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K Number
K023688
Device Name
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2003-01-30

(90 days)

Product Code
GAF
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

The LeMaitre Vascular Disposable Vein Stripper is designed for the removal of the long saphenous vein (LSV) by invagination stripping from the knee to the groin, without a distal incision for the treatment of varicose veins.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) approval letter for the LeMaitre Vascular Disposable Vein Stripper does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It focuses on regulatory classification, general controls, and compliance requirements.

The document does NOT include the following information you requested:

  • A table of acceptance criteria and the reported device performance.
  • Sample size used for the test set and the data provenance.
  • Number of experts used to establish the ground truth for the test set and their qualifications.
  • Adjudication method for the test set.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
  • If a standalone (algorithm only) performance study was done.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  • The sample size for the training set.
  • How the ground truth for the training set was established.

Medical device clearance letters like this typically refer to information provided in the 510(k) submission, but they do not reproduce the detailed study results or performance data within the letter itself. To find the information you're looking for, you would generally need to consult the full 510(k) submission document, which is often not publicly available in its entirety in an easily searchable format.

§ 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.