(100 days)
Not Found
No
The description focuses on mechanical principles and image-guided positioning based on third-party planning software output, with no mention of AI or ML.
Yes
The device is used to perform stereotactic neurosurgical procedures such as deep brain stimulation, lesioning, biopsies, targeted injections, aspirations, and minimal invasive tumor treatments, which are all therapeutic interventions.
No
Explanation: The device is a stereotactic system used for surgical procedures, not for diagnosis. Its purpose is to localize and fix the patient's head for precise neurosurgical interventions like deep brain stimulation, lesioning, and biopsies. While it uses imaging for localization, its primary function is therapeutic/interventional, not diagnostic.
No
The device description explicitly details physical components like a Skull Anchor Key, titanium stand-off pins, bone anchor screws, and a Stereotactic Positioner, indicating it is a hardware device with software components for planning.
Based on the provided information, the NaviNetics D1 Stereotactic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures." This describes a device used on the patient during a surgical procedure, not a device used to examine specimens from the body outside of the body.
- Device Description: The description details a system that is physically attached to the patient's skull and used to guide surgical instruments. This is consistent with a surgical navigation or guidance system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The NaviNetics D1 Stereotactic System's function is to aid in the physical execution of a surgical procedure by providing precise positioning and guidance.
N/A
Intended Use / Indications for Use
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Product codes
HAW
Device Description
The NaviNetics D1 Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned.
The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four self-tapping bone anchor screws. The Key serves as the common attachment platform for the D1 Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible interventional instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the device to approach the target from a multitude of directions. Linear adjustments can move the arc-quadrant, medial/lateral (X), anterior/posterior (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of the third-party planning software provides the values of the target coordinates (XT, YT, ZT) and the surgical trajectory (CT, AT) which dictate the settings of the D1 stereotactic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Brain/Intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Accuracy:
- Mechanical: assembly to position known stereotactic test points at the focus of the arc-quadrant. All test cases were shown acceptable for expected outcome. Overall system accuracy is equivalent to the predicate device.
- Systemic Image: Accuracy of selecting an image target on CT or MRI and positioning the selected point at the focus of the arc-quadrant. Results are that all test cases were shown acceptable for expected outcome. Overall system accuracy is equivalent to the predicate device.
- Systemic Surgical: Accuracy of placing a DBS lead, including implantation technique, as verified by post-implant CT scan. Results are that all test cases were shown acceptable for expected outcome. Overall system accuracy is equivalent to the predicate device.
- Handling and process step accuracy (e.g., repeated mounting of parts to each other and scale setting accuracy) during mechanical and repeatability accuracy testing. Results are that all test cases were shown acceptable for expected outcome. Overall system accuracy is equivalent to the predicate device.
- Skull anchor key design renders displacement due to head weight as inconsequential. Results are that all test cases were shown acceptable for expected outcome. Overall system accuracy is equivalent to the predicate device.
MR Safety Testing:
- The device was subjected to and complies with all FDA guidance for MR environment safety and compatibility, including the following safety standards: ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503. Substantial equivalence to the predicate device is demonstrated through passing results to FDA guidance and these consensus standards.
Cleaning- reusable parts:
- Validated for manual cleaning and cleaning with a washer-disinfector. Manual and washer/disinfector cleaning methods were validated using instructions in the IFU using artificial blood. Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.
Sterilization- reusable parts:
- Performed on the subject device, reusable parts were validated for steam sterilization. The validation was used to show the device can obtain a sterility assurance level (SAL) of at least 10-6 when steam sterilized at 132°C (270°F) for 4 minutes. Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.
