LogoFDA 510(k) Search
K Number
K100780
Device Name
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
Manufacturer
UNILENE S.A.C.
Date Cleared
2010-12-14

(270 days)

Product Code
NEW,GAM,GAN
Regulation Number
878.4840
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

The absorbable sutures (Polyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Unilene, S.A.C. regarding their "VITAL SUTURES, SUTUREX, CIRUGIA PERUANA" device (absorbable polydioxanone surgical suture).

The letter primarily:

  • States that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
  • Informs the company that they can market the device subject to general controls of the Act.
  • Details the general controls and other FDA regulations that apply to the device.
  • Provides contact information for further inquiries.

The "Indications for Use" section (page 2) describes the intended applications of the sutures but does not present any performance metrics, study results, or acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.