(45 days)
VARI-LASE is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
The VARI-LASE Laser is a semiconducter diode laser operating at 810 ± 20 nanometers.
The provided text describes a 510(k) summary for the Vari-Lase Laser Console. It primarily focuses on the device's characteristics, intended use, and a declaration of substantial equivalence to predicate devices based on non-clinical testing and technology comparison.
Based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, accuracy).
The "Summary of Non-Clinical Testing" section lists various electrical and safety performance standards (EN60601-1, EN60601-1-1, EN60601-2, EN60601-1-4, EN60601-2-22) that the laser console complies with. These are general safety and performance standards for medical electrical equipment, not specific "acceptance criteria" related to a study on the clinical performance of the device's intended use against a defined ground truth.
Therefore, I cannot populate the requested table and information points as they pertain to clinical performance studies. The document only references compliance with general electrical and safety standards.
The document does not contain information on:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics).
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance of an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
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NOV 2 0 2003
KO33232 - 1 - 1 6 - 1
510(K) SUMMARY
| Common/Usual Name: | Laser Instrument |
|---|---|
| Product Trade Name: | Vari-Lase Laser Console |
| Classification Name: | Laser Surgical Instrument for use in General and Plastic Surgery and inDermatology 21 CFR 878-4810 (Product Code GEX) |
| Manufacturer: | Vascular Solutions, Inc.2495 Xcnium Lane NorthMinneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah JensenV. P., Regulatory Affairs, Clinical Affairs, and Quality Systems(763) 656-4349 phone(763) 656-4250 fax |
| Performance Standards: | No performance standards have been developed under section 514 forthis device. The laser console is in compliance with the standardsestablished in 21 CFR 1040. |
| Device Description: | The VARI-LASE Laser is a semiconducter diode laser operating at 810± 20 nanometers. |
| Intended Use: | The VARI-LASE laser is indicated for the treatment of varicose veinsand varicosities associated with superficial reflux of the GreaterSaphenous Vein. |
| Summary of Non-ClinicalTesting: | Testing has been conducted to verify the laser console is in compliancewith the following standards: |
| EN60601-1 | Medical Electrical Equipment - Part 1: General Requirements ForSafety" |
| EN60601-1-1 | Medical Electrical Equipment - Part 1: General Requirements For Safety1: Collateral Standard: Safety Requirements For Medical ElectricalSystems |
| EN60601-2 | Medical Electrical Equipment - Part 1-2: General Requirements ForSafety - Collateral Standard: Electromagnetic Compatibility - |
| EN60601-1-4 | Requirements And TestsMedical Electrical Equipment - Part 1-4. General Requirements For |
| EN60601-2-22 | Safety - Collateral Standard: Programmable Electrical Medical SystemsMedical Electrical Equipment - Part 2: Particular Requirements Forsafety - Section 2.22: Specification For Diagnostic And TherapeuticLaser Equipment |
| Predicate Devices: | Diomed 15/30 Plus Diomed, Inc. (K023543)Medart 425P/426 Laser Consoles (K991659) |
| Conclusions: | The VARI-LASE Laser is substantially equivalent to the identifiedpredicate devices based on a comparison of the indications for useand the technological characteristics. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Ms. Deborah Jensen Vice President, Regulatory Affairs, Clinical Affairs and Quality Systems Vascular Solutions, Inc. 2495 Xenium Lane North Minneapolis, Minnesota 55441
Re: K033237
Trade/Device Name: Vascular Solutions 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 30, 2003 Received: October 7, 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.
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:
033237
Device Name:
Vascular Solutions Vari-Lase™ Endovenous Laser Console
Indications for Use:
VARI-LASE is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.
Miriam
(Division Sign-Off) (Division Sigil-On)
Division of General, Restorative Division of Sical Devices
< 033237 510(k) Number -
§ 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.