(363 days)
The PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The PENTAX Video Bronchoscopes (EB Family); Model Numbers: EB-1970TK, EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1975K, EB-1990i are used with a Video Processor. The PENTAX Video Bronchoscopes (EB 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 Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel 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 lever, Suction Cylinder, Suction nipple, Remote Button, and Instrument Channel Inlet. The Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Bending Section is bent by the Angulation Control lever to operate the endoscope angulation. 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. Endotherapy Device such as Biopsy Forceps is 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 PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. 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 quides the light Guide Plug which is connected to the Light Source. 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 Video Bronchoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
The provided text is a 510(k) summary for PENTAX Video Bronchoscopes (EB Family). It describes the device, its intended use, and indicates that safety and performance data (non-clinical tests) have been conducted. However, it does not contain information about a clinical study involving AI or human readers, acceptance criteria related to such a study, or reported performance against clinical metrics.
Instead, the document focuses on compliance with established medical device standards and non-clinical testing.
Here's a breakdown of what can be extracted based on the request, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists several international and industry standards that the device's test results satisfy. These standards serve as the "acceptance criteria" for various aspects of the device's non-clinical performance. The "reported device performance" is generally stated as meeting these criteria.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 60601-1-1:2000 requirements for safety- Collateral standard: Safety requirements for medical electrical systems | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Biocompatibility confirmed (Cytotoxicity, Sensitization, Intracutaneous Reactivity). |
| ISO 10993-10:2010 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization | Biocompatibility confirmed (Cytotoxicity, Sensitization, Intracutaneous Reactivity). |
| 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 | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 8600-1:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 8600-3:1997+A1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion | Test results satisfy acceptance criteria specified by the applicable standard. |
| AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers | All study results satisfy acceptance criteria specified by the applicable standards (for Reprocessing). |
| AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices | All study results satisfy acceptance criteria specified by the applicable standards (for Reprocessing). |
| ANSI/AAMI TIR79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities | All study results satisfy acceptance criteria specified by the applicable standards (for Reprocessing). |
| ISO13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 14971:2007 (corrected version): Medical devices -Application of risk management to medical devices | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 60601-1-4:2000 Ed. 1.1 Medical electrical equipment- Part 1-4: General requirements for safety- Collateral Standard: Programmable electrical medical systems | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 62366:2007 Medical devices -Application of usability engineering to medical devices | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 62304:2006 Medical device software- Software life cycle processes | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment-12-month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000 | Test results satisfy acceptance criteria specified by the applicable standard. |
| ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements | Test results satisfy acceptance criteria specified by the applicable standard. |
| IEC 60878:2003 Graphical symbols for electrical equipment in medical practice | Test results satisfy acceptance criteria specified by the applicable standard. |
| FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: ' Validation Methods and Labeling (May 2, 2011) | Cleaning and High-Level Disinfection validation studies satisfy acceptance criteria. Reprocessing Instructions (Manual) validated as complete, understandable, and executable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Design Verification and Validation testing" and "simulated use conditioned test samples" for reprocessing, but does not specify sample sizes or data provenance in the context of clinical or AI-based testing. This document describes non-clinical testing.
3. 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)
This information is not provided in the document. No expert review for establishing ground truth is mentioned, as the studies are non-clinical and focus on adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is described, consistent with the non-clinical nature of the tests.
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
The document does not mention or describe any MRMC comparative effectiveness study, nor does it refer to AI or human reader assistance. The device in question is a video bronchoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the document describes a physical medical device (video bronchoscope), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is typically defined by technical specifications, established performance criteria within the referenced standards, and objective measurements according to the test protocols. For example, for biocompatibility, the ground truth is the chemical and biological response observed in controlled in vitro and in vivo tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity). For reprocessing, the ground truth is the reduction of microbial load or absence of residue to predetermined levels.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.