(119 days)
Not Found
No
The summary describes navigation instruments that interface with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on compatibility and functionality with the existing navigation system.
No.
The device (Brainlab Compatible K2M Navigation Instruments) is an instrument used during spinal surgery to assist in precisely locating anatomical structures and placing pedicle screws, and it does not directly treat or cure a medical condition.
No
The device is intended to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of screws, using a navigation system that references patient anatomy. It is an instrument for surgical guidance, not for diagnosing a medical condition.
No
The device description explicitly states that the device includes "inserters, taps, probes and awls," which are physical instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that these instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They are tools used in vivo (within the living body) for surgical guidance, not for analyzing samples in vitro (outside the living body).
- Intended Use: The intended use describes assisting in the preparation and placement of pedicle screws during spinal surgery, which is a surgical procedure, not a diagnostic test performed on a sample.
Therefore, the Brainlab Compatible K2M Navigation Instruments fall under the category of surgical instruments or navigation systems, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
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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 / 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)
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.
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.
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).
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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
1
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. 0910-0120
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 ) | 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.