Biocompatibility:
- Patient-contacting materials were evaluated for biocompatibility to the following tests: ISO10993-1, ISO10993-5, ISO10993-10 and ISO10993-11. Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
June 17, 2021
NaviNetics, Inc Patrick Gora V.P. Regulatory Affairs and Quality 206 S Broadway, Suite 700 Rochester, Minnesota 55904
Re: K210700
Trade/Device Name: NaviNetics D1 Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 17, 2021 Received: May 18, 2021
Dear Patrick Gora:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210700
Device Name NaviNetics D1 Stereotactic System
Indications for Use (Describe)
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
| 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
NaviNetics D1 Stereotactic System 510(k) Summary
Date Prepared: June 17, 2021
Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| NaviNetics, Inc. | |
| 206 South Broadway, Suite 700 | |
| Rochester, MN 55904 | |
| Tel 507.361.3570 | Patrick Gora |
| VP Regulatory Affairs and Quality | |
| gora.patrick@navinetics.com | |
| 507.361.3570 |
General Information
| Device Trade Name | NaviNetics D1 Stereotactic System |
|---|---|
| Common / Usual Name | Stereotaxic Instrument |
| Classification Name | Stereotaxic Instrument, 21 CFR 882.4560 Class II |
| Product Code | HAW |
| Predicate Device(s) | K190887 – Leksell® Vantage™ Stereotactic System |
| (clearance August 1, 2019) |
Device Description
The NaviNetics D1 Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned.
The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four self-tapping bone anchor screws. The Key serves as the common attachment platform for the D1 Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible interventional instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the device to approach the target from a multitude of directions. Linear adjustments can move the arc-quadrant, medial/lateral (X), anterior/posterior (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of the third-party planning software provides the values of the target coordinates (XT, YT, ZT) and the surgical trajectory (CT, AT) which dictate the settings of the D1 stereotactic device.
Intended Use
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections and minimal invasive tumor treatments.
4
Summary of Technological Characteristics Compared to Predicate
The NaviNetics D1 Stereotactic System has equivalent technological characteristics as its predicate device, Leksell® Vantage™ Stereotactic System. It utilizes the same coordinate system and center-ofarc principle which allows guidance of compatible interventional instruments at any trajectory angle to the brain target.
Substantial Equivalence
The NaviNetics D1 Stereotactic System has equivalent technology, features, and characteristics as the predicate device. K190887, the Leksell® Vantage™ Stereotactic System. The table below provides a comparison of technological characteristics between the NaviNetics D1 Stereotactic System (subject device) and the Leksell® Vantage™ Stereotactic System (predicate device).
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | NaviNetics D1 Stereotactic System | K190887 |
| Leksell® Vantage™ Stereotactic System | ||
| Regulation Number | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW |
| Product Class | II | II |
| Indications for use | The Intended Purpose of the | |
| NaviNetics D1 Stereotactic System is | ||
| intended to be used for target | ||
| localization and fixation of the patient | ||
| head in a coordinate system in order | ||
| to perform stereotactic neurosurgical | ||
| procedures, for example; deep brain | ||
| stimulation, lesioning, biopsies, | ||
| targeted injections, aspirations and | ||
| minimal invasive tumor treatments. | The Intended Purpose of Leksell® | |
| Vantage™ Stereotactic System is | ||
| intended to be used for target | ||
| localization and fixation of the patient | ||
| head in a coordinate system in order | ||
| to perform stereotactic neurosurgical | ||
| procedures, for example; deep brain | ||
| stimulation, lesioning, biopsies, | ||
| targeted injections, aspirations and | ||
| minimal invasive tumor treatments. | ||
| Description | The NaviNetics D1 Stereotactic | |
| System is included in the arc | ||
| centered category of stereotactic | ||
