ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR

K070874 · Arthro Kinetics, Inc. · HRX · Nov 2, 2007 · Orthopedic

Device Facts

• Record ID: K070874
• Device Name: ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
• Applicant: Arthro Kinetics, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.

Device Story

Arthro Kinetics Vesalius MR Generator is an electrosurgical device; provides energy for resection, ablation, and coagulation of soft tissue; achieves hemostasis of blood vessels. Used in surgical settings including orthopedic, arthroscopic, and spinal procedures. Operated by surgeons/clinicians. Device transforms electrical energy into output for tissue interaction; facilitates surgical precision; aids in controlling bleeding and tissue removal. Benefits patient by enabling minimally invasive or targeted surgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; intended for soft tissue cutting and coagulation. Operates under 21 CFR 878.4400 (Product Code HRX).

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels during surgical procedures, including orthopedic, arthroscopic, and spinal surgeries.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

Arthro Kinetics. Inc. % Mr. James Hobbs President 8 Faneuil Hall, 3rd Floor Boston, Massachusetts 02109

Re: K070874

Trade/Device Name: Arthro Kinetics Vesalius MR Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX Dated: October 15, 2007 Received: October 17, 2007

Dear Mr. Hobbs:

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 – Mr. James Hobbs

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 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/industry/support/index.html.

Sincerely yours,

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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K070874

## 4. Indications for Use

## Indications for Use

| 510(k) Number: | K070874 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Arthro Kinetics Vesalius MR Generator |
| Indications for Use: | Intended for resection, ablation, and coagulation of soft tissue and<br>hemostasis of blood vessels in surgical procedures such as but not<br>limited to orthopedic, arthroscopic, and spinal procedures. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)

(Division Sign-Of
Concurrence of CDRH Office of Device Evaluation (ODE)
Division of Gener
and Neurological L......

510(k) Number 1070874
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