(550 days)
Not Found
No
The summary explicitly states that the device "does not generate or create rules for the placement of intracranial catheters by any means" and there are no mentions of AI, DNN, or ML. The functionality described is based on visualizing existing guidelines and anatomical information.
No
The device is described as a "planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries" and a "dedicated tool for planning trajectories of intracranial catheters." Its primary mode of action is creating surgical plans, not directly treating a disease or condition. Therefore, it is not a therapeutic device.
No
Explanation: The device is designed as a planning system for pre- and intra-operative stereotactic or image-guided surgeries, specifically for planning trajectories of intracranial catheters. Its primary mode of action is creating surgical plans, not diagnosing conditions or diseases.
Yes
The device description explicitly states, "The system is a software-only medical device to be installed on common IT hardware." Additionally, the non-clinical tests summary confirms that no electrical safety or electromagnetic testing was required, which is consistent with a software-only device.
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 a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries, specifically for planning trajectories of intracranial catheters. This is a surgical planning tool, not a diagnostic test performed on samples from the human body.
- Device Description: It's described as a software tool running on a computer, used by surgeons for planning. This aligns with a surgical planning system, not an IVD.
- Mode of Action: The primary mode of action is creating surgical plans. IVDs work by examining samples (like blood, urine, tissue) to provide diagnostic information.
- Input: The input is medical imaging data (MR, CT, DTI), not biological samples.
- No mention of analyzing biological samples: There is no indication that this device analyzes any biological samples from the patient.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution.
The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
Product codes (comma separated list FDA assigned to the subject device)
HAW, QRI
Device Description
Molecular Flow Simulations is a software tool running on a standard, standalone computer (PC or Laptop), or being accessible via the intranet connection, that can be used by surgeons for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems. The system is a software-only medical device to be installed on common IT hardware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR.
Anatomical Site
intracranial (brain tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons; pre- or intraoperative planning settings
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)
Several tests were performed, in concordance with Duke University, using synthetic, animal and human imaging. Therefore, Molecular Flow Simulations does not raise any new questions regarding safety and effectiveness.
All necessary testing has been performed with Molecular Flow Simulations to assure substantial equivalence to the predicate device.
Summary of non-clinical tests:
Molecular Flow Simulations is a software application; therefore no electrical safety or electromagnetic testing was required.
Testing conducted to demonstrate software validation and substantial equivalence included:
- Verification testing that product meets product performance and functional specifications.
- Verification that data submitted is stored properly to maintain data integrity (e.g. no loss of data or corruption).
- User performance testing to demonstrate adequate instructional utility of the User Manual.
The Requirements Traceability Matrix (RTM) provides a mapping between requirements, risks, test cases, and shows related test results. The RTM confirms that there was a test case authored and executed for all requirements and any applicable risks.
After extensive bench testing to performance requirements and criteria established in accordance with application of ISO 14971, risk analysis standard, no new issues of safety, performance, technology or intended use were identified.
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.
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
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 3, 2021
Therataxis, LLC % Al Memmolo President, Convergent Clinical, Inc. 6648 Surf Crest St. Carlsbad, California 92011
Re: K201435
Trade/Device Name: Molecular Flow Simulations Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, QRI Dated: November 11, 2021 Received: November 15, 2021
Dear Al Memmolo:
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) K201435
Device Name Molecular Flow Simulations
Indications for Use (Describe)
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution.
The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
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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3
| A. Device Information: | 510(k) Summary |
|---|---|
| Category | Comments |
| Sponsor: | Therataxis, LLC |
| Johns Hopkins Eastern Building Suite B305 | |
| 1101 East 33rd Street Baltimore, MD 21208 | |
| (443) 451-7154 | |
| Correspondent Contact | |
| Information: | Al Memmolo |
| Convergent Clinical, Inc. | |
| Carlsbad, CA 92011 | |
| Email: almemmolo@gmail.com | |
| Device Common Name: | Planning System, Stereotaxic Instrument |
| Device Regulation & Name: | CFR 882.4560 Stereotaxic Instrument |
| Classification & Product Code: | |
| 510(k) Number: | Classification: Class II Product Code: HAW, QRI |
| K201435 | |
| Device Proprietary Name: | Molecular Flow Simulations |
Molecular Flow Simulations
Predicate Device Information:
| Predicate Device: | iPlan Flow |
|---|---|
| Predicate Device Manufacturer: | Brainlab AG |
| Predicate Device Common Name: | iPlan Flow |
| Predicate Device Premarket Notification # | K053164 |
| Predicate Device Classification & Name | Classification: Class II |
| Name: Stereotaxic Instrument | |
| Predicate Device Classification | |
| & Product Code: | Classification: Class II |
| Product Code: HAW |
B. Date Summary Prepared
December 3, 2021
C. Description of Device
Molecular Flow Simulations is a software tool running on a standard, standalone computer (PC or Laptop), or being accessible via the intranet connection, that can be used by surgeons for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems. The system is a software-only medical device to be installed on common IT hardware.
