(143 days)
The VARI-LASE Wire Fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
The Vari-Lase Wire Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in a ceramic and platinum/iridium (provides ultrasound visibility during clinical use) and includes a distal floppy spring tip.
The provided 510(k) summary for the Vari-Lase® WireFiber focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human subjects, AI/algorithm performance, ground truth establishment by experts, or MRMC studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Energy Transmission | Confirmed suitability |
| Tip Integrity (post-simulated use) | Confirmed suitability |
| - Tensile Strength (ceramic/metal tip) | Confirmed suitability |
| - Burn-back | Confirmed suitability |
| - Torque Response | Confirmed suitability |
| - Torsional Strength | Confirmed suitability |
| Biocompatibility | Confirmed suitability |
| Suitability for Intended Use | Confirmed suitability |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable. The testing was described as "Bench testing" and indicated physical property assessments and simulated clinical use, not testing on a clinical data test set.
- Data Provenance: Not applicable. No clinical data was used.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable. Ground truth was not established by experts, as no clinical data or expert review was mentioned.
- Qualifications: Not applicable.
4. Adjudication Method:
- Adjudication Method: Not applicable. No expert review or adjudication process was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission relies solely on bench testing and comparison to a predicate device.
- Effect Size of AI Improvement: Not applicable, as this is a device and not an AI/algorithm, and no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. The "ground truth" for this submission was based on the performance of the device in various bench tests (e.g., measuring energy transmission, tensile strength, etc.) and confirming it met suitability criteria, rather than clinical outcomes or expert consensus on patient data.
8. Sample Size for Training Set:
- Sample Size: Not applicable. No training set was used as this is a physical device and not an AI/algorithm.
9. How Ground Truth for Training Set Was Established:
- Ground Truth Establishment: Not applicable. No training set or associated ground truth was established.
Summary of Study:
The "study" described in the 510(k) summary is purely bench testing. This testing involved:
- Energy transmission assessment: To ensure the fiber effectively transmits laser energy.
- Integrity of the tip following simulated clinical use: This included evaluations of:
- Tensile strength of the ceramic/metal tip.
- Burn-back characteristics.
- Torque response.
- Torsional strength.
- Biocompatibility testing: To ensure the materials are safe for use in the human body.
The conclusion of these bench tests was that they "confirmed the suitability of the device for its intended use" and supported its substantial equivalence to the predicate device (Vari-Lase Endovenous Bright™ Tip Fiber). The 510(k) process in this instance primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing for devices with similar technological characteristics and intended use.
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Image /page/0/Picture/1 description: The image is a logo for Vascular Solutions. The logo features a black square with a pixelated top, giving the impression of movement or dissolving. Below the square, the words "Vascular" and "Solutions" are written in a bold, serif font, with "Vascular" in a larger size than "Solutions."
510(k) Summary (As required by 21 CFR 807.92(c))
JAN. 10 2008
510(k) Number:_
Date Prepared
October 1, 2007
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore CourtMinneapolis, MN 55369 |
Contact Person:
Deborah L. Neymark Vice President, Regulatory Affairs Phone 763-656-4349 Fax 763-656-4250
Device Information
| Trade Name: | Vari-Lase® WireFiber |
|---|---|
| Common Name: | Optical Fiber |
| Class: | II |
| Classification Name: | Laser Surgical Instrument for use in General and PlasticSurgery and in Dermatology(21 CFR 870.4810, Product Code GEX) |
Predicate Device
Vari-Lase Endovenous Bright™ Tip Fiber (K070216) manufactured by Vascular Solutions, Inc.
Device Description
The Vari-Lase Wire Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in a ceramic and platinum/iridium (provides ultrasound visibility during clinical use) and includes a distal floppy spring tip.
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510(k) Summary Varilase Wire Fiber Page 2
Intended Use/Indications for Use
The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Summary of Testing
Bench testing was conducted on the modified laser fiber and included an assessment of physical properties and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Bench tests included energy transmission, integrity of the tip following simulated clinical use (tensile strength of the ceramic/metal tip, burn-back, torque response and torsional strength) and biocompatibility.
Statement of Equivalence
The Vari-Lase Wire fiber is substantially equivalent to the currently marketed Vari-Lase Bright Tip Fiber, based on comparisons of the device classification, indications for use, technological characteristics, and sterilization methods.
Conclusion
The Vari-Lase Wire Fiber is substantially equivalent to the currently marketed Vari-Lase Fibers, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the department's three main goals: protecting the health of all Americans, providing essential human services, and fostering advances in medicine and public health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
JAN 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. % Ms. Deborah Neymark VP, Regulatory Affairs, Clinical Research and Reimbursement 6464 Sycamore Court Minnesapolis, Minnesota 55369
Re: K072332
Trade/Device Name: Vari-Lase® Wire Fiber 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: November 30, 2007 Received: December 3, 2007
Dear Ms. Neymark:
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
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Page 2 - Ms. Deborah Neymark
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,
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M Millerson
Mark N. Melkerson 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: K072332
Device Name:
Vari-Lase® Wire Fiber
seat the same of the states
Indications for Use:
The VARI-LASE Wire Fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
| Prescription Use | X | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, of(Division Sign Off) (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number 1072332
§ 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.