(23 days)
Not Found
No
The description focuses on the physical components and intended use of a laser fiber, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of varicose veins and varicosities, which are therapeutic interventions.
No
The device is described as a laser fiber indicated for the treatment of varicose veins and superficial venous incompetence and reflux, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a laser fiber comprised of physical components (platinum/iridium tip, laser fiber, SMA connector) and is used with a laser console, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of varicose veins and reflux in superficial veins. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is a laser fiber used in conjunction with a laser console. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
This device is a therapeutic medical device used for a surgical procedure.
N/A
Intended Use / 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 treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
great saphenous vein, superficial veins in the 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
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.
Key Metrics
Not Found
Predicate Device(s)
K070216, Vari-Lase Bright Tip (Vascular Solution, Inc.)
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 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
1
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 .
2
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
3
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)