OSCAR, MODEL OE3000DB

K051053 · Orthosonics, Ltd. · JDX · Jul 21, 2005 · Orthopedic

Device Facts

• Record ID: K051053
• Device Name: OSCAR, MODEL OE3000DB
• Applicant: Orthosonics, Ltd.
• Product Code: JDX · Orthopedic
• Decision Date: Jul 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopaedic applications.

Device Story

The Orthosonics OSCAR OE3000DB is an ultrasonic surgical instrument system used for cutting and removing bone and acrylic bone cement in orthopedic applications. The system comprises a power module that generates ultrasonic energy and provides control, two distinct handsets (one for bone cement removal, one for bone cutting/removal), and various probes and accessories. Three power modules are mounted on a cart for clinical use. The device operates by converting electrical energy into ultrasonic mechanical energy to facilitate tissue and material removal. It is intended for use by surgeons in an operating room environment. The device provides the surgeon with a tool for precise bone and cement management, potentially improving surgical efficiency and outcomes in orthopedic procedures.

Clinical Evidence

Performance testing was conducted via an animal study to validate the device's capabilities for bone cutting and removal. Biocompatibility was established through reference to the previous OSCAR (K961725) application. Electrical safety testing was successfully completed.

Technological Characteristics

Ultrasonic surgical instrument; power module generates ultrasonic energy; includes two handsets (bone cement removal and bone cutting/removal); utilizes probes and accessories; digital tuning module; cart-mounted power modules; class II device.

Indications for Use

Indicated for patients requiring cutting and removal of bone and acrylic bone cement during orthopedic surgical procedures.

Regulatory Classification

Identification

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Predicate Devices

• Biomet Ultra-Drive 3 (K031280)
• Orthosonics OSCAR (K961725)
• Orthosonics OSCAR (K021502)

Submission Summary (Full Text)

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# JUL 2 1 2005

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# 510(k) Summary

# Orthosonics OSCAR OE3000DB

| Common: | Ultrasonic Surgical Instrument |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Classification Name: | Instrument, Surgical, Sonic and<br>Accessories/Attachments (21 C.F.R. 888.4580) |
| Sponsor: | Orthosonics Ltd<br>Bremridge<br>Ashburton<br>Devon TQ13 7JX<br>T: [phone]<br>F: [phone] |
| Contact: | Dr. Michael J. R. Young |
| Prepared: | April 25, 2005 |

### REASON FOR SUBMISSION A.

This 510(k) is being filed for two main reasons. Firstly, it is to cover improvements in the existing OSCAR (K961725, K021502) which includes a new digital tuning module and new single use probes. Secondly there is a change to the intended use that now includes the cutting and removal of bone via an additional, optional handset.

# LEGALLY MARKETED PREDICATE DEVICES B.

The Orthosonics OSCAR OE3000DB is substantially equivalent to the Biomet Ultra-Drive® 3 (K031280), and the Orthosonics OSCAR (K961725, K021502).

#### DEVICE DESCRIPTION C.

The Orthosonics OSCAR OE3000DB consists of a power module which generates the ultrasonic energy and provides overall control of the device, 2 gefferent handsets; one for acrylic bone cement removal and the other for the cutting and removal of bone, and a variety of probes and other accessories. Three independent power modules are mounted in a cart for ease of use.

#### D. INTENDED USE

The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopaedic applications.

## SUBSTANTIAL EQUIVALENCE SUMMARY E.

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The Orthosonics OSCAR OE3000DB is a medical device, and it has the same indications for use and target population as the legally marketed predicate device.

The Orthosonics OSCAR OE3000DB has the same technological characteristics The Oredicate device. However, the descriptive characteristics may not be as the precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k).

## TECHNOLOGICAL CHARACTERISTICS F.

The basic technological characteristics of the OSCAR OE3000DB device are the same as those of the predicate devices.

### TESTING G.

Testing to electrical/ safety standards was successfully carried out. Biocompatibility issues were covered by the OSCAR (K961725) application. Performance testing was carried out in an animal study and the results are included in this 510(k).

#### CONCLUSIONS H.

This premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2005

Orthosonics c/o T. Whit Athey, Ph.D. Health Policy Resources Group, LLC 2305 Gold Mine Road Brookeville, Maryland 20833

Re: K051053

Trade/Device Name: OSCAR OE3000DB Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: II Product Code: JDX, and LZV Dated: April 25, 2005 Received: April 25, 2005

Dear Dr. Athey:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rots) premium is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the chelosure) to regally manative personal perice Americal period for to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food, Drug, devices that have been reculire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P You may, therefore, market the device, subject to the general controls provisions of the Act. The Y ou may, therefore, manol the Act include requirements for annual registration, listing of general controls provisions of the 1100 lines and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc aboro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlio "Little 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouch Smo
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 Frease be advised that I DA 3 issualites our device complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that I DA has made a dolorimiation administered by other Federal agencies. You must of any reactal slatures and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 607), labeling (21 OFR Part 820); go a carrers 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailier of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of easification 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 If you desire specific advice for Jour 2011 5. Also, please note the regulation entitled, Comact the Office of Complanes at (21 to 21 to 21 Station" (21CFR Part 807.97). You may obtain " Misolanding by releveles to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Conson http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Euch

Miriam C. Provost, Ph.D. Acting 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

1-051053 510(k) Number (if known):

OSCAR OE3000DB Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Orthosonics OSCAR OE3000DB is intended to be used for cutting and The Orthosomes OSCAN OES000DD is them.
removal of bone and acrylic bone cement in orthopedic applications.

Prescription Use × (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)

Eunice Chan

; E estorative

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