(289 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 Video Upper G.I. scopes (EG Family), Model Numbers: EG-2990i, EG-2790i, EG-1690K. EG-2490K. EG-2790K. EG-2990K. EG-3490K. EG-3890TK, EG27-i10. EG29-i10 are used with a Video Processor.
The PENTAX Video Upper G.I. scopes (EG Family) are 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 Control Button, Magnification Control Lever, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction 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 angulation. 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 Air/Water 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 Remote Button is used to operate the function of video processor and external device from the control body, as necessary.
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 do not change.
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.
This document describes a 510(k) premarket notification for the PENTAX Video Upper G.I. Scopes (EG Family). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of AI/ML or clinical efficacy.
Therefore, many of the requested elements pertaining to acceptance criteria and performance studies for AI/ML devices or new clinical functionalities are not present in this regulatory filing. The document primarily details non-clinical tests performed to ensure fundamental safety and performance.
Here's a breakdown of the information available based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics for clinical efficacy. Instead, it states that the "EG Family Master Device (EG-2990i) test results satisfy the acceptance criteria specified by the above applicable standards." The applicable standards listed are for aspects like electrical safety, electromagnetic compatibility, biocompatibility, reprocessing, and general requirements for medical electrical equipment and endoscopes.
| Acceptance Criterion (Category) | Reported Device Performance (Summary) |
|---|---|
| Non-clinical Tests | Performance of the EG Family Master Device (EG-2990i) evaluated using methodologies specified in FDA recognized consensus standards: |
- IEC 60601-1 (Basic Safety & Essential Performance)
- IEC 60601-1-1 (Safety for Medical Electrical Systems)
- IEC 60601-1-2 (EMC)
- ISO 10993-1, -5, -10 (Biological Evaluation: Cytotoxicity, Irritation, Sensitization)
- IEC 60601-2-18 (Endoscopic Equipment Specific Requirements)
- ISO 8600-1, -3, -4 (Optics & Photonics, Field of View, Direction of View, Max Width of Insertion Portion)
- AAMI TIR12, TIR30 (Designing, Testing, Labeling Reusable Medical Devices for Reprocessing)
- ANSI/AAMI TIR79 (Steam Sterilization & Sterility Assurance)
- ISO 13485 (Quality Management Systems)
- ISO 14971 (Risk Management)
- IEC 60601-1-4 (Programmable Medical Systems)
- IEC 60601-1-6 (Usability)
- IEC 62366 (Usability Engineering)
- IEC 62304 (Medical Device Software)
- IEC 60417/ISO 7000-DB-12M (Graphical Symbols)
- ISO 15223-1 (Symbols for Labels)
- IEC 60878 (Graphical Symbols for Electrical Equipment) |
| Biocompatibility | Confirmed by testing Cytotoxicity, Sensitization, and Intracutaneous Reactivity in accordance with ISO 10993-1, 5, and 10 and FDA's guidance for surface device, mucosal membrane contact less than 24 hours. |
| Reprocessing Validation | Validated cleaning and high-level disinfection for reusable devices using simulated use conditioned test samples, following FDA's Draft Guidance (May 2, 2011), AAMI TIR 12:2010, AAMI TIR 30:2011, and AAMI TIR79:2010. All study results satisfied specified acceptance criteria. Reprocessing Instructions (Manual) also validated for completeness, understandability, and executability by the user. |
| EMC and Electrical Safety | Acceptable level confirmed by testing in accordance with IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; and IEC 60601-2-18 standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to a traditional medical device (endoscope) and does not describe clinical studies with "test sets" in the context of evaluating an AI/ML algorithm's performance on a dataset of patient data. The "test results" refer to engineering and bench testing against recognized standards. Therefore, information about sample size for a test set and data provenance in the way it's requested for AI/ML is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring expert-established ground truth from medical image interpretation for performance evaluation. The "ground truth" for this device would relate to engineering specifications and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically employed in studies where human experts provide interpretations that need to be reconciled to establish a consensus ground truth, which is not the type of study described here.
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
No such MRMC study was done or reported. This document is for an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm-only device. It is a physical medical instrument. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is compliance with established engineering standards, safety regulations, and performance specifications for endoscopes (e.g., optical properties, mechanical integrity, electrical safety, biocompatibility, reprocessing effectiveness). This is verified through various physical and chemical tests, rather than clinical ground truth like pathology or expert consensus on medical images.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
§ 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.