(84 days)
The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.
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This document is a 510(k) clearance letter from the FDA for a medical device: a Suction Catheter Kit. This type of letter generally does not contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria. The 510(k) process primarily demonstrates "substantial equivalence" to a predicate device, focusing on similar intended use and technological characteristics, rather than extensive clinical efficacy studies in many cases, especially for Class I devices like this one.
Therefore, most of the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is typically not found in a 510(k) clearance letter for a Class I device.
Here's what can be inferred or explicitly stated from the provided text, and what cannot:
What can be inferred or explicitly stated:
- Device Name: Suction Catheter Kit
- Intended Use: "for the physician to aspirate liquids or semi-solids from a patient's upper airway."
- Regulatory Class: I (one)
- Product Code: 73 BSY
- Device Manufacturer: Ni-Med, Inc.
Information NOT available in this document and therefore cannot be provided:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria (e.g., flow rate, suction pressure, material integrity over time) or the results of tests against such criteria. The FDA review focuses on substantial equivalence to a predicate, not necessarily detailed performance metrics for this specific device.
- Sample size used for the test set and the data provenance: No information about a "test set" in the context of clinical studies is provided. The 510(k) submission would have included technical specifications and comparisons to a predicate device, but not detailed study design for a performance test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described in this regulatory letter.
- Adjudication method: 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: This device is a physical medical device (suction catheter), not an AI-driven diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are entirely irrelevant and not performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as detailed performance studies with a "ground truth" are not described. The "ground truth" for a Class I device in a 510(k) context is often compliance with established standards, biocompatibility, and manufacturing quality, rather than clinical efficacy against a "ground truth" outcome.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory clearance for marketing, not a scientific publication detailing performance studies. For a Class I device like a suction catheter, the "study" proving it meets acceptance criteria typically refers to engineering tests, material compatibility tests, and comparison to a legally marketed predicate device, rather than extensive clinical trials or AI performance evaluations.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.