(72 days)
Not Found
Not Found
No
The summary describes a procedure kit with physical components (laser fiber, guide wire, sheath, needles, fiber lock) for treating varicose veins. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biocompatibility and component performance, not algorithmic performance.
Yes
The device is indicated for the "treatment of varicose veins and varicosities," which directly addresses a medical condition.
No
The device description and intended use clearly state that the VARI-LASE procedure kit is for "treatment" of varicose veins, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly lists physical components such as a laser fiber, guide wire, introducer sheath, needles, and fiber lock, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on the patient's body (treatment of varicose veins and reflux in superficial veins). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The components listed (laser fiber, guide wire, sheath, needles) are instruments used for a surgical or interventional procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
This device is clearly intended for a therapeutic procedure performed directly on the patient.
N/A
Intended Use / 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 and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VARI-LASE procedure kit contains one or more of the following: 600 um laser fiber, 0.035" or 0.018" guide wire, Introducer sheath or catheter, 19 Gauge/7cm Percutancous Entry Needle, 21 Gauge/7 cm Percutaneous Entry Needle, Fiber lock
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been conducted to verify the biocompatility and performance of the components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 2 9 2005
:
:
火651287
| 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 Plastic | |
| Surgery and in Dermatology | ||
| 21 CFR 878-4810 (Product Code GEX) | ||
| Manufacturer: | Vascular Solutions, Inc. | |
| 6464 Sycamore Court | ||
| Minneapolis, Minnesota 55369 | ||
| Establishment Registration: | 2134812 | |
| Contact: | Linda Busklein | |
| St. Regulatory Affairs Associate | ||
| (763) 656-4217 phone | ||
| (763) 656-4250 fax | ||
| Performance Standards: | No performance standards have been developed under | |
| section 514 for this device. | ||
| Device Description: | The VARI-LASE procedure kit contains one or more of the | |
| following: | ||
| 600 um laser fiber | ||
| 0.035" or 0.018" guide wire | ||
| Introducer sheath or catheter | ||
| 19 Gauge/7cm Percutancous Entry Needle | ||
| 21 Gauge/7 cm Percutaneous Entry Needle | ||
| Fiber lock | ||
| Intended 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 and for | ||
| treatment of incompetence and reflux of superficial veins in | ||
| the lower extremity. | ||
| Summary of Non-Clinical Testing: | Testing has been conducted to verify the biocompatility and | |
| performance of the components. | ||
| Predicate Devices: | Vari-Lase Endovenous Laser Procedure Kit | |
| Diomed EVLT kit | ||
| Angiodynamics EVLS kit | ||
| Conclusions: | The VARI-LASE Procedure Kit is substantially equivalent | |
| to the identified predicate devices based on a comparison of | ||
| the indications for use and the components supplied and | ||
| the technological characteristics of the supplied | ||
| components. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2005
Ms. Linda Busklein Sr. Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K051287
Trade/Device Name: Vascular Solutions 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 17, 2005 Received: May 18, 2005
Dear Ms. Busklein:
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.
2
Page 2- Ms. Linda Busklein
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 (240) 276-0115. 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.
Stypt Rhodes
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
102128 510(k) Number:
Vascular Solutions Vari-Lase® Endovenous Laser Procedure Kit Device Name:
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 and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt. Kurda
-on)
of General, Rest orative.
logical Devices
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