MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT

K033652 · Zimmer, Inc. · GEI · Feb 4, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033652
• Device Name: MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
• Applicant: Zimmer, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.

Device Story

The Minimally Invasive Solutions™ Osteotomy Guide Instrument is an electrosurgical tool used by orthopedic surgeons during minimally invasive joint arthroplasty. The device utilizes high-frequency electrical current to perform local coagulation of soft tissues. This coagulation serves as a visual marker on the periosteal tissue, assisting the surgeon in accurately locating the site for subsequent osteotomy cuts in the femoral calcar. The device is intended for use in clinical settings (OR) by trained surgeons. By providing a precise mark on the tissue, the device aids in surgical navigation, potentially improving the accuracy of bone resection during joint replacement procedures.

Clinical Evidence

No clinical data was required or provided for this device. Bench testing was performed to verify electrical safety per IEC 60601-1 (1988) second edition with Amendments 1 and 2.

Technological Characteristics

Electrosurgical cutting and coagulation device; utilizes high-frequency electrical current for soft tissue coagulation; designed for minimally invasive orthopedic applications. Tested for electrical safety per IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995).

Indications for Use

Indicated for patients undergoing minimally invasive orthopedic surgeries, including hip, knee, shoulder, and elbow arthroplasty, requiring local soft tissue coagulation to mark sites for subsequent osteotomies.

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

• Saphyre Bipolar Ablation Probes (K031371)

Submission Summary (Full Text)

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## KO33652 (pg 1 of 2

Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | November 19, 2003 |
| Trade Name: | Minimally Invasive Solutions™ Osteotomy Guide<br>Instrument |
| Common Name: | Osteotomy Guide |
| Classification Name<br>and Reference: | Electrosurgical Cutting and Coagulation Device and<br>Accessories, 21 CFR § 878.4400 |
| Predicate Device: | Saphyre Bipolar Ablation Probes, manufactured by<br>Smith and Nephew, Inc., K031371, cleared May 23,<br>2003. |
| Device Description: | The Osteotomy Guide will be used as an aid to help<br>the surgeon mark the periosteal location of the<br>osteotomy cut in the calcar of the femur as part of a<br>replacement surgery. |
| Intended Use: | This device is intended for local coagulation of soft<br>tissues during minimally invasive orthopedic<br>surgeries, such as, but not limited to hip, knee,<br>shoulder and elbow arthroplasty by use of high-<br>frequency electrical current. This local coagulation<br>serves to mark the tissue to aid the surgeon in the<br>location of subsequent osteotomies. |
| Comparison to Predicate Device: | Both the predicate and proposed device are used to<br>coagulate soft tissue. |

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Traditional 510(k) Premarket Notification

## K033652 (pg 2 of 2)

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

UL Testing was performed per IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995) and passed all applicable tests.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K033652

Trade/Device Name: Minimally Invasive Solutions™ Osteotomy Guide Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 19, 2003 Received: November 20, 2003

Dear Mr. McKelvey:

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 commercc 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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. Stephen H. McKelvey

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost
les

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

KO33652 510(k) Number (if known):

Device Name:

Minimally Invasive Solutions™ Osteotomy Guide Instrument

## Indications for Use:

This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.

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)

Ko 33652

iriam C. Provost

Jusion Sign-Off) reision of General, Restorative . | Neurologi ******************************************************************************************************************************************************************************

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