(87 days)
No
The summary describes navigated surgical instruments used with a navigation system (StealthStation™) that relies on anatomical landmarks and imaging modalities (CT, MR, fluoroscopy) for guidance. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on navigation accuracy and compatibility with existing systems.
No
The device is described as "Navigated Instruments" designed to assist surgeons during spinal surgery for precise anatomical location and screw placement, not to treat a medical condition directly.
No
The device is described as "Navigated Instruments" intended to be used by a surgeon to assist in the precise location of anatomical structures during spinal surgery. It is an instrument for surgical assistance, not for diagnosing a condition.
No
The device description explicitly states the Navigated INFINITY™ Instruments are "non-sterile, reusable and single use instruments" which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Medtronic Navigated Instruments are surgical instruments used during surgery to assist the surgeon in precisely locating anatomical structures and placing screws. They are used directly on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use clearly states they are used "during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is an in-vivo (within the living body) application, not in-vitro (in glass or outside the living body).
- Input: The input is imaging data (CT, MR, fluoroscopy, digitized landmarks) of the patient's anatomy, not biological specimens.
Therefore, the Medtronic Navigated Instruments fall under the category of surgical instruments or navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which 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 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems. Note: The subject devices are not intended to support occipital screw placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
rigid anatomical structure, such as a skull, a long bone, or vertebra (specifically for spinal surgery; not intended for occipital screw placement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spinal surgery
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)
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products.
Performance testing completed:
- Navigation Accuracy Analysis: Confirmed navigated instrument accuracy
- Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions
- Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions
- CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software
- Implant/Instrument Mating Conditions: Verified that the instruments can be assembled with the appropriate devices according to their intended use
- Spine Tools Package Functional Testing: Verified that the Spine Tools package has met the required interface needs of the spine application software
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.
Navigated VERTEX SELECT® Instruments (K143628)
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.
INFINITY™ OCT System (K163375), IPC® POWEREASE® System (K111520, K123270), SteathStation® System (K050438, K170011), NavLock™ tracker (K124004)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Medtronic Sofamor Danek USA, Inc. Tejas Patel Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K173338
Trade/Device Name: Navigated INFINITY™ Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2017 Received: October 23, 2017
Dear Tejas Patel:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
January 18, 2018
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173338
Device Name Navigated INFINITY™ Instruments
Indications for Use (Describe)
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which 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 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. Medtronic Navigated Instruments are also compatible with the IPCTM POWEREASE™ System.
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
January 10, 2018
- l. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Tejas Patel Sr. Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: tejaskumar.r.patel@medtronic.com
- II. Proprietary Trade Name: Navigated INFINITY™ Instruments
Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap, Navigated Drill Bit and Navigated Drill Tap (DT) Guide
Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II
Product Code: OLO
lll. Predicate Device:
Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015) This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.
The following reference devices are also used in this submission:
- INFINITY™ OCT System (K163375, S.E. 08/21/2017) ●
- IPC® POWEREASE® System (K111520, S.E. 10/26/2011; K123270, S.E. 01/11/2013)
- SteathStation® System (K050438, S.E. 06/02/2005; K170011, S.E. 05/01/2017) ●
- NavLock™ tracker (K124004, S.E. 03/22/2013) ●
IV. Device Description:
The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The
4
Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.
Note: The subject devices are not intended to support occipital screw placement.
V. Indications for Use:
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation® System, which 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 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. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.
VI. Comparison of the Technological Characteristics with the Predicate Device:
The Navigated INFINITY™ Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. Identical to the predicates, the Navigated INFINITY™ Instruments attach to the NavLock™ Tracker, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation and use with the IPC® POWEREASE® System, when desired.
The following technological differences exist between the subject and predicate devices:
- . The subject Navigated INFINITY™ Instruments are intended to be used with INFINITY™ OCT System screws whereas the predicate Navigated VERTEX SELECT® Instruments are intended to be used with the VERTEX® Reconstruction System screws.
- . The subject navigated drill bits are non-sterile and single use while the predicate drill bits are sterile and single use.
- The subject devices include an additional drill tap guide with an optional Navlock positioner feature to hold the Navlock tracker in position to face the camera throughout the drilling and tapping process.
The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® and IPC® POWEREASE® Systems.
5
VII. Performance Data:
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 |
| Anatomical Simulated Use | Confirmed instrument functionality under |
| expected use conditions | |
| Navigation Simulated Use | Confirmed navigation system functionality under |
| expected use conditions | |
| CAD Model Evaluation | Verified that the CAD models are accurately |
| reflected in the application software | |
| Implant/Instrument Mating | |
| Conditions | Verified that the instruments can be assembled |
| with the appropriate devices according to their | |
| intended use | |
| Spine Tools Package | |
| Functional Testing | Verified that the Spine Tools package has met the |
| required interface needs of the spine application | |
| software |
VIII. Conclusions
The Navigated INFINITY™ Instruments have shown through comparison and testing to be substantially equivalent to the identified predicate devices.