(226 days)
No
The summary describes a traditional image-guided surgical system using optical tracking and pre-operative images. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or automated image analysis beyond basic processing verified with known datasets. The focus is on tool tracking, registration, and visualization.
No.
The device is a planning and intraoperative guidance system, which assists in surgery by tracking instruments and visualizing them relative to patient images. It does not directly provide therapy or treatment to the patient.
No
Explanation: The device is described as a "planning and intraoperative guidance system" for computer-assisted surgery, which displays the location and orientation of surgical instruments relative to pre-operative scan images. Its purpose is to guide surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of a software application installed on a computer, tracked surgical instruments, and accessories to enable the tracking of those instruments. It also mentions an optical Tracking Camera and single-use passive reflective markers, which are hardware components.
Based on the provided text, the Modus Nav device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery." It is used during surgical procedures to guide instruments based on pre-operative images.
- Device Description: The description reinforces this by stating it's a "surgical planning and image guided surgical system" that uses optical tracking to display the location of surgical instruments relative to patient images.
- Lack of IVD Characteristics: An IVD is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Modus Nav device does not perform any such analysis of biological specimens. It is a surgical navigation tool used in vivo (within the body) during surgery.
Therefore, the Modus Nav device falls under the category of a surgical guidance system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Modus Nav is intended as a planning and intraoperative quidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative quidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with imagequided surgical systems.
Product codes
HAW
Device Description
The subject device, Modus Nav, is a modified version of its predicate, BrightMatter Guide with SurfaceTrace Registration. The system is a surgical planning and image guided surgical system that enables open or percutaneous computer-assisted cranial surgery. The system uses optical 3D tracking technology to display the location and orientation of tracked (also known as navigated) surgical instruments relative to the pre-operative scan images of the patient. The system consists of a software application installed on a computer, tracked surgical instruments, and accessories to enable the tracking of those instruments.
The planning functionality of the device is provided by an already cleared device called BrightMatter Plan 1.6.0 (K180394). The remaining functionality of the system can be broadly grouped into data preparation, registration and visualization of surqical tools. Data preparation and registration is performed during the initial stages of a surgical procedure and visualization of the tools is performed as needed during the surgical procedure.
General use of the system as an image guided surgical tool is composed of the following key steps:
- . Equipment setup
- . Plan selection and data preparation
- Patient registration .
- . Tool localization and visualization
An optical Tracking Camera provides the position and orientation of the tools with respect to the tracking origin. The navigated surgical tools are tracked using singleuse passive reflective markers (K033621) that are attached to the surgical tools prior to each surqical procedure. An external display can be used by the surgical staff if needed, given that the Tracking Camera mounted on a cart maintains a line of sight between the Cranial Reference and the Tracked Surqical Tools. Both the User Cart (also known as Navigation Cart) and Auxiliary Carts are placed outside the sterile field.
The primary purpose of this 510(k) submission is to introduce new navigated tools such as the Short Pointer, Shunt Stylet, and the corresponding Calibration Device. It also introduces new software features to support the navigation of these tools, the ability to navigate with Synaptive's Trackable Suction tools, and minor workflow improvements to facilitate the surgical procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pre-operative scan images of the patient
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals who are trained in performing surgery and are familiar with image-guided surgical systems.
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)
Nonclinical performance testing was conducted including:
- Software verification testing (system, sub-system, functional block, and compatibility testing)
- Testing of resolved anomalies
- Algorithm pipeline verification: Automated performance verification of the core data processing facility of the software (known as 'algorithm pipeline'). Uses known data sets and expert review of output generated by the pipeline at various stages of processing. Performance verified using known data sets or 'truth data sets' to evaluate image processing pipeline and its outputs.
- System Requirements Verification: Biocompatibility, Cleaning Validation, Sterilization Validation, Medical Electrical System Safety, Electromagnetic Compatibility
- System Validation: User acceptance testing by intended user group in a simulated use environment; Human Factors Validation.
- Accuracy Characterization: System accuracy was characterized using an accuracy measurement phantom of similar volume to an adult head. The values of the ground truth data from the accuracy phantom were obtained using a Coordinate Measurement Machine (CMM). Testing was conducted with all tracked tools calculating positional and angular error for both registration methods: Surface Trace Registration and Touch Point Registration. Testing confirmed that the Modus Nav system is accurate to within 2 mm and 2 degrees of the physical tip of the tracked tool. This is equivalent to the predicate device.
- Latency Testing: The video latency of the subject device and the predicate device were compared and deemed to be equivalent.
Clinical testing was not considered necessary as this technology is not new.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Characterization: accurate to within 2 mm and 2 degrees of the physical tip of the tracked tool.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is placed inside a blue square. The text is stacked in three lines, with "ADMINISTRATION" on the bottom line.
July 14, 2019
Synaptive Medical Inc. Maham Ansari Director of Regulatory Affairs 555 Richmond Street West, Suite 800 Toronto, ON M5V 3B1
Re: K183325
Trade/Device Name: Modus Nav Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: June 12, 2019 Received: June 14, 2019
Dear Maham Ansari:
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
1
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 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 (OS) 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,
Matthew Krueger 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) K183325
Device Name Modus Nav 1.7
Indications for Use (Describe)
Modus Nav is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with image-guided surgical systems.
