(168 days)
iPlan D, K101627
Yes
The device description mentions "automatic detection of leads in post-operative images," which strongly suggests the use of AI/ML for image analysis and feature detection.
No.
The device is a software for image-based planning and review of neurosurgical procedures, creating coordinates and measurements for surgical intervention, rather than directly treating a medical condition.
No
This device is described as software for "image-based planning and review" for neurosurgical procedures, focusing on "placement of instruments/devices." It processes anatomical images and creates coordinates for surgical intervention. While it uses medical images, its primary function is pre-surgical planning and intraoperative guidance, not to diagnose a patient's medical condition.
Yes
The device description explicitly states "Trajectory planning is a software device" and details its function as processing and viewing images and planning content, with input and output being DICOM data. While it mentions user interaction via touchscreen, mouse, and keyboard on a laptop, these are standard computing peripherals and the core medical device functionality resides solely in the software.
Based on the provided information, the Brainlab Elements Trajectory Planning software is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Brainlab Elements Trajectory Planning software is used for planning and reviewing surgical procedures based on medical images of the patient's anatomy. It helps in determining the optimal path for instruments or devices during neurosurgery.
- Input Data: The input data is DICOM data, which represents medical images, not biological specimens.
- Output Data: The output data is also DICOM data and information used for surgical intervention (like coordinates and measurements), not diagnostic results from analyzing biological samples.
- Intended Use: The intended use is for surgical planning and guidance, not for diagnosing a condition by analyzing a sample from the body.
The software is a medical device used in the context of surgical procedures, but it does not fit the definition of an in vitro diagnostic device.
No
The input text does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Brainlab Elements Trajectory Planning software is intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.
Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
- · Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- · Probe placement
- · Cranial biopsies
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
Trajectory planning is a software device which is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co registrations, segmentations, trajectories, etc.). The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g. stereotactic arc settings).
The software is used in three different configurations:
-
- Trajectory (Element): allows the creation of trajectories
-
- Stereotaxy (Element); allows the creation of trajectories and supports also frame based procedures
- Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images
The software takes (DICOM) data as input and provides (DICOM) data as outputs. This data can be transferred by removable memory devices like USB sticks or via network.
The user interaction can be done with a touchscreen and/or with a mouse, optionally combined with a keyboard on a laptop which fulfill minimum requirements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. The device processes and views "anatomical images", including "multi-modal co-registration images". It takes (DICOM) data as input.
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found. The device is for "pre-, intra- and postoperative" use in "neurosurgical and neurological procedures".
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)
Software Verification: Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," Software verification was carried out for all the specifications and all tests met the acceptance criteria. In addition to the verification activities, the risk analysis shows that all relevant hazards have been taken into consideration, that risk control is complete and that the corresponding measures are in place.
Usability: Data from the Summative Usability test concluded that there is no indication that the use of the device could lead to critical errors resulting in a hazardous situation for patient or user.
Clinical Evaluation: Clinical claims were supported via data from literature and post market data collected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
iPlan K101627
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
November 3, 2021
Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Germany 81829
Re: K211544
Trade/Device Name: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 29, 2021 Received: October 4, 2021
Dear Chiara Cunico:
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 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
1
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,
Adam D. Pierce, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K211544
Device Name
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Indications for Use (Describe)
The Brainlab Elements Trajectory Planning software is intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.
Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):
- · Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- · Probe placement
- · Cranial biopsies
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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510(k) Summary
November 3, 2021
| General Information | ||
|---|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany | |
| Establishment Registration | 8043933 | |
| Trade Name | Trajectory Planning, Elements Trajectory Planning, Elements Lead | |
| Localization | ||
| Classification Name | Neurological Stereotaxic Instrument | |
| Product Code | HAW | |
| Regulation Number | 882.4560 | |
| Regulatory Class | Class II | |
| Panel | Neurology | |
| Predicate Device(s) | iPlan K101627 | |
| Contact Information | ||
| Primary Contact | Alternate Contact | |
| Chiara Cunico | Regulatory Affairs Brainlab | |
| Manager RA | Phone: +49 89 99 15 68 0 | |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 | |
| Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
1. Indication for Use
The Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.
Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/ device can be identified relative to images of the anatomy.
This includes, but is not limited to, the following Cranial procedures (including frame-based
stereotaxy and frame alternative-based stereotaxy):
- Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- Probe placement
- Cranial biopsies
2. Device Description
Trajectory planning is a software device which is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co registrations, segmentations, trajectories, etc.). The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g. stereotactic arc settings).
4
The software is used in three different configurations:
-
- Trajectory (Element): allows the creation of trajectories
-
- Stereotaxy (Element); allows the creation of trajectories and supports also frame based procedures
- Lead Localization (Element): allows the creation of trajectories and automatic detection of ဒေ.
က leads in post-operative images
The software takes (DICOM) data as input and provides (DICOM) data as outputs. This data can be transferred by removable memory devices like USB sticks or via network.
The user interaction can be done with a touchscreen and/or with a mouse, optionally combined with a keyboard on a laptop which fulfill minimum requirements.
3. Substantial Equivalence
The Subject Device is similar to the predicate device in terms of:
- Support of frame based procedures including stereotactic localization and arc settings । calculation
- -Trajectory planning on multi-modal co-reqistration images
- Multiple views for reconstructed medical images -
- -Visualization for supplemental information like segmented structure and fiber tracts
- Definition and usage of AC/PC coordinate system for Trajectory Planning -
The Subiect Device differs from the predicate device in terms of:
- Additional indications included for SEEG procedures, DBS procedures, Probe placement -
- -Spine and ENT indications
- Additional stereotactic hardware support (Elekta Vantage) -
- Predicate device was split into multiple medical software modules -
- -Addition of automatic lead detection in CT images
- User Interfaces -
4. Performance Data
Software Verification
Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,"
Software verification was carried out for all the specifications and all tests met the acceptance criteria. In addition to the verification activities, the risk analysis shows that all relevant hazards have been taken into consideration, that risk control is complete and that the corresponding measures are in place.
5
Usability
Data from the Summative Usability test concluded that there is no indication that the use of the device could lead to critical errors resulting in a hazardous situation for patient or user.
Clinical Evaluation
Clinical claims were supported via data from literature and post market data collected.
5. Conclusion
The comparison of the Subject Device with the predicate device shows that the device has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification and validation activities ensured that the design specifications are met and that the Subject Device substantially equivalent to the predicate device.