(163 days)
Not Found
No
The summary describes a surgical navigation system that uses pre-existing imaging data (CT, MRI, fluoroscopy) and digitized landmarks for anatomical reference. There is no mention of AI/ML terms, image processing for automated analysis, or descriptions of training/test sets typically associated with AI/ML development. The focus is on instrument navigation based on established imaging and registration techniques.
No
The device is a navigation module for spinal surgery, assisting in the placement of screws, rather than directly treating a medical condition itself.
No.
The device assists in surgical navigation and screw placement during spinal surgery, which is a treatment procedure, not a diagnosis.
No
The device description explicitly states that the Navigation Module of the Momentum System contains non-sterile, reusable manual instruments, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a surgical navigation system used during surgery to assist the surgeon in placing spinal screws. It interacts directly with the patient's anatomy during the procedure, not with a specimen taken from the patient.
The description clearly states its purpose is to "assist the surgeon in precisely locating anatomical structures" and is used "during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery." This is a surgical tool, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation 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 MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Navigation Module of the Momentum System contains non-sterile, reusable manual instruments including taps and screwdrivers. The instruments are designed for use with the Medtronic StealthStation System for implantation of the Momentum Posterior Spinal Fixation System components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI based model, fluoroscopy images
Anatomical Site
Vertebra (spinal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, during 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)
Navigation accuracy, registration, rigidity and simulated surgery validations were performed in side-by-side testing of the Navigation Module of the Momentum System and predicate devices. The test results demonstrate that the Navigation Module of the Momentum System performance is substantially equivalent to the 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 10, 2020
Ulrich Medical USA Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K200845
Trade/Device Name: Navigation Module of the Momentum System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2020 Received: August 13, 2020
Dear Hans Stover:
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.
1
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Navigation Module of the Momentum System
Indications for Use (Describe)
The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation 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 MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.
| 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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K200845 510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" in white against a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.
| Date: | 30 March 2020 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Sponsor Contact: | Hans Stover, President & CEO |
| Proposed Trade | |
| Name: | Navigation Module of the Momentum System |
| Common Name: | Orthopaedic navigation system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Product Code: | OLO |
| Device Description: | The Navigation Module of the Momentum System contains non-sterile, |
| reusable manual instruments including taps and screwdrivers. The | |
| instruments are designed for use with the Medtronic StealthStation System | |
| for implantation of the Momentum Posterior Spinal Fixation System | |
| components. | |
| Indications for Use: | The Navigation Module of the Momentum System is intended to be used |
| during the preparation and placement of Momentum Posterior Spinal Fixation | |
| System screws during spinal surgery, to assist the surgeon in precisely | |
| locating anatomical structures in either open or minimally invasive | |
| procedures. The Navigation Module of the Momentum System is designed | |
| for use with the Medtronic SteathStation 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 MRI based model, fluoroscopy | |
| images, or digitized landmarks for the anatomy. | |
| Materials: | The Navigation Module instruments are manufactured from stainless steels |
| per ASTM F899. | |
| Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic Sofamor |
| Danek, USA Inc. – K140454) | |
| Additional Predicates: | Navigated CD Horizon® Solera™ Screwdrivers, CD Horizon® Solera™ Taps |
| and CD Horizon® Legacy™ Taps (Medtronic Navigation, Inc. – K124004) | |
| Performance Data: | Navigation accuracy, registration, rigidity and simulated surgery validations |
| were performed in side-by-side testing of the Navigation Module of the | |
| Momentum System and predicate devices. The test results demonstrate that | |
| the Navigation Module of the Momentum System performance is | |
| substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The Navigation Module of the Momentum System possesses similar |
| technological characteristics as one or more of the predicate devices. The | |
| fundamental scientific technology of the Navigation Module of the Momentum | |
| System is the same as previously cleared devices. |
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The Navigation Module of the Momentum System possesses the same Conclusion: intended use and similar technological characteristics as the predicate devices. The Navigation Module of the Momentum System is substantially equivalent for its intended use.