(20 days)
No
The summary describes a navigated surgical instrument used with a navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The system relies on anatomical landmarks and imaging modalities for navigation, not AI/ML processing.
No.
The device is a navigated drill bit used during spinal surgery to assist in precisely locating anatomical structures, not to treat a condition directly.
No
Explanation: The device is described as a surgical instrument (drill bit) intended to assist in the precise location of anatomical structures during surgery, not to diagnose a medical condition. Its function is to aid in the preparation and placement of screws, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use instrument" which is a physical hardware component, not software.
Based on the provided text, 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 description clearly states that the Medtronic Navigated Instruments are used during surgery to assist the surgeon in precisely locating anatomical structures and placing screws. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
- Intended Use: The intended use is for surgical guidance and instrument placement, not for analyzing biological specimens to diagnose or monitor a medical condition.
The device is a surgical instrument used in conjunction with a navigation system to aid in surgical procedures.
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 subject Navigated INFINITY™ drill bit is a sterile, single-use instrument that can be operated manually or under power. This instrument is intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Drill bit is 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon in either open or minimally invasive procedures
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)
Sterilization: The addition of the sterile drill bit does not create a new "worst case" and it was adopted in to the existing product family as detailed in the sterilization rationale provided in this submission since the design, material, manufacturing process, and manufacturing facilities of the sterile subject devices are equivalent to that of the referenced product family. The sterilization justification supports an SAL of 10-6. Based on the information provided in this submission, Medtronic believes that adequate evidence has been provided to show that we have fully validated the sterilization parameters.
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.
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.
K163375, K111520, K123270, K050438, K170011, 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Medtronic Sofamor Danek USA, Inc. Tejas Patel Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K18111
Trade/Device Name: Navigated INFINITY TM Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 26, 2018 Received: April 27, 2018
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.
May 17, 2018
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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,
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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181111
Device Name Navigated INFINITYTM 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 IPC™ POWEREASETM 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)
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510(k) Summary
April 26, 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
- ll. Proprietary Trade Name: Navigated INFINITY™ Instruments
Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Common Name: Navigated Drill Bit
Classification: Class II
Product Code: OLO
lll. Predicate Device:
Primary Predicate:
-
Navigated INFINITY™ Instruments (K173338, S.E. 01/18/2018) .
Additional Predicate: -
. Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015)
These predicates have not been subject to a design-related recall
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)
- NavLockTM tracker (K124004, S.E. 03/22/2013)
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IV. Device Description:
The subject Navigated INFINITY™ drill bit is a sterile, single-use instrument that can be operated manually or under power. This instrument is intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Drill bit is 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 subject drill bit has identical indications, intended use, fundamental scientific technology, materials, dimensions and design features as the Navigated INFINITY™ Instruments recently cleared in K173338 (S.E. 01/18/2018). Identical to the predicate drill bit, the subject drill bit is available in stainless steel. The only technological difference between the subject and predicate Navigated INFINITY™ Instrument is as below:
- The subject navigated drill bit is sterile and single use while the predicate drill bit is non-sterile and single use.
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.
VII. Performance Data:
The following information is provided in support of substantial equivalence.
Sterilization:
The addition of the sterile drill bit does not create a new "worst case" and it was adopted in to the existing product family as detailed in the sterilization rationale provided in this submission since the design, material, manufacturing process, and
5
manufacturing facilities of the sterile subject devices are equivalent to that of the referenced product family. The sterilization justification supports an SAL of 10-6. Based on the information provided in this submission, Medtronic believes that adequate evidence has been provided to show that we have fully validated the sterilization parameters.
VIII. Conclusions
Based on the sterilization assessment and additional supporting documentation provided in this pre-market notification, the subject Navigated INFINITY™ Instrument demonstrates substantially equivalent to the identified predicate devices.