(26 days)
Not Found
Not Found
Unknown
The device description mentions "software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets." While this suggests advanced processing, it doesn't explicitly state or imply the use of AI/ML. The lack of information on training/test sets or performance metrics further supports this ambiguity.
No.
The device is described as an aid for precisely locating anatomical structures during surgical procedures, not as a device that delivers therapy or treats a medical condition directly.
No
Explanation: The device is described as an "aid for precisely locating anatomical structures in either open or percutaneous procedures" and is used for "stereotactic surgery." This indicates a guidance or navigational function during surgical procedures, rather than a diagnostic one.
No
The device description explicitly states it is an update to the StealthStation® System, which is a system used for surgical navigation and requires hardware components for tracking and localization. While the update is software-based ("software algorithms"), it is part of a larger hardware system.
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 Description and Intended Use: The description and intended use clearly state that the StealthStation System and its Imageless Knee Module are used for surgical navigation and guidance during procedures performed directly on the patient's body (in vivo). It helps surgeons precisely locate anatomical structures.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The system works by referencing anatomical structures relative to imaging data or, in the case of the Imageless Knee Module, establishing coordinates without images.
Therefore, the device falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the Imageless Knee Module for the StealthStation® System are identical to the StealthStation® System indications for use. The indications for use are as 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
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw Placement
Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
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)
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
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model or fluoroscopy images of the anatomy.
Anatomical Site
skull, a long bone, or vertebra, includes specifically: Cranial (e.g. skull base), Spinal (e.g. pedicle), Orthopedic (e.g. knee, hip, pelvis, femur), ENT (e.g. sphenoid, maxillary, ethmoid, frontal sinus)
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): 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
K0305-52
Summary of Safety and Effectiveness Imageless Knee Module for the StealthStation® System
I. Manufacture:
Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: (720) 890-3200 Fax Number: (720) 890-3500
MAR 1 9 2003
II. Contact:
Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies
Product Name/ Classification Name: III.
Product Name: Imageless Knee Module for the StealthStation® System Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW
Date Summary Submitted IV.
February 19, 2003
V. Description of Device Modification:
This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.
VI. Substantial Equivalence:
The Imageless Knee Module for the StealthStation® System was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.
1
VII. Indications For Use:
The indications for use for the Imageless Knee Module for the StealthStation® System are identical to the StealthStation® System indications for use. The indications for use are as 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: | Spinal Procedures: | Orthopedic Procedures: |
|---|---|---|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle | Total Knee Arthroplasty (Primary and Revision) |
| Tumor Resections | Screw Placement | Unicompartmental Knee Arthroplasty |
| Craniotomies/ Craniectomies | Minimally Invasive Orthopedic Procedures | |
| Skull Base procedures | Total Hip Replacement (Primary and Revision) | |
| Thalamotomies/Pallidotomies | Tumor Resection and Bone/Joint Reconstruction | |
| Pituitary Tumor Removal | Femoral Revision | |
| CSF Leak Repair | Placement of Iliosacral Screws | |
| Pediatric Catheter Shunt Placement | Stabilization and Repair of Pelvic Fractures | |
| General Catheter Shunt Placement | (Including but not Limited to Acetabular | |
| Fractures) | ||
| ENT Procedures: | ||
| Transphenoidal Procedures | ||
| Intranasal Procedures | ||
| Orbital Nerve Decompression Procedures |
Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoidotomies/Sphenoid
Explorations, Turbinate Resections, and Frontal Sinusotomies
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the seal. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2003
Ms. Victoria G. Rendon Clinical and Regulatory Affairs Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027
Re: K030552
Trade/Device Name: Imageless Knee Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 19, 2003 Received: February 21, 2003
Dear Ms. Rendon:
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. Iisting 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. Victoria G. 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), 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) you may obtain. 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 vours.
Mark H. Milkenon
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
Page 1 of of l
510(k) Number (if known):
Device Name: Imageless Knee Module for the StealthStation® System
Indications for Use:
The indications for use for the StealthStation® System Imageless Knee Software Module is identical to the StealthStation® System indications for use. The indications for use are as 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 Pediatric Catheter Shunt Placement General Catheter Shunt Placement
ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement
Ko30552
Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Hiosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
(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
(Optional Format 1-2006) |
| ------------------------------------------ | -------------------------------- |
|---|
| | Over-The-Counter Use
(Division of n-Off) |
|--|--------------------------------------------------------------|
| | Division of General, Restorative
and Neurological Devices |
| §10(k) Number | K0 30552
06469 |
| --------------- | ------------------- |
|---|