(30 days)
StealthStation System cleared in previous 510(k)'s.
Not Found
No
The summary describes updates to software algorithms for a registration method but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is an aid for precisely locating anatomical structures during surgery and does not directly treat a medical condition. It assists in surgical procedures that are therapeutic, but it is a guidance system, not a therapeutic device itself.
No
The device is intended as an aid for precisely locating anatomical structures during surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states "updates made to the StealthStation® System to include software algorithms". The StealthStation® System is a surgical navigation system, which inherently includes hardware components for tracking and guidance, not just software. This submission describes updates to the software component of an existing hardware/software system.
Based on the provided information, the StealthStation® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- StealthStation® System's Function: The description clearly states the StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It uses imaging data (CT, MR, fluoroscopy) to guide surgical procedures within the body.
- Lack of Specimen Testing: There is no mention of the device analyzing or testing any biological specimens.
Therefore, the StealthStation® System falls under the category of a surgical navigation or guidance system, which is a type of medical device used during surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The indications for use for the StealthStation® System Advanced Contour Registration Software Module are identical to the StealthStation® System indications for use. The indications for use are as follows:
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
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw Placement
Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Placement of Iliosacral Screws
Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)
ENT Procedures:
Transphenoidal Procedures
Intranasal Procedures
Orbital Nerve Decompression Procedures
Optic Nerve Decompression Procedures
Polyposis Procedures
Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.
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
rigid anatomical structure, such as the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
StealthStation System cleared in previous 510(k)'s.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K030/06
Summary of Safety and Effectiveness StealthStation® System Advanced Contour Registration Software Module
I. Manufacture:
Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: (720) 890-3200 Fax Number: (720) 890-3500
FEB 1 2 2003
II. Contact:
Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies
III. Product Name/ Classification Name:
Product Name: StealthStation® System Advanced Contour Registration Software Module Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification Panel: 84 HAW
Date Summary Submitted IV.
January 10, 2003
Description of Device Modification: V.
This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.
VI. Substantial Equivalence:
The StealthStation® System Advanced Contour Registration Software Module was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.
1
VII. Indications For Use:
Encephalocele Procedures
The indications for use for the StealthStation® System Advanced Contour Registration Software Module are identical to the StealthStation® System indications for use. The indications for use are as follows:
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: | Spinal Procedures: | Orthopedic Procedures: |
|---|---|---|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle | Total Knee Arthroplasty (Primary and Revision) |
| Tumor Resections | Screw Placement | Unicompartmental Knee Arthroplasty |
| Craniotomies/ Craniectomies | Minimally Invasive Orthopedic Procedures | |
| Skull Base procedures | Total Hip Replacement (Primary and Revision) | |
| Thalamotomies/Pallidotomies | Tumor Resection and Bone/Joint Reconstruction | |
| Pituitary Tumor Removal | Femoral Revision | |
| CSF Leak Repair | Placement of Iliosacral Screws | |
| Pediatric Catheter Shunt Placement | Stabilization and Repair of Pelvic Fractures | |
| General Catheter Shunt Placement | (Including but not Limited to Acetabular | |
| Fractures) | ||
| ENT Procedures: | ||
| Transphenoidal Procedures | ||
| Intranasal Procedures | ||
| Orbital Nerve Decompression Procedures | ||
| Optic Nerve Decompression Procedures | ||
| Polyposis Procedures | ||
| Endoscopic Dacryocystorhinostomy |
Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
FFB 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Surgical Navigation Technologies Victoria G. Rendon Clinical and Regulatory Affairs Associate 826 Coal Creek Circle Louisville, Colorado 80027
Re: K030106
Trade/Device Name: StealthStation System Advanced Contour Registration Software Module
Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: January 10, 2003 Received: January 13, 2003
Dear Ms. Rendon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Victoria G. Rendon
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of of l
510(k) Number (if known): ≤030 l o 6
Device Name: StealthStation® System Advanced Contour Registration Software Module
Indications for Use:
The indications for use for the StealthStation® System Advanced Contour Registration Software Module is identical to the StealthStation® System indications for use. The indications for use are as follows:
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: | Spinal Procedures: | Orthopedic Procedures: |
|---|---|---|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle | Total Knee Arthroplasty (Primary and Revision) |
| Tumor Resections | Screw Placement | Unicompartmental Knee Arthroplasty |
| Craniotomies/ Craniectomies | Minimally Invasive Orthopedic Procedures | |
| Skull Base procedures | Total Hip Replacement (Primary and Revision) | |
| Thalamotomies/Pallidotomies | Tumor Resection and Bone/Joint Reconstruction | |
| Pituitary Tumor Removal | Femoral Revision | |
| CSF Leak Repair | Placement of Iliosacral Screws | |
| Pediatric Catheter Shunt Placement | Stabilization and Repair of Pelvic Fractures | |
| (Including but not Limited to Acetabular | ||
| General Catheter Shunt Placement | ||
| ENT Procedures: | ||
| Transphenoidal Procedures | ||
| Intranasal Procedures |
Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures
Fractures)
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, 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 (Per 21 CFR 801.109)
OR Over-The-Counter Use
Miriam C. Provost
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510/k) Niimker
0469