(21 days)
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
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement
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: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty
This submission describes updates made to the StealthStation® System to include an interface that enables the StealthStation® System to cohesively communicate with a Three Dimensional C-Arm.
The provided text is a 510(k) summary for the StealthStation® System Three Dimensional C-Arm Interface. It describes a device modification and claims substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any specific study results demonstrating that the device meets defined acceptance criteria.
The document primarily focuses on:
- Identification of the device and manufacturer.
- Contact information.
- Product name and classification.
- Description of the device modification: an interface enabling communication between the StealthStation® System and a Three Dimensional C-Arm.
- Claim of substantial equivalence to previous StealthStation® System devices, stating that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence."
- Indications for Use, which are identical to the predicate device.
- FDA's clearance letter, confirming substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table. The provided text lacks the necessary information for these points.
{0}------------------------------------------------
AUG 1 4 2002
StealthStation® System Three Dimensional C-Arm Interface
Summary of Safety and Effectiveness StealthStation® Svstem Three Dimensional C-Arm Interface
- Manufacture: I.
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® System Three Dimensional C-Arm Interface Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW
Date Summary Submitted IV.
July 22, 2002
Description of Device Modification: V.
This submission describes updates made to the StealthStation® System to include an interface that enables the StealthStation® System to cohesively communicate with a Three Dimensional C-Arm.
Substantial Equivalence: VI.
The StealthStation® System Three Dimensional C-Arm Interface 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.
1380
{1}------------------------------------------------
VII. Indications For Use:
·
The indications for use for the StealthStation® System Three Dimensional C-Arm Interface 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: |
|---|---|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle Screw |
| Placement | |
| Tumor Resections | |
| Craniotomies/ Craniectomies | |
| Skull Base procedures | |
| Thalamotomies/Pallidotomies | |
| Pituitary Tumor Removal | |
| CSF Leak Repair | |
| ENT Procedures: | |
| Orthopedic Procedures: | |
| Total Knee Arthroplasty (Primary and Revision) | |
| Unicompartmental Knee Arthroplasty |
Transphenoidal Procedures Intranasal Procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Ellecphaloocies, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
Ms. Victoria G. Rendon Clinical and Regulatory Affairs Associate Metronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville. Colorado 80027
K022414 Re:
Trade/Device Name: Stealthstation System Three Dimensional C-Arm Interface Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: July 23, 2002 Received: July 24, 2002
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
and the same of the same of the same
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,
Hyl Rurde
Ann-Sophie M. Witmer, Ph.D., M.D.
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
510(k) Number (if known):
Device Name: StealthStation® System Three Dimensional C-Arm Interface
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:
Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement
Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty
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
(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) | |
|---|---|
| ------------------------------------------ | ------------- |
| Over-The-Counter Use | |
|---|---|
| -- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022414 |
|---|---|
| --------------- | --------- |
§ 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).