(160 days)
Not Found
No
The summary explicitly states the device is "imageless" and there are no mentions of AI, DNN, or ML, nor any descriptions of training or test sets which are typical for AI/ML devices.
No.
The StealthStation® System is a surgical navigation system intended as an aid for precisely locating anatomical structures during surgery, not directly providing therapy.
No.
This device is described as an aid for precisely locating anatomical structures during surgical procedures, which is a treatment or surgical planning function, not a diagnostic one.
No
The device description explicitly states it is a "Module for the StealthStation® System," implying it is a component of a larger hardware system (the StealthStation® System). The intended use also refers to the StealthStation® System as a whole, which is a hardware-based navigation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the StealthStation System and its Imageless Hip Module are intended as an aid for precisely locating anatomical structures and positioning instruments/implants during surgical procedures. This is a surgical navigation system, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description focuses on establishing stereotactic coordinates for surgical guidance, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The input is related to anatomical structures and potentially digitized landmarks, not biological markers.
Therefore, the StealthStation System with the Imageless Hip Module 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 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. The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to: Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, skull, a long bone, or vertebra, Pelvic
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 performed by designated individuals 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.
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
Summary of Safety and Effectiveness Imageless Hip Module for the StealthStation® System
l. Manufacturer
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
1441 2 2006
11. Contact
Tina Dreiling Associate Requlatory Affairs Specialist Medtronic Navigation, Inc.
lll. Product Name / Classification
Common Name: Stereotaxic instrument Classification Name: Instrument, Stereotaxic Trade Name: Imageless Hip Module for the StealthStation® System Stereotaxic instrument - Class II as described in 21 CFR § 882 4560 Product Code: HAW
IV. Date Summary Submitted September 22, 2005
V. Description of Device Modification
The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.
VI. Substantial Equivalence
The Imageless Hip Module for the StealthStation® System is substantially equivalent to the Hip Module for the StealthStation® System (K021980).
The only difference between the Hip Module for the StealthStation® System and the Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative images. In addition, the substantial equivalence for this application is established with the accuracy testing provided in this filing. As required by risk analysis, all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence.
VII. 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.
The Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:
Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited to Acetabular Fractures)
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of a stylized human figure. The figure is composed of three overlapping profiles, representing the department's focus on health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 2
Medtronic Navigation, Inc. c/o Ms. Tina Dreiling Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K052623
Trade/Device Name: Imageless Hip Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 2, 2006 Received: February 3, 2006
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. IDrug. 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 lisung (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. 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 premated 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" (21 CFR 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,
elmpe
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K052623
Device Name: Imageless Hip Module for the StealthStation® System
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.
The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:
Orthopedic Procedures:
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Placement of Iliosacral Screws
Femoral Revision
Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General, Restorative. and Neurological Devices
K052623 510(k) Number ...