The Vari-Lase WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.

Device Description

The WireFiber is a laser fiber that is compatible with a solid state diode laser console operating at a maximum power of 14 watts and wavelengths of 810 nm and 980 mm. The laser fiber is comprised of a 600 um silica core with a dual clad of silica hard clad and polymer, an outer nylon buffer, a strain relief, and an SMA connector. The distal tip of the laser fiber consists of a platinum/iridium sleeve that terminates with a stainless steel/nitinol wire. The laser fiber lengths are between 2.4 meters and 3.6 meters, as measured from the proximal end of the SMA connector to the distal tip, with a maximum diameter of 0.038". The laser fiber is provided with positioning marks.

AI/ML Overview

The provided text is a 510(k) summary for the Vari-Lase WireFiber, detailing its substantial equivalence to predicate devices. It describes the device, its intended use, and the tests performed to demonstrate its safety and effectiveness. However, the document does not present a formal study with acceptance criteria and a detailed report of device performance in the manner requested. Instead, it lists various tests conducted to show equivalence, rather than a specific study designed to meet pre-defined acceptance criteria for a new clinical efficacy claim. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications of what is not available or not applicable.

Acceptance Criteria and Device Performance Study for Vari-Lase WireFiber

This document is a 510(k) summary for the Vari-Lase WireFiber. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. As such, the submission focuses on tests demonstrating equivalence rather than a new standalone clinical study to establish explicit acceptance criteria for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied/General)	Reported Device Performance (Implied/General)
Simulated Use Blood Burn	Performance comparable to predicate device; no adverse events/failures.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Simulated Anatomy	Performance comparable to predicate device; no adverse events/failures.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Ultrasound Visualization	Clear visualization comparable to predicate device.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Corrosion Resistance	Adequate resistance for intended use; comparable to predicate.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Tensile Strength	Maintains structural integrity under expected forces; comparable to predicate.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Compressive Force	Maintains structural integrity under expected forces; comparable to predicate.	Results did not raise new safety or performance questions; confirmed substantial equivalence.
Biocompatibility	Compliant with ISO standards for medical devices in contact with tissue.	Results did not raise new safety or performance questions stemming from biomaterial assessments; confirmed substantial equivalence.
Intended Use	Same as predicate devices.	Vari-Lase WireFiber has the same indications for use as predicate devices.
Technological Characteristics	Similar to predicate devices, or differences do not raise new safety/effectiveness questions.	Modifications (sleeve/wire tip design, adhesive, dimensions, buffer material) were qualified and shown not to raise new safety/performance concerns.

Note: The acceptance criteria listed are implied from the nature of a 510(k) submission and the statement "results... did not raise any new safety or performance questions and confirm that the Vari-Lase WireFiber is substantially equivalent to the predicate Vari-Lase laser fibers." Explicit, quantitative acceptance criteria are not provided in this summary document.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not specified. The document mentions "tests" were conducted but does not provide the number of devices or units tested for each specific characteristic.
Data Provenance: Not specified. The document does not indicate the country of origin for the data or whether the test data was retrospective or prospective. Given these are bench and materials tests, the concept of "retrospective or prospective" for human patient data doesn't directly apply here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. For a 510(k) submission based on bench testing of physical properties and biocompatibility, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not relevant. The ground truth for these tests would be the measurement standards, engineering specifications, and established scientific methodologies used in materials and device testing.

4. Adjudication Method for the Test Set

Not Applicable. As the tests described are primarily engineering and materials assessments, adjudication methods typically used for expert disagreement in clinical or diagnostic studies are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This document pertains to a medical device (laser fiber) for surgical procedures, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. As this device is a physical medical instrument and not an algorithm, a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

For the engineering and materials tests (e.g., tensile strength, corrosion resistance, biocompatibility), the "ground truth" would be established by:
- Validated Test Methods: Standard test protocols (e.g., ISO standards, ASTM standards) for materials characterization.
- Engineering Specifications: Pre-defined performance parameters and limits.
- Predicate Device Performance: Benchmarking against the known performance of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set was used.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through various engineering, performance, and biocompatibility tests. It does not present a clinical study with clearly defined acceptance criteria, sample sizes, or expert-established ground truth in the way a diagnostic AI device submission would. The "performance" is demonstrated by showing that the modified device functions similarly to the predicate devices and that the design changes do not introduce new safety or effectiveness concerns.

Summary

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510(k) Summary 2

Date Prepared: October 24, 2011

Submitter's Name / Contact Person

Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763-656-4300; Fax: 763-656-4250 Establishment Registration # 2134812

Contact Person Jennifer Ruether Sr. Regulatory Product Specialist

General Information

Trade Name Common / Usual Name Classification Name Predicate Devices

Vari-Lase WireFiber Laser Fiber 878.4810; GEX; Laser instrument, surgical, powered; Class II K072332 - Vari-Lase WireFiber (Vascular Solutions, Inc.) K091551 - Vari-Lase Platinum Bright Tip (Vascular Solutions, Inc.)

Device Description

Intended Use/Indications for Use

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Technological/Performance Characteristics

The overall design features of the modified WireFiber are the same as the predicate WireFiber. These devices consist of a laser fiber with a proximal strain relief and SMA connector, and terminate in a distal platinum/iridium sleeve with a wire tip. Sleeve and wire tip design changes were made to improve device reliability. These improvements include removal of the ceramic sleeve, use of a high temperature epoxy adhesive, minor dimensional changes to the platinum/iridium sleeve, and an angled wire tip material change to stainless steel and nitinol. Minor dimensional changes were made to the modified WireFiber to align with those of the Platinum Bright Tip, as well as a buffer material change to nylon. Performance characteristics are the same as those of the predicate Vari-Lase laser fibers.

Substantial Equivalence and Summary of Studies

The Vari-Lase WireFiber is substantially equivalent to the currently marketed predicate devices, based on comparisons of the device classifications, technological and performance characteristics, and the indications for use. Technological and performance differences in design and materials have been qualified through the following tests:

Simulated use blood burn .
Simulated anatomy ●
Ultrasound visualization .
. Corrosion resistance
. Tensile strength
Compressive force .
Biocompatibility .

The results of the verification and biomaterial assessments did not raise any new safety or performance questions and confirm that the Vari-Lase WireFiber is substantially equivalent to the predicate Vari-Lase laser fibers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2 2011

Vascular Solutions, Inc. % Ms. Jennifer Ruether Sr. Regulatory Product Specialist 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K113140

Trade/Device Name: Vari-Lase WireFiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 28, 2011 Received: November 29, 2011

Dear Ms. Ruether:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jennifer Ruether

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K13140

Device Name: Vari-Lase WireFiber

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

...

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Net Rp. Dade for mka
(Posted November 13, 2003)

Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K113140

Vari-Lase WireFiber Laser Fiber Special 510(k) - Page 4 of 140

Regulation Number and Section

§ 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.