4
D. Indications for Use
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI)-data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2weighted MR images to suggest likely volumes of fluid distribution.
The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or imageguided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
| Characteristic | Application Device:
Molecular Flow
Simulations
(K201435) | Predicate Device:
iPlan Flow
(K053164) | Impact on
Substantial
Equivalence |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Company | Therataxis, LLC | Brainlab | - |
| Regulation
Number | 882.4560 | 882.4560 | Identical |
| Product Code | HAW | HAW | Identical |
| Intended Use | Molecular Flow Simulations
is designed as a planning
system for pre- and
intraoperative planning of
stereotactic or image guided
surgery treatments. It is
specially designed to display
anatomical images of a
patient acquired with MR
and/or CT as well as images
derived from DTI-data
acquired with Magnetic
Resonance Imaging (MRI). | iPlan Flow is designed as a
planning system for pre-
and intraoperative planning
of stereotactic or image
guided surgery treatments.
It is specially designed to
display anatomical images
of a patient acquired with
MR and/or CT as well as
images derived from DTI-data
acquired with
Magnetic Resonance
Imaging (MRI). | Equivalent |
| Indications for Use | Molecular Flow | iPlan Flow | K201435 |
| | Molecular Flow
Simulations is designed as
a planning system for pre-
and intra-operative
planning of stereotactic or
image-guided surgeries. It
is specially designed to
display anatomical images
of a patient acquired with
magnetic resonance (MR)
or computed tomography
(CT) scanners as well as
images derived from
diffusion tensor imaging
(DTI)-data acquired with
MR. Molecular Flow
Simulations is a dedicated
tool for planning
trajectories of intracranial
catheters. Guidelines for the
catheter placement, such as
from catheter suppliers, can
be visualized and displayed
to support the surgeon in
improving catheter
placement planning. The
guidelines, in combination
with anatomical
information, can be used to
suggest areas that are
compliant with the
guidelines. Molecular Flow
Simulations does not
generate or create rules for
the placement of
intracranial catheters by
any means. Molecular Flow
Simulations uses MR-DTI
and T2- weighted MR
images to suggest likely
volumes of fluid
distribution. | iPlan Flow is designed as a
planning system for pre-
and intraoperative planning
of stereotactic or image
guided surgery treatments.
It is specially designed to
display anatomical images
of a patient acquired with
MR and/or CT as well as
images derived from DTI-
data acquired with
Magnetic Resonance
Imaging (MRI). iPlan Flow
is a dedicated tool for
planning trajectories of
intra-cranial catheters.
Guidelines for the catheter
placement e.g. from
catheter suppliers can be
visualized and displayed to
support the surgeon in
improving catheter
placement planning. The
guidelines, in combination
with anatomical
information, can be used to
suggest areas that are
compliant with the
guidelines. iPlan Flow does
not generate or create rules
for the placement of
intracranial catheters by
any means. iPlan Flow uses
MR-DTI and T2- weighted
MR images to suggest
likely volumes of fluid
distribution. | Equivalent |
| | The primary mode of action
for Molecular Flow
Simulations is a device for
creating stereotactic or
image-guided surgical plans,
especially for the creation of
plans for the placement of
intracranial catheters. | The Primary mode of
action for iPlan Flow is a
device for creating
treatment plans for
stereotactic or image
guided surgical treatment,
especially for the creation
of plans for the placement
of intra-cranial catheters.
The treatment plans can be
used in conjunction with
other BrainLAB medical
devices such as
VectorVision for image
guided surgical treatment. | |
| | | | K201435, Pag |
| Technology | Molecular Flow
Simulations can be used
for the planning of
intracranial catheters, with
image guided surgery.
