(211 days)
The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g., video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.
The Microscope Navigation Software (also referred to as subject device or Microscope App) is a software. It runs on a Brainlab navigation system consisting of a computer, a display and an IR tracking camera (referred to as platform) and a Brainlab Image Guided Surgery software (referred to as IGS software).
The Microscope Navigation encapsulates microscope specific functionality and separates it from the IGS software.
The device interfaces with the IGS software and e.g. utilizes the registration provided by the IGS software.
The device assists surgeries where a surgical microscope is used. It provides information based on the field of view through the microscope, the microscope position relative to the patient and the medical imaging data of the patient.
The subject device provides functionality to verify and correct a patient registration. The Microscope Navigation does not provide its own registration.
The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the typical sense of a clinical or standalone performance study.
The document is a 510(k) summary for the "Microscope Navigation" software, which is a component of a larger Brainlab navigation system. The submission is a Special 510(k), indicating that the changes made (re-implementing motorized movement functionality that was already present in an earlier predicate device, K082060 VECTORVISION CRANIAL) do not significantly alter the device's fundamental technology or indications for use.
Instead of a traditional clinical performance study, the verification and validation for this submission focus on demonstrating that the re-implemented features work as expected and maintain substantial equivalence to the predicate device.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Verification summary" and "Validation summary" which describe tests performed and their results, but it does not explicitly state quantitative acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. The acceptance criteria described are qualitative ("All tests passed") and relate to functional and safety aspects.
| Test | Acceptance Criteria (General Description) | Reported Device Performance |
|---|---|---|
| Safety Measures | Verification of implemented limits and automatic safety measures for motorized movements. (Implicitly: limits are respected, safety measures activate correctly, no hazardous operation). | All tests passed |
| Motorized movement user interface | Interactive testing of user interface. (Implicitly: UI is functional, intuitive, and allows correct control of motorized movements. No specific quantitative performance metric like speed or precision is mentioned). | All tests passed |
| Communication protocols | Verification of the communication between the subject device and integrated microscopes, ensuring compliance with communication protocols provided by the microscope manufacturer. (Implicitly: proper data exchange, correct command execution, no communication errors). Additionally, "Protocols and acceptance criteria are unchanged between subject device and predicate device." | All tests passed |
| Usability Tests | Ensure that the user interface can be used safely and effectively. (Implicitly: UI is safe, effective, and user errors are minimized). | All tests rated as successfully passed according to their acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The verification and validation summaries suggest testing of the software's functionality and usability rather than a dataset of patient cases.
- Data Provenance: Not applicable in the context of this type of software verification. There are no patient data sets mentioned for testing. The validation was performed "with software and equipment that are identical or equivalent to the final version of the product," indicating lab-based testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified. The document refers to "usability tests," which typically involve target users, but their number and specific qualifications are not detailed beyond being users of a surgical microscope navigation system.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The tests described are functional verification and usability validation, not diagnostic performance studies requiring human expert adjudication of medical images.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a microscope navigation software, not an AI-assisted diagnostic tool that aids human readers in interpreting medical images. Its purpose is to guide surgeons using a microscope by linking instruments and the surgical field view to patient image data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The verification tests the algorithm's functional aspects (safety measures, motorized movement UI, communication protocols) in a standalone manner (i.e., the software itself is tested without a human actively interpreting results in a diagnostic sense). However, its ultimate intended use is within a human-in-the-loop surgical navigation system. There isn't a "standalone performance" metric provided that would typically correspond to diagnostic algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The concept of "ground truth" as typically defined for diagnostic AI (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for these tests would be the correct functional behavior of the software and hardware according to specifications (e.g., a motorized movement correctly moves a certain distance, communication protocols correctly transmit data). The usability tests would have "ground truth" as the expected successful and safe interaction of users with the system.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document describes a software module for a navigation system, not a machine learning or AI model that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned for this device.
