(231 days)
No
The summary describes manual surgical instruments used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned, but its specific technology is not detailed as AI/ML.
No
The device is a set of manual surgical instruments used during spinal surgery to assist in the placement of pedicle screws by precisely locating anatomical structures. It is not designed to treat or alleviate a medical condition directly.
No
The K2M Navigation Instruments are surgical instruments intended for use during spinal surgery to assist in the placement of pedicle screws by helping surgeons locate anatomical structures. They interface with a navigation system but do not themselves provide a medical diagnosis.
No
The device description explicitly states that the K2M Navigation Instruments are "manual surgical instruments" and are intended to be used "when implanting previously cleared components." 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:
- Intended Use: The intended use clearly states that the instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures. This is an in vivo application (within a living organism).
- Device Description: The description confirms they are manual surgical instruments used when implanting spinal system components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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
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 Brainlab Navigation 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, or digitized landmarks of the anatomy.
Anatomical Site
rigid anatomical structure, such as a skull, 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
Non-clinical Performance Evaluation: Dimensional comparisons and simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System. The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Brainlab Spine and Trauma (K083310), DePuy VIPER® and EXPEDIUM® navigated instruments (K120867), Range/Mesa/Denali Spinal System (K171832), Everest Spinal System (K161369)
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).
0
Image /page/0/Picture/0 description: The image shows the logo for 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K171556
Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2017 Received: December 18, 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. Iisting 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.
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,
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) SUMMARY K2M Navigation Instruments
Submitter
K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 12/14/2017
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: Brainlab Spine and Trauma (K083310) Additional Predicates: DePuy VIPER® and EXPEDIUM® navigated instruments (K120867) Range/Mesa/Denali Spinal System (K171832) Everest Spinal System (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 Brainlab Navigation 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 pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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.
3
Technological Comparison to Predicate(s)
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
Dimensional comparisons and simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System. The results of these evaluations 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.
4
Indications for Use
510(k) Number (if known) K171556
Device Name
K2M Navigation Instruments
Indications for Use (Describe)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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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