VANGUARD REPROCESSED ARTHROSCOPIC WANDS

K012695 · Vanguard Medical Concepts, Inc. · GEI · Oct 30, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012695
• Device Name: VANGUARD REPROCESSED ARTHROSCOPIC WANDS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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

Bipolar electrosurgical probe; consists of shaft with distal electrode array and proximal connector. Input: high-frequency electrical energy from compatible electrosurgical unit. Operation: probe positioned near target tissue in conductive liquid (e.g., isotonic saline); liquid provides current path between active and return electrodes. High voltage gradients cause molecular dissociation/disintegration for tissue ablation; lower voltage creates thermal zone for coagulation/shrinkage. Used in arthroscopic surgery (knee, shoulder, ankle, elbow, wrist) by surgeons. Vanguard reprocesses previously used OEM wands via cleaning, refurbishing (insulation replacement), inspection, testing, and sterilization.

Clinical Evidence

Bench testing only. Validation included sterilization and packaging integrity, functional/performance testing, and biocompatibility testing to demonstrate equivalence to OEM predicates.

Technological Characteristics

Bipolar electrosurgical probe; shaft with distal electrode array and proximal connector. Active and return electrodes electrically insulated and spaced for conductive fluid circuit. Materials: OEM-based with replaced shaft insulation. Energy: high-frequency RF. Sterilization: validated process for reprocessed devices.

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. Contraindicated for non-arthroscopic procedures, procedures without conductive irrigant, patients contraindicated for arthroscopy, and patients with pacemakers or electronic implants.

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

• ArthroCare® ArthroWand® Arthroscopic Wands/Electrodes
• Mitek® VAPR® Arthroscopic Wands/Electrodes

Submission Summary (Full Text)

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OCT 3 0 2001

## 510(k) Summary of Safety & Effectiveness KO12695

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.<br>Director, Research and Development<br>[phone], extension 228<br>[phone] (facsimile)<br>[e-mail] |
| Date | August 13, 2001 |
| Device | <ul><li>Trade Names: Vanguard Reprocessed Arthroscopic Wands</li><li>⇒ ArthroCare® ArthroWand® Arthroscopic Wands/Electrodes</li><li>⇒ Mitek® VAPR® Arthroscopic Wands/Electrodes</li><li>Common Name: Arthroscopic wand or electrode</li><li>Classification: 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories – Class II</li><li>Product Code GEI</li></ul> |
| Predicate<br>Devices | Respective ArthroCare® ArthroWand®, and Mitek® VAPR® legally<br>marketed arthroscopic wands under various 510(k) premarket notifications. |
| Indications for<br>Use | When coupled with a compatible electrosurgical unit, an arthroscopic wand<br>electrode is intended for resection, ablation and coagulation of soft tissues,<br>and for hemostasis of blood vessels during arthroscopic procedures (of the<br>knee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant. |
| | Continued on next page |

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## 510(k) Summary of Safety & Effectiveness, Continued

| Contra-<br>indications | Use of this device is contraindicated for:<br><ul><li>non-arthroscopic surgical procedures,</li><li>arthroscopic procedures during which a conductive irrigant is not used,</li><li>patients for whom arthroscopy is contraindicated, and</li><li>patients with pacemakers or other electronic device implants.</li></ul> |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The arthroscopic wand electrode is bipolar electrosurgical probe comprised of a shaft with an electrode array at its distal end and a connector at its proximal end for coupling the electrode array to a high frequency power supply. The electrode array has at least one active electrode and at least one return electrode. Return electrodes are electrically insulated from the active ones and are spaced so as not to contact the tissue being treated. The spacing also ensures that the electrical circuit is always completed by a surrounding |

number and configuration can vary in number and spacing, electrode material, or angle of the distal tip. In use, the probe is positioned in close proximity to a target site within an electrically conducting liquid, such as an isotonic saline. The conducting liquid provides a current path between the active electrode(s) and the return electrode(s). When radio frequency voltage is applied between the active and return electrodes, high voltage gradients in the distal boundary of the active electrode(s) is sufficiently high to break down the tissue through molecular dissociation or disintegration. The ablative process can be precisely

conductive fluid, and not simply arcing between electrodes. The electrode

Formation of an ionized layer or plasma does not occur when the electrodes are activated with a lower voltage. In this case, electrical current passes through the tissue creating a thermal zone for coagulation of blood vessels and shrinkage of some collagenous tissues of the joints during arthroscopic surgery.

controlled to remove a layer of tissue as thin as a few cells.

Vanguard receives previously used arthroscopic wands from healthcare facilities; cleans, refurbishes (replaces shaft insulation), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

Continued on next page

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## 510(k) Summary of Safety & Effectiveness, Continued

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| Technological<br>Characteristics | The Vanguard reprocessed arthroscopic wands are essentially identical to<br>the currently marketed OEM wands. No changes are made to the currently<br>marketed device's specifications (except for the insulation material) and they<br>possess the same technological characteristics. Biocompatibility and<br>performance/functional testing demonstrate that the devices are equivalent<br>and continue to be safe and effective for their intended use. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Data | Sterilization and packaging validations, functional/performance, nd<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>reprocessed arthroscopic wands are substantially equivalent to the predicate<br>devices under the Federal Food, Drug and Cosmetic Act. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2001

Mike Sammon, Ph.D. Director, Research and Development Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815

Re: K012695 Trade/Device Name: Vanguard Reprocessed Arthroscopic Wands Regulation Number: 878.4400, 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: August 8, 2001 Received: August 14, 2001

Dear Dr. Sammon:

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 - Mike Sammon, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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,

Susan Walker, MS

Celia M. Witten, Ph.D., M.D. 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: K 012 695

Device Name: Vanguard Reprocessed Arthroscopic Wands

Indications for 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012695

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