(135 days)
K200723 StealthStation FlexENT, StealthStation S8 ENT Software 1.3
K213989 Cranial EM System
Yes
The "Mentions AI, DNN, or ML" section explicitly states that a new algorithm using artificial intelligence and machine learning (AI/ML) is incorporated for the registration step, specifically for landmark detection using a Convolutional Network (CNN) developed with Supervised Learning.
No.
The device is an image-guided planning and navigation system for ENT procedures, providing guidance for surgical navigation rather than directly treating a medical condition.
No
Explanation: The device is an image-guided planning and navigation system for surgical procedures, not for diagnosing medical conditions. It aids in surgery by tracking instruments relative to patient anatomy, but it does not identify or characterize diseases.
No
The device description explicitly states that ENT EM consists of "Several software modules... IGS platforms and surgical instruments for navigation, patient referencing and registration." The IGS platforms are described as consisting of a "mobile Monitor Cart and an EM tracking unit." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The ENT EM system is an image-guided planning and navigation system. Its purpose is to assist surgeons during ENT procedures by providing real-time localization of instruments relative to patient anatomy based on medical images. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "image-guided planning and navigation system to enable ENT procedures." This is a surgical guidance system, not a diagnostic test performed on a sample.
- Device Description: The description focuses on tracking instruments, linking real-world anatomy to image data, and providing navigation during surgery. This aligns with a surgical navigation system, not an IVD.
While the device uses AI/ML for a pre-registration step based on landmarks derived from images, this is a function within a surgical navigation system, not a diagnostic test performed on a biological sample.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
ENT EM is intended as an image-guided planning and navigation system to enable ENT 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:
· Intranasal structures and Paranasal Sinus Surgery
o Functional endoscopic sinus surgery (FESS)
o Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy
· Anterior skull base procedures
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
The Subject Device ENT EM is an image guided planning and navigation system to enable navigated surgery during ENT procedures. It offers guidance for setting up the EM equipment, different patient image registration methods and instrument selection and calibration to allow surgical navigation by using electromagnetic tracking (EM) technology. The device provides different workflows guiding the user through preoperative and intraoperative steps.
To fulfill this purpose, 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 ENT procedures.
The software is installed on a mobile Image Guided Surgery (IGS) platform (Kick 2 Navigation Station or Curve Navigation 17700) to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart and an EM tracking unit for image guided surgery purposes.
ENT EM consists of: Several software modules for registration, instrument handling, navigation and infrastructure tasks, IGS platforms and surgical instruments for navigation, patient referencing and registration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
This submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML). This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on quide points. These guide points or landmarks are delivered by a ML based calculation. The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach.
Input Imaging Modality
CT, CTA, X-Ray, MR, MRA and ultrasound
Anatomical Site
Intranasal structures and Paranasal Sinus, Anterior skull base
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the training process begins with the model observing, learning, and optimizing its parameters based on the training pool data.
Description of the test set, sample size, data source, and annotation protocol
The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project. This is a static algorithm (locked).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: 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." This included product specifications, risk analysis and software verification testing. The software (ENT EM 1.2) for this device was considered as a "major" level of concern. Performance testing comparing conventional to machine learning based landmark detection were performed showing equivalent performance as in the reference device.
System accuracy testing: The positional and angular navigation accuracy for ENT procedures of the Subject Device including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst case scenarios. The results show the following acceptance criteria are fulfilled:
Mean Positional Error of the placed instrument's tip ≤ 2 mm
Mean Anqular Error of the placed instrument's axis ≤ 2º
Therefore, the Subject Device achieves the same accuracy performance as both predicate and reference device.
Usability: To account for differences regarding the intended user group compared to the reference device and the different workflow steps and GUI implementation compared to the predicate device a summative usability evaluation in a simulated clinical environment was carried out, where the user had to go through all main steps and frequently used functions. This showed ENT EM is safe and effective for use by the intended user group.
Electrical safety and electromagnetic compatibility (EMC): Compliance to electrical safety, RFID and EMC was evaluated on the Subject device according to the standards: IEC 60601-1, AIM 7351731 and IEC 60601-1-2. The tests have shown that the subject device performs as intended.
Instruments: Due to the change in legal manufacturer of the skull reference instruments, the biocompatibility testing and reprocessing validation for the instruments was provided in order to demonstrate their biological safety and appropriateness of the cleaning, disinfection and sterilization methods. This included:
Biocompatibility assessment considering different end points.
