(83 days)
EG Family: 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.
EC Family: 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.
The PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC 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 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. 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 Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function 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 and Colonoscopes 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 high-level disinfection or sterilization processes.
This document describes a 510(k) premarket notification for PENTAX Medical Video Upper GI Scopes (EG Family) and PENTAX Medical Video Colonoscopes (EC Family). The submission focuses on changes to reprocessing instructions, not the devices themselves.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria or performance metrics for the device itself in terms of diagnostic accuracy, sensitivity, specificity, or similar clinical performance measures. This 510(k) submission is for a modification to the reprocessing instructions for existing, already cleared devices (K131902 and K131855). Therefore, the "acceptance criteria" here relate to the reprocessing instructions being safe and effective.
The primary "performance" reported is related to human factors and the safety/effectiveness of the reprocessing process as modified.
Acceptance Criterion (Implicit for Reprocessing) Reported Performance (from Human Factors Study) Reprocessing instructions are effective A Summative Human Factors Study was conducted to validate the effectiveness and risk management measures for reprocessing. Reprocessing instructions are safe The study aimed to ensure reprocessing can be performed in a safe manner. Although use errors, close calls, and difficulties were observed, "it is estimated that the risks identified, and the root causes assigned to those risks can be reduced and/or mitigated via additional modifications of the rIFU design and the further refinement of the training materials." -
Sample Size Used for the Test Set and Data Provenance:
The document mentions a "Summative Human Factors Study." While the number of participants (test set size) is not explicitly stated, it refers to "the same group of stakeholders." The provenance of this data (e.g., country of origin) is not provided, but such studies are typically conducted with users representative of the intended clinical environment. The study is implicitly prospective, as human factor studies involve observing users interacting with the device/instructions.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable in the context of this 510(k) submission. The ground truth for a human factors study on reprocessing focuses on whether users can correctly and safely follow the instructions. This isn't a diagnostic accuracy study requiring expert adjudication of clinical findings. The "experts" involved would likely be human factors professionals and potentially subject matter experts in endoscope reprocessing, but their number and specific qualifications are not detailed.
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Adjudication Method for the Test Set:
This is not a clinical study involving diagnostic outputs requiring adjudication. In a human factors study, observations of user performance (following instructions, committing errors) are typically recorded and analyzed by human factors specialists. There is no mention of a traditional adjudication method (like 2+1, 3+1 consensus) for this type of test.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This submission is about reprocessing instructions, not a diagnostic AI device to be used by human readers for clinical diagnosis.
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Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
No, a standalone algorithm study was not done. This submission is for endoscopes and their reprocessing instructions, not an AI algorithm.
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Type of Ground Truth Used:
For the human factors study, the "ground truth" would be the correct and safe steps for reprocessing the endoscopes, as defined by the manufacturer's validated procedures. The performance of the participants is compared against these predetermined correct steps. It is not clinical ground truth derived from pathology or patient outcomes.
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Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning submission with training data.
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How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI algorithm.
§ 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.