(33 days)
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25 or 45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit
This document is a 510(k) premarket notification for a medical device. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, study performance, or ground truth as requested in the prompt.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device (a laser procedure kit for treating varicose veins) and details its substantial equivalence to a previously marketed device, not the performance of an AI model.
The sections for AI/ML device evaluation within your prompt (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content of this document.
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K032204 1 of 1
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AUG 2 0 2003
510(K) SUMMARY
| Common/Usual Name: | Laser Instrument Fiber and Procedure Kit |
|---|---|
| Product Trade Name: | Vari-Lase Endovenous Laser Procedure Kit |
| Classification Name: | Laser Surgical Instrument for use in General and PlasticSurgery and in Dermatology21 CFR 878-4810 (Product Code GEX) |
| Manufacturer: | Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah JensenV. P., Regulatory Affairs, Clinical Affairs, and QualitySystems(763) 656-4349 phone(763) 656-4250 fax |
| Performance Standards: | No performance standards have been developed undersection 514 for this device. |
| Device Description: | The VARI-LASE procedure kit contains a 600µm fiber andmay contain one ore more of the following accessories usedto gain endovascular access:0.035" / stainless steel guide wire (lengths from 75 to150cm)5Fr/25 or 45cm introducer sheath19 Gauge/7cm Percutaneous Entry Needle orMicropuncture Kit |
| Intended Use: | The VARI-LASE procedure kit is indicated for thetreatment of varicose veins and varicosities associated withsuperficial reflux of the Greater Saphenous Vein. |
| Summary of Non-Clinical Testing: | No testing was required to document the safety andeffectiveness of this modified procedure kit. |
| Predicate Devices: | VARI-LASE Procedure Kit (K000737) |
| Conclusions: | The VARI-LASE Procedure Kit is substantially equivalentto the currently marketed VARI-LASE kit based on acomparison of the indications for use and the componentssupplied and the technological characteristics of thesupplied components. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah Jensen Vice President, Regulatory Affairs, Clinical Affairs and Quality Systems Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K032204
Trade/Device Name: Vascular Solutions Vari-Lase™ Endovenous Laser Products Kit 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: July 17, 2003 Received: July 23, 2003
Dear Ms. Jensen:
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 Jensen
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millman
Celia M. Witten, Ph.D., M.D. 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:
Device Name:
Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit
Indications for Use:
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
Mark N. Milliken
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
KO32204 510(k) Number ________________________________________________________________________________________________________________________________________________________________
2
§ 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.