(82 days)
original StealthStation® System with active probes, BrainLAB VectorVision System
None
No
The summary describes updates to an existing navigation system focused on optical tracking technology and does not mention AI or ML.
No
The device is an aid for precisely locating anatomical structures during surgery, not directly treating a medical condition or restoring function. Its primary role is navigation support, not therapeutic intervention.
No
The device description states its intended use is to aid in precisely locating anatomical locations, indicating it is an assistive tool for surgery rather than a diagnostic device.
No
The device description explicitly mentions "optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments," indicating the presence of hardware components (optical tracking system, reflective spheres).
Based on the provided information, the StealthStation® System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an aid for precisely locating anatomical locations in either open or percutaneous procedures. This describes a surgical navigation system used during a medical procedure on a patient.
- 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. The StealthStation® System does not perform any such tests on biological samples.
- Device Description: The description focuses on optical tracking of instruments during a procedure, not on analyzing biological samples.
Therefore, the StealthStation® System falls under the category of a surgical navigation or guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.
Product codes
84HAW
Device Description
This submission describes updates made to the StealthStation® System to provide for optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model of the anatomy.
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance data was provided to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
original StealthStation® System with active probes, BrainLAB VectorVision System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 6 1997
Summary of Safety and Effectiveness
StealthStation® System - Passive Instrument Option
| I. | Company: Surgical Navigation Technologies
530 Compton St.
Broomfield, CO 80020
(303) 439-9709 |
| ---- | -------------------------------------------------------------------------------------------------------- |
|---|
- StealthStation® System Passive Instrument Option Product Name: II.
- III. This submission describes updates made to the StealthStation® System to provide for optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments.
- IV. The indications for use for the StealthStation® System have not changed and are as follows:
The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.
- v. The StealthStation® System - Passive Instrument Option was shown to be substantially equivalent to the original StealthStation® System with active probes. Performance data was provided to support the claim of substantial equivalence. In addition, the StealthStation System with the Passive Instrument Option was shown to be substantially equivalent to the BrainLAB VectorVision System.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. Roger N. White Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: K972398 StealthStation® Treatment Guidance Platform Trade Name: Requlatory Class: II Product Code: 84HAW Dated: June 25, 1997 Received: June 26, 1997
Dear Mr. White:
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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
2
Page 2 - Mr. Roger N. White
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 requlations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callawan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ___ 1__ of__1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: StealthStation® System - Passive Instrument Option ______________________________________________________________________________________________________________
Indications For Use:
The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K972398 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |