Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mathematical modeling (finite element and neural activation models) for VTA visualization, not AI/ML algorithms. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

No
The device is a software tool designed to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It does not directly provide therapy or interact with the patient's body for therapeutic purposes. Its function is to aid in the planning process for an approved therapeutic device (DBS).

Diagnostic

No

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It does not diagnose a condition or disease.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that Bullsai Confirm is a software that imports images, processes them, and provides visualizations and reports. There is no mention of any accompanying hardware component that is part of the device itself. While it interacts with external hardware (PACS, AWS S3, Abbott DBS devices), the device being cleared is the software application.

IVD (In Vitro Diagnostic)

Based on the provided information, Bullsai Confirm is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
Bullsai Confirm's Function: Bullsai Confirm's intended use is to assist medical professionals in planning the programming of stimulation for patients receiving deep brain stimulation (DBS) devices. It does this by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy using medical imaging data (MRI and CT).
No Specimen Examination: The device does not involve the examination of any specimens derived from the human body. It operates on medical imaging data and mathematical models to predict the effect of stimulation.

In summary, Bullsai Confirm is a software tool for treatment planning based on medical imaging, not a diagnostic tool that analyzes biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Product codes (comma separated list FDA assigned to the subject device)

QQC

Device Description

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface.

Bullsai Confirm is used to do the following:

Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images.
. Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage
. Combine MR images, CT images, and patient specific 3D structures for more detail
Localize graphical compatible DBS lead models (based on preoperative imaging) .
. Visualize VTA fields relative to structures of interest in the patient anatomy or lead position

The software provides a workflow for clinicians to:

Create patient-specific stimulation plans for DBS programming .
. Export reports that summarize stimulation plans for patients (PNG screenshot)

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

magnetic resonance imaging (MRI) and computed tomography (CT)

Anatomical Site

Not Found (Implied: Brain)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals

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)

A hazard analysis and software verification and validation testing were performed for Bullsai Confirm. Bullsai Confirm also underwent formative usability testing and technical performance evaluation of the lead artifact detection and registration between image types.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

SureTune4 Software, DEN210003

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.

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

Regulation Number and Section

§ 882.5855 Brain stimulation programming planning software.

(a)
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.

Summary

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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2025

Turing Medical Technologies, Inc. Christa Nova Director of Quality Assurance and Regulatory Affairs 393 N Euclid Ave Suite 310 Saint Louis, Missouri 63108

Re: K243520

Trade/Device Name: Bullsai Confirm Regulation Number: 21 CFR 882.5855 Regulation Name: Brain Stimulation Programming Planning Software Regulatory Class: Class II Product Code: OOC Dated: March 14, 2025 Received: November 15, 2024

Dear Christa Nova:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

2

Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243520

Device Name

Bullsai Confirm

Indications for Use (Describe)

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Device Trade Name:	Bullsai Confirm
Manufacturer:	Turing Medical Technologies, Inc.
393 N EUCLID AVE STE 310,
SAINT LOUIS, MISSOURI 63108 UNITED STATES
Contact:	Christa Nova
Director, QARA
419-388-3288
Date Prepared:	March 28, 2025
Classification:	Brain stimulation programming planning software, 21 CFR
882.5855
Class:	II
Product Code:	QQC
Primary Predicate:	SureTune4 Software, DEN210003

Indications For Use:

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Device Description:

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface.

Bullsai Confirm is used to do the following:

Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images.
. Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage
. Combine MR images, CT images, and patient specific 3D structures for more detail
Localize graphical compatible DBS lead models (based on preoperative imaging) .
. Visualize VTA fields relative to structures of interest in the patient anatomy or lead position

5

The software provides a workflow for clinicians to:

Create patient-specific stimulation plans for DBS programming .
. Export reports that summarize stimulation plans for patients (PNG screenshot)

Predicate Device:

Turing Medical Technologies, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Bullsai Confirm is substantially equivalent in indications, design principles, and performance to the following predicate device.

Primary Predicate: SureTune4 Software (DEN210003)

| Item | Predicate:
SureTune4
Software
DEN210003 | Subject Device:
Bullsai Confirm | Comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Identical |
| Product Code | QQC | QQC | Identical |
| Device
Description | The SureTune4 Software is
intended to assist medical
professionals in planning the
programming of deep brain
stimulation (DBS) by
visualizing the Volume of
Neural Activation (VNA)
relative to patient anatomy. It
is used to visualize patient-
specific information within the
patient's anatomy. Integrated
preoperative and
postoperative magnetic
resonance imaging (MRI), O-
armTM, and computed
tomography (CT) images are
uploaded to SureTune4 and
can be navigated through in
multiple 2D projections and 3D
reconstructions. Medtronic
DBS lead models are
positioned in the
corresponding artifacts and
potential stimulation settings
and electrode configurations
entered. The SureTune4
Software mathematically
combines finite element (FE)
based electric field model of
the lead with an axon based
neural activation model to | Bullsai Confirm is intended to
assist medical professionals
in planning the programming
of deep brain stimulation
(DBS) by visualizing the
Volume of Tissue Activated
(VTA) relative to patient
anatomy. It is used to
visualize patient-specific
information within the patient's
anatomy. Integrated
magnetic resonance imaging
(MRI) and computed
tomography (CT) images are
uploaded to Bullsai Confirm
and can be navigated through
in multiple 2D projections and
3D reconstructions.
Abbott DBS lead models are
positioned in the
corresponding artifacts and
potential stimulation settings
and electrode configurations
entered. Bullsai Confirm
mathematically combines
finite element (FE) based
electric field model of the lead
with an axon based neural
activation model to translate
potential stimulation settings
and electrode configurations | Similar;

Bullsai Confirm
does not import or
combine O-arm™
images.
Bullsai Confirm
does not import from
physical media.
Bullsai Confirm
shares results,
including input image
quality assessments,
in an output PDF
report and visualized
in a web-based
software interface.
Bullsai Confirm
does not enter
electrophysiological
annotations.
Bullsai Confirm
does not superimpose
an anatomical atlas.
Bullsai Confirm
does not manually
segment structures of |
| | translates potential stimulation
settings and electrode
configurations into a visualized
VNA field to indicate the
shape and the area or volume
of anatomy that will be
activated by the stimulation.