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September 6, 2019
Brainlab AG Hugo Morales Regulatory Affairs Manager Olof-Palme-Str. 9 81829 Munich Germany
Re: K190250
Trade/Device Name: Microscope Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 7, 2019 Received: August 9, 2019
Dear Hugo Morales:
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
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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 (QS) 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,
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K190250
Device Name Microscope Navigation
Indications for Use (Describe)
The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g., video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY MICROSCOPE NAVIGATION 1.5
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AGOlof-Palme-Straße 981829 MunichGermany |
|---|---|
| Submitter: | Oliver Fleig |
| Contact person: | Alexander Schwiersch |
| Summary date | December 14, 2018 |
| Device | Microscope Navigation |
| Trade name | Microscope Navigation Software |
| Common name: | Frameless Stereotaxic Navigation System |
| Classification name: | Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW) |
| Predicate Device: | K172820 Microscope Navigation |
| Regulatory Class: | Class II |
| Regulation Number: | 882.4560 |
| Intended use: | The Brainlab Navigation System - Microscope Navigation Software is a softwaremodule, that when used with a Brainlab navigation system and compatible instrumentaccessories, is intended as image guided planning and navigation system to enableopen and minimally invasive surgery.It links an instrument and the view of the surgical field (e.g. video, view through surgicalmicroscope) to a virtual computer image space on patient image data being processedby the navigation workstation. The system is indicated for any medical condition inwhich a reference to a rigid anatomical structure can be identified relative to images(CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy. |
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| Device description: | The Microscope Navigation Software (also referred to as subject device or MicroscopeApp) is a software. It runs on a Brainlab navigation system consisting of a computer, adisplay and an IR tracking camera (referred to as platform) and a Brainlab ImageGuided Surgery software (referred to as IGS software).The Microscope Navigation encapsulates microscope specific functionality andseparates it from the IGS software.The device interfaces with the IGS software and e.g. utilizes the registration providedby the IGS software.The device assists surgeries where a surgical microscope is used. It providesinformation based on the field of view through the microscope, the microscope positionrelative to the patient and the medical imaging data of the patient.The subject device provides functionality to verify and correct a patient registration.The Microscope Navigation does not provide its own registration. |
|---|---|
| Reason for 510(k)submission: | Microscope Navigation Version 1.0 has been cleared under K172820, with K082060VECTORVISION CRANIAL as predicate device. Compared to its predicate device,Microscope Navigation Version 1.0 provides limited interface implementation andcompatibilities of the microscope protocols. These interface implementation andcompatibilities have been present in K082060 VECTORVISION CRANIAL and havebeen re-implemented in Microscope Navigation Version 1.5. |
Substantial Microscope Navigation has been verified and validated using non-clinical data equivalence: according to Brainlab procedures for product design and development. The information provided by Brainlab in this Special 510(k) application supports the claim of substantial equivalence to the predicate device.
Microscope Navigation separates microscope specific functionality in an separate application. Microscope specific views are bundled in this application.
Comparison to the Predicate Device
Motorized movement functionality has been re-implemented in the Subject Device to provide full interface implementation to motorized microscopes. All features have already been present in K082060 VECTORVISION CRANIAL:
- Set focus depth to instrument tip ●
- Bookmarking ●
- . Align to trajectory
- Follow instrument tip
- Align to instrument axis
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Verification summary:
| Test | Test Method Summary | Results |
|---|---|---|
| Safety Measures | Verification of implemented limits and automaticsafety measures for the motorized movements | All tests passed |
| Motorized movementuser interface | Interactive testing of user interface | All tests passed |
| Communicationprotocols | Verification of the communication between thesubject device and the integrated microscopes. Thetests verify compliance of the subject device to thecommunication protocols provided by the microscopemanufacturer. | Protocols and acceptancecriteria are unchangedbetween subject device andpredicate device. All testspassed |
Validation summary:
The validation comprises usability tests which ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. The non-clinical validation has been performed with software and equipment that are identical or equivalent to the final version of the product.
§ 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).