(214 days)
No
The provided text does not mention AI, ML, or related terms, and the device description is not available to assess its internal workings. The focus is on image-guided navigation based on pre-existing imaging data.
No
The device is intended as an aid for precisely locating anatomical structures during surgery, which is a navigational or guidance function, not a direct therapeutic intervention.
No
The device is an aid for precisely locating anatomical structures during surgical procedures and is indicated for conditions where stereotactic surgery is appropriate. It uses imaging for surgical planning and navigation, not for diagnosing a medical condition.
No
The description refers to a "StealthStation® System" which is a navigation system used in surgery. While it likely includes software, the description of its intended use in precisely locating anatomical structures during procedures strongly implies the presence of hardware components (e.g., tracking systems, displays, probes) necessary for surgical navigation. The lack of a "Device Description" section prevents a definitive statement, but the context points away from a 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 that the system is "intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures." This describes a surgical navigation or guidance system used during a medical procedure on a patient.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health status. The StealthStation® System does not perform this function. It uses imaging data of the patient's anatomy to guide surgical tools.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a disease state based on laboratory results.
Therefore, the StealthStation® System falls under the category of a surgical navigation or guidance 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 or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies.
Spinal Procedures:
Spinal implant procedures, such as pedicle screw placement.
ENT Procedures:
Transphenoidal procedures. Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model or fluoroscopy images
Anatomical Site
skull, a long bone, or vertebra (for Cranial Procedures, Spinal Procedures, ENT Procedures)
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)
A review of clinical study data originally submitted in K954276 was provided to support the claim of substantial equivalence.
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
StealthStation® System - Indications Modification
Date Summary Prepared: February 9, 2000
- Contact: Roger N. White I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Trade Name: StealthStation® System with Indications Modification II. Common or usual name: Frameless Stereotactic System Classification name: Stereotactic Instrument (84HAW per 21 CFR 882.4560)
- The above device is substantially equivalent to the StealthStation® System cleared in III. K954276/K972398/K974187. This submission describes a change to the indications for use only. A review of clinical study data originally submitted in K954276 was provided to support the claim of substantial equivalence.
- This 'submission describes a modification to the StealthStation® System indications for IV. use to provide specific examples of surgical procedures on which use of the StealthStation System® may be appropriate.
- The indications for use for the StealthStation® System are as follows: V.
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 fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies.
1
Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '992461'. The characters are written in a handwritten style, with varying stroke thicknesses.
Spinal Procedures:
Spinal implant procedures, such as pedicle screw placement.
ENT Procedures:
:
| Transphenoidal procedures |
|---|
| Intranasal procedures. |
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
- Since this submission is a change only to the indications for use, the technological VI. characteristics of the device are the same as or similar to those for the predicate device. A review of clinical study data was provided to support the claim of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three lines above them.
FEB 22 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger N. White Group Director Ouality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020
Re: K992461
Trade Name: StealthStation Treatment Guidance Platform Regulatory Class: II Product Code: HAW Dated: December 17, 1999 Received: December 20, 1999
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.
3
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,
Stypto Rlivelu
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K992461
Device Name: StealthStation® System - Indications Modification
Indications For Use:
: 1
=
The StealthStation® System is intended as an aid for precisely locating anatomical structures I he bearn Dation & Bystem is procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where medical continuen in "himical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies.
Spinal Procedures:
Spinal implant procedures, such as pedicle screw placement.
ENT Procedures:
Transphenoidal procedures. Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectornies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992461