(72 days)
Not Found
No
The summary describes a computer-assisted surgical navigation system that uses optical tracking and pre-operative imaging (CT/MR) or fluoroscopy for guidance. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The system appears to rely on traditional navigation techniques based on image registration and tracking.
No.
The device is indicated for surgical procedures involving the drilling, burring, and removal of hard tissue and bone, and it aids in precisely locating anatomical structures. While it is used in a surgical context, it does not directly treat or alleviate a disease, but rather facilitates a surgical intervention.
No
The device is described as a surgical system for drilling, burring, and removing hard tissue and bone, functioning as an aid for precise anatomical localization during spinal surgical procedures. Its purpose is operative, not diagnostic.
No
The device description explicitly states that the system consists of electric and pneumatic drill handpieces, which are hardware components.
Based on the provided information, the Stealth-Midas System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Stealth-Midas System Function: The Stealth-Midas System is a surgical tool used during spinal surgical procedures for drilling, burring, and tissue removal. It uses navigation technology to aid in precisely locating anatomical structures within the body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient. Its function is directly related to surgical intervention and guidance within the body.
Therefore, the Stealth-Midas System falls under the category of a surgical device with navigation capabilities, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
Product codes
OLO
Device Description
The Stealth-Midas System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, fluoroscopic images
Anatomical Site
rigid anatomical structure, such as 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
| Test | Description |
|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software |
| Formative Usability | Confirmed users can follow the navigated workflow and assemble the device |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Powered Surgical Solutions Mr. John Connor Senior Regulatory Affairs Specialist Medtronic Navigation 826 Coal Creek Circle Louisville, Colorado 80027
Re: K160713
Trade/Device Name: Stealth-Midas System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 14, 2016 Received: March 15, 2016
Dear Mr. Connor:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
May 26, 2016
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160713
Device Name Stealth-Midas System
Indications for Use (Describe)
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
March 14, 2016
- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach St. Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
- II. Proprietary Trade Name: Stealth-Midas System
- III. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
- Product Code: OLO VI.
VII. Product Description:
The Stealth-Midas System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable.
VIII. Indications for Use:
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 a long bone, or vertebra, can be identified relative to a CTor MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
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IX. Identification of Legally Marketed Devices (Predicate Devices)
- Midas Rex Electric Surgical Drill/Saw System (K081475) ●
- . Midas Rex MR7 Pneumatic High Speed System (K090112)
- Navigated VERTEX SELECT® Instruments (K143628)
X. Comparison of the Technological Characteristics:
The currently available Midas Rex Drill System consists of pneumatic and electric handpieces, attachments, and surgical dissecting tools. There are no changes to any of the attachments or surgical dissecting tools. The only significant difference between the subject navigated handpieces and the currently available handpieces is the addition of a passive optical tracker to the hind to enable navigation of a selection of dissecting tools, and a secondary lock to eliminate any motion of the dissecting tool relative to the optical tracker. The addition of a tracker does not impact the ability of the drill system to perform to their intended use as a drill system.
The passive optical tracking technology is identical to that employed in the use of the predicate navigated Vertex Select instruments. Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate navigated Vertex Select instruments.
XI. Discussion of the Performance Testing
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:
| Test | Description |
|---|---|
| Navigation Accuracy | |
| Analysis | Confirmed navigated instrument accuracy |
| CAD Model Evaluation | Verified that the CAD models are accurately |
| reflected in the application software | |
| Formative Usability | Confirmed users can follow the navigated |
| workflow and assemble the device |
XII. Conclusions
The Stealth-Midas System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.