(72 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 and for treatment of incompetence and reflux of superficial veins in the lower extremity.
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
Due to the nature of the submitted document, which is a 510(k) summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit), the information provided focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for the device's performance.
Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, MRMC studies, specific performance metrics against acceptance criteria) are not present in this type of regulatory submission. The 510(k) process primarily relies on non-clinical testing and comparison to legally marketed predicate devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated as acceptance criteria, but implied as a necessary characteristic for a medical device. | "Testing has been conducted to verify the biocompatibility..." |
| Performance of Components | Not explicitly stated as acceptance criteria. | "...and performance of the components." |
| Substantial Equivalence | The device should be substantially equivalent to predicate devices in terms of indications for use, components, and technological characteristics. | "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." |
| Intended Use | The device should be effective 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. | The device is indicated for these uses, implying it meets the necessary performance for these indications, as demonstrated by equivalence to predicates. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "testing" but does not provide details on sample sizes for any experimental test sets.
- Data Provenance: Not specified. Given the nature of a 510(k) for a laser kit, the testing mentioned (biocompatibility, component performance) would likely be laboratory-based/bench testing rather than clinical study data from patients, especially if relying on substantial equivalence to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the submission focuses on non-clinical testing and substantial equivalence, not on clinical performance studies that would typically involve expert-adjudicated ground truth.
4. Adjudication method for the test set
- This information is not provided. Clinical adjudication methods are generally not part of a 510(k) submission for this type of device, which relies on demonstrating equivalence to predicates through non-clinical means.
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
- No, an MRMC comparative effectiveness study was not done and is not mentioned or required for this type of device (a laser procedure kit with no explicit AI component). The device is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable as the device is a physical surgical instrument kit, not an algorithm or AI software, and does not operate in a standalone algorithmic capacity.
7. The type of ground truth used
- For the non-clinical testing (biocompatibility, component performance), the "ground truth" would likely be established through scientific testing standards, material specifications, and validated laboratory methods. For the overall device, the "ground truth" for its clinical utility is implicitly established by the legally marketed predicate devices to which it claims substantial equivalence. No pathology or outcomes data is explicitly mentioned as being used for ground truth in this 510(k) summary.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physical medical instrument, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI/ML model, this information is not relevant.
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JUL 2 9 2005
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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 PlasticSurgery and in Dermatology21 CFR 878-4810 (Product Code GEX) | |
| Manufacturer: | Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 | |
| Contact: | Linda BuskleinSt. Regulatory Affairs Associate(763) 656-4217 phone(763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed undersection 514 for this device. | |
| Device Description: | The VARI-LASE procedure kit contains one or more of thefollowing:600 um laser fiber0.035" or 0.018" guide wireIntroducer sheath or catheter19 Gauge/7cm Percutancous Entry Needle21 Gauge/7 cm Percutaneous Entry NeedleFiber lock | |
| Intended Use: | The VARI-LASE procedure kit is indicated for thetreatment of varicose veins and varicosities associated withsuperficial reflux of the Greater Saphenous Vein and fortreatment of incompetence and reflux of superficial veins inthe lower extremity. | |
| Summary of Non-Clinical Testing: | Testing has been conducted to verify the biocompatility andperformance of the components. | |
| Predicate Devices: | Vari-Lase Endovenous Laser Procedure KitDiomed EVLT kitAngiodynamics EVLS kit | |
| 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 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.
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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
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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
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of General, Rest orative.
logical Devices
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§ 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.