(119 days)
Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) 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. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.
Brainlab Compatible K2M Navigation Instruments include inserters, taps, probes and awls intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems.
Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.
The provided text is a 510(k) summary for the "Brainlab Compatible K2M Navigation Instruments." This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device.
Therefore, many of the requested details, such as specific performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, are not applicable and not present in this type of regulatory submission. The device described is a set of surgical instruments used with a navigation system, not an AI or algorithmic device that performs independent analysis or diagnosis.
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations for the requested information format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality and compatibility with the Brainlab Navigation System | "Simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System." "In addition, testing met the acceptance criteria established by Brainlab for these devices." |
| Equivalence to predicate devices in design, function, material, and intended use | "The results of these evaluations confirmed that the Brainlab Compatible K2M Navigation Instruments are equivalent to predicate devices." "There are no significant differences between the Brainlab Compatible 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." |
| Dimensional comparisons | "Dimensional comparisons... was performed to ensure functionality and compatibility..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document describes "simulated use testing" and "dimensional comparisons" for surgical instruments, not a test set of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable / Not provided. Ground truth in the context of an algorithm's performance is not relevant for this type of device (surgical instruments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable / Not provided. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable / Not provided. This device is surgical instrumentation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would refer to its physical properties (dimensions) and its ability to mechanically interface with the Brainlab Navigation System as intended. The acceptance criteria were established by Brainlab.
8. The sample size for the training set
Not applicable / Not provided. There is no algorithm or training set mentioned.
9. How the ground truth for the training set was established
Not applicable / Not provided. There is no algorithm or training set mentioned.
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K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
November 9, 2018
Re: K181890
Trade/Device Name: Brainlab Compatible K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 10, 2018 Received: August 13, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Image /page/1/Figure/5 description: The image shows a digital signature from Jesse Muir -S. The signature includes the date 2018.11.09 and the time 13:48:41 -05'00'. The signature is displayed in a clear, sans-serif font, making it easily readable. The text is arranged in a way that emphasizes the name and the date of the signature.
Date: 2018.11.09 13:48:41 -05'00'
For: 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. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. | DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use |
|---|---|
| 510(k) Number ( if known ) | K181890 |
| Device Name | Brainlab Compatible K2M Navigation Instruments |
| Indications for Use ( Describe ) | Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) 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. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws. |
| 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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FORM FDA 3881 (7/17) Page 1 of 1
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510(k) SUMMARY Brainlab Compatible K2M Navigation Instruments
Submitter
K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 11/09/2018
Classification
Brainlab Compatible K2M Navigation Instruments Trade Name: 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: K2M Navigation Instruments (K171556) Additional Predicates: Brainlab Spine and Trauma (K083310) Aesculap AIS S4 Spinal System (K130887)
Device Description
Brainlab Compatible K2M Navigation Instruments include inserters, taps, probes and awls intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems.
Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.
Indications for Use
Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) 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. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.
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Technological Comparison to Predicate(s)
Brainlab Compatible 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. In addition, testing met the acceptance criteria established by Brainlab for these devices. The results of these evaluations confirmed that the Brainlab Compatible K2M Navigation Instruments are equivalent to predicate devices.
Conclusion
There are no significant differences between the Brainlab Compatible 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.
§ 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).