(100 days)
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Not Found
No
The document describes updates to existing hardware and operating system options for a surgical navigation system, focusing on locating anatomical structures using imaging modalities. There is no mention of AI or ML in the intended use, device description, or specific sections dedicated to AI/ML information.
No.
The device is intended as an aid for precisely locating anatomical structures for surgical procedures, not for therapeutic treatment itself.
No
The device is described as an aid for precisely locating anatomical structures during surgery, not for identifying or diagnosing a condition.
No
The device description explicitly states that this submission includes updates to the StealthStation System, including new computer hardware, operating system options, a passive-only optical digitizer option, and new cranial and EM reference frames. These are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the StealthStation System is intended as an aid for precisely locating anatomical structures in vivo (within the body) during surgical procedures. It uses imaging data (CT, MR, fluoroscopy) and digitized landmarks to guide the surgeon.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on specimens taken from the patient.
The device is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures, 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, fluoroscopy images, or digitized landmarks of the anatomy.
For the optical-based and EM-based system, 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. 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. Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies. Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty.
Additional example procedures for the optical-based system include, but are not limited to: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty, Minimally Invasive Orthopaedic Procedures, Pediatric Orthopaedics, Total Hip Replacement (Primary and Revision), Periacetabular Osteotomies, 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).
Product codes
HAW
Device Description
This submission provides an update to the StealthStation® System, including a new computer hardware and operating system options, a passive-only optical digitizer option, new cranial reference frame and EM reference frame.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT or MR based model, fluoroscopy images
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
KOSO438
Summary of Safety and Effectiveness StealthStation® System Update
Manufacturer Medtronic Navigation, Inc. 826 Coal Creek Circle
l.
Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
II. Contact Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.
III. Product Name / Classification
Stereotaxic instrument Common Name: Instrument, Stereotaxic Classification Name: StealthStation® System Update Trade Name:
Stereotaxic instrument - Class II as described in 21 CFR § 882.4560 Product Code: HAW
IV. Date Summary Submitted February 18, 2005
V. Description of Device Modification
This submission provides an update to the StealthStation® System, including a new computer hardware and operating system options, a passive-only optical digitizer option, new cranial reference frame and EM reference frame.
VI. Substantial Equivalence
The StealthStation® System Updates were shown to be substantially equivalent to the StealthStation® System cleared in previous 510(k) submissions. As required by risk analysis, all verification and validation activities were performed by designated individuals and the results demonstrated the substantial equivalence.
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1
Image /page/1/Figure/0 description: The image shows a sequence of alphanumeric characters. The characters are 'KOSOG38'. The characters are written in a handwritten style.
This submission does not change the indications for use for the StealthStation System.
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, fluoroscopy images, or digitized landmarks of the anatomy.
For the optical-based and EM-based system, example procedures include, but are not limited to:
| Cranial Procedures: | Spinal Procedures: |
|---|---|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle |
| Tumor Resections | Screw Placement |
| Craniotomies/ Craniectomies | |
| Skull Base procedures | ENT Procedures: |
| Thalamotomies/Pallidotomies | Transphenoidal Procedures |
| Pituitary Tumor Removal | Intranasal Procedures |
| CSF Leak Repair | Orbital Nerve Decompression Procedures |
| Pediatric Catheter Shunt Placement | Optic Nerve Decompression Procedures |
| General Catheter Shunt Placement | Polyposis Procedures |
| Endoscopic Dacryocystorhinostomy | |
| Orthopaedic Procedures: | Encephalocele Procedures |
| Total Knee Arthroplasty (Primary and Revision) | Sinus procedures, such as Maxillary |
| Unicompartmental Knee Arthroplasty | Antrostomies. Ethmoidectomies, |
| Sphenoidotomies/Sphenoid Explorations |
Turbinate Resections, and Frontal
Sinusotomies
Additional example procedures for the optical-based system include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision) Unicompartmenta! Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies 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)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circle around the eagle.
JUN 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation Incorporated 826 Coal Creek Circle Louisville, Colorado 80027
Re: K050438
Trade/Device Name: StealthStation® System Update Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 16, 2005 Received: May 17, 2005
Dear Ms. Dreiling:
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. Tina Dreiling
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 (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
510(k) Number (if known): K050438
Device Name: StealthStation® System Update
Indications for Use
This submission does not change the indications for use for the StealthStation System.
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, fluoroscopy images, or digitized landmarks of the anatomy.
For the optical-based and EM-based system, 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
Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement
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. Ethmoidectornies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Additional example procedures for the optical-based system include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies 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)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z. le. le
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Medtronic Navigation, Inc.
Restorative
Devices CONFIDENTIAL