(253 days)
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.
The PENTAX Medical Video Upper GI Scope EG34-i10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. The PENTAX Medical Video Upper GI Scope EG34-i10 is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727).
The PENTAX Medical Video Upper GI Scope EG34-i10 is composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Distal End of the Insertion Portion includes the Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle.
The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. The Air/Water Feeding Valve is attached to the Air/Water Cylinder. 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. A Water Jet System is used to stream forward the sterile water from the Water Jet Nozzle.
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 Control Button, and Instrument Channel Inlet. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.
The Inlet Seal is attached to the 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 PENTAX Medical Video Upper Gl Scope EG34-i10 is a reusable semi-critical device. Since it is packaged non-sterile, it must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, it must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.
This FDA 510(k) summary describes the PENTAX Medical Video Upper GI Scope EG34-i10, a reusable semi-critical device intended for endoscopy and endoscopic surgery within the upper digestive tract. The submission primarily focuses on demonstrating substantial equivalence to its predicate device, the PENTAX Video Upper GI Scopes EG29-i10 (K131902), by showing that minor differences in dimensional specifications and materials do not adversely impact safety or effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/software-based medical devices with specific performance metrics like sensitivity, specificity, or AUC. Instead, it details various engineering and performance tests conducted to establish substantial equivalence. The "acceptance criteria" are implied by the successful completion and "passing results" of these engineering tests, confirming that the device meets relevant standards and performs comparably to the predicate.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation: | All acceptance criteria must be satisfied for each test. | All acceptance criteria were satisfied for: |
| - Soil Accumulation Study | (e.g., demonstrably low soil retention) | Performed with passing results. |
| - Cleaning Efficacy Study | (e.g., effective removal of soil/microorganisms) | Performed with passing results. |
| - HLD Efficacy Study | (e.g., effective high-level disinfection) | Performed with passing results. |
| - Rinsing Validation | (e.g., effective removal of disinfectants) | Performed with passing results. |
| - Sterilization Validation | (e.g., effective sterilization where applicable) | Performed with passing results. |
| Biocompatibility | Compliance with ISO 10993-1. | Conducted with passing results. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-18, ANSI/AAMI ES60601-1. | Complies with all listed standards. |
| EMC | Compliance with IEC 60601-1-2 / EN 60601-1-2. | Complies with listed standard. |
| Software V&V | Software is identical to the predicate device. | Utilizes the same software as the predicate device. |
| Optical Testing: | ||
| - Light Distribution | Comparable to predicate device. | Comparable to predicate device (EG29-i10). |
| - Spectral Distribution | Comparable to predicate device. | Comparable to predicate device (EG29-i10). |
| - Total Luminous Flux | Comparable to predicate device. | Comparable to predicate device (EG29-i10). |
| - Photobiological Safety (IEC 62471) | Risk group 2 or lower; safety equivalent to predicate. | All subject/predicate combinations are risk group 2 or lower and considered equivalent. |
| Usability Testing | No difference in operations; usability equivalent to predicate. | No difference in all operations, usability is equivalent. |
2. Sample size used for the test set and the data provenance
The document describes device performance testing and validation, not a study with a traditional "test set" of clinical data for a diagnostic algorithm. The tests conducted (reprocessing, biocompatibility, electrical safety, EMC, optical, usability) involve physical samples of the device and its components, or measurements under controlled lab conditions.
- Sample Size: Not specified in terms of number of devices or units used for each test, but it is implied that a sufficient number was tested to demonstrate compliance and comparability. These are engineering tests, not statistical clinical trials with patient populations.
- Data Provenance: The data comes from internal testing conducted by PENTAX Medical, as implied by the "PENTAX Medical completed optical testing" and "Testing revealed..." statements. These are laboratory-based, prospective engineering tests rather than retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML algorithm requiring expert ground truth or adjudication for diagnostic performance. Its validation is based on engineering standards and comparisons to a physical predicate device.
4. Adjudication method for the test set
Not applicable. As this is not a study requiring expert clinical adjudication for diagnostic outcomes, no such method was employed.
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 device is an endoscope, a hardware instrument, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve a standalone algorithm for performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical diagnostic ground truth. The "ground truth" for the engineering tests would be defined by the specifications, standards (e.g., IEC, ISO), and the performance characteristics of the predicate device. For example:
- For reprocessing: Standardized microbiological assays or chemical residue tests demonstrating inactivation/removal targets.
- For optical testing: Direct measurement of light properties and comparison to predicate's measured values, and adherence to photobiological safety standards.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
§ 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.