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
[As required by 21 CFR 807.92(c)]
| Manufacturer: | Synaptive Medical Inc. |
|---|---|
| Address: | 555 Richmond Street West, Suite 800 |
| Toronto, ON M5V 3B1 | |
| Canada | |
| Establishment Registration: | 3012075008 |
| Contact Name: | Ms. Maham Ansari, MS, RAC |
| Title: | Director, Regulatory Affairs |
| Phone Number: | +1 647 925 3435 |
| Fax Number: | 1 888 650 5230 |
| Date Prepared: | 15 November 2018 |
| Device Proprietary Name: | Modus Nav |
| Device Common or Usual Name: | Neurological Stereotaxic Instrument |
| Classification Panel: | Neurology |
| Product Code: | HAW |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Class: | II |
| Regulation Description: | Stereotaxic Instrument |
Predicate Devices:
Substantial equivalence is claimed to the following device:
| Trade name | Manufacturer | 510(k)
Number | Date Cleared |
|----------------------------------------------------------|---------------------------|------------------|-------------------|
| BrightMatter Guide with
Surface Trace
Registration | Synaptive
Medical Inc. | K153281 | March 30,
2016 |
Device Description
The subject device, Modus Nav, is a modified version of its predicate, BrightMatter Guide with SurfaceTrace Registration. The system is a surgical planning and image guided surgical system that enables open or percutaneous computer-assisted cranial surgery. The system uses optical 3D tracking technology to display the location and orientation of tracked (also known as navigated) surgical instruments relative to the pre-operative scan images of the patient. The system consists of a software application installed on a computer, tracked surgical instruments, and accessories to enable the tracking of those instruments.
Synaptive
4
The planning functionality of the device is provided by an already cleared device called BrightMatter Plan 1.6.0 (K180394). The remaining functionality of the system can be broadly grouped into data preparation, registration and visualization of surqical tools. Data preparation and registration is performed during the initial stages of a surgical procedure and visualization of the tools is performed as needed during the surgical procedure.
General use of the system as an image guided surgical tool is composed of the following key steps:
- . Equipment setup
- . Plan selection and data preparation
- Patient registration .
- . Tool localization and visualization
An optical Tracking Camera provides the position and orientation of the tools with respect to the tracking origin. The navigated surgical tools are tracked using singleuse passive reflective markers (K033621) that are attached to the surgical tools prior to each surqical procedure. An external display can be used by the surgical staff if needed, given that the Tracking Camera mounted on a cart maintains a line of sight between the Cranial Reference and the Tracked Surqical Tools. Both the User Cart (also known as Navigation Cart) and Auxiliary Carts are placed outside the sterile field.
The primary purpose of this 510(k) submission is to introduce new navigated tools such as the Short Pointer, Shunt Stylet, and the corresponding Calibration Device. It also introduces new software features to support the navigation of these tools, the ability to navigate with Synaptive's Trackable Suction tools, and minor workflow improvements to facilitate the surgical procedure.
Indications for Use
Modus Nav is intended as a planning and intraoperative quidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative quidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and are familiar with imagequided surgical systems.
Summary of Technological Comparisons
Modus Nav is an enhanced implementation of BrightMatter Guide with Surface Trace Registration, its previously FDA-cleared version. The primary function of both
Image /page/4/Picture/15 description: The image shows the word "Synaptive" in a bold, sans-serif font. The letters are black against a white background. The word is horizontally oriented and appears to be the primary focus of the image.
5
devices is to track surgical instruments using an optical 3D tracking system and to show the location and orientation of these instruments relative to the pre-operative scan images of the patient during cranial procedures. The primary difference between Modus Nav and the predicate device is enhanced functionality through the introduction of new hardware involving tracked instruments, and minor workflow improvements.
Main advantages compared to the predicate device are:
- . Minor improvements to usability introduced as a result of user acceptance testing, human factors testing and field feedback.
- . Ability to track new instrumentation for enhanced functionality.
There are no known disadvantages.
Modus Nav remains substantially unchanged from the predicate with respect to its intended use and performance claims.
Nonclinical Performance Testing
Verification and validation testing has been conducted on the Modus Nav system to ensure the safety and effectiveness of the device to perform in accordance to its intended use. The following table provides a summary of the testing performed on the Modus Nav system.
| Type | Activity | Description of
Activity | Documentation
Results |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Software
verification
testing
(system,
sub-system,
functional
block, and
compatibility
testing) | Functional
verification of
integrated
software system | Test of software
application based on
functional blocks and
test cases developed to
verify software
requirements
specifications (SRS)
items.
