(198 days)
The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
The Bronchoscope System comprises two components: (1) a Portable Video Processor (model: EA101) and (2) a compatible Flexible Bronchoscope (model: BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US).
The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor.
The Flexible Bronchoscope has following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- CMOS Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single use
Portable Video Processor has following physical and performance characteristics: - Displays the image from the Flexible Bronchoscope on the built-in screen.
- Can be connected to an external monitor.
- Non-sterile Reusable device.
The provided 510(k) clearance letter and summary for K243497 indicate that the device in question is a Flexible Bronchoscope System. This submission appears to be a change to an already cleared flexible bronchoscope (K211169) to make it compatible with a new Portable Video Processor (EA101).
Crucially, there is no mention of any AI or machine learning component in the device description, indications for use, or the non-clinical and/or clinical tests summary. The document describes standard performance testing for medical devices, focusing on electrical safety, EMC, photobiological safety, optical performance, biocompatibility, sterilization, shelf life, and package validation. Software verification and validation are mentioned in the context of IEC 62304, which covers medical device software lifecycle processes, but this does not imply AI.
Therefore, many of the questions related to AI-specific acceptance criteria, study methodologies (like MRMC studies, standalone AI performance), ground truth establishment for AI training/testing sets, and expert involvement for AI adjudication are not applicable to the information provided in this document.
The document does provide information relevant to the overall device's performance validation, which can be presented as acceptance criteria and proof for a non-AI medical device.
Non-AI Device Acceptance Criteria and Study Proof
Since the device described is not an AI/ML device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of regulatory clearance for a traditional medical device rather than for AI performance. The studies performed are primarily bench testing and phantom/component level evaluations to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards and demonstration of equivalent performance to a predicate device. The "reported device performance" is the evidence presented to show this compliance.
| Acceptance Criterion | Reported Device Performance (Summary from K243497) |
|---|---|
| Electrical Safety | In compliance with ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
| Electromagnetic Compatibility (EMC) | In compliance with ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021] and IEC 60601-2-18 Edition 3.0 2009-08, IEC/TR 60601-4-2 Edition 1.0 2016-05 |
| Photobiological Safety | Tested according to IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems. |
| Optical Performance | Designed to comply with applicable parts of ISO 8600. Optical measurements performed according to applicable parts of ISO 8600 standard. Comparative testing performed for image quality parameters (direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Distortion, Image intensity uniformity) against predicate device. |
| Biocompatibility | Performed according to ISO 10993-1 and FDA Guidance. Tests conducted: Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity. |
| Sterilization Efficacy | Validated to ISO 11135:2014. EO/ECH residual test per ISO 10993-7:2008. |
| Shelf Life | Determined based on stability study including accelerated aging per ASTM F1980-21. |
| Package Integrity | Validated per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15. Transport and shipping testing per ASTM D4169-22. |
| Software Verification & Validation | Conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". |
| Equivalence to Predicate Device (Flexible Bronchoscope) | Flexible Bronchoscopes are the same as cleared in K211169, with changes related to compatibility with new video processor and package configuration. Other performance data from K211169 is applicable. |
| Equivalence to Predicate Device (Portable Video Processor) | Demonstrated through comparison of technological characteristics and performance testing to show substantial equivalence. Key differences (IV pole mount, built-in screen, battery power, no USB) were addressed. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes: Not explicitly stated as "sample sizes" in the manner of a clinical trial. For bench testing (electrical safety, EMC, optical, biocompatibility, sterilization, shelf life, packaging), samples of the device and/or its components were tested to meet specific standard requirements. For example, biocompatibility involves testing material extracts, and sterilization validation involves processing batches of devices. The exact number of units tested for each specific bench test is not detailed in this summary.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given the applicant is in Shanghai, China, it is highly likely the testing was conducted in China. These were non-clinical bench tests, not clinical studies collecting patient data, so "retrospective or prospective" doesn't directly apply in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable in the context of AI/ML ground truth. For traditional device validation, "ground truth" is established by the specifications in recognized consensus standards (e.g., ISO, ASTM, IEC) and the performance characteristics of the predicate device. Expert involvement would be in the form of engineers, test technicians, and quality assurance personnel who perform and verify the tests according to established protocols and standards. Their qualifications are inherent in their professional roles, but not quantified as "number of experts" for ground truth establishment as would be done for clinical image annotation.
4. Adjudication Method for the Test Set
- Not applicable in the context of AI/ML adjudication. For traditional device testing, the "adjudication" is compliance with objective, measurable parameters defined by standards. Test results either meet the specified limits/criteria or they do not. QA processes would review and approve test reports, but there isn't a human "adjudication" process in the way it's used for clinical data interpretation differences.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/ML device. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved and needs to be evaluated for improvement with or without AI assistance. This device is a bronchoscope system for visualization and intervention, not for diagnostic image interpretation by humans that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- No. This is not an AI/ML device. Standalone performance is relevant for AI algorithms. The performance of this device is assessed through its physical, electrical, and optical properties as a medical instrument.
7. The Type of Ground Truth Used
- For this traditional medical device, "ground truth" equates to compliance with recognized industry standards and the specifications / validated performance of the predicate device. For example:
- Electrical Safety: Ground truth is defined by the limits and test methods of IEC 60601-1.
- Biocompatibility: Ground truth is established by the accepted biological responses defined in ISO 10993 series.
- Optical Performance: Ground truth is established by the parameters defined in ISO 8600 and comparative measurements against the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML model or training set, this question is not relevant.
§ 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.