(107 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 600um fiber and the following accessories used to gain endovascular access: 0.035" / 150cm stainless steel guide wire 5Fr/45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle
The provided text is a 510(k) Summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit) and the FDA's clearance letter. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The reasons are as follows:
- No specific acceptance criteria are listed for device performance. The submission relies on comparing the device's characteristics and intended use to an already cleared (predicate) device.
- No detailed study is described to demonstrate performance against acceptance criteria. The "Summary of Non-Clinical Testing" mentions tests for integrity and biocompatibility of marker bands, but these are general safety and materials tests, not performance studies as typically envisioned for clinical efficacy.
- There is no mention of a test set, ground truth, experts, or adjudication methods. These are elements of a clinical trial designed to prove effectiveness, which is not the primary purpose of a 510(k) submission focused on substantial equivalence.
- No information on MRMC studies or standalone algorithm performance is present, as this device is a physical instrument, not an AI or imaging diagnostic tool.
- No sample size for training or establishment of ground truth for a training set is applicable here, again because it's not an AI or algorithm-driven device.
In summary, the provided document is a regulatory submission for substantial equivalence, not a performance study report. It shows that the device is considered safe and effective because it is very similar to other devices already on the market, not through a head-to-head performance study against derived acceptance criteria.
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030654
JUN 1 8 2003
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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.2495 Xenium Lane NorthMinneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah JensenV. P., Regulatory Affairs, Clinical Affairs, and QualitySystems(763) 656-4349 phone(763) 656-4252 fax |
| Performance Standards: | No performance standards have been developed undersection 514 for this device. |
| Device Description: | The VARI-LASE procedure kit contains a 600um fiber andthe following accessories used to gain endovascular access:0.035" / 150cm stainless steel guide wire5Fr/45cm introducer sheath19 Gauge/7cm Percutaneous Entry Needle |
| 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: | Testing has been conducted to verify the integrity andbiocompatility of the marker bands that are placed on thefiber and introducer sheath. |
| Predicate Devices: | EVLT Kit (Diomed, Inc. K023543)SLT Venous Fiber Delivery Systems (Surgical LaserTechnologies, Inc. K023624)Angiodynamics ELVS Kit (Angiodynamics, Inc.) |
| Conclusions: | The VARI-LASE Procedure Kit is substantially equivalentto the identified predicate devices based on a comparison ofthe indications for use and the components supplied andthe technological characteristics of the suppliedcomponents. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Public Health Service
JUN 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah L. Jensen Vice President, Regulatory Affairs, Clinical Research, and Quality Systems Vascular Solutions, Inc. 2495 Xenium Lane North Minneapolis, Minnesota 55441
Re: K030654
Trade/Device Name: Vari-Lase Endovenous Laser Procedure 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: May 30, 2003 Received: June 2, 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 L. 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Miriam C. Provost
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 Veion
Miriam C. Provost
ion Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K036654
§ 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.