(292 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 lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38i10L are used with a Video Processor. The EC-3890TLK 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 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 Button, Suction Selector Cylinder, and Instrument Channel Inlet. The AirMater Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector 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 anqulation. 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 AirMater 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 EC-3890TLK has two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PENTAX Video Colonoscopes (EC Family):
This document describes the safety and performance testing for a traditional medical device (colonoscope), not an AI/ML-enabled device. Therefore, many of the requested fields pertinent to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not applicable or explicitly mentioned in the provided text.
The acceptance criteria are primarily related to general safety and performance standards for endoscopes and medical electrical equipment.
Acceptance Criteria and Device Performance for PENTAX Video Colonoscopes (EC Family)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Design Control | 21 CFR Part 820.30 (Design Verification and Validation testing) | "Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the PENTAX Video Colonoscopes (EC Family) were evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our in-house test protocols and use of external testing laboratories." |
| Basic Safety & Essential Performance | IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for basic safety and essential performance) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| Safety - Medical Electrical Systems | IEC 60601-1-1:2000 (Safety requirements for medical electrical systems) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2001+A1:2004 (Electromagnetic compatibility - Requirements and tests) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the IEC 60601-1-2..." | ||
| Biocompatibility | ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process) | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | ||
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | ||
| FDA's guidance 'Use of International Standard ISO-10993, Part 1' | "Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1, 5, and 10 Biological evaluation of medical devices standard and the FDA's guidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." | |
| Reprocessing Validation | FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2, 2011) | |
| AAMITIR12:2010 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities) | ||
| AAMITIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) | ||
| ANSI/AAMI TIR79:2010 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) | "Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Colonoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance... AAMI TIR 12:2010... AAMI TIR 30:2011... and AAMI TIR79:2010..." | |
| "All the study results satisfy the acceptance criteria specified by the above applicable standards." | ||
| "The validation confirmed that the PENTAX Video Colonoscopes (EC Family)... Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user." | ||
| Endoscopic Equipment Specific | IEC 60601-2-18:1996+A1:2000 (Particular requirements for the basic safety and essential performance of endoscopic equipment) | |
| ISO 8600-1:2005 (Optics and photonics Medical endoscopes and endotherapy devices - Part 1: General requirements) | ||
| ISO 8600-3:1997+A1:2003 (Determination of field of view and direction of view of endoscopes with optics) | ||
| ISO 8600-4:1997 (Determination of maximum width of insertion portion) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." | |
| "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the... IEC 60601-2-18..." | ||
| Quality Management Systems | ISO13485:2003 (Medical devices Quality management systems Requirements for regulatory purposes) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| Risk Management | ISO 14971:2007 (corrected version) (Medical devices -Application of risk management to medical devices) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| Programmable Electrical Medical Systems | IEC 60601-1-4:2000 Ed. 1.1 (General requirements for safety- Collateral Standard: Programmable electrical medical systems) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the... IEC 60601-1-4..." | ||
| Usability | IEC 60601-1-6:2010 (General requirements for basic safety and essential performance - Collateral standard: Usability) | |
| IEC 62366:2007 (Medical devices -Application of usability engineering to medical devices) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." | |
| Software Life Cycle Processes | IEC 62304:2006 (Medical device software- Software life cycle processes) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." |
| Graphical Symbols | IEC 60417ISO 7000-DB-12M:2004 (Graphical symbols for use on equipment) | |
| ISO 15223-1:2012 (Medical devices Symbols to be used with medical device labels, labeling and information) | ||
| IEC 60878:2003 (Graphical symbols for electrical equipment in medical practice) | "Master Device (EC-3890TLK) test results satisfy the acceptance criteria specified by the above applicable standards." | |
| Electrical Safety | IEC 60601-1 (General requirements for basic safety and essential performance) | "The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Video Colonoscopes (EC Family)... were confirmed by testing in accordance with the IEC 60601-1-2; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Safety requirements for medical electrical systems, Electromagnetic compatibility - Requirements and tests; and IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment." |
Regarding AI/ML-Specific Information:
The provided text details the submission for PENTAX Video Colonoscopes (EC Family), which are traditional endoscopy devices. The safety and performance data presented are for the physical device itself (electrical safety, biocompatibility, reprocessing, etc.) as per various international standards. There is no mention of artificial intelligence (AI) or machine learning (ML) within this document. Therefore, the following AI/ML-specific points cannot be addressed from the given text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device submission, not an AI/ML algorithm. Testing was on the physical device and its components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for AI/ML is usually related to disease presence/absence or other assessments by human experts. For this device, "ground truth" refers to compliance with engineering and biological standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as there is no AI component.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or acceptance criteria are defined by recognized consensus standards (e.g., IEC, ISO, AAMI) regarding safety, performance, and functionality.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study for PENTAX Video Colonoscopes (EC Family):
The study was a comprehensive non-clinical design verification and validation testing program focused on ensuring the device meets established safety and performance standards for endoscopes. The testing confirmed:
- Design Compliance: Adherence to 21 CFR Part 820.30 (Design Control).
- Safety (Electrical & Mechanical): Compliance with IEC 60601 series for basic safety, essential performance, and specific requirements for endoscopic equipment (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-4).
- Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.
- Biocompatibility: Confirmation that materials are safe for patient contact, tested according to ISO 10993 series for cytotoxicity, sensitization, and intracutaneous reactivity.
- Reprocessing Validation: Validation of cleaning and high-level disinfection procedures through simulated use conditioned test samples, adhering to FDA draft guidance and AAMI TIR standards to ensure the device can be effectively reprocessed for reuse. User comprehensibility of reprocessing instructions was also validated.
- Usability: Compliance with IEC 60601-1-6 and IEC 62366.
- Software Life Cycle: Compliance with IEC 62304 (if applicable to the device's embedded software).
- Optical Characteristics: Compliance with ISO 8600 series for field of view, direction of view, and insertion portion dimensions.
- Quality Management and Risk Management: Compliance with ISO 13485 and ISO 14971.
- Labeling and Symbols: Compliance with relevant IEC and ISO standards for graphical symbols.
The "Master Device (EC-3890TLK)" was used for testing, and its results were stated to satisfy the acceptance criteria of all applicable standards, indicating the entire EC Family is substantially equivalent and safe/effective.
§ 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.