ARTHROSCOPE

K091398 · Orthopedic Sciences, Inc. · HRX · Aug 26, 2009 · Orthopedic

Device Facts

• Record ID: K091398
• Device Name: ARTHROSCOPE
• Applicant: Orthopedic Sciences, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears

Device Story

Arthroscope provides illumination and visualization of joint spaces (hip, shoulder, knee, elbow, wrist, ankle) during diagnostic and operative procedures. Device enables surgeons to perform open or closed arthroscopic procedures, including removal of loose bodies and soft tissue. Used in clinical settings by physicians; provides direct optical visualization to assist in surgical decision-making and intervention. Benefits include minimally invasive access to joint pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Arthroscope for joint visualization and illumination. Device is a mechanical optical instrument. No software, electronics, or energy-based algorithms described.

Indications for Use

Indicated for patients requiring diagnostic or operative arthroscopic procedures of the hip, shoulder, knee, elbow, wrist, and ankle. Includes visualization for staging avascular necrosis, chondral injuries, joint sepsis, synovial chondromatosis, unresolved hip pain, labral tears, and removal of loose bodies/soft tissue.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Orthopedic Sciences, Inc. % Mr. Wm. Jeffrey Hartter 3020 Old Ranch Parkway, Suite 325 Seal Beach, California 90740

Re: K091398

AUG 2 6 2009

Trade/Device Name: Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II . Product Code: HRX Dated: August 14, 2009 Received: August 17, 2009

Dear Mr. Hartter:

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 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 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. Wm. Jeffrey Hartter

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours

incerely yours,

for

ark N. Melkerson

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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Section 4 Indications for Use

## INDICATIONS FOR USE

Device Name: Arthroscope

## Indications for Use:

The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.

Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears

Concurrence of CDRH, Office of Device Evaluation (ODE)

·Prescription Use _ X (part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (part 21 CFR 801 Subpart C)

Nilse dade
Formkon

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

510(k) Number K091398