(118 days)
Not Found
No
The summary describes manual surgical instruments used for navigation with a separate system (Medtronic StealthStation). There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The focus is on the instruments' compatibility and accuracy with the navigation system.
No.
The device is a surgical instrument that assists in precisely locating anatomical structures during spinal surgery, which is a tool for a medical procedure, not a device that provides therapy.
No
The device is described as "manual surgical instruments" used in conjunction with a navigation system to "assist the surgeon in precisely locating anatomical structures" for screw placement during spinal surgery. It is not designed to diagnose a medical condition or disease.
No
The device description explicitly states "K2M Navigation Instruments are manual surgical instruments" and describes their function as interfacing with a navigation system. This indicates a physical hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The K2M Navigation Instruments are described as "manual surgical instruments" used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They interface with a navigation system (Medtronic StealthStation) that uses imaging data (CT, MR, fluoroscopy) and digitized landmarks.
- No sample analysis: The device does not perform any tests on biological samples taken from the patient. Its function is to aid in the physical placement of surgical implants based on imaging and anatomical references.
Therefore, the K2M Navigation Instruments fall under the category of surgical instruments used in vivo (within the living body) and are not IVDs.
N/A
Intended Use / Indications for Use
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medtronic 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.
Function: These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during spinal surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Spinal, skull, a long bone, or vertebra
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)
Rigidity, registration, and accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation. The results of testing determined that the K2M Navigation Instruments are equivalent to predicate devices.
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.
Medtronic Navigated Instruments (K143375), Medtronic Navigated Instruments (K143628, K143375), K2M Range/Mesa/Denali Spinal System (K070229, K153031), K2M Everest Spinal System (K103440, K161369)
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.
Not Found
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2017
K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K171321
Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2017 Received: August 1, 2017
Dear Nancy Giezen:
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 devicerelated adverse events) (21 CFR 803); 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.
1
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 (DICE) 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" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.
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) K171321
Device Name K2M Navigation Instruments
Indications for Use (Describe)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALL MESA. EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medronic 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
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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3
510(k) SUMMARY K2M Navigation Instruments
Submitter
K2M 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 7/26/2017
Classification
Trade Name: K2M Navigation Instruments Common Name: Navigation Instrument Regulatory Class: Class II
Classification Name(s): Stereotaxic instrument (21 CFR 882.4560, Product Code OLO)
Predicate Device(s)
Primary Predicate: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369)
Device Description
K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.
Function: These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during spinal surgery.
Intended Use
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medtronic 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.
Technological Comparison to Predicate(s)
4
K2M Navigation Instruments were compared to predicate devices and the design features, materials and indications were the same or similar to the previously cleared devices.
Non-clinical Performance Evaluation
Rigidity, registration, and accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation. The results of testing determined that the K2M Navigation Instruments are equivalent to predicate devices.
Conclusion
There are no significant differences between the K2M Navigation Instruments and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.