(211 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the described functionality is consistent with traditional image-guided navigation systems.
No.
The device is an image-guided planning and navigation system for surgical procedures, it does not directly treat a disease or condition.
No
Explanation: The device is described as an image-guided planning and navigation system for surgery. Its purpose is to assist in surgical procedures by linking instruments and the surgical field view to patient image data, providing information for navigation during surgery. It does not perform diagnosis or generate diagnostic findings.
No
The device is described as a software module that runs on a Brainlab navigation system, which includes hardware components like a computer, display, and IR tracking camera. While the subject device is software, it is part of a larger system that is not software-only.
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 device is an "image guided planning and navigation system to enable open and minimally invasive surgery." It assists surgeons during procedures by providing navigation based on medical images and the surgical field.
- Device Description: The description details a software module that runs on a navigation system and interfaces with surgical microscopes. It provides information to the surgeon during surgery.
- Lack of In Vitro Activity: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not perform any tests on biological samples outside of the body. It uses medical images and real-time tracking during surgery.
The device is a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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 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.
Product codes
HAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CTA, X-Ray, MR, MRA and ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification summary:
Test: Safety Measures; Test Method Summary: Verification of implemented limits and automatic safety measures for the motorized movements; Results: All tests passed
Test: Motorized movement user interface; Test Method Summary: Interactive testing of user interface; Results: All tests passed
Test: Communication protocols; Test Method Summary: Verification of the communication between the subject device and the integrated microscopes. The tests verify compliance of the subject device to the communication protocols provided by the microscope manufacturer.; Results: Protocols and acceptance criteria are unchanged between subject device and predicate device. All tests passed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 AG
Olof-Palme-Straße 9
81829 Munich
Germany |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 workstation. 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. |
4
| Device description: | 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. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for 510(k)
submission: | Microscope Navigation Version 1.0 has been cleared under K172820, with K082060
VECTORVISION CRANIAL as predicate device. Compared to its predicate device,
Microscope Navigation Version 1.0 provides limited interface implementation and
compatibilities of the microscope protocols. These interface implementation and
compatibilities have been present in K082060 VECTORVISION CRANIAL and have
been 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 automatic | |
| safety measures for the motorized movements | All tests passed | |
| Motorized movement | ||
| user interface | Interactive testing of user interface | All tests passed |
| Communication | ||
| protocols | Verification of the communication between the | |
| subject device and the integrated microscopes. The | ||
| tests verify compliance of the subject device to the | ||
| communication protocols provided by the microscope | ||
| manufacturer. | Protocols and acceptance | |
| criteria are unchanged | ||
| between subject device and | ||
| predicate device. All tests | ||
| passed |
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.