(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.
The VARI-LASE procedure kit contains a 600µm fiber and the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150 cm) 5Fr/25. 45, or 55 cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture kit
The provided text is a 510(k) summary for the Vari-Lase Endovenous Laser Procedure Kit. It describes the device, its intended use, and the conclusion that it is substantially equivalent to a predicate device. However, it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics.
Therefore, I cannot populate most of the requested fields. The document primarily focuses on regulatory submission and substantial equivalence rather than detailed performance testing.
Here's what I can extract and what remains unknown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states, "Testing has been conducted to verify the biocompatibility and performance of the fiber." However, it does not detail what those performance criteria were, how performance was measured, or the results of those tests. It concludes "substantial equivalence" based on indications for use and components, not specific performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified
- Data Provenance: Not specified (No details provided about the nature or origin of the "testing" mentioned).
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)
- Number of Experts: Not specified
- Qualifications of Experts: Not specified
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified
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
- MRMC Study: No
- Effect Size: Not applicable (No MRMC study mentioned, and the device is a laser procedure kit, not an AI diagnostic tool for human readers).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable (The device is a physical medical instrument, not an algorithm, so "standalone" performance in the context of AI does not apply). The "performance of the fiber" mentioned likely refers to physical properties tested in a lab, not an algorithmic standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified (since performance criteria and actual test results are not detailed).
8. The sample size for the training set
- Sample Size (Training Set): Not applicable / Not specified (No "training set" in the context of an algorithm is discussed for this physical device).
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable / Not specified.
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MAR 1 8 2005
KO 50021 510(K) SUMMARY Laser Instrument Fiber and Procedure Kit Common/Usual Name: Vari-Lase Endovenous Laser Procedure Kit Product Trade Name: Laser Surgical Instrument for use in General and Plastic Classification Name: Surgery and in Dermatology 21 CFR 878-4810 (Product Code GEX) Vascular Solutions, Inc. Manufacturer: 6464 Sycamore Court Minneapolis, Minnesota 55369 2134812 Establishment Registration: Linda Busklein Contact: St. Regulatory Affairs Associate (763) 656-4217 phone (763) 656-4253 fax No performance standards have been developed under Performance Standards: section 514 for this device. The VARJ-LASE procedure kit contains a 600µm fiber and Device Description: the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150 cm) 5Fr/25. 45, or 55 cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture kit The VARI-LASE procedure kit is indicated for the Intended Use: treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein. T'esting has been conducted to verify the biocompatility and Summary of Non-Clinical Testing: performance of the fiber. Vari-Lase Endovenous Laser Procedure Kit Predicate Devices: The VARI-LASE Procedure Kit is substantially equivalent Conclusions: to the identified predicate device based on a comparison of the indications for use and the components supplied and the technological characteristics of the supplied components.
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Busklein Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K050021
K050021
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: January 4, 2005 Received: January 5, 2005
Dear Ms. Busklein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regard nament date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that to not requently subject to the general controls provisions of the Act. The You may, merciole, manel the device, books of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device ts classified (socre) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the may be subject to suell doditions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a seculations administered by other Federal agencies. You must of any rederal statures and regarations salading, but not limited to: registration and listing (21 Comply with an the Act 870girls Part 801); good manufacturing practice requirements as set CFR in the quality systems (2) CFR egulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by stems (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) This letter will allow you to begin harketing your device of your device of your device to a legally premarket notification. The FDA inding of substantial equively 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 if you desire specific advice for your ac not the consisted on the regulation entitled, the regulation of the regulation contact the Office of Compliance at (210) 275 on (21CFR Pat1807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Musbranding by reference to prematics noutheansmall of the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) other general information on your responsionnies and its toll-free number (800) 6.8-204 or 1 Manufacturers, International and Consumer Assistance at no restaurantes and consistences himl.
Sincerely yours,
Elther
Miriam C. Provost, PhD
Miriam C. Provost, Ph 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
510(k) Number: Ko Sopal
STO(R) Patents ..
Device Name:
Vascular Solutions Vati-Lase® Endovenous Laser Procedure Kit
Indications for Use:
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and The VARF-LASE procedure int as as as the Greater Saphenous Vein.
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)
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Grative
§ 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.