(190 days)
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.
Not Found
The provided text is a 510(k) clearance letter from the FDA for reprocessed arthroscopic wands. It confirms that the devices are substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving that the device meets such criteria in terms of performance metrics.
The letter explicitly refers to "supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002," and mentions that the FDA "reviewed your supplemental validation data." However, the content of that validation data, including acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or details of any comparative effectiveness studies, is not included in this clearance letter.
Therefore, I cannot provide the requested information based solely on the provided text. The document acts as an approval notice, not the study report itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAY 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director, Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044
Re: K043198- Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: November 17, 2004 Received: November 18, 2004
Dear Ms. Barton-Varty:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 27, 2005. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable requirements, including, but not limited to: registration and
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Page 2 - Ms. Moira Barton-Varty
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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours
Mark N. Melkerson
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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Page 3 – Ms. Moira Barton-Varty
Indications for Use
510(k) Number (if known): K043198
Vanguard Reprocessed Arthroscopic Wands Device Name:
Indications for Use:
Prescription Use _____________________________________________________________________________________________________________________________________________________________
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K043198 |
|---|---|
| Page 1 of |
AND / OR
Over-The-Counter Use
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Page 4 - Ms. Moira Barton-Varty
Reprocessed Arthroscopic Wand or Soft Tissue Ablators found to be substantially equivalent:
ArthroWand®, TurboVac® 90, ASC 1335-01 ArthroWand®, CoVac 50®, ASC 2530-01 ArthroWand®, TriStar 50®, ASC 4630-01 ArthroWand®, Eliminator™, AC 1345-01 ArthroWand®, Sabre 30, AC 4335-01
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.