NON-INVASIVE PATIENT FIXATION SYSTEM

K023449 · Stryker Leibinger · IYE · Jan 13, 2003 · Radiology

Device Facts

• Record ID: K023449
• Device Name: NON-INVASIVE PATIENT FIXATION SYSTEM
• Applicant: Stryker Leibinger
• Product Code: IYE · Radiology
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.

Device Story

Non-invasive patient fixation system; used for patient positioning and immobilization during stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets. Device provides stable, reproducible patient orientation to ensure accurate delivery of radiation therapy. Operated by clinical staff in radiation oncology settings. System facilitates precise targeting of extracranial/cranial regions; ensures patient remains stationary during diagnostic or therapeutic procedures. Benefits include improved accuracy of radiation delivery and patient safety through non-invasive stabilization.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to existing legally marketed devices.

Technological Characteristics

Non-invasive mechanical fixation system for patient positioning and immobilization. Designed for stereotactic diagnostic localization and radiotherapy. Technical specifications and materials are consistent with existing predicate fixation systems.

Indications for Use

Indicated for patient positioning and immobilization, stereotactic diagnostic localization, and stereotactic radiotherapy of cranial targets.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Reference Devices

• Stryker patient fixation systems
• BrainLab patient fixation systems
• Medical Intelligence patient fixation systems

Submission Summary (Full Text)

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K023449

JAN 1 3 2003

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: NON-INVASIVE PATIENT FIXATION SYSTEM

## General Information

| Proprietary Name: | Non-Invasive Patient Fixation<br>System |
|--------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Patient Fixation |
| Classification Name(s): | System, Radiation Therapy, Charged<br>Particle, Medical |
| Classification Code(s): | 90LHN |
| Submitter: | Stryker Corporation<br>Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Kelli J. Bitterburg<br>Regulatory Affairs Associate<br>Phone: [phone] x4026<br>Fax: [phone] |
| Summary Preparation Date: | October 14, 2002 |

## Summary of Safety and Effectiveness

The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.

The Stryker Non-Invasive Patient Fixation System is equivalent in intended use, safety, and effectiveness to existing patient fixation systems being marketed by companies such as Stryker, BrainLab and Medical Intelligence. It does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Non-Invasive Patient Fixation System is substantially equivalent to these existing devices.

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Kelli J. Ritterburg

Kelli-J. Bitterburg
Regulatory Affairs Associate
October 14, 2002

.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 3 2003

Ms. Kelli J. Bitterburg Regulatory Affairs Associate Stryker Leibinger 4100 East Milham Avenue KALAMAZOO MI 49001

Re: K023449 Trade/Device Name: Non-Invasive Patient Fixation System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle Radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 15, 2002 Received: October 16, 2002

Dear Ms. Bitterburg:

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); 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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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(K) Number (if known): | K023449 |
|---------------------------|--------------------------------------|
| Device Name: | Non-Invasive Patient Fixation System |

Page 1 of 1Indication for Use:

The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﻌﺼﺮ Prescription Use (per 21 CFR 801.109)

or

Over-The-Counter Use ________

Nancy Chrzadon

(Division Sign-Off) Division of Reproduct ve. A and Radiological Devices 510(k) Number _

(Optional Format 1-2-96)