(163 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the "Navigation Module of the Momentum System" as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Navigation Accuracy | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Registration | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Rigidity | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Simulated Surgery | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
Important Note: The document states that the device performance was "substantially equivalent" to predicate devices, but it does not provide specific numerical acceptance criteria or performance metrics for navigation accuracy, registration, rigidity, or simulated surgery. It only confirms that these validations were performed and met the equivalency standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "side-by-side testing" but gives no further details on the methodology or data characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. The device in question is a navigation system accessory, not an AI-based diagnostic tool for interpretation.
6. Standalone (Algorithm Only) Performance Study
The document does not discuss standalone performance of an algorithm. The device is a "Navigation Module" and instruments designed for use with an existing navigation system (Medtronic StealthStation System), implying it's an integrated component rather than a standalone algorithm.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, given it's a navigation system for spinal surgery, the typical ground truth in such studies would involve highly accurate measurements (e.g., using a coordinate measuring machine or high-resolution imaging) to verify the accuracy of instrument tip localization.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This type of medical device (navigation instrument) typically undergoes engineering verification and validation rather than machine learning model training.
9. How Ground Truth for the Training Set Was Established
The document does not describe how ground truth for a training set was established, as it pertains to a hardware device validation rather than a machine learning application that would require a training set.
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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.
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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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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 TradeName: | 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. Theinstruments are designed for use with the Medtronic StealthStation Systemfor implantation of the Momentum Posterior Spinal Fixation Systemcomponents. |
| Indications for Use: | The Navigation Module of the Momentum System is intended to be usedduring the preparation and placement of Momentum Posterior Spinal FixationSystem screws during spinal surgery, to assist the surgeon in preciselylocating anatomical structures in either open or minimally invasiveprocedures. The Navigation Module of the Momentum System is designedfor use with the Medtronic SteathStation 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 MRI based model, fluoroscopyimages, or digitized landmarks for the anatomy. |
| Materials: | The Navigation Module instruments are manufactured from stainless steelsper ASTM F899. |
| Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic SofamorDanek, USA Inc. – K140454) |
| Additional Predicates: | Navigated CD Horizon® Solera™ Screwdrivers, CD Horizon® Solera™ Tapsand CD Horizon® Legacy™ Taps (Medtronic Navigation, Inc. – K124004) |
| Performance Data: | Navigation accuracy, registration, rigidity and simulated surgery validationswere performed in side-by-side testing of the Navigation Module of theMomentum System and predicate devices. The test results demonstrate thatthe Navigation Module of the Momentum System performance issubstantially equivalent to the predicate devices. |
| TechnologicalCharacteristics: | The Navigation Module of the Momentum System possesses similartechnological characteristics as one or more of the predicate devices. Thefundamental scientific technology of the Navigation Module of the MomentumSystem 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.
§ 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).