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K Number
K972459
Device Name
RHINOCELL NASAL PACKINGS
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1997-08-04

(34 days)

Product Code
EMX
Regulation Number
874.4100
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a nasal packing to treat epistaxis.

Device Description

RHINOCELL™ Nasal Packings are constructed of polyvinyl alcohol (PVA) sponge using a patented formula. The packings will expand as fluid is introduced, giving the surgeon time for accurate positioning. There is a variety of RHINOCELL™ shapes and sizes to choose from, both with and without integral airways. All RHINOCELL™ packings are sold sterile, ready to use.

AI/ML Overview

The provided text is a 510(k) summary for the RHINOCELL™ Nasal Packings device and a corresponding FDA letter. This document does not describe any acceptance criteria or a study proving the device meets said criteria in the way you've outlined for performance of a diagnostic or AI-based device.

Instead, this is a premarket notification for a medical device (a nasal packing). The "testing" mentioned is a general statement about its construction from "well-established polyvinyl alcohol (PVA) sponge," which implies prior knowledge of the material's properties, not a specific performance study against defined acceptance criteria for the final device. The FDA's review focuses on "substantial equivalence" to predicate devices, not on a detailed analysis of performance metrics.

Therefore, I cannot extract the information requested as it is not present in the provided text.

Here's why each point cannot be fulfilled based on the given information:

  1. A table of acceptance criteria and the reported device performance: Not provided. The document describes the device and its indication for use, but not specific performance metrics or acceptance criteria for those metrics.
  2. Sample sized used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test or ground truth mentioned.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device involving human readers or AI.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is a physical medical device.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: No training set is mentioned.
  9. How the ground truth for the training set was established: Not applicable.

The document indicates that the device's approval is based on its substantial equivalence to predicate devices (Product Nos. Q600314 - Q603113 manufactured by M-Pact) and its construction from a "well-established polyvinyl alcohol (PVA) sponge." This is a regulatory pathway for approving devices that are similar to already legally marketed devices, rather than requiring extensive de novo performance studies with acceptance criteria as one might see for novel diagnostic or AI technologies.

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.