(262 days)
No
The description focuses on electromagnetic tracking and image-guided navigation based on pre-operative scans, without mentioning any AI/ML algorithms for image analysis, planning, or navigation. The software modules listed are standard for navigation systems.
No
The device is an image-guided planning and navigation system for neurosurgery, used to localize instruments and anatomy during procedures, which is a diagnostic/locational function rather than a therapeutic one.
No
Explanation: The device is described as an "image-guided planning and navigation system" that "links patient anatomy ... and instruments in the real world ... to patient scan data." Its purpose is to "support the surgeon during various surgical interventions" by continuously localizing medical instruments and patient anatomy. It uses pre-acquired images but does not perform diagnostic functions such as detecting, classifying, or quantifying disease or conditions. Its role is surgical guidance, not diagnosis.
No
The device description explicitly states that the Cranial EM System consists of both software and hardware components, and lists specific hardware components included in the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as an "image-guided planning and navigation system to enable neurosurgery procedures." This involves using pre-acquired images to guide surgical interventions directly on the patient's anatomy.
- Device Description: The device description focuses on linking patient anatomy in the real world to image data for surgical navigation. It describes hardware components like platforms and instruments used for tracking and localization during surgery.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are designed to perform tests on these types of samples.
The device is a surgical navigation system, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device 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, such as:
- Cranial Resection
- Resection of tumors and other lesions
- Resection of skull-base tumor or other lesions
- Intracranial catheter placement
Product codes
HAW
Device Description
The Subject Device, Cranial EM System, consists of software and hardware components. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. The tracking data are acquired via electromagnetic tracking.
Cranial EM is a touchscreen-based intraoperative navigation software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as MR and/or CT, can support the surgeon during various surgical interventions. Cranial EM uses scanned images of the patient that are acquired before surgery is performed.
The following software make up the main module of the device:
-
- EM Setup 2.1 2. Head Registration 2.1 3. EM Instruments 2.1
-
- Navigation 2.1
The Subject Device Consists of the following hardware components:
Platforms:
-
- Kick 2 Navigation Station (Article Number: 18202)
-
- Curve Navigation 17700 (Article Number: 17700)
Instruments:
-
- EM Patient Reference 2.0 (18099-24)
-
- EM Pointer (18099-02C)
-
- EM Instrument Reference (18099-05A)
-
- EM Registration Pointer (18099-23)
-
- EM Stylet 2.0 (18097-01)
-
- EM Short Pointer (18099-27)
-
- EM Skull Reference Base (18099-06)
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
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgery 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)
The following tests were conducted:
- System accuracy tests (Software + platforms + instruments)
- Platform expected service life verification
- Biocompatibility and reprocessing and shelf life sterility tests for applicable instruments
- User contact biocompatibility assessment
- Routine Software verification
- Platform Verification
- Usability Evaluation
No clinical testing submitted for the Subject Device. Data from existing literature was leveraged for validating the Subject Device's indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Under representative worst-case configuration, the Cranial EM System is tested to ensure that its mean location error is ≤ 2 mm and its mean trajectory angle error is ≤ 2 degrees.
Predicate Device(s)
Reference Device(s)
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 8, 2022
Brainlab AG Chiara Cunico Manager, Regulatory Affairs Olof-Palme-Str. 9 Munchen, 81829 Germany
Re: K213989
Trade/Device Name: Cranial EM System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 9, 2022 Received: August 9, 2022
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
1
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 mediation-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) K213989
Device Name Cranial EM System
Indications for Use (Describe)
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device 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, such as:
- · Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
- Intracranial catheter placement
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
September 8, 2022
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment | |
| Registration | 8043933 |
| Device Name | Neurological Stereotaxic Instrument |
| Trade Name | • Cranial EM system |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Neurology |
| Predicate Devices | Primary: StealthStation Cranial Software v1.3.0 (K201175) by Medtronic |
| Secondary: Kolibri Cranial Magnetic (K042391) by Brainlab AG | |
| Reference Device: Cranial IGS System (K192703) by Brainlab AG | |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Chiara Cunico | |
| Manager RA | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com | Regulatory Affairs Brainlab |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 5033 | |
| Email: regulatory.affairs@brainlab.com |
1. Indications for Use
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures.
The device 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, such as:
- Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
- Intracranial catheter placement
2. Device Description
The Subject Device, Cranial EM System, consists of software and hardware components. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. The tracking data are acquired via electromagnetic tracking.
4
K213989 Page 2 of 9
Cranial EM is a touchscreen-based intraoperative navigation software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as MR and/or CT, can support the surgeon during various surgical interventions. Cranial EM uses scanned images of the patient that are acquired before surgery is performed.
The following software make up the main module of the device:
-
- EM Setup 2.1 2. Head Registration 2.1 3. EM Instruments 2.1
-
- Navigation 2.1
The Subject Device Consists of the following hardware components:
Platforms:
-
- Kick 2 Navigation Station (Article Number: 18202)
-
- Curve Navigation 17700 (Article Number: 17700)
Instruments:
-
- EM Patient Reference 2.0 (18099-24)
-
- EM Pointer (18099-02C)
-
- EM Instrument Reference (18099-05A)
-
- EM Registration Pointer (18099-23)
-
- EM Stylet 2.0 (18097-01)
-
- EM Short Pointer (18099-27)
-
- EM Skull Reference Base (18099-06)
3. Substantial Equivalence
5
| Topic | Subject Device: Cranial EM
System | Primary Predicate:
StealthStation Cranial
Software v1.3.0 (K201175) | Secondary Predicate:
Kolibri Cranial Magnetic
(K042391) | Reference Device: Cranial
Image Guided Surgery
System (K192703) | Comment |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Cranial EM is intended as an image-
guided planning and navigation system
to enable neurosurgery procedures.
