(30 days)
Not Found
No
The summary describes manual surgical instruments used with a navigation system, with no mention of AI or ML capabilities in the device description, intended use, or performance studies. The focus is on mechanical compatibility and user experience enhancements.
No.
The device is a surgical instrument used for navigation and placement of screws during spinal surgery, not for treating a disease or condition itself.
No
The device is described as "manual surgical instruments" intended for use in the "preparation and placement of K2M pedicle screws" during spinal surgery with a navigation system to assist the surgeon in locating anatomical structures. It facilitates surgery rather than diagnosing a condition.
No
The device description explicitly states "Brainlab Compatible K2M Navigation Instruments are manual surgical instruments" and mentions "modification of the connection mechanism geometry and material," indicating a physical hardware component.
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 the Brainlab Compatible K2M Navigation Instruments are manual surgical instruments used during spinal surgery to assist in the placement of pedicle screws. They are used in conjunction with a navigation system to guide the surgeon's actions on the patient's body.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, the function and intended use of this device fall outside the scope of 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 are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems.
These instruments are designed to interface with the Brainlab Navigation system when used for navigation during spinal surgery. The subject instruments feature a modification of the connection mechanism geometry and material to enhance user experience.
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 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)
A risk assessment including sterilization, biocompatibility, and additional rotational testing was conducted to confirm that the subject Brainlab Compatible K2M Navigation Instruments do not introduce new issues of safety or effectiveness.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2019
K2M, Inc. % Megan Callanan Regulatory Affairs Associate Stryker 2 Pearl Court Allendale, New Jersey 07401
Re: K192911
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: October 11, 2019 Received: October 15, 2019
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.
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
1
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 mediation-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,
For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192911
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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| 510(k) Summary: Brainlab Compatible 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: | 11/14/2019 |
| Trade Name: | Brainlab Compatible 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 Device: | Primary Predicate: Brainlab Compatible K2M Navigation Instruments (K181890) |
| Device Description: | Brainlab Compatible K2M Navigation Instruments are manual surgical instruments |
| intended be used when implanting previously cleared components of MESA, DENALI, | |
| EVEREST and YUKON Spinal Systems. |
These instruments are designed to interface with the Brainlab Navigation system
when used for navigation during spinal surgery. The subject instruments feature a
modification of the connection mechanism geometry and material to enhance user
experience. |
| 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. |
| Summary of the Technological
Characteristics | 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. The subject instruments feature a modification of
the connection mechanism geometry and material to enhance user experience. |
| Non-clinical Performance
Evaluation | A risk assessment including sterilization, biocompatibility, and additional rotational
testing was conducted to confirm that the subject Brainlab Compatible K2M
Navigation Instruments do not introduce new issues of safety or effectiveness. |
| Conclusion | There are no significant differences between the Brainlab Compatible K2M Navigation
Instruments and other legally marketed systems. It is substantially equivalent to these
other devices in design, function, material and intended use. |