(120 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on image-guided tracking of a motorized instrument placement tool, which is a common function in traditional navigation systems.
No
The device is described as an aid for precisely locating anatomical structures for surgical procedures, focusing on guidance rather than direct treatment or therapy.
No
The device is described as an aid for precisely locating anatomical structures during surgery, not for diagnosing medical conditions. Its intended use focuses on guidance during procedures, not on identifying diseases or conditions through analysis of medical data.
No
The device description explicitly states it is a "modification to the StealthStation® System," which is a hardware-based image-guided surgery system. The modification is to provide tracking for a "motorized instrument placement tool," further indicating hardware interaction.
Based on the provided information, the StealthStation® System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- StealthStation® System's Intended Use: The intended use clearly states that the system is an "aid for precisely locating anatomical structures in either open or percutaneous procedures." It uses imaging modalities (CT, MR, fluoroscope) to guide surgical procedures based on the patient's anatomy.
- Lack of Biological Sample Analysis: There is no mention of the StealthStation® System analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is purely related to image-guided navigation during surgery.
Therefore, the StealthStation® System falls under the category of a surgical navigation system or image-guided surgery 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 structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where 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 a modification to the StealthStation® System to provide for image-guided tracking of a motorized instrument placement tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model or fluoroscope images
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 (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)
K992927: StealthStation System with the SNT Image Guided Biopsy Needle and the Compass Stereotactic Positioning 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
Summary of Safety and Effectiveness
StealthStation® System - NATREXTM Device
Submitter Information: I.
Contact: Angelique Destruel Clinical and Regulatory Affairs Associate Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Trade Name: StealthStation® System with NATREX™M Device II. Common or usual name: Stereotactic System Stereotactic Instrument Classification name:
- The above device was shown to be substantially equivalent to the StealthStation System III. with the SNT Image Guided Biopsy Needle and the Compass Stereotactic Positioning System. Performance data was provided to support the claim of substantial equivalence.
- This submission describes a modification to the StealthStation® System to provide for IV. image-guided tracking of a motorized instrument placement tool.
- The indications for use for the StealthStation® System have not changed and are as V. follows:
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where 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.
- VI. The technological charecteristics are the same as or similar to those found with the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Ms. Angelique Destruel Clinical and Regulatory Affairs Associate Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020
Received: November 18, 1999
K992927 Re: Trade Name: NATREXTM Device for StealthStation® System Regulatory Class: II Product Code: HAW Dated: November 17, 1999
Dear Ms. Destruel:
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 - Ms. Angelique Destruel
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 vours.
Russell Sage
Sur James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
K992927 510(k) Number (if known):
Device Name: StealthStation® System - NATREX™ Device
Indications For Use:
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where 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 or fluoroscope images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Vernell Lyons 80125
(Division Sign-Off) Division of General Restor 510(k) Number .