RADIOSYSTEM/NT, MODEL 80-13020

K020320 · Styker Instruments · IYE · Aug 28, 2002 · Radiology

Device Facts

• Record ID: K020320
• Device Name: RADIOSYSTEM/NT, MODEL 80-13020
• Applicant: Styker Instruments
• Product Code: IYE · Radiology
• Decision Date: Aug 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers. In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.

Device Story

RadioSystem/NT is a software-based stereotactic planning system for radiation therapy. It enables creation of treatment plans for high-energy photon therapy, interstitial radiosurgery (brachytherapy), and stereotactic procedures. Used by radiation therapy experts under medical supervision in clinical settings suitable for computer operation. Software processes clinical data to generate treatment plans, assisting clinicians in defining target volumes and radiation delivery parameters. Benefits include precise, individualized radiation treatment planning for patients requiring therapy.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Software-based planning system for radiation therapy. Supports high-energy photon therapy, brachytherapy, and stereotactic planning. Operates on standard computer hardware in clinical environments.

Indications for Use

Indicated for patients requiring precise radiation therapy for arbitrary body parts based on medical diagnosis. Supports planning for high-energy photon radiation therapy, interstitial radiosurgery (brachytherapy), and stereotactic approaches.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 8 2002

Re: K020320

Trade/Device Name: RadioSystem/NT V1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 IYE and KXK Dated: May 29, 2002 Received: May 30, 2002

Dear Ms. Bitterburg:

Ms. Kelli Bitterburg

Stryker Leibinger

Regulatory Affairs Associate

4100 East Milham Avenue

KALAMAZOO MI 49001

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):

RadioSystem/NT Device Name:

Indications For Use:

1 :

The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

Kozo320

In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The- Counter Use

(Optional Format 1-2-96)

Nancy L. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number.