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

Device Description

The Vari-Lase Bright Tip Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in ceramic which provides ultrasound visibility during clinical use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Vari-Lase® Bright Tip™ Fiber." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of a diagnostic or AI-based system.

Therefore, many of the requested categories for a study proving acceptance criteria, especially those related to AI model performance, expert ground truth, and comparative effectiveness studies, are not applicable to this submission.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with corresponding numerical performance metrics as might be found for a new diagnostic algorithm. Instead, the acceptance criteria are implicitly met by successful completion of various bench tests that confirm the device's functional and safety attributes.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Ultrasound visibility	Confirmed suitability for intended use (e.g., "visibility under ultrasound")
Energy transmission	Confirmed suitability for intended use
Tip integrity (tensile strength)	Confirmed suitability for intended use
Tip integrity (burn-back)	Confirmed suitability for intended use
Ability to achieve intended use	Confirmed suitability for intended use
Substantial Equivalence to Predicate Device	Achieved; stated as "substantially equivalent"

Inapplicability for AI-Specific Questions:

The device in question, the Vari-Lase® Bright Tip™ Fiber, is an optical fiber used in laser surgical procedures. It is a physical medical device, not an AI or diagnostic software. Therefore, the following points are not applicable to this 510(k) submission:

Sample size used for the test set and the data provenance: Not applicable. The testing involved bench tests on physical devices, not a dataset of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and objective measurements, not expert consensus on medical images or patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or interpretation device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance would be engineering specifications and physical test results (e.g., measurements of light transmission, force required to break the tip, visual confirmation of ultrasound visibility).
The sample size for the training set: Not applicable. There is no training set for an AI model.
How the ground truth for the training set was established: Not applicable.

Summary of Testing and Conclusion (from the document):

Study Type: Bench testing.
Purpose: To confirm the suitability of the modified laser fiber for its intended use, specifically "visibility under ultrasound, energy transmission, and integrity of the tip following simulated clinical use (tensile strength of the ceramic tip and burn-back)."
Conclusion: The tests "confirmed the suitability of the device for its intended use." The device was also found "substantially equivalent to the currently marketed Vari-Lase Fiber, based on comparisons of the device classification, indications for use, technological characteristics, and sterilization methods."

Summary

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510(k) Summary (As required by 21 CFR 807.92(c))

510(k) Number:_ n 0 702 1 p

Date Prepared

January 17, 2007

Submitter Information

Submitter's Name:	Vascular Solutions, Inc.
Address:	6464 Sycamore CourtMinneapolis, MN 55369

Contact Person:	Deborah L. Neymark
	Vice President, Regulatory Affairs
	Phone 763-656-4349
	Fax 763-656-4250

Device Information

Trade Name:	Vari-Lase® Bright Tip™
Common Name:	Optical Fiber
Class:	II
Classification Name:	Laser Surgical Instrument for use in General and PlasticSurgery and in Dermatology(21 CFR 870.4810, Product Code GEX)

Predicate Devices

Vari-Lase Endovenous Laser Procedure Kits (K050021) manufactured by Vascular Solutions, Inc.

Device Description

The Vari-Lase Bright Tip Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in ceramic which provides ultrasound visibility during clinical use.

Intended Use/Indications for Use

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Summary of Testing

Bench testing was conducted on the modified laser fiber and included an assessment of physical properties and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Bench tests included visibility under ultrasound, energy transmission, and integrity of the tip following simulated clinical use (tensile strength of the ceramic tip and burn-back)

Statement of Equivalence

The Vari-Lase Brite Tip fiber is substantially equivalent to the currently marketed Vari-Lase Fiber, based on comparisons of the device classification, indications for use, technological characteristics, and sterilization methods.

Conclusion

The Vari-Lase Bright Tip Fiber is substantially equivalent to the currently marketed Vari-Lase Fibers, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black line drawing, and the text is also in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. % Ms. Deborah L. Neymark Vice President, Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369

MAR 1 6 2007

Re: K070216

Trade/Device Name: Vari-Lase® Bright Tip" Regulation Number: 21 CFR 870.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 17, 2007 Received: January 23, 2007

Dear Ms. Neymark:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); 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.

.....

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Page 2 - Ms. Deborah L. Neymark

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vouts.

for
Mark N. Molkerson

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

Enclosure

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Indications for Use Statement

510(k) Number: K070216

Device Name:

Vari-Lase® Bright Tip™ Fiber

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
14070216

510(k) Number

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.