(112 days)
Not Found
No
The summary describes navigation instruments that interface with a separate navigation system (Medtronic StealthStation®). The description focuses on the instruments themselves and their compatibility, not on any AI/ML capabilities within the instruments or explicitly stated for the navigation system in this context. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No.
The device is a surgical instrument intended to assist surgeons in precisely locating anatomical structures during spinal surgery, rather than providing therapy itself.
No
The device is intended for surgical navigation and assistance during spinal surgery, not for diagnosing medical conditions. It helps precisely locate anatomical structures during screw placement.
No
The device description explicitly states that the K2M Navigation Instruments are "nonsterile, reusable surgical instruments (inserters, taps, probes, and awls) and single use drill bits," which are physical hardware components.
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 and placing screws. This is a surgical aid, not a diagnostic test performed on a sample from the body.
- Device Description: The device description confirms they are surgical instruments (inserters, taps, probes, awls, drill bits) used for implanting components.
- No mention of analyzing biological samples: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. There is no indication of this device interacting with or analyzing any biological samples.
- Focus on surgical navigation: The core function is to interface with a navigation system (Medtronic StealthStation) to guide surgical procedures.
Therefore, the K2M Navigation Instruments fall under the category of surgical instruments or navigation aids, not In Vitro Diagnostics.
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, 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.
Product codes
OLO
Device Description
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.
Mentions image processing
Not Found
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 vertebra, cervical and thoracolumbar spinal surgery
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
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.
Key Metrics
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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 SE | |
| Leesburg, VA 20175 | |
| Contact Person: | Name: Megan Callanan |
| Phone: (551)262-2429 | |
| Email: 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 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. |
| Indications for use: | 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. |
| 510(k) Summary: K2M Navigation Instruments | |
| Summary of the
Technological
Characteristics | K2M Navigation Instruments have the same technological characteristics as
the predicate devices including design, material composition, intended use,
function, and range of sizes. Additional instruments for use with Yukon
System are identical in function and fundamental technology.
Biocompatibility of patient-contacting materials was demonstrated by using
materials that meet applicable standards or are used in 510(k) cleared
devices. |
| Summary of the
Performance Data | 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. |
| Conclusion | K2M Navigation Instruments are substantially equivalent to the noted
predicate devices as they have the same intended use, technological
characteristics, and performance specifications. Furthermore, these
instruments do not introduce any new concerns related to the safety and
efficacy of the associated systems. The content of this submission supports
the determination of substantial equivalence. |
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