(131 days)
Not Found
Not Found
No
The summary focuses on the intended use and device description, which is a revised indications statement for an existing system. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used to assist in precisely locating anatomical locations during surgery, which is a diagnostic or surgical aid, not a therapeutic intervention itself.
No
The device is described as an aid for precisely locating anatomical locations during surgical procedures. Its purpose is to guide surgery based on existing CT or MR models, not to diagnose medical conditions or identify diseases.
No
The device description and intended use clearly indicate a "StealthStation™ System," which is a surgical navigation system. These systems are hardware-based, utilizing tracking technology and other physical components to aid in surgical procedures. The submission describes a revised indications statement for an existing system, not a new, software-only device.
Based on the provided information, the StealthStation™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an aid for precisely locating anatomical locations during surgical procedures. This is a surgical navigation system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on a revised indications statement for a specific surgical application (ENT).
- Input: The input is based on CT or MR images of the patient's anatomy, not biological specimens.
- Anatomical Site: The anatomical sites are parts of the patient's body (skull, bones, sinuses), not biological samples.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids or substances outside the body to provide diagnostic information. The StealthStation™ System is used during surgery to guide the surgeon based on imaging data.
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
84 HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data was provided to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
StealthStation 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
Ki 14,51
JAN 2 1 1998
510(k) Summary
StealthStation™ System - ENT Application
Surgical Navigation Technologies I. Company: 530 Compton Street Broomfield, CO 80020 (303) 439-9709
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Product Name: StealthStation System ENT Application II.
}) -
This submission describes a revised indications statement for the III. StealthStation System to provide specifically for the ENT application of intranasal or sinus use.
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The indications for use for the StealthStation System are as follows: IV.
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.
- The StealthStation System ENT Application was shown to be V. substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1998
Roger White Group Director Quality Systems and Regulatory Affaris Surgical Navigation Technologies 530 Compton Street Broomfield, CO 80020
Re:
K974187 StealthStation™ System - ENT Application Dated: December 15, 1997 Received: December 16, 1997 Regulatory class: II 21 CFR 882.4560/Procode: 84 HAW
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 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 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 OS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. ... . . . . . . . . . .
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) 594-4613. 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/cdrb/dsmamain.html":---------------------------------------------------------------------------------------------
Sincerely yours,
hìàu Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K974187 ____________________________________________________________________________________________________________________________________________
Device Name: StealthStation System - ENT Application
Indications For Use:
D
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
| David C. Seymour | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K974187 |
| Prescription Use | X | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |