(52 days)
The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.
The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit contains items for obtaining and handling of cytologic and histological specimens in the context of a transbronchial aspirating needle procedure.
This submission describes a kit composed of several components, not a single device with a specific performance. The regulatory review (510(k)) found the kit substantially equivalent to legally marketed predicate devices because all its components were either already cleared, exempt from notification, or had undergone their own 510(k) process. This means the individual components were likely evaluated for their individual performance and safety, but there isn't a single study describing the overall performance of the kit in terms of specific acceptance criteria.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC study, standalone performance) are not applicable to this particular 510(k) submission, as it focuses on the equivalence of a combination of components.
Here's an attempt to answer the questions based on the provided document, noting where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
Based on the provided K983122 510(k) summary, there are no specific performance acceptance criteria or reported device performance metrics for the overall kit as a single device. The submission focuses on the substantial equivalence of its individual components to already legally marketed devices. The "performance" in this context refers to the intended function of each component, which is assumed to be met based on their prior clearances or exempt status.
| Acceptance Criteria (Not Explicitly Stated for the Kit) | Reported Device Performance (Kit Equivalence) |
|---|---|
| (Implicit for individual components: e.g., sterility, material compatibility, functional integrity) | The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. This is based on the individual components' existing 510(k) clearances, exemptions, or pre-amendment status. |
| (Implicit for kit: safe and effective retrieval and handling of specimens for cytopathic and histological examination) | The technological characteristics of the kit components do not vary from those of the components when used individually and not in the context of the kit, implying expected performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) is about substantial equivalence of a medical device kit composed of pre-existing components. There is no specific test set or clinical study described in this document for the kit itself. The performance and safety of the individual components would have been established in their respective original clearances or through their general purpose exemption status.
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 applicable. As there is no specific test set or clinical study for the kit's performance, there's no mention of experts establishing a ground truth for such a study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set is described for the kit's performance.
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 applicable. This submission is for a medical device kit for specimen collection and preparation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a medical device kit, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no explicit mention of a ground truth being established for the kit's performance in this document. The "ground truth" for each component implicitly relates to their established safety and efficacy for their individual intended uses, as determined during their original regulatory pathways.
8. The sample size for the training set
Not applicable. This submission does not involve a training set for an algorithm or model.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this submission.
§ 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.