(62 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the laser technology, not AI/ML processing.
Yes
The device is indicated for the treatment of varicose veins and superficial reflux, which are medical conditions, and it is a laser that provides an output wavelength to perform a procedure.
No
The device description and intended use focus on treatment (ablation of varicose veins) rather than diagnosis. It's a therapeutic laser, not a diagnostic tool.
No
The device description explicitly states "The Vari-Lase Console is a software controlled diode laser," indicating it includes hardware (a diode laser) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Description and Intended Use: The Vari-Lase™ system is a laser device used for the treatment of varicose veins. It directly interacts with the patient's body (specifically, superficial veins in the lower extremity) to perform a therapeutic procedure. It does not analyze samples taken from the body.
Therefore, the Vari-Lase™ system falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vari-Lase™ procedure 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.
Product codes
GEX
Device Description
The Vari-Lase Console is a software controlled diode laser that provides an output wavelength of 810 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical evaluations of this product have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
510(k) Number: K 062822
Date Prepared
September 15, 2006
NOV 2 1 2006
Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Contact Person:
Patrice Stromberg Sr. Regulatory Affairs Associate pstromberg@vascularsolutions.com (763) 656-4300 (phone) (763) 656-4250 (fax)
Device Information
Trade Name: Common Name: Classification Name:
Product Code: Regulation:
Predicate Devices
Vari-Lase™ Endovenous Laser Console and Laser Instrument Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology GEX Class II, 21 CFR 878-4810
Vascular Solutions Vari-Lase™ Laser Console (K033237) Diomed, Inc. Diomed 15 Plus Laser System (K023543 and K041957)
Device Description
The Vari-Lase Console is a software controlled diode laser that provides an output wavelength of 810 nm.
Intended Use/Indications for Use
The Vari-Lase™ procedure 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.
Summary of Non-Clinical Testing
Additional testing was not conducted for the upgrades to this device. Testing was previously conducted to verify the laser console is in compliance with the following clectrical safety standards. No circuitry was changed that would affect the electrical safety of the Vari-Lase Console.
1
- . EN 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety
- EN 60601-1-1: Medical Electrical Equipment Part 1-1: General . Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
- EN 60601-2: Medical Electrical Equipment -- Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- EN 60601-1-4: Medical Electrical Equipment Part 1-4, General . Requirements for Safety – Collateral Standard: Programmable Electrical Medical Systems
- EN 60601-2-22: Medical Electrical Equipment -- Part 2: Particular . Requirements for Safety - Section 2.22: Specification for Diagnostic and Therapeutic Laser Equipment
Summary of Non-Clinical Testing
No clinical evaluations of this product have been conducted.
Statement of Equivalence
The Vari-Lase Endovenous Laser Console is substantially equivalent to the identified predicate devices based on a comparison of the indications for use and the technological characteristics.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three streams emanating from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions % Ms. Patrice Stromberg Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
NOV 2 1 2006
Re: K062822
Trade/Device Name: Vari-Lase" Endovenous Laser Console Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 18, 2006 Received: September 20, 2006
Dear Ms. Stromberg:
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 complics 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
3
Page 2 - Ms. Patrice Stromberg
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.
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 yours
Sincerely yours
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 (if known): K 062822
Device Name:
Vari-Lase™ Endovenous Laser Console
Indications for Use:
The Vari-Lase™ procedure 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.
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, Offide & Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 11 062722