The device 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,
such as:
• Cranial Resection
o Resection of tumors and other
lesions
o Resection of skull-base tumor or
other lesions
• Intracranial catheter placement | The StealthStation™ System, with
StealthStation™ Cranial Software, is
intended as an aid for locating
anatomical structures in either open
or percutaneous neurosurgical
procedures. Their use 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 the skull, can be identified relative
to images of the anatomy.
This can include, but is not limited
to, the following cranial procedures
(including stereotactic frame-based
and stereotactic frame alternatives-
based procedures):
• Tumor resections
• General ventricular catheter
placement
• Pediatric ventricular catheter
placement
• Depth electrode, lead, and probe
placement
• Cranial biopsies | The BrainLAB Kolibri IGS
System is intended to be an
intraoperative image guided
localization system to enable
minimally invasive surgery. It
links a freehand probe, tracked
by a magnetic sensor system
or a passive marker sensor
system to a virtual computer
image space on a patient's
preoperative diagnostic image
data set being processed by
the Kolibri computer
workstation. The system is
indicated for any medical
condition in which the use of
stereotactic surgery may be
appropriate and where a
reference to a rigid anatomical
structure, such as the skull, a
long bone, or vertebra, can be
identified relative to a CT, X-ray
or MR based model of the
anatomy.
Example image guided cranial
surgery procedures include but
are not limited to:
- Tumor resections
- Skull base surgery
- Cranial biopsies
- Craniotomies/Craniect
omies - Pediatric Catheter
Shunt Placement - General Catheter
Shunt Placement | The Cranial IGS System, when used
with a compatible navigation
platform and compatible instrument
accessories, is intended as an
image-guided planning and
navigation system to enable
navigated surgery. It links
instruments to a virtual computer
image space on patient image data
that is being processed by the
navigation platform.
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,
including:
•Cranial Resection
o Resection of tumors and
other lesions
o Resection of skull-base
tumor or other lesions
•AVM Resection
•Cranial biopsies
•Intracranial catheter placement
•Intranasal structures and Paranasal
Sinus Surgery
•Functional endoscopic sinus
surgery (FESS)
•Revision & distorted anatomy
surgery all intranasal structures and
paranasal sinuses | The wording has been
rephrased with the
purpose to improve
readability and clarity
without affecting the
content.
The included procedures
are grouped differently:
resections are bundled
and approaches as
craniotomy not listed
separately. Catheter
placement are bundle
without patient population
specifications. Biopsies,
depth electrode
placement, ENT
indications or AVM are not
part of the indications of
the subject device.
The Subject Devices'
indications are within the
subset of the primary
predicate and reference
devices' indications. |
| Topic | Subject Device: Cranial EM
System | Primary Predicate:
StealthStation Cranial
Software v1.3.0 (K201175) | Secondary Predicate:
Kolibri Cranial Magnetic
(K042391) | Reference Device: Cranial
Image Guided Surgery
System (K192703) | Comment |
| Localization
technique
based on: | Electromagnetic tracking
The Field generator emits low
intensity and varying
electromagnetic field which induce
small currents in the sensors
embedded in the EM instruments.
The position and spatial orientation
of the sensors integrated in the EM
instruments are calculated in the
Base station. | Electromagnetic tracking
The Side Emitter emits low
intensity and varying
electromagnetic field which
induce small currents in the
sensors embedded EM
instruments. The position and
spatial orientation of the sensors
integrated in the EM instruments
are calculated in the Instrument
Interface Box. | Electromagnetic tracking
The Field generator emits
low intensity and varying
electromagnetic field which
induce small currents in the
sensors of the EM
instruments. The position
and spatial orientation of the
sensors integrated in the EM
instruments are calculated in
the Base station. | Optical Tracking- N/A | General localization
techniques
remain the same w.r.t.
the predicate devices:
K201175 and K042391.
K19270 uses an optical
tracking system.
Therefore it´s not
comparable with the
other systems |
| Tracking
Accuracy | Under representative worst-case
configuration, the Cranial EM
System is tested to ensure that its
mean location error is ≤ 2 mm and
its mean trajectory angle error is ≤ 2
degrees. | Under representative worst-case
configuration, the StealthStation
S8 System with StealthStation
Cranial Software v1.3.0, has
demonstrated performance in
3D positional accuracy with a
mean error ≤ 2.0 mm and in
trajectory angle accuracy with a
mean error ≤ 2 degrees. | ≤ 2.5 mm distance RMS
(Root Mean Square)
≤ 2.5° angle RMS (Root
Mean Square) | Under representative worst-case
configuration, the Cranial EM
System is tested to ensure that
its mean location error is ≤ 2 mm
and its mean trajectory angle
error is ≤ 2 degrees. | The subject device and
primary predicate
device are both
meeting the same
accuracy requirements.
Refer to Ground truth
accuracy test report
[0000279513] |
| Topic | Subject Device: Cranial EM System | Primary Predicate:
StealthStation Cranial
Software v1.3.0 (K201175) | Secondary Predicate:
Kolibri Cranial Magnetic
(K042391) | Reference Device: Cranial
Image Guided Surgery
System (K192703) | Comment |
| Field
Generator | Manufacturer: NDI
Localizer: Aurora V3
Emitter Type: side
Tracking Volume: 500x500x400 mm
Image: Drawing of tracking volume
Image: Drawing of tracking volume
Field strength:
Image: Graph of field strength | Manufacturer: Medtronic
Localizer: AXIEM III
Emitter Type: side, flat
Tracking Volume: 460x460x310 mm (side), 400x400x375 mm (flat)
Image: Drawing of tracking volume
Image: Drawing of tracking volume
Field strength:
$