(147 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image-guided navigation based on pre-existing CT/MR models or fluoroscopy, which is a standard technique in surgical navigation systems and does not inherently require AI/ML.
No
The device aids in precision during surgical procedures by locating anatomical structures and is indicated for use in stereotactic surgery. It does not directly treat a disease or condition but rather assists the surgeon in performing the therapeutic procedure.
No
The device is intended as an aid for precisely locating anatomical structures during surgical procedures, not for diagnosing medical conditions.
No
The device is described as a "System" and a "Module" which are terms typically associated with hardware components. The description also mentions modifications to a "Module" and the intended use involves "precisely locating anatomical structures" using imaging modalities, which strongly implies the use of physical hardware for tracking and guidance, not just software.
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 an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This describes a surgical navigation system used during a medical procedure on a patient.
- 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. The StealthStation® System does not perform such tests.
- Device Description: The description focuses on image-guided surgery and orthopedic indications, which are procedures performed on the patient's body.
- Input Imaging Modality: The input is imaging data (CT, MR, fluoroscopy) of the patient's anatomy, not samples from the patient.
- Anatomical Site: The anatomical sites listed are parts of the patient's body (knee, skull, long bone, vertebra).
The StealthStation® System is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures by providing real-time guidance based on pre-operative or intra-operative imaging. This falls under the category of surgical instruments or systems, not in vitro diagnostics.
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 Pituitary Tumor Removal CSF Leak Repair
ENT Procedures:
Transphenoidal procedures Intranasal procedures Orbital 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 Orthopedic Procedures:
pedicle screw placement.
Spinal Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
Spinal implant procedures, such as
Product codes
HAW
Device Description
This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.
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
anatomical structures; skull, a long bone, or vertebra; Cranial; ENT; Spinal; Knee
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
Performance data was provided to support the claim of substantial equivalence.
Key Metrics
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
JAN 2 5 2002
Summary of Safety and Effectiveness
Knee Module for the StealthStation® System
- Medtronic Surgical Navigation Technologies I. Company: 826 Coal Creek Circle Louisville, CO 80027 (720) 890-3200
- Product Name: Knee Module for the StealthStation® System II.
- This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.
- The indications for use for the Knee Module for the StealthStation® System are as IV. 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
ENT Procedures:
Transphenoidal procedures Intranasal procedures Orbital 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 Orthopedic Procedures:
pedicle screw placement.
Spinal Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
Spinal implant procedures, such as
- The Knee Module for the StealthStation® System was shown to be substantially equivalent V. 1110 Knoor inoade 101 Ris Brown. System, the FluoroNav™ Module for the StealthStation® System and the Orthopilot® System. Performance data was provided to support the claim of substantial equivalence.
1
Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is an abstract image of a bird or eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027
Re: K012937
Trade Name: Knee Module for the Stealthstation® System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 26, 2001 Received: November 27, 2001
Dear Ms. Rendon:
We have reviewed your Section 510(k) premarket 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) 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.
2
Page 2 - Ms. Victoria 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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 yours,
bo Mich n Millerson
Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Knee Module for the StealthStation® System
Indications For Use:
The StealthStation® System is intended as an aid for precisely locating anatomical structures in I he Steallinstation® System is an are for processor System is indicated for any medical entified of perculaneous proceants. The creating be appropriate, and where reference to a condition in wincil the use of stereoucate only of your sprestebra, 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
ENT Procedures:
Transphenoidal procedures
Intranasal procedures
Orbital 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
Spinal Procedures:
Spinal implant procedures, such as pedicle screw placement.
Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Mark McNemar
Restorative and Neurologic
510(k) Number
(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
(Optional Format 1-2-96)