(47 days)
Not Found
Not Found
No
The device description explicitly states the modification is to allow for the use of a wireless Bluetooth mouse, and there are no mentions of AI, DNN, or ML in the provided text.
No.
The StealthStation System is a surgical navigation system intended to aid in precisely locating anatomical structures during various procedures, not to directly treat a medical condition.
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 it is a "Modification to the StealthStation® System," which is a system used for surgical navigation and involves hardware components for tracking and localization. The modification is the addition of a wireless Bluetooth mouse, which is also a hardware component. Therefore, the device is not software-only.
Based on the provided information, 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 StealthStation System is described as an aid for precisely locating anatomical structures during surgical procedures. It uses imaging data (CT, MR, fluoroscopy) and digitized landmarks to guide the surgeon.
- Intended Use: The intended use clearly states its purpose is for surgical navigation and localization within the body, not for analyzing samples taken from the body.
- Device Description: The modification is the addition of a wireless mouse, which is a user interface component for controlling the system during surgery.
The device operates in vivo (within the living body) to assist in surgical procedures, which is distinct from the in vitro (in glass/outside the body) nature of IVDs.
N/A
Intended Use / Indications for Use
The StealthStation® System is intended as an aid for precisely locating anatomical structures in enner open of persulanced in which the use of stereotactic surgery may be Indicated for any medical condition in which the aconcel structure, such as the skull, a long appropriate, and where references to a nigra that 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, 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), 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 Piacement of Iliosacral Screws r labornent of Medarer of Pelvic Fractures (Including but not limited to Acetabular Fractures)
Product codes
HAW
Device Description
Description of Device Modification® System to allow for the use of a wireless Bluetooth mouse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
skull, a long vertebra, acetabular
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 equired by risk analysis, all verification and validation activities were performed by required by nok analyons, and the results demonstrated the substantial equivalence.
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
221029
Summary of Safety and Effectiveness StealthStation® Wireless Surgeon Mouse
- Manufacturer l. Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
- Contact 11. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.
Product Name / Classification III.
| Common Name: | Stereotaxic instrument |
|---|---|
| Classification Name: | Instrument, Stereotaxic |
| Trade Name: | StealthStation® Wireless Surgeon Mouse |
Stereotaxic instrument - Class II as described in 21 CFR § 882.4560 Product Code: HAW
- IV. Date Summary Submitted April 20, 2005
- Description of Device Modification V. Description of Device Modification® System to allow for the use of a wireless Bluetooth mouse.
- VI. Substantial Equivalence Substantial Lqurvalenoo The use of the StealthStation® Wirenton ourgressions 510(K) submissions. As equired by risk analysis, all verification and validation activities were performed by required by nok analyons, and the results demonstrated the substantial equivalence.
1
VII. Indications for Use
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 The StealthStation® Oystem is Intended as an and an and StealthStation® System is structures in enner open of persulanced in which the use of stereotactic surgery may be Indicated for any medical condition in which the aconcel structure, such as the skull, a long appropriate, and where references to a nigra that 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 |
|---|---|
| Cranial Biopsies | Spinal |
| Tumor Resections | Screw |
| Craniotomies/ Craniectomies | |
| Skull Base procedures | ENT P |
| Thalamotomies/Pallidotomies | Trans |
| Pituitary Tumor Removal | Intrana |
| CSF Leak Repair | Orbital |
| Pediatric Catheter Shunt Placement | Optic |
| General Catheter Shunt Placement | Polyp |
| Endos |
Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
Spinal Procedures: Implant Procedures, such as Pedicle Placement
rocedures: henoidal Procedures asal Procedures Nerve Decompression Procedures Nerve Decompression Procedures sis Procedures copic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary 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) 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)
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 features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
JUN 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027
Re: K051029
Trade/Device Name: StealthStation® Wireless Surgeon Mouse Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 31, 2005 Received: June 1, 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) remarket 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 other general mixernational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Signature
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
4
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: StealthStation® Wireless Surgeon Mouse
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 rite ofcalthorions operations of the StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a Condition in which the doe of etersetablications of 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 Turnor 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, 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) 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 Piacement of Iliosacral Screws r labornent of Medarer 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)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K05/029
CONFIDENTIAL