(220 days)
PENTAX Medical Video Upper GI Scope EG27-i20c:
The PENTAX Medical Video Upper GI Scope EG27-i20c 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: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.
PENTAX Medical Video Colonoscope EC34-i20cL:
The PENTAX Medical Video Colonoscope EC34-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
PETNAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.
PENTAX Medical Video Colonoscope EC34-i20cL
The PENTAX Medical Video Colonoscope EC34-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract.
The provided document describes the clearance of two PENTAX Medical Video Scopes, the Upper GI Scope (EG27-i20c) and the Colonoscope (EC34-i20cL), and does not contain acceptance criteria for specific device performance metrics in the format of a table with reported performance. The document focuses on showing substantial equivalence to predicate devices through various non-clinical performance data categories.
Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance".
However, I can extract information related to the studies conducted to support the substantial equivalence:
Non-Clinical Performance Data / Studies Conducted:
The document mentions several non-clinical performance tests but does not define specific acceptance criteria or report numerical performance results against those criteria. Instead, it generally states that "All acceptance criteria were satisfied" or that the devices demonstrated equivalence.
Here's a breakdown of the studies mentioned and related information:
- Sample size used for the test set and the data provenance: Not specified for any of the tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified for any of the tests. The document does not mention the use of experts to establish ground truth for testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The document primarily focuses on technical and safety equivalence.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The devices are endoscopes, which are human-in-the-loop devices. The document does not describe any standalone algorithm performance testing.
- The type of ground truth used: Not explicitly stated for any test. For the "Animal Image Capture Study," it compares "visualizations of vascularity and mucosal surfaces" to predicate devices, implying a qualitative assessment.
- The sample size for the training set: Not applicable, as these are hardware medical devices (endoscopes) and not AI/machine learning algorithms that require training sets in the typical sense.
- How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
Detailed Information from the Document Regarding Studies:
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Reprocessing Validation:
- Study: Simulated use testing, cleaning, high-level disinfecting, and rinsing validation studies for EG27-i20c and EC34-i20cL.
- Purpose: Confirmed effectiveness of reprocessing procedures.
- Acceptance Criteria: Established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency.
- Results: "All acceptance criteria were satisfied."
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Sterilization and Shelf Life:
- Study: Validation of System 1E liquid chemical sterilization with STERIS Corporation.
- Purpose: Confirmed suitable sterilization method.
- Results: Devices are not provided sterile, shelf-life not applicable.
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Biocompatibility:
- Study: Assessment of cytotoxicity, sensitization, and intracutaneous reactivity for direct and indirect contact materials.
- Standard: In accordance with ISO 10993-1:2018.
- Results: Risk levels of local toxicity determined as "Acceptable."
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Software and Cybersecurity:
- Study: Software verification and validation, including cybersecurity assessments.
- Standards/Guidance: IEC 62304:2006 + A1:2015 and FDA Guidance for Industry and Staff.
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Electrical Safety and EMC:
- Study: Testing to confirm acceptable levels of electrical safety (ES) and electromagnetic compatibility (EMC).
- Standards: IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601-2-18:2009.
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System Performance:
- Results: "The system performance of the subject device demonstrated the equivalence to the predicate/reference devices."
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Optical Performance:
- Study: Measurement of optical properties of imaging and illumination performances.
- Results: "All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices."
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Animal Image Capture Study:
- Study: Used as part of optical and color performance testing.
- Purpose: To demonstrate visualization capabilities.
- Results: "The findings demonstrate that the subject devices provide visualizations of vascularity and mucosal surfaces for each anatomical area comparable to those achieved by the predicate devices."
In summary, the document provides evidence of various non-clinical performance studies demonstrating that the new PENTAX Medical Video Scopes meet established safety and performance standards and are substantially equivalent to predicate devices. However, it does not present this information in the specific structured format requested for acceptance criteria and reported numerical performance values.
§ 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.