(23 days)
The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
The Platinum Bright Tip is a laser fiber that is compatible with a solid state diode laser console. The laser fiber is comprised of a platinum/iridium distal tip, a 600 um core laser fiber and an SMA connector. The laser fiber lengths are between 2.4 meters and 3.6 meters, with a maximum diameter of 0.038". The laser fiber is available with or without positioning marks.
The provided text is a 510(k) summary for a medical device (Vari-Lase Platinum Bright Tip laser fiber) and its FDA clearance letter. It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert involvement, MRMC study, standalone performance, training set details) are not applicable or extractable from the provided document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through design verification testing and biomaterial assessments, rather than extensive clinical efficacy studies with the requested level of detail for AI/image analysis.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document describes "biomaterial assessments and other design verification testing," but does not provide specific quantitative acceptance criteria or performance metrics for these tests. The focus is on demonstrating substantial equivalence to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No specific test set sample sizes or data provenance are described for clinical performance. The testing mentioned appears to be design and material verification, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This type of information is typically relevant for studies involving image analysis or diagnostic performance, which is not the primary focus of this 510(k) for a laser fiber. Ground truth establishment by experts is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical test set requiring expert ground truth or adjudication is described, this is not relevant.
5. 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 device is a laser fiber for surgical procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical instrument (laser fiber), not an algorithm or AI. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The document does not describe the use of ground truth in the context of clinical studies for performance evaluation. The "ground truth" for this type of device would primarily be its adherence to material specifications and functional performance in in-vitro or simulated use tests, not clinical outcomes data for a "ground truth" comparison.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this device is a physical medical instrument, not an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
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510(k) Summary 2
Date Prepared: April 15, 2009
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
General Information
| Trade Name | Vari-Lase Platinum Bright Tip laser fiber |
|---|---|
| Common / Usual Name | Laser Fiber |
| Classification Name | 878.4810, Laser Instrument, Surgical, Powered |
| Predicate Device | K070216, Vari-Lase Bright Tip (Vascular Solution, Inc.) |
Device Description
The Platinum Bright Tip is a laser fiber that is compatible with a solid state diode laser console. The laser fiber is comprised of a platinum/iridium distal tip, a 600 um core laser fiber and an SMA connector. The laser fiber lengths are between 2.4 meters and 3.6 meters, with a maximum diameter of 0.038". The laser fiber is available with or without positioning marks.
Intended Use / Indications
The Vari-Lase Platinum Bright Tip laser 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.
Substantial Equivalence and Summary of Studies
The Vari-Lase Platinum Bright Tip is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.
O91SSI
Contact Person
Loucinda Bjorklund Senior Regulatory Affairs Associate Tel: 763.656.4208 (direct); Fax: 763.656.4253 Email: 1bjorklund(@vascularsolutions.com
JUN 19 2009
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DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Incorporated % Ms. Loucinda Bjorklund Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K091551
Trade/Device Name: Vari-Lase® Platinum Bright Tip Laser Fiber Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument for use in General Surgery and Plastic Surgery and in Dermatology
Regulatory Class: II Product Code: GEX Dated: May 26, 2009 Received: May 27, 2009
Dear Ms. Bjorklund:
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 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); medical device reporting .
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Page 2-Ms. Loucinda Bjorklund
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Vascular Solutions, Inc.
Indications for Use
ભ્ત દિવેલા દિવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયે 510(k) Number (if known):
Device Name: Vari-Lase® Platinum Bright Tip laser fiber
Indications for Use:
The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NulRPOgular for mkn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number Kogissl
Page 1 of 1 (Posted November 13, 2003)
§ 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.