(120 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, fluoroscopy images, or digitized landmarks of the anatomy.
The AxiEM™ 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)
The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation
The provided text does NOT include acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the AxiEM™ Imageless Hip Module for the StealthStation® System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
The document discusses:
- Manufacturer and Contact Information
- Product Name and Classification
- Date Summary Submitted
- Description of Device Modification: States that the AxiEM™ Imageless Hip Module uses electromagnetic navigation instead of optical tracking (the primary difference from its predicate).
- Substantial Equivalence: Claims substantial equivalence to the Imageless Hip Module for the StealthStation® System (K052623) and highlights the difference from the AxiEM™ Imageless Knee Module (hip vs. knee procedures). It vaguely mentions that "all verification and validation activities will be performed... and will demonstrate the safety and effectiveness of the device," but does not provide details about these activities, specific acceptance criteria, or study results.
- Indications for Use
- FDA Letter of Substantial Equivalence: This letter confirms that the FDA reviewed the 510(k) and determined the device is substantially equivalent to predicate devices, thus allowing it to be marketed. It reiterates that substantial equivalence does not mean the device complies with all other requirements of the Act, such as GPM, labeling, etc.
Therefore, I cannot populate the requested table or provide information on the study, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness, as this information is not present in the provided text.
The document only serves as a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.
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KOG1248
Summary of Safety and Effectiveness AxiEM™ 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
II. Contact
Tina Dreiling Associate Requlatory Affairs Specialist Medtronic Navigation, Inc.
111. 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 April 28, 2006
V. Description of Device Modification
The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation
VI. Substantial Equivalence
The primary difference between the Imageless Hip Module for the StealthStation® System and the AxiEM™ Imageless Hip Module for the StealthStation® System is that the AxiEM™ Imageless Hip Module utilizes electromagnetic navigation technology rather than optical tracking.
The primary difference between the AxiEM™ Imageless Knee Module for the StealthStation® System and the AxiEM ™ Imageless Hip Module for the StealthStation® System is that the subject device navigates instruments for use in hip procedures and the AxIEM™ Imageless Knee application navigates instruments for use in knee procedures.
As required by risk analysis, all verfication and validation activities will be performed by designated individuals and will demonstrate the safety and effectiveness of the device.
The information provided in this 510(k) application supports that the AxiEM™ Imageless Hip Module for the StealthStation® System is substantially equivalent to the Imageless Hip Module for the StealthStation® System (K052623).
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 AxiEM™ 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)
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2006
Medtronic Navigation, Inc. % Ms. Tina Dreiling Associate RA Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K061248
Trade/Device Name: AxiEM™ Imageless Hip Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 9, 2006 Received: August 10, 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, 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, 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 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.
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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 7700) 978
Device Name: AxiEM ™ 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 perculaneous 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 AxiEM™ 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)
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)
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| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
Number F06/244
Medtronic
CONFIDENTIAL
Page 20 of
§ 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).