(154 days)
The Single-use Flexible Bronchoscope has been designed to be used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. Single-use Sampler is designed as an add-on for use during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedures which enable aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Video Bronchoscope System is for use in professional Healthcare Facility Environment.
The Video Bronchoscope System consists of Single-use Flexible Bronchoscope, Single-use sampler and digital video monitor. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The video monitor receives the real-time image signal from Bronchoscope and displays the live image. During the bronchoscope sputum aspiration and collection, the fluid in the patient's body can be sucked out by pressing the suction button on the bronchoscope. The sampler control switch can collect liquid into the sampler.
The provided text is a Premarket Notification 510(k) Submission for the Hunan Vathin Medical Instrument Co. Ltd.'s Video Bronchoscope System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain specific acceptance criteria, reported device performance metrics in a tabular format, details about a clinical study (sample size, data provenance, expert qualifications, adjudication methods), information on multi-reader multi-case (MRMC) studies, standalone algorithm performance, or details about training set ground truth.
The submission focuses on non-clinical tests to demonstrate safety and performance. Here's a summary of the information that is available based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. The document lists the performance tests conducted but does not provide specific numerical acceptance criteria or the measured performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The document details non-clinical tests (biocompatibility, sterilization, electrical safety, software verification, performance testing) but does not describe a clinical test set with human subjects or data provenance.
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)
- Not provided in the document. This information would typically be relevant for a clinical study involving interpretation of images or data, which is not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document. This is relevant for clinical studies with expert reviewers, which are not described.
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
- Not mentioned in the document. The device is a physical bronchoscope system; there is no indication of it incorporating AI or being subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned in the document. The device is a bronchoscope system, not an AI algorithm. While it has software, standalone algorithm performance is not a focus here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the document. For non-clinical tests, "ground truth" often refers to engineering specifications or validated test methods. The document states that "All evaluation acceptance criteria were met" for biocompatibility and that electrical safety and EMC tests comply with relevant IEC standards. Performance tests were conducted based on engineering specifications.
8. The sample size for the training set
- Not applicable/Not mentioned in the document. This device is hardware with integrated software, not a machine learning model that requires a "training set" in the typical sense. Software verification and validation were conducted.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned in the document. See point 8.
Summary of Conducted Studies (from the document):
The document primarily describes non-clinical tests to demonstrate the safety and effectiveness of the Video Bronchoscope System, ensuring its substantial equivalence to predicate devices. These tests include:
- Biocompatibility testing: Evaluated according to ISO 10993-1:2018 for "Surface – Mucosal Membrane" body contact for "Limited (
§ 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.