(85 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on passive markers, not advanced algorithms.
No
The device is described as an aid for precisely locating anatomical locations during surgery, not as a treatment or therapy itself. It assists in surgical procedures rather than providing a therapeutic effect.
No
The provided text focuses on the StealthStation™ System being an "aid for precisely locating anatomical locations" during surgical procedures ("stereotactic surgery"). It uses CT or MR based models for navigation during surgery, not for diagnosing a medical condition.
No
The device description explicitly states it provides "pre-sterilized passive markers for the StealthStation™ instruments," indicating a hardware component. The intended use also describes a "StealthStation™ System," which is a larger navigation system that includes hardware.
Based on the provided information, the StealthStation™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- StealthStation™ System's 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 means it's used during surgical procedures on the patient's body, not for testing specimens outside the body.
- Device Description: The device description focuses on updates to the system for providing pre-sterilized passive markers for instruments used in these procedures. This aligns with a surgical navigation system, not an IVD.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, laboratory testing, or diagnostic information derived from samples.
Therefore, the StealthStation™ System is a surgical navigation system used to guide procedures within the body, not an IVD.
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 updates made to the StealthStation™ System to provide the option for providing pre-sterilized passive markers for the StealthStation™ instruments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary
Sterile Passive Markers for the StealthStation™ System
I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Sterile Passive Markers for the StealthStation™ System II. Product Name:
- This submission describes updates made to the StealthStation™ System to provide III. the option for providing pre-sterilized passive markers for the StealthStation™ instruments.
- The indications for use for the StealthStation™ System have not changed and are as IV. follows:
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.
- V. The Sterile Passive Marker for the StealthStation™ System was shown to be substantially equivalent to the Passive Marker Option for the StealthStation™ System that was cleared in K972398.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUM. SERVICES USA" are written around the eagle in a circular pattern. The eagle is a symbol of the United States, and the seal represents the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Roger N. White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: K981684 Trade Name: StealthStation™ System - Battery Powered Marker Option Regulatory Class: II Product Code: HAW Dated: May 12, 1998 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 (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 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 N. 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
3
510(k) Number (if known): 9871684
Device Name: StealthStation™ System - Battery Powered Marker Option
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.
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(Division Sign-Off)
Division of General Restorative Devices K981684
510(k) Number
Prescription Use U (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)