ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080

K093086 · Orthodynamix, LLC · GEI · Feb 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093086
• Device Name: ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080
• Applicant: Orthodynamix, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.

Device Story

ArthroSteer Ablator & Coagulator (Models 1070 & 1080) are electrosurgical devices for soft tissue management. Used in orthopedic and arthroscopic procedures; operated by surgeons in clinical/OR settings. Device functions via electrosurgical cutting and coagulation to resect, ablate, or excise soft tissue and achieve hemostasis. Provides surgeons with precise tissue control during joint procedures (knee, shoulder, wrist, hip). Benefits include efficient tissue removal and bleeding control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation device; 21 CFR 878.4400; Product Code GEI. Operates via electrical energy for tissue ablation and hemostasis.

Indications for Use

Indicated for general surgical use, including orthopedic and arthroscopic soft tissue resection, ablation, excision, and hemostasis in joints such as the knee, shoulder, wrist, and hip.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OrthoDynamix, LLC % Mr. Brian S. Zimovan Engineering Manager 10302 Deerwood Park Boulevard, Suite 209 Jacksonville, Florida 32256

FEB 2 8 2010

Re: K093086

Trade Name: Arthrosteer Ablator & Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 15, 2010 Received: February 17, 2010

Dear Mr. Zimovan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Brian Zimovan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# APPENDIX E

# Indications for Use

510(k) Number : K093086

Device Name: ArthroSteer Ablator & Coagulator, Models: Ref 1070 & 1080

Indications For Use:

The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M.MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093086

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