| frames which provide an arc | ||
| quadrant and a 3D slide to move the | ||
| arc quadrant about the head. A | ||
| minimally intrusive Skull Anchor Key | ||
| attaches to the patient's skull with the | ||
| use of four (4) skull anchor screws. | ||
| used to affix the arc centered device | ||
| to the skull of the patient. The D1 | ||
| Stereotactic device mounts to the | ||
| Skull Anchor Key allowing it to | ||
| pinpoint intracranial targets and | ||
| guide neurosurgical instruments to | ||
| these brain targets. | The Leksell® Vantage™ Stereotactic | |
| System is a device used for | ||
| minimally invasive neurosurgical | ||
| procedures. It enables coordinate | ||
| referencing and fixation of the | ||
| patient's skull and brain during image | ||
| acquisition and treatment. The | ||
| coordinate referencing enables target | ||
| localization and accurate stereotactic | ||
| treatment of brain targets. | ||
| The system consists of a head frame | ||
| that is fixated to the patient skull by | ||
| minimally invasive disposable fixation | ||
| pins and a number of accessories for | ||
| frame application and imaging as | ||
| well as a stereotactic arc and | ||
| Subject Device | Predicate Device | |
| operating room accessories for the | ||
| sterile surgical procedure. | ||
| Coordinate System | NaviNetics Coordinate System using | |
| Cartesian coordinates. The X axis | ||
| runs left/right, the Y axis runs | ||
| anterior/posterior and the Z axis runs | ||
| inferior posterior. The origin of the | ||
| coordinate system is located to the | ||
| right, posteriorly, and superiorly to | ||
| the patient's head. The center of the | ||
| work envelope, located near the | ||
| center of the cranial cavity, has a | ||
| coordinate of (100,100,100) | Leksell Coordinate System using | |
| Cartesian coordinates. The X axis | ||
| runs left/right, the Y axis runs | ||
| anterior/posterior and the Z axis runs | ||
| inferior posterior. The origin of the | ||
| coordinate system is located to the | ||
| right, posteriorly, and superiorly to | ||
| the patient's head. The center of the | ||
| work envelope, located near the | ||
| center of the cranial cavity, has a | ||
| coordinate of (100,100,100) | ||
| Fixation | Minimally intrusive Skull Anchor Key | |
| with three fixation pins and four self- | ||
| tapping screws. | Head frame attached to patient skull | |
| with four fixation pins driven into the | ||
| outer table of the skull. | ||
| Fixation Pins/Screws | Single use titanium pins and self- | |
| tapping titanium screws that secure | ||
| the minimally intrusive Skull Anchor | ||
| Key to the patient skull. | Single use fixation pins and inserts | |
| that secure the Vantage head frame | ||
| to the patient skull using Leksell | ||
| Vantage keys. | ||
| Principles of Use | The NaviNetics D1 Stereotactic | |
| System uses arc center stereotactic | ||
| principle in which the two angular | ||
| degrees of freedom rotate | ||
| orthogonally to each other about a | ||
| single point called the "focus. A 3D | ||
| slide alters the position of the focus | ||
| within the brain. The D1 System has | ||
| an arc radius of 150mm. This is | ||
| 40mm less that the predicate which | ||
| helps reduce the mechanical error by | ||
| reducing the length of instruments | ||
| being projected from the arc. | ||
| The D1 Skull Anchor Key | ||
| immobilizes the patient within the | ||
| stereotactic coordinate system called | ||
| the work envelope. The Skull Anchor | ||
| Key provides the common | ||
| attachment site for all components of | ||
| the D1 System. | ||
| comprises a Skull Anchor key, a | ||
| 3D slide, and arc is target centered defines the surgical targets as | ||
| Cartesian (x,y,z) coordinates | ||
| within the work envelope of the | ||
| system | Leksell® Vantage™ Stereotactic | |
| System is Center of the arc principle | ||
| stereotactic device in which the two | ||
| angular degrees of freedom rotate | ||
| orthogonally to each other about a | ||
| single point called the "focus. The | ||
| working radius of the arc is 190mm. | ||
| The head frame of the Leksell | ||
| system immobilizes the patient within | ||
| the stereotactic coordinate system | ||
| called the work envelope. The | ||
| headframe provides the common | ||