Cleaning and disinfection evaluation/reprocessing validation
The mechanical properties of instruments were also evaluated considering the typical torsional strengths, torques and conditions the instruments can be subject to during their use.
No clinical testing was needed for the Subject Device since the EM tracking technology in the scope of image guided surgery for the included indications for use is well established in the market. Bench testing demonstrated that the device performs as the predicate and that no different questions on safety or effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Positional Error of the placed instrument's tip ≤ 2 mm
Mean Anqular Error of the placed instrument's axis ≤ 2º
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K200723 StealthStation FlexENT, StealthStation S8 ENT Software 1.3
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K213989 Cranial EM System
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).
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April 27, 2023
Brainlab AG Esther Moreno Garcia QM Consultant Olof-Palme-Str. 9 Munich, 81829 Germany
Re: K223734
Trade/Device Name: Ent Em Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 28, 2023 Received: March 28, 2023
Dear Esther Moreno Garcia:
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 f ound 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K223734
Device Name ENT EM
Indications for Use (Describe)
ENT EM is intended as an image-guided planning and navigation system to enable ENT 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:
· Intranasal structures and Paranasal Sinus Surgery
- o Functional endoscopic sinus surgery (FESS)
o Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy
· Anterior skull base procedures
| 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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Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a medical symbol or a stylized brain. To the right of the symbol, the word "BRAINLAB" is written in large, bold, pink letters. The overall design is clean and modern.
510(k) Summary
April 27, 2023
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | ENT EM |
| Classification Name | Ear, nose, and throat stereotaxic instrument |
| Product Code | PGW |
| Regulation Number | 882.4560 |
| Regulatory Class | Class II |
| Panel | Neurology - Ear Nose & Throat |
| Predicate Device(s) | K200723 StealthStation FlexENT, StealthStation S8 ENT Software 1.3 |
| Reference Device(s) | K213989 Cranial EM System |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Esther Moreno Garcia | Chiara Cunico |
| QM Consultant - Regulatory Affairs | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: regulatory.affairs@brainlab.com | Email: chiara.cunico@brainlab.com |
1. Indication for Use
ENT EM is intended as an image-guided planning and navigation system to enable ENT 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:
- . Intranasal structures and Paranasal Sinus Surgery
- Functional endoscopic sinus surgery (FESS) o
- Intranasal structures and paranasal sinus surgery, including revision and distorted o anatomy
- . Anterior skull base procedures
-
- Device Description
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain with interconnected pathways. To the right of the symbol, the word "BRAINLAB" is written in capital letters, also in pink. The overall design is clean and modern.
The Subject Device ENT EM is an image guided planning and navigation system to enable navigated surgery during ENT procedures. It offers guidance for setting up the EM equipment, different patient image registration methods and instrument selection and calibration to allow surgical navigation by using electromagnetic tracking (EM) technology. The device provides different workflows guiding the user through preoperative and intraoperative steps.
To fulfill this purpose, 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 ENT procedures.
The software is installed on a mobile Image Guided Surgery (IGS) platform (Kick 2 Navigation Station or Curve Navigation 17700) to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart and an EM tracking unit for image guided surgery purposes.
ENT EM consists of: Several software modules for registration, instrument handling, navigation and infrastructure tasks, IGS platforms and surgical instruments for navigation, patient referencing and registration.
With this submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML). This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on quide points. These guide points or landmarks are delivered by a ML based calculation. The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the training process begins with the model observing, learning, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project. This is a static algorithm (locked).
3. Substantial Equivalence
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICE
| Characteristic | Predicate Device K200723 | Reference Device K213989 | Subject device
ENT EM |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The StealthStation
FlexENT™ system with the
StealthStation™ ENT
software, is intended as an
aid for precisely locating
anatomical structures in | 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 | All devices are intended
for the localization of
anatomical structures
(navigation). Compared to
predicate device, same
indications for use (Sinus |
| | either open or percutaneous ENT 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 procedures:
- Functional Endoscopic Sinus Surgery (FESS)
- Endoscopic Skull Base procedures
- Lateral Skull Base procedures | 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 | surgery and anterior skull base procedures). |
| Localization technique | 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 embedded in the EM instruments. The position and spatial orientation of the sensors integrated in the EM instruments are calculated in the Base station. | Same localization technique compared to both predicate and reference device. The EM tracking device used is the same as in the reference device. |
| System accuracy | Under representative worst-case configuration, the StealthStation FlexENTt and S8 Systems With StealthStation S8 ENT vl.3 Software, has demonstrated performance in 3D positional accuracy with a mean error