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K Number
K973273
Device Name
XOMED T-STENT, FRONTAL SINUS STENT
Manufacturer
XOMED, INC.
Date Cleared
1997-09-29

(27 days)

Product Code
KAM
Regulation Number
878.4800
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The selfretaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs. Indications: Any sinus surgery requiring the placement of a drainage stent for the frontal sinus.

Device Description

The T-Stent is a one-piece radiopaque C-Flex thermoplastic elastomer drainage tube with T-shaped flanges at the proximal end for positioning and retention in the prepared sinus cavity.

AI/ML Overview

This 510(k) premarket notification (K973273) for the Xomed T-Stent does not contain information on acceptance criteria or a study proving that the device meets such criteria.

The submission is a declaration of substantial equivalence to a predicate device (Rains stent) based on having the same intended use and similar technological characteristics, without raising new issues of safety or effectiveness. As such, it does not detail performance metrics, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: Not available.
  2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.