(210 days)
BrainSUITE NET from BrainLAB is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible BrainLAB devices. It provides centralized access for managing video data, medical images and patient data. BrainSUITE NET can be used in the operating theater for various surgical procedures involving video processing, image recording, patient data viewing and software application control.
BrainSUITE NET enables full control of video signals from a single touchscreen interface and display of ore-, intra- and post-operative patient data. Physicians can easily manibulate how and where information is displayed, to monitors for the entire OR team or to remote rooms for consulting and real-time education.
The provided text is a 510(k) summary for the BrainSUITE NET device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed performance study with acceptance criteria, human readers, or ground truth-based evaluation as typically seen for AI/ML-driven diagnostic devices.
Therefore, much of the requested information cannot be extracted from this specific document. The BrainSUITE NET is described as a platform for integrating devices and distributing video signals and multimedia content, essentially a communication and data management system for operating rooms, not a diagnostic or therapeutic device requiring performance metrics like sensitivity or specificity.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied by 510(k) process) | BrainSUITE NET has been verified according to BrainLAB's procedures for product design and development. The evaluation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate devices Control Digital Operating Room System (K050209) and Switch Point Infinity (K033132). |
| Conformance to Voluntary Standards | Conforms to IEC 60601-1-1:2000 (Safety Requirements for Medical Electrical Systems) and IEC 60601-1-2:2001 (Electromagnetic Compatibility). |
| Functional Capabilities (Derived from Device Description) | - Video Data Management and Documentation: Can route a wide range of video signals to displays within or outside the OR. Offers preconfigured layouts and viewing modes (e.g., Picture-in-picture, Tile View, Quad View). Allows screenshots and recording of PAL and NTSC signals on DVD. - Touchscreen based Centralized Access: Enables full control of video signals from a single touchscreen. Users can switch between devices via a system-wide identical interface. Supports simultaneous use with multiple touchscreens. Access schemes can be defined for security. |
| Substantial Equivalence to Predicate Devices (Regulatory threshold) | Found to be substantially equivalent to Smith & Nephew Control Digital Operating Room System (K050209) and Stryker Switch Point Infinity (K033132). FDA review confirms this. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The document does not describe a performance study with a test set of data (e.g., medical images or patient cases) in the context an AI/ML diagnostic device. The evaluation mentioned is related to product design and development, conformity to standards, and substantial equivalence to predicate devices, not performance on specific clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. As there's no mention of a test set requiring ground truth, no experts for this purpose are cited.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or human adjudication process is described for this type of device.
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
- Not Applicable / Not Provided. This is not a diagnostic device with an AI component being evaluated for its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is an integration and communication platform, not a standalone algorithm performing a specific task that would require such evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No ground truth data is mentioned for testing this device. The "evaluation" spoken of relates to system functionality, safety, and equivalence, not to diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
- Not Applicable / Not Provided. This document does not describe the development or training of an AI/ML algorithm that would use a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no mention of a training set, the method for establishing its ground truth is also not applicable.
Summary of Device Evaluation and Regulatory Clearance:
The BrainSUITE NET obtained 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices (Smith & Nephew Control Digital Operating Room System K050209 and Stryker Switch Point Infinity K033132). The evaluation focused on ensuring the device's safety and effectiveness as a system for integrating devices and managing video/patient data in the operating room, and its adherence to relevant safety and electromagnetic compatibility standards (IEC 60601-1-1 and IEC 60601-1-2). This type of clearance does not typically involve the detailed performance metrics and comparative studies associated with AI-powered diagnostic tools.
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510 (k) Summary of Safety and Effectiveness for the BrainSUITE NET K070556
Manufacturer: BrainLAB AG Address: Kapellenstrasse 12 85622 Feldkirchen Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33 Mr. Per Persson Contact Person: Summary Date: January 31, 2007 Device Name:
Trade name:
BrainSUITE NET
Common/Classification Name:
Instrument, stereotaxic
Predicate Devices: Smith & Nephew Control Digital Operating Room System (K050209) Stryker Switch Point Infinity (K033132)
Device Classification Name: Instrument, stereotaxic Requiatory Class: Class II
Indications for Use:
BrainSUITE NET from BrainLAB is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible BrainLAB devices.
It provides centralized access for managing video data, medical images and patient data.
BrainSUITE NET can be used in the operating theater for various surgical procedures involving video processing, image recording, patient data viewing and software application control.
Device Description:
BrainSUITE NET enables full control of video signals from a single touchscreen interface and display of ore-, intra- and post-operative patient data. Physicians can easily manibulate how and where information is displayed, to monitors for the entire OR team or to remote rooms for consulting and real-time education.
Video Data Management and Documentation
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A wide range of video signals, e.g. from the microscope or endoscope, can be routed to displays within or outside the operating room. Preconfigured layouts can be chosen to facilitate the initial routing setup. Additionally, users can choose viewing modes for displays, for example "Picture-in-picture", "Tile View", "Quad View", etc.
For documentation purposes, screenshots can be taken from every available video source and saved for later consultation. PAL and NTSC signals may also be recorded on DVD.
Touchscreen based Centralized Access
Every device can be used inside the sterile field from a single touchscreen. Users can switch from one device to another through a system wide identical user interface.
If necessary, the same device can also be used simultaneously with multiple touchscreens. For security and safety reasons, certain access schemes can be defined, especially to exclude interference with the surgeon while he is performing a critical procedure on the patient.
Substantial equivalence:
BrainSUITE NET has been verified according to BrainLAB's procedures for product design and development. The evaluation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate devices Control Digital Operating Room System (K050209) manufactured by Smith & Nephew, and Switch Point Infinity (K033132) manufactured by Stryker.
BrainLAB's BrainSUITE Net conforms to the following voluntary standards:
- IEC 60601-1-1:2000 Medical Electrical Equipment Part 1: General Requirements for Safety; -Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2:2001 Medical Electrical Equipment Part 1: General Requirements for Safety; -Electromagnetic Compatibility
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, possibly representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BrainLAB AG % Mr. Ranier Birkenbach Executive Vice President Kappellenstrabe 12 85622 Feldkirchen Germany
SEP 2 5 2007
Re: K070556
Trade/Device Name: BrainSUITE NET Regulation Number: 21 CFR 882.4560 and 21 CFR 876.1500 Regulation Name: Stereotaxic instrument and Endoscope and accessories Regulatory Class: II Product Code: HAW, GCJ Dated: September 10, 2007 Received: September 10, 2007
Dear Mr. Birkenbach:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Ranier Birkenbach
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: BrainSUITE NET
Indications For Use:
BrainSUITE NET from BrainLAB is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible BrainLAB devices.
lt provides centralized access for managing video data, medical images and patient data.
BrainSUITE NET can be used in the operating theater for various surgical procedures involving video processing, image recording, patient data viewing and software application control,
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millan
(Division Sign-Off storative. Division of General, and Neurologica
510(k) Number
Page
§ 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).