| attachment site for all components of | ||
| the Leksell system. Cartesian | ||
| coordinates applied to the brain of | ||
| the patient by the use of a head | ||
| frame fixated to the skull. comprises a headframe, a 3D | ||
| slide and arc is target centered defines the surgical targets as | ||
| Cartesian (x,y,z) coordinates | ||
| within the work envelope of the | ||
| system utilizes fiducial markers on CT | ||
| and/or MRI images to locate the | ||
| Subject Device | Predicate Device | |
| utilizes fiducial markers on CT and/or MRI images to locate the images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target | images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target | |
| Materials | Invasive components: | Invasive components: |
| Titanium | PEEK with Aluminum tip | |
| Skull Anchor Key: | ||
| Delrin® | ||
| Arc: | ||
| Aluminum | Head Frame: | |
| Glass fiber reinforced Epoxy | ||
| Arc: | ||
| Aluminum | ||
| Accuracy | 0.9mm (mechanical) | 0.9mm (mechanical) |
| Accessories | Neurosurgical instruments designed | |
| for a 150 mm working length | Neurosurgical instruments designed | |
| for a 190 mm working length |
5
6
Summary of Non-Clinical Performance Data
| Test | Method/Summary | Results |
|---|---|---|
| Accuracy | • Mechanical: assembly to position | |
| known stereotactic test points at | ||
| the focus of the arc-quadrant | All test cases were shown acceptable | |
| for expected outcome. Overall | ||
| system accuracy is equivalent to the | ||
| predicate device. | ||
| • Systemic Image: Accuracy of | ||
| selecting an image target on CT or | ||
| MRI and positioning the selected | ||
| point at the focus of the arc- | ||
| quadrant | ||
| • Systemic Surgical: Accuracy of | ||
| placing a DBS lead, including | ||
| implantation technique, as verified | ||
| by post-implant CT scan | ||
| • Handling and process step | ||
| accuracy (e.g., repeated mounting | ||
| of parts to each other and scale | ||
| setting accuracy) during | ||
| mechanical and repeatability | ||
| accuracy testing | ||
| Skull anchor key design renders | ||
| displacement due to head weight as | ||
| inconsequential |
7
| Test | Method/Summary | Results |
|---|---|---|
| MR Safety Testing | The device was subjected to and | |
| complies with all FDA guidance for | ||
| MR environment safety and | ||
| compatibility, including the following | ||
| safety standards: | Substantial equivalence to the | |
| predicate device is demonstrated | ||
| through passing results to FDA | ||
| guidance and these consensus | ||
| standards. | ||
| • ASTM F2052 | ||
| • ASTM F2119 | ||
| • ASTM F2182 | ||
| • ASTM F2213 | ||
| • ASTM F2503 | ||
| Cleaning- reusable | ||
| parts | Validated for manual cleaning and | |
| cleaning with a washer-disinfector | ||
| Manual and washer/disinfector | ||
| cleaning methods were validated | ||
| using instructions in the IFU using | ||
| artificial blood | Parts passed final validation and met | |
| all pre-determined acceptance | ||
| criteria while demonstrating predicate | ||
| device substantial evidence. | ||
| Sterilization- reusable | ||
| parts | Performed on the subject device, | |
| reusable parts were validated for | ||
| steam sterilization. The validation | ||
| was used to show the device can | ||
| obtain a sterility assurance level | ||
| (SAL) of at least 10-6 when steam | ||
| sterilized at 132°C (270°F) for 4 | ||
| minutes | Parts passed final validation and met | |
| all pre-determined acceptance | ||
| criteria while demonstrating predicate | ||
| device substantial evidence. | ||
| Biocompatibility | Patient-contacting materials were | |
| evaluated for biocompatibility to the | ||
| following tests: ISO10993-1, | ||
| ISO10993-5, ISO10993-10 and | ||
| ISO10993-11 | Parts passed final validation and met | |
| all pre-determined acceptance | ||
| criteria while demonstrating predicate | ||
| device substantial evidence. |
Summary of Clinical Performance Data
Based on product classification and predicate devices, clinical testing is not required to demonstrate substantial equivalence.
Conclusion
The performance testing presented demonstrates the NaviNetics D1 Stereotactic System is substantially equivalent with the predicate device, the Leksell® Vantage™ Stereotactic System cleared under K190887.