(86 days)
No
The summary describes a surgical navigation system that tracks instruments based on pre-operative imaging and rigid anatomical structures. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections. The focus is on tracking and localization, not on automated analysis or decision-making typically associated with AI/ML in medical devices.
No.
The device is intended as an aid for precisely locating anatomical locations during surgery, which is a navigational and guidance function, not a therapeutic intervention itself.
No.
The "Intended Use" section states that the StealthStation™ System is intended as an aid for precisely locating anatomical locations during surgical procedures and for stereotactic surgery, using pre-existing CT or MR models of the anatomy. This describes a surgical navigation or guidance system, which assists in treatment by providing location information, rather than diagnosing a medical condition or disease.
No
The device description explicitly mentions a "StealthStation™ Drill Attachment" and its ability to track a "powered surgical drill," indicating 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 surgical navigation system used during a medical procedure on a patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The StealthStation™ does not perform such tests on bodily samples.
- Device Description: The description focuses on tracking surgical instruments (a powered surgical drill) relative to anatomical structures based on imaging data. This is consistent with surgical navigation, not in vitro testing.
- Input Imaging Modality: The input is CT or MR based models of anatomy, which are used for surgical planning and navigation, not for analyzing bodily fluids or tissues.
Therefore, the StealthStation™ System, as described, falls under the category of a surgical navigation 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
HAW
Device Description
StealthStation™ Drill Attachment
This submission is an addendum to K954276 which allows the StealthStation™ to track a powered surgical drill.
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
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
The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.
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
NOV 2 1 1997
Summary of Safety and Effectiveness
K954276 Addendum - August 14, 1997 StealthStation™ Drill Attachment
Surgical Navigation Technologies, Inc. I. Company: 530 Compton Street Broomfield, CO 80020
- Product Name: StealthStation™ Drill Attachment II.
- This submission is an addendum to K954276 which allows the III. StealthStation™ to track a powered surgical drill.
- The StealthStation™ Drill Attachment's ability to track a drill bit of known IV. length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol, which is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person's head and shoulders. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 21 1997
Mr. David A. Mire Clinical and Regulatory Affairs Associate Surgical Navigation Technologies, Incorporated 530 Compton Street Broomfield, Colorado 80020
Re : K974161 StealthStation™ System Trade Name: Requlatory Class: II Product Code: HAW Dated: August 26, 1997 Received: August 27, 1997
Dear Mr. Mire:
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, Druq, 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, labelinq, and prohibitions aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
. . *
2
Page 2 - Mr. Mire
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, MD Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
510(k) Number (if known): K 9741 C /
Device Name: _________________________________________________________________________________________________________________________________________________________________
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)
Coneurrence of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
on Control Division of Dental, Into and General Hospita 510(k) Number _
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)