(86 days)
No
The summary describes a change to the camera array technology for anatomical localization, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is used for precise anatomical localization during surgical procedures, not for treating a disease or condition itself. It aids in surgery rather than providing therapy.
No
The device is described as an aid for precisely locating anatomical locations during surgery, using CT or MR-based models. Its purpose is navigational assistance during procedures, not to diagnose a medical condition.
No
The device description explicitly mentions a "camera array utilizing two 2-dimensional cameras," indicating the presence of hardware components beyond just software.
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 the StealthStation® System is an aid for precisely locating anatomical locations in either open or percutaneous procedures. This describes a device used during a surgical or interventional procedure on a patient, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the camera system used for tracking anatomical locations during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on sample analysis, or providing information for diagnosis based on laboratory tests.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The StealthStation® System's function is to provide surgical navigation and guidance based on imaging data and real-time tracking of instruments relative to the patient's anatomy.
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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.
Product codes
HAW
Device Description
This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
skull, a long bone, or vertebra, intranasal or sinus
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
Performance data was provided to support the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
AUG - 7 1998
Summary of Safety and Effectiveness
StealthStation® System - Digitizer Change
K981686
- Surgical Navigation Technologies I. Company: 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Name: StealthStation™ System Digitizer Change II.
- III. This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.
- 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 perculaneous 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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.
- V. The StealthStation™ System - Digitizer Change was shown to be substantially equivalent to the original StealthStation™ System cleared in K954276. Performance data was provided to support the claim of substantial equivalence.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1998
Mr. Roger White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: K981686 Trade Name: StealthStation® System Digitizer Change Regulatory Class: II Product Code: HAW Dated: June 25, 1997 Received: May 13, 1998
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, 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 (QS) 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
Page 2 - Mr. Roger White
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1__ of__ 1
510(k) Number (if known): K981686 --------------------------------------------------------------------------------------------------------------------------------------------
Device Name: StealthStation® System Digitizer Change
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 General Restorative Devices |
| K981686 |
5100k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)