690K	EG-2790K	EG-3490K	EG27-i10
EG-2790i	EG-2490K	EG-2990K	EG-3890TK	EG29-i10

Table 5.2: Model Numbers Associated with the PENTAX Medical Video Upper GI Scopes

The PENTAX Medical Video Upper G.I. scopes (EG Family) are used with Video Processors. They are composed of three main components: 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, 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. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens.

The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity.

The GI Family of scopes also contains a Magnification Control Lever used to magnify the image on the video monitor, as necessary. As this magnification is performed electrically, focus and depth of field are not changed.

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PENTAX Medical Video Upper G.I. (EG Family) Optimized IFU Traditional 510(k) Submission

The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. 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. 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 PENTAX Medical Video Upper G.I. scopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.

VI. INDICATIONS FOR USE

There are no changes to the Indications for Use for the subject device. The sole purpose of this 510(k) is to modify the manual pre-cleaning and cleaning portions of the instructions to streamline them and improve clarity. No changes are being made to the high-level disinfection instructions.

VII. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE

The subject device is identical to the predicate device. The subject device has 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 fiberoptic illumination. There are no differences in specifications, including, but not limited to, the depth of field, distal end width, insertion tube width, instrument channel width, and total length. The sole difference between the subject and predicate device is that the reprocessing instructions have been modified. This modification does not impact the intended use and does not raise different questions of safety and effectiveness.

VIII. PERFORMANCE DATA

The optimization of the reprocessing instructions for the PENTAX Medical Video Upper GI scopes do not affect the biocompatibility, electromagnetic compatibility,

P E N T A X M e d i c a l C o n f i d e n t i d e n t i d e n t i a l

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PENTAX Medical Video Upper G.I. (EG Family) Optimized IFU Traditional 510(k) Submission

software verification and validation, or performance testing for the scopes.

Reprocessing validation data is provided to support the equivalence of the subject and predicate devices, including soil accumulation and cleaning efficiency studies.

VIII. CONCLUSION

The subject device is identical to the predicate device. The subject device has the same intended use and technological characteristics as the predicate device. There are no changes to the design of the subject device.

The data submitted support the optimization of reprocessing instructions for the PENTAX Medical Video Upper G.I. scopes demonstrate that the scopes 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.