VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE

K991706 · Stryker Corp. · HAW · Dec 7, 1999 · Neurology

Device Facts

• Record ID: K991706
• Device Name: VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
• Applicant: Stryker Corp.
• Product Code: HAW · Neurology
• Decision Date: Dec 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VIRTUOSO is a software-based planning system used to create treatment plans for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment 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.

Device Story

VIRTUOSO is a software-based planning system for radiation therapy. It enables radiation therapy experts to create treatment plans for patients requiring high-energetic photon radiation. Operated by clinicians in computer-equipped environments, the software assists in the precise planning of therapeutic radiation delivery. The output is a treatment plan used by medical professionals to guide radiation therapy, aiming to improve the accuracy and efficacy of patient treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based planning system for radiation therapy. Operates on standard computer hardware. No specific materials, energy sources, or connectivity standards detailed.

Indications for Use

Indicated for patients selected for precise radiation therapy using high-energetic photons, managed by radiation therapy experts under medical supervision.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• STP treatment planning software (K892425D)

Submission Summary (Full Text)

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K 99 1706

# VIRTUOSO Summary of Safety and Effectiveness

### Device Name:

| Classification Name: | Instrument, Stereotaxic: 21 CFR 882.4560, Class II |
|----------------------|----------------------------------------------------|
| Common/Usual Name: | Stereotaxic Planning Software |
| Proprietary Name: | VIRTUOSO – Stereotaxic Planning Software |

#### Device Sponsor:

| Manufacturer: | Stryker Corporation<br>Stryker Leibinger GmbH and Co. KG<br>Botzinger Straße 41<br>D-79111 Freiburg Germany<br>Registration No.: 8010177 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | Stryker Corporation<br>Stryker Leibinger<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>Registration No.: 1811755 |
| Regulatory Class: | Class II |

# Summary of Safety and Effectiveness:

The VIRTUOSO Stereotaxic Planning Software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-onergetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment 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.

The VIRTUOSO Stereotaxic Planning Software is equivalent to the STP treatment planning software K892425D. The VIRTUOSO Stereotaxic Planning Software does not raise any new safety and efficacy concerns when compared to this similar legally marketed software. Therefore, the VIRTUOSO Stereotaxic Planning Software is substantially equivalent to this existing software.

By: Nicole Petty

Nicole Petty Regulatory Affairs Representative Stryker Instruments

Dated: 5-18-99

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 1999

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Corporation 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K991706 Trade Name: VIRTUOSO Stereotactic Planning Software Regulatory Class: II Product Code: HAW Dated: September 20, 1999 Received: September 21, 1999

Dear Ms. Petty:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

pcollyer

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) K 99/706
Number

Number

VIRTUOSO - Stereotaxic Planning Software Device Name

VIRTUOSO is a software-based planning system used to create treatment plans Indications for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
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OR

| Over-The-Counter Use | |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991706 |