(271 days)
The PENTAX Medical Video Upper GI Scope EG17-J10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems of esophagus, stomach and duodenum.
This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
The PENTAX Medical Video Upper GI Scope EG17-J10 is intended to be used with a PENTAX Video Processor, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum,
The EG17-J10 is 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 portion includes the distal end and bending section. The objective lens, light guide, instrument channel and air/water 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 cylinder, suction cylinder, remote button, 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 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 functions of the video processor and any external device from the control body, as necessary.
Endoscopic devices such as biopsy forceps are inserted from the instrument channel inlet into the body cavity through the instrument channel.
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.
The PENTAX Medical Video Processors EPK-i5010. EPK-i7010 and EPK-3000 are compatible with PENTAX Medical Video Upper GI Scope EG17-J10.
The PENTAX Medical Video Upper GI Scope EG17-J10 is provided with the following accessories:
- . Inlet Seal - prevents suctioned fluid from coming out of the Instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
- Bite Block prevents patients from biting the endoscope insertion tube during an ● endoscopic examination.
- Suction Control Valve - intended to control suction.
- Air/Water Valve intended to control air and water feeding. ●
Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O- Rings.
PENTAX Medical Scope Stand (General accessory)
The PENTAX Medical Scope Stand is consisted of the PENTAX Medical Scope Stand (SS-1) and the PENTAX Medical Single Use Scope Holder (SCH-G2). This scope stand allows physicians to transfer the weight of the endoscope during an endoscopic procedure, and is a general accessory that can be used with other PENTAX Medical Video GI Scopes.
This scope holder is designed to hold the endoscope control body at a swivel joint in a desired angle during an endoscopic procedure. The scope holder is disposable and sterilized for single use.
The provided text describes the regulatory clearance for the PENTAX Medical Video Upper GI Scope EG17-J10. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics of an AI-powered device.
Therefore, the following information cannot be fully extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are detailed in a tabular format for the device. The text broadly states that "All results show that the optical characteristics of the subject device is equivalent to those of the predicate device" and that reprocessing validation "All acceptance criteria were satisfied." However, the criteria themselves and the exact performance values are not given.
- Sample size used for the test set and the data provenance: The text mentions "bench testing and animal imaging study results" for optical performance and "simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD)" for reprocessing validation. However, specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are not provided for these tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of a ground truth established by experts for this type of device.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The device is an endoscope, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an endoscope, not an algorithm.
- The type of ground truth used: Not applicable in the context of an endoscope. The studies performed are engineering validations (reprocessing, biocompatibility, electrical safety, system performance, optical performance).
- The sample size for the training set: Not applicable as this is not an AI/ML device trained on data.
- How the ground truth for the training set was established: Not applicable.
Based on the provided text, here is what can be inferred about acceptance criteria (though not presented in a table with specific numbers) and the studies conducted:
The PENTAX Medical Video Upper GI Scope EG17-J10 underwent various studies to demonstrate substantial equivalence to its predicate device, the PENTAX Video Upper G.I. Scope EG-1690K (K131902). The studies focused on confirming its functions, performance, and safety according to FDA recognized consensus standards.
General Acceptance Criteria (Inferred from the text):
The overarching acceptance criterion is substantial equivalence to the predicate device in terms of safety and effectiveness, meaning the new device performs at least as well as the predicate and poses no new safety concerns.
Specific inferred acceptance criteria for various aspects include:
- Reprocessing: Effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance and AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
- Sterilization: Verification of ethylene oxide sterilization for the single-use scope holder.
- Biocompatibility: Local toxicity risk levels determined as "Acceptable" based on cytotoxicity, sensitization, and intracutaneous reactivity assessments.
- Software and Cybersecurity: Compliance with IEC 62304: 2006 + A1: 2015 and relevant FDA guidances.
- Electrical Safety and EMC: Compliance with IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.
- System Performance: Equivalence to the predicate device and demonstration of a six-year service life for the endoscope and five years for the scope stand.
- Optical Performance: Equivalence of optical characteristics (imaging and illumination) to the predicate device.
Study Summaries and Performance (as reported):
| Acceptance Criteria Category | Reported Device Performance / Study Finding |
|---|---|
| Reprocessing Validation | Simulated use testing, cleaning, high level disinfecting, and rinsing validation studies were conducted. All acceptance criteria (established per AAMI TIR 30:2011 for residual soil and extraction efficiency) were satisfied. |
| Sterilization & Shelf Life | EG17-J10: Not provided sterile; shelf-life not applicable. |
| PENTAX Medical Single Use Scope Holder (SCH-G2): Ethylene Oxide sterilization was conducted, and a shelf-life of 1 year after sterilization was verified. | |
| Biocompatibility | Direct and indirect contact materials were assessed for cytotoxicity, sensitization, and intracutaneous reactivity. The risk levels of local toxicity were determined as "Acceptable." |
| Software & Cybersecurity | Software verification and validation, including cybersecurity assessments, were conducted according to IEC 62304: 2006 + A1: 2015 and relevant FDA Guidances. |
| Electrical Safety & EMC | The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by compliance with IEC 60601-1-2:2014; IEC 60601-1; and IEC 60601-2-18:2009. |
| System Performance | The system performance demonstrated equivalence to the predicate device. Test results also demonstrated six years of service life for the EG17-J10 and five years for the Scope Stand SS-1. |
| Optical Performance | Optical properties of imaging and illumination performances were measured (in conjunction with various Video Processors). All results show that the optical characteristics of the subject device are equivalent to those of the predicate device. (This was also confirmed through bench testing and animal imaging study results mentioned earlier in the document regarding technological changes). |
§ 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.