(26 days)
Not Found
Not Found
No
The summary describes a navigation system that merges pre-operative and intra-operative datasets. There is no mention of AI, ML, or related concepts in the intended use, device description, or specific sections for AI/ML information. The core function appears to be image registration and navigation, not AI-driven analysis or decision support.
No.
The device is described as an aid for precisely locating anatomical structures during surgical procedures, not as a device that directly treats a condition.
No
The device aids in precisely locating anatomical structures for surgical procedures, it does not diagnose medical conditions.
No
The device description explicitly states it is an "optional software package" that is part of the larger StealthStation® System, which is a navigation system used in surgical procedures and relies on hardware components for tracking and guidance.
Based on the provided information, the StealthStation® System is not an In Vitro Diagnostic (IVD) 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.
- Device Description: The description focuses on software updates for merging pre-operative and intra-operative datasets, which is consistent with a surgical navigation system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The StealthStation® System does not perform this function. It uses imaging data of the patient's anatomy to guide surgical procedures.
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 indications for use for the FluoroMerge™ Software 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 Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary tumor removal CSF Leak Repair
Spinal Procedures: Spinal implant procedures, such as pedicle screw procedures
ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies /Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures
Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
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 an optional software package that enables a user to merge a patient's pre-operative dataset with a patient's intra-operative dataset.
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
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.)
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.
StealthStation System cleared in previous 510(k)'s.
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
K02033d
FEB 2 7 2002
Summary of Safety and Effectiveness StealthStation® with FluoroMerge™ Software
I. Manufacture:
Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: (720) 890-3200 Fax Number: (720) 890-3500
II. Contact:
Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies
Product Name/ Classification Name: III.
Product Name: StealthStation® with FluoroMerge™ Software Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW
IV. Date Summary Submitted
January 30, 2002
V. Description of Device Modification:
This submission describes updates made to the StealthStation® System to include an optional software package that enables a user to merge a patient's pre-operative dataset with a patient's intra-operative dataset.
VI. Substantial Equivalence:
The StealthStation® with the FluoroMerge™ 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 FluoroMerge™ Software 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 Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary tumor removal CSF Leak Repair
Spinal Procedures: Spinal implant procedures, such as pedicle screw procedures
ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies /Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures
Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or eagle with its wings spread, with three human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Ms. Victoria G. Rendon Clinical and Regulatory Affairs Associate Medironic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027
Re: K020338
Trade/Device Name: StealthStation® with FluoroMerge™ Software Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 30, 2002 Received: February 1, 2002
Dear Ms. Rendon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) is regists of the Medical Device Amendments, or to conninered prices to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have been received require approval of a premarket approval application (PMA). and Cosmetic rece (1101) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, marres of the Act include requirements for annual registration, listing of general condon profiseturing 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 II your device is classinod toonal 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 or unly I valuates and 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 er it rate 607); accems (21 (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) This icter will anow you to ocgin maisog of substantial equivalence of your device to a legally premarket notincation. The Pro Primating of Eastification 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 If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 607.10 for his nally, for questions on the promotion and advertising of Compliance at (301) 594-1057. Ticalizense at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation cirities, "Ninorananing oresponsibilities under the Act may be obtained from the Other general information of your respational 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,
Marla n Milleess
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
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Page 1 of 1
510(k) Number (if known): K020338
Device Name: StealthStation® with FluoroMerge™ Software
Indications for Use:
Indications for OSC.
The StealthStation® System is intended as an aid for precisely locating anatomical structures in The StealthStation® Dystem is mentors. The StealthStation® System is indicated for any medical enner open of perodianoods probodated is surgery may be appropriate, and where reference to a condition in which and use of sters outs 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
Spinal Procedures: Spinal Implant, such as pedicle screw procedures
ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures
Orthopedic Indications: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
(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) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K020338 |
|---|---|
| --------------- | --------- |
510(k) Number -