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K Number
K973573
Device Name
DURALASTIC ANATOMICAL NASAL IMPLANTS
Manufacturer
HANSON MEDICAL, INC.
Date Cleared
1997-11-13

(55 days)

Product Code
FZE,ESR
Regulation Number
878.3680
Type
Traditional
Panel
SU
Reference & Predicate Devices
K971481
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Duralastic Nasal implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

To augment or reconstruct the nasal contour

Device Description

Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies's MAF 612 for their MED 4211 Silicone Rubber -Unrestricted. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for Duralastic Nasal Implants from 1997, and it focuses on product description, substantial equivalence to a predicate device, intended use, physical/chemical properties, sterilization, and packaging. It also includes the FDA's clearance letter.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about any specific study (clinical or otherwise) designed to prove the device meets acceptance criteria.
  • Information on sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, as these are typically associated with performance evaluations of diagnostic or AI-driven devices, not simply material properties and substantial equivalence claims for an implantable medical device like this one.

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.