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K Number
K101712
Device Name
ENDOVASCULAR LAER VEIN SYSTEM KIT
Manufacturer
BIOLITEC, INC.
Date Cleared
2010-10-27

(131 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K924258
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in the thigh in patients with superficial vein reflux.

Device Description

The ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire.

AI/ML Overview

The provided text describes a 510(k) submission for the "Endo Laser Vein System Kit with Radial Fiber," and it focuses primarily on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that "The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7." However, it does not specify acceptance criteria derived from these standards, nor does it report device performance against specific metrics.

The document's central argument for substantial equivalence is based on:

  • The use of previously cleared radial fiber technology (K924258).
  • Having the same intended use and indications for use as cleared predicate devices (Ceralas D 1470, 980 and 810nm ELVeS kits).
  • The ELVeS kit not representing a new technological characteristic for diode lasers in endovascular coagulation of the greater saphenous vein.

Here's a breakdown of the other requested information based on the provided text:

  1. A table of acceptance criteria and the reported device performance:

    • Not provided in the document. The submission relies on substantial equivalence to predicate devices and compliance with general consensus standards, not on specific performance data against defined acceptance criteria.

  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

    • Not applicable / Not provided. The document does not describe a performance study with a test set.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    • Not applicable / Not provided. No performance study with a test set is described.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable / Not provided. No performance study with a test set is described.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No. This device is a laser system for endovascular coagulation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • No. This is a medical device (laser system), not an algorithm. Standalone performance for an algorithm is not applicable.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable / Not provided. No performance study requiring ground truth is described.

  8. The sample size for the training set:

    • Not applicable / Not provided. This device is a laser system, not a machine learning algorithm requiring a training set.

  9. How the ground truth for the training set was established:

    • Not applicable / Not provided. As above, no training set for an algorithm is relevant here.

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.