The SureTune4 software is
used to do the following:
• Import MR, O-armTM, and
CT patient images over a
DICOM network or from
physical media (hard
drive, USB drive, CD, or
DVD)
• Import DICOM archives
from StealthStationTM
S7TM systems with
Cranial 3.x software and
StealthStationTM S8
Cranial software systems,
and SureTune4 systems
over a DICOM network
• Combine MR, O-armTM
and CT images for more
detail
• Superimpose an
anatomical atlas to better
understand the position of
structures of interest
relative to a patient's
anatomy
• Manually segment
structures of interest to
highlight particular brain
structures
• Localize graphical
Medtronic DBS lead
models (based on
preoperative imaging)
• Enter electrophysiological
annotations
• Visualize VNA fields
relative to structures of
interest in the patient
anatomy or lead position
• Create patient-specific
stimulation plans for DBS
programming
• Generate reports that
summarize stimulation
plans for patients
• Export patient sessions to
SureTune4 XLS
spreadsheets (in
MicrosoftTM Excel format) | into a visualized VTA field to
indicate the shape and the
area or volume of anatomy
that will be activated by the
stimulation. Results, including
input image quality
assessments, are shared in
an output PDF report and
visualized in a web-based
software interface.

Bullsai Confirm is used to do
the following:
• Import DICOM images from
a picture archiving and
communication system
(PACS), including MRI and
CT DICOM images.
• Import preoperative
planning outputs (including
tractography, structural
ROIs, etc.) from AWS S3
Cloud Storage
• Combine MR images, CT
images, and patient specific
3D structures for more
detail
• Localize graphical
compatible DBS lead
models (based on
preoperative imaging)
• Visualize VTA fields relative
to structures of interest in
the patient anatomy or lead
position

The software provides a
workflow for clinicians to:
• Create patient-specific
stimulation plans for DBS
programming
• Export reports that
summarize stimulation
plans for patients (PNG
screenshot) | interest to highlight
particular brain
structures. |
| Indication for Use | The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices. | Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices. | Similar |

Substantial Equivalence:

6

7

Bullsai Confirm is substantially equivalent to the identified predicate (legally marketed) device. Bullsai Confirm has the same intended use and technological characteristics as the predicate device and or different intended use and technological characteristics that do not raise different questions of safety and effectiveness.

At a high level, Bullsai and predicate device are based on the following same elements:

Bullsai Confirm is intended to assist medical professionals in planning the programming of . deep brain stimulation (DBS).
Bullsai Confirm visualizes neural activation tissue through Volume of Tissue Activated (VTA). •
Bullsai Confirm visualizes relative to patient anatomy.
Bullsai Confirm is used to visualize patient-specific information within the patient's anatomy.
. Bullsai Confirm imports preoperative and postoperative MR and CT images.
Bullsai Confirm displays integrated preoperative and postoperative MR and CT images.
Bullsai Confirm accepts uploaded images which can be navigated through in multiple 2D projections and 3D reconstructions.
. Bullsai Confirm positions DBS lead models in the corresponding artifacts, and potential stimulation settings and electrode configurations are displayed.
. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation.
. Bullsai Confirm imports patient images.
Bullsai Confirm uses DICOM networks (PACS). •
Bullsai Confirm uses DBS lead models. •
Bullsai Confirm combines images for more detail.
Bullsai Confirm localizes graphical DBS lead models based on preoperative imaging.
. Bullsai Confirm visualizes fields relative to structures of interest in the patient anatomy or lead position.
. Bullsai Confirm provides a workflow for clinicians to create and export patient-specific summary stimulation plans.

At a high level, Bullsai Confirm and predicate device have the following different elements:

Bullsai Confirm does not import or combine O-arm™ images. .
Bullsai Confirm does not import from physical media.
Bullsai Confirm shares results, including input image quality assessments, in an output PDF . report and visualized in a web-based software interface.
Bullsai Confirm does not enter electrophysiological annotations.
. Bullsai Confirm does not superimpose an anatomical atlas.
Bullsai Confirm does not manually segment structures of interest to highlight particular brain ● structures.

8

Performance Data:

The subject device meets the special controls under 21 CFR 882.5855 for brain stimulation programming planning software, which include the following:

1. Software verification, validation, and hazard analysis must be performed.
1. Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
1. Labeling must include:
- a. The implanted brain stimulators for which the device is compatible.
- b. Instructions for use.
- c. Instructions and explanations of all user-interface components.
- d. A warning regarding use of the data with respect to not replacing clinical judgement.

A hazard analysis and software verification and validation testing were performed for Bullsai Confirm. Bullsai Confirm also underwent formative usability testing and technical performance evaluation of the lead artifact detection and registration between image types. The User Manual for Bullsai Confirm contains the labeling statements in accordance with the special controls.

Conclusion:

The subject device and the predicate devices have the same intended use and have similar technological characteristics. The data included in this submission demonstrates substantial equivalence to the predicate device listed above.