Guidelines for the exact
placement of intracranial
catheters can be
visualized. These
guidelines comprise the
minimal depth of the
catheter tip in the brain
tissue, the minimal
distance of the catheter tip
from intra-cranial surfaces
and the minimal distance
between different catheter
tips. The depth guideline
can be calculated from the
flow rate and the catheter
diameter and warnings
will be displayed if the
trajectory of a planned
catheter is likely to cross
an intra-cranial surface.
Molecular Flow
Simulations is able to
calculate a likely fluid
distribution from the
planned catheter positions
to support the physician in
his decision about
appropriate catheter
positions. These features
enable the surgeon to
better plan and place intra-
cranial catheters. | iPlan Flow can be used for
the planning of
intracranial catheters, with
image guided surgery.
Guidelines for the exact
placement of intracranial
catheters can be
visualized. These
guidelines comprise the
minimal depth of the
catheter tip in the brain
tissue, the minimal
distance of the catheter tip
from intra-cranial surfaces
and the minimal distance
between different catheter
tips. The depth guideline
can be calculated from the
flow rate and the catheter
diameter and warnings
will be displayed if the
trajectory of a planned
catheter is likely to cross
an intra-cranial surface.
iPlan Flow is able to
calculate a likely fluid
distribution from the
planned catheter positions
to support the physician
in his decision about
appropriate catheter
positions. These features
enable the surgeon to
better plan and place intra-
cranial catheters. | Technology is
identical. |
| Characteristic | Application Device:
Molecular Flow
Simulations
(K201435) | Predicate Device:
iPlan Flow
(K053164) | Impact on
Substantial
Equivalence |
| Features | Comprehensive Target
Planning: Automatically
defines margins around
the tumor. | Comprehensive Target
Planning: Automatically
defines margins around
the tumor. | |
| Features | Guided Entry Point
Planning: The sulcus
detection feature
automatically segments
cerebrospinal fluid spaces
as they are potential
leakage pathways. | Guided Entry Point
Planning: The sulcus
detection feature
automatically segments
cerebrospinal fluid spaces
as they are potential
leakage pathways. | Equivalent |
| | Guided Catheter
Planning: Catheter
planning guidelines
indicate potential
backflow and other drug
leakage pathways around
the catheter tip in order to
maximize infusate
distribution. | Guided Catheter
Planning: Catheter
planning guidelines
indicate potential
backflow and other drug
leakage pathways around
the catheter tip in order to
maximize infusate
distribution. | |
| | 3D Distribution
Simulation: The likely
distribution of infusate for
a given catheter position
is predicted in 3D based
on patient-specific
information and
mathematical modeling.
Flux boundary conditions
can be utilized. This more
accurately models CED
infusions, in which the
infusate is delivered at a
constant flow rate rather
than a constant pressure. | 3D Distribution
Simulation: The likely
distribution of infusate for
a given catheter position
is predicted in 3D based
on patient-specific
information and
mathematical modeling. | |
| | 3D capillary loss maps
from DCE, poroelastic
expansion of the
extracellular space, and
flux boundary modeling of
the infusion sources. | | |
E. Comparison of the Technological Characteristics
5
6
7
8
F. Summary of Supporting Data
Several tests were performed, in concordance with Duke University, using synthetic, animal and human imaging. Therefore, Molecular Flow Simulations does not raise any new questions regarding safety and effectiveness.
G. Discussion of Performance Testing
All necessary testing has been performed with Molecular Flow Simulations to assure substantial equivalence to the predicate device.
Summary of non-clinical tests:
Molecular Flow Simulations is a software application; therefore no electrical safety or electromagnetic testing was required.
Testing conducted to demonstrate software validation and substantial equivalence included:
- . Verification testing that product meets product performance and functional specifications.
- Verification that data submitted is stored properly to maintain data integrity (e.g. no loss of data or corruption).
- User performance testing to demonstrate adequate instructional utility of the User Manual. ●
The Requirements Traceability Matrix (RTM) provides a mapping between requirements, risks, test cases, and shows related test results. The RTM confirms that there was a test case authored and executed for all requirements and any applicable risks.
After extensive bench testing to performance requirements and criteria established in accordance with application of ISO 14971, risk analysis standard, no new issues of safety, performance, technology or intended use were identified.
H. Conclusion
Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, Molecular Flow Simulations is determined to be substantially equivalent to the predicate device.