VANGUARD REPROCESSED ARTHROSCOPIC WANDS

K043198 · Vanguard Medical Concepts, Inc. · NUJ · May 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043198
• Device Name: VANGUARD REPROCESSED ARTHROSCOPIC WANDS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Reprocessed single-use arthroscopic wand electrodes; used with compatible electrosurgical units; intended for soft tissue resection, ablation, coagulation, and hemostasis during arthroscopic procedures (knee, shoulder, ankle, elbow, wrist); requires conductive irrigant; operated by surgeons in clinical/OR settings; device restores functionality of previously used single-use electrosurgical instruments through validated cleaning and sterilization processes.

Clinical Evidence

Bench testing only. Validation data provided to demonstrate that the reprocessing process does not adversely affect the safety or performance of the arthroscopic wands compared to the original single-use devices.

Technological Characteristics

Electrosurgical wand electrode; functions via high-frequency electrical energy for tissue ablation/coagulation; requires conductive irrigant; intended for single-use; reprocessed via validated cleaning and sterilization protocols.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during arthroscopic procedures of the knee, shoulder, ankle, elbow, and wrist using conductive irrigant. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• ArthroWand® (K043198)
• TurboVac® 90 (K043198)
• CoVac 50® (K043198)
• TriStar 50® (K043198)
• Eliminator™ (K043198)
• Sabre 30 (K043198)

Submission Summary (Full Text)

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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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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 [phone]. 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 [phone] or [phone] 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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## 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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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