(112 days)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) 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. These 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.
K2M Navigation Instruments are nonsterile, reusable surgical instruments (inserters, taps, probes, and awls) and single use drill bits intended be used when implanting previously cleared components of Mesa, Denali, Everest, and Yukon Spine Systems. These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during cervical and thoracolumbar spinal surgery.
The provided text is a 510(k) summary for the K2M Navigation Instruments. It discusses the device's indications for use, its substantial equivalence to predicate devices, and the design validation testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, associated performance data, test set details (sample size, provenance, ground truth establishment, adjudication), training set details, or any multi-reader multi-case (MRMC) comparative effectiveness study.
The document states:
- "Design validation testing was conducted to ensure the K2M Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments."
This indicates that performance testing was done for the navigational instruments themselves, focusing on their functionality and compatibility with a navigation system, rather than evaluating the performance of an AI/ML algorithm that predicts or diagnoses. The device described, "K2M Navigation Instruments," appears to be physical surgical instruments (inserters, taps, probes, and awls) designed to work with a stereotactic navigation system (Medtronic StealthStation® System) to assist surgeons with screw placement. It is not an AI/ML powered diagnostic or predictive device.
Therefore, since the device is not an AI/ML system, the requested information regarding AI/ML acceptance criteria and study results (including AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set details, etc.) is not applicable to the content of this 510(k) summary.
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August 7, 2020
K2M. Inc. % Megan Callanan Senior Regulatory Affairs Specialist Stryker 2 Pearl Court Allendale, New Jersey 07401
Re: K201006
Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 16, 2020 Received: April 17, 2020
Dear Megan Callanan:
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.
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201006
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 (Denali, Mesa, Everest, and Yukon) 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. These instruments are designed for use with the Medtronic 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K201006
510(k) Summary
| 510(k) Summary: K2M Navigation Instruments | |
|---|---|
| Submitter: | K2M, Inc.600 Hope Pkwy SELeesburg, VA 20175 |
| Contact Person: | Name: Megan CallananPhone: (551)262-2429Email: megan.callanan1@stryker.com |
| Date Prepared: | 7/30/2020 |
| Trade Name: | K2M Navigation Instruments |
| Common Name: | Navigation Instruments |
| Proposed Class: | Class II |
| Classification Name: | Orthopedic / Orthopedic Stereotaxic Instruments |
| Regulation Number: | 21 CFR 882.4560 |
| Product Code: | OLO |
| Predicate Devices: | Primary Predicate: K2M Navigation Instruments (K171321)Additional Predicates:Brainlab Compatible K2M Navigation Instruments (K181890)Stryker Navigation Enabled Instruments (K183381) |
| Device Description: | K2M Navigation Instruments are nonsterile, reusable surgical instruments(inserters, taps, probes, and awls) and single use drill bits intended be usedwhen implanting previously cleared components of Mesa, Denali, Everest, andYukon Spine Systems. These instruments are designed to interface with theMedtronic StealthStation® System when used for navigation during cervicaland thoracolumbar spinal surgery. |
| Indications for use: | K2M Navigation Instruments are intended to be used in the preparation andplacement of K2M screws (Denali, Mesa, Everest, and Yukon) during spinalsurgery to assist the surgeon in precisely locating anatomical structures ineither open or minimally invasive procedures. MESA screw navigation isintended for open procedures only. These instruments are designed for usewith the Medtronic StealthStation® System, which is indicated for anymedical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as avertebra, can be identified relative to a CT or MR based model, fluoroscopyimages, or digitized landmarks of the anatomy. Navigated Screw Insertersare also compatible with the Medtronic IPC POWEREASE System. The K2MNavigation Instruments are not intended for navigation of occipital screws. |
| 510(k) Summary: K2M Navigation Instruments | |
| Summary of theTechnologicalCharacteristics | K2M Navigation Instruments have the same technological characteristics asthe predicate devices including design, material composition, intended use,function, and range of sizes. Additional instruments for use with YukonSystem are identical in function and fundamental technology.Biocompatibility of patient-contacting materials was demonstrated by usingmaterials that meet applicable standards or are used in 510(k) cleareddevices. |
| Summary of thePerformance Data | Design validation testing was conducted to ensure the K2M NavigationInstruments are acceptable for their intended use, to ensure functionality andcompatibility with the Medtronic StealthStation® using the NavLock tracker,and to demonstrate substantial equivalence to the predicate instruments. |
| Conclusion | K2M Navigation Instruments are substantially equivalent to the notedpredicate devices as they have the same intended use, technologicalcharacteristics, and performance specifications. Furthermore, theseinstruments do not introduce any new concerns related to the safety andefficacy of the associated systems. The content of this submission supportsthe determination of substantial equivalence. |
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§ 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).