This activity was
repeated in its entirety
in this submission. | Verified acceptance
criteria for all SRS
items have been met. |
| | Testing of
resolved
anomalies | Testing of anomalies
present in previously
released versions of the
device that have been
resolved in the Modus
Nav release. | Previous errors were
tested and verified to
no longer occur. |
| Type | Activity | Description of Activity | Documentation Results |
| Algorithm pipeline verification | Performance verification | Automated performance verification of the core data processing facility of the software (known as 'algorithm pipeline'). Uses known data sets and expert review of output generated by the pipeline at various stages of processing. | Performance verified using known data sets or 'truth data sets' to evaluate image processing pipeline and its outputs. |
| System Requirements Verification | Biocompatibility | See section below. | Testing passed all acceptance criteria. |
| | Cleaning Validation | External testing to validate cleaning instructions for re-usable tools as per ISO 15883-1. | |
| | Sterilization Validation | External testing to validate sterilization parameters for re-usable tools per AAMI TIR12, AAMI TIR30, ANSI AAMI ISO 17665-1, ANSI AAMI ISO TIR17665-2. | |
| | Medical Electrical System Safety | External testing against the requirements of ANSI AAMI IEC ES60601-1 to verify electrical and mechanical safety of the system. | |
| | Electromagnetic Compatibility | External testing against the requirements of IEC 60601-1-2 to verify that the system operates within safe limits of emission and interference requirements. | |
| Type | Activity | Description of
Activity | Documentation
Results |
| System
Validation | User acceptance
testing by
intended user
group | Testing of Modus Nav
by intended user in a
simulated use
environment to validate
customer needs and
intended use. | All acceptance criteria
met. |
| | Human Factors
Validation | Testing of critical
features by intended
users to determine if
device is safe and
effective for intended
users, uses and
environments. Testing
completed as per IEC
ANSI AAMI 62366 and
FDA Guidance:
"Applying Human
Factors and Usability
Engineering to Medical
Devices." | All acceptance criteria
met. |
Svnaptive
6
7
Biocompatibility Testing
The following biocompatibility testing was also conducted on the material used for Modus Nav Tracked Tools, Shunt Stylet and Trackable Suction:
| Test | Test
Description | Results | Conclusions |
|---------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Bacterial Endotoxins | Limulus
amebocyte
lysate (LAL) in
vitro test | Detected endotoxin
is not more than
2.15 EU / device. | Non-endotoxic |
| Cytotoxicity | MEM Elution
Cytotoxicity | Cell culture treated
with samples
exhibited slight
reactivity (Grade
1). | Non-cytotoxic |
| Irritation/Intracutaneous
toxicity | Intracutaneous
Irritation
Test (GLP – 2
Extracts) | None of the
animals on study
showed any clinical
signs or dermal
reactions. | Non-irritant |
| Sensitization | Guinea
Pig
Maximization | A negative
sensitization
incidence was | Non-sensitizing |
| Test | Test Description | Results | Conclusions |
| | Sensitization
Test (GLP -
2 Extracts) | interpreted for all
test animals. No
abnormal clinical
signs observed
during test period. | |
| Material-mediated
pyrogenicity | Materials
Mediated
Rabbit
Pyrogen (GLP) | None of the rabbits
administered with
the test article
extract had
a temperature rise
~ 0.5 °C at the
required
observation time
points. | Non-pyrogenic |
| Acute systemic toxicity | Acute
Systemic
Injection Test
(GLP - 2
Extracts) | None of the
animals on study
were observed with
abnormal clinical
| Non-toxic |
| Hemocompatibility | Hemolysis
(Extract
Method) | The difference
between the
hemolytic indexes
of the test article
and the negative
control
was not higher
than 0.49 percent
for all tools. | Non-hemolytic |
| Extractables (Shunt
Stylet only) | Toxicological
evaluation of
extractable
chemicals | Gas
Chromatography-
Mass Spectrometry
(GC-MS) and
Inductively
Coupled Plasma
Mass Spectrometry
(ICP-MS) met
acceptance criteria. | Non-toxic |
Synaptive
8
The Biocompatibility tests for the material used in both pointers were cleared in K160523.
Synaptive
9
The Biocompatibility test results indicate that Modus Nav can be considered safe and suitable for the intended use and is as safe and effective as the predicate device.
The following performance testing was also conducted on Modus Nav:
-
Accuracy Characterization: .
System accuracy was characterized using an accuracy measurement phantom of similar volume to an adult head. The values of the ground truth data from the accuracy phantom were obtained using a Coordinate Measurement Machine (CMM). Testing was conducted with all tracked tools calculating positional and angular error for both registration methods: Surface Trace Registration and Touch Point Registration. Testing confirmed that the Modus Nav system is accurate to within 2 mm and 2 degrees of the physical tip of the tracked tool. This is equivalent to the predicate device. -
. Latency Testing:
The video latency of the subject device and the predicate device were compared and deemed to be equivalent.
All nonclinical testing described in this section successfully passed, demonstrating that the Modus Nav system is safe and effective for its intended use and substantially equivalent to its predicate device.
Clinical Testing
This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing.
Conclusion
Modus Nav has been shown through comparison and performance testing to be substantially equivalent to the identified predicate device. Any technological differences do not raise new questions of safety and effectiveness.