(87 days)
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Not Found
No
The summary describes a navigation system that uses infrared markers and pre-operative imaging (CT/MR) to guide instruments. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The technology described is consistent with traditional image-guided surgery systems.
No.
The device is described as an aid for precisely locating anatomical locations, indicating it's a navigational or guidance system for surgery, not one that directly treats a medical condition.
No.
The device is described as an aid for precisely locating anatomical locations and image-guiding surgical instruments, not for diagnosing medical conditions. It uses pre-existing CT or MR models of anatomy.
No
The device description explicitly mentions a "Universal Attachment with infrared markers," which is a hardware component.
No, this device 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.
- Device Function: The StealthStation™ System with the Universal Attachment is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures during surgical procedures using pre-operative imaging (CT or MR). It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical locations in either open or percutaneous procedures" and is used in "stereotactic surgery." This is a surgical tool, not a diagnostic test.
The information provided about the device description, input imaging modality, anatomical site, and predicate devices all support its classification as a surgical navigation system, not an IVD.
N/A
Intended Use / Indications for Use
The StealthStation™ System with the Universal Attachment 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 appropriate, 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 is also indicated for intranasal or sinus use.
Product codes
HAW
Device Description
This submission describes a Universal Attachment with infrared markers that allows a StealthStation® System user to image guide rigid surgical instruments.
Mentions image processing
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Mentions AI, DNN, or ML
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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, intranasal or sinus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 1 4 1999
510(k) Summary
Universal Attachment for the StealthStation® System
- I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Universal Attachment II. Product Name:
- This submission describes a Universal Attachment with infrared markers that III. allows a StealthStation® System user to image guide rigid surgical instruments.
- The StealthStation® System with the Universal Attachment is intended as an aid IV. 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 appropriate, 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 is also indicated for intranasal or sinus use.
- V. The Universal Attachment for the StealthStation@ System was shown to be substantially equivalent to the previously cleared StealthStation® System and the BrainLAB VectorVision™ System.
1
JAN 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger White Group Director Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020
Re: K983670
Trade Name: StealthStation™ System Universal Attachment Regulatory Class:II Product Code: HAW Dated: October 15, 1998 Received: October 19, 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
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page __ 1__ of_ 1
510(k) Number (if known):
Device Name: __ Universal Attachment
Indications For Use:
The StealthStation™ System with the Universal Attachment 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 appropriate, 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 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)
(Divisign St
Division of General Restorative Devices 12983670
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)