(58 days)
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Not Found
No
The summary describes a navigation system for surgical procedures using imaging modalities and digitized landmarks. There is no mention of AI or ML in the intended use, device description, or other sections. The focus is on electromagnetic navigation technology.
No
The device aids in precisely locating anatomical structures during surgery and is used for navigation, not directly for treating a condition or disease.
No
The device is described as an aid for precisely locating anatomical structures during surgical procedures, not for diagnosing medical conditions. Its purpose is to guide surgery, not to identify diseases or injuries.
No
The device description explicitly states it is an "Imageless Knee Module for the StealthStation" and incorporates "AxiEM™ electromagnetic navigation technology." This indicates the device includes hardware components (the StealthStation system and the AxiEM™ technology) beyond just software.
Based on the provided information, the StealthStation® System is not an IVD (In Vitro Diagnostic) device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- StealthStation® System Function: The StealthStation® System is a surgical navigation system. Its intended use is to aid in precisely locating anatomical structures during surgical procedures. It uses imaging data (CT, MR, fluoroscopy) and digitized landmarks to create a model of the anatomy and track surgical instruments in relation to that model.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The system operates on imaging data and physical tracking within the surgical field.
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 perculaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate. The anatomical structures of interest, such as in 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.
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, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Orthopaedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Knee Procedures
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
This submission describes updates made to the Imageless Knee Module for the StealthStation to This Submission desembed that the AxiEM™ electromagnetic navigation technology.
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, or digitized landmarks of the anatomy.
Anatomical Site
anatomical structures in 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
K043088 1/2
Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module JAN - 5 2005
Summary of Safety and Effectiveness
Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
l. Manufacturer Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
- Contact ll. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Surgical Navigation Technologies
Product Name / Classification lll. Product Name / Classification
Product Name: Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW
Date Summary Submitted IV.
December 13, 2004
Description of Device Modification V.
This submission describes updates made to the Imageless Knee Module for the StealthStation to This Submission desembed that the AxiEM™ electromagnetic navigation technology.
Substantial Equivalence VI.
The Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module is shown to be substantially The Meditorille (UNT) Clous Hip Module and the GoldenEye Micro-Magnetic Tracking System equivalent to the magolooo hip models required by risk analysis, all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence.
1
K0430688 2/2
Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module
Indications for Use VII.
The indications for use are as follows:
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either The SteatinStation® System is intended as art har process you and on the indicated for any medical condition in
open or perculaneous procedures. The StealthStation® System i open of perculariedus procedures. The Stametalier is a rigid analomical which the use of stereolable surgery that , and be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks 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
ENT Procedures:
Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Elicephalocele Frocedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Orthopaedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Knee Procedures
2
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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2005
Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027
Re: K043088
KU43086
Trade/Device Name: Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 4, 2004 Received: November 8, 2004
Dear Ms. Dreiling:
We have reviewed your Section 510(k) premarket notification of intent to market the device in die in die in we nave reviewed your becaon 310(t) premeire is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 tise stated in the encrosule) (c regars comment date of the Medical Device Amendments, or to commence provided in accordance with the provisions of the Federal Food, Drug, devices mat have occh receasoned in access approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, merclore, market the act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 abor 0) als. 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 be found in the Oous of reason
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 I loast be advised that I Dri brisean that your device complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must or any i-coloral statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Hot 8 requirements, as a manufacturing practice requirements as set CFR I at 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module
510(k) Number (if known): K043088
Device Name: Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module
Indications for Use:
The indications for use are as follows:
The SteathStation® System is intended as an aid for precisely locating anatomical structures in either open or perculaneous proce- നന്ദ അമന്നതിനേത്ര System is indicated for any medical condition in which the use of stereotactic surgery may be appropriultr.s. "The occurreductions by title in 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.
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 Enceptatocele Trocodies
Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Knee Procedures
Prescription Use
X
(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)
uriam C. Provost
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number Ko43088
Medtronic Surgical Navigation Technologies