(202 days)
K892425D
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard treatment planning software functionality.
No
The device is a planning system for radiation therapy, not the therapy itself. It assists in creating treatment plans for a therapeutic procedure but does not directly administer the therapy.
No
The device is described as a "software-based planning system used to create treatment plans for radiation therapy." It aids in treatment planning based on an existing medical diagnosis, rather than making a diagnosis itself.
Yes
The device description explicitly states "The VIRTUOSO Stereotaxic Planning Software is a software-based planning system". There is no mention of any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VIRTUOSO is a software-based planning system used to create treatment plans for radiation therapy. This is a therapeutic application, not a diagnostic one.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. VIRTUOSO does not perform any such tests.
- Device Description: The device description reinforces its role in creating treatment plans for radiation therapy.
The information provided focuses on the planning and delivery of a medical treatment (radiation therapy), which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
HAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K892425D
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
Stryker Leibinger GmbH and Co. KG
Botzinger Straße 41
D-79111 Freiburg Germany
Registration No.: 8010177 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | Stryker Corporation
Stryker Leibinger
4100 E. Milham Avenue
Kalamazoo, MI 49001
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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.
2
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991706 |