(63 days)
No
The description focuses on mechanical principles and established stereotactic techniques, with no mention of AI or ML. The device relies on surgical planning software for coordinates, but the device itself is a mechanical system for positioning.
No.
The device is a stereotactic system used for target localization and fixation during neurosurgical procedures, which are therapeutic interventions themselves, but the device solely facilitates these procedures by providing a coordinate system and guiding instruments, rather than directly treating or diagnosing a condition.
No
The device is described as a stereotactic system for target localization and fixation during neurosurgical procedures, focusing on guiding surgical interventions, not on diagnosing medical conditions.
No
The device description explicitly details hardware components like a Skull Anchor Key, titanium stand-off pins, bone anchor screws, a Stereotactic Positioner, MRI and CT localizers, and instruments based on stereotactic center-of-arc principles. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures." This describes a surgical guidance and positioning system used during a medical procedure on a patient.
- Device Description: The description details a physical system with components like a Skull Anchor Key, pins, screws, and a stereotactic positioner. It focuses on mechanical principles and how it's used to guide surgical instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of biological samples.
The device is a surgical instrument/system used directly on the patient for guidance and positioning during neurosurgery.
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 Reusable 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 bone anchor screws. The Key serves as the common attachment platform for the Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible instruments. These 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 target from a multitude of directions. Linear adjustments can move the ar-quadrant, medial/ateral (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of surgical planning software provides the target coordinates (X, Y, Z) and the surgical trajectory (CT, AT) which dictate the settings of the stereotactic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI and CT
Anatomical Site
patient head, brain
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing presented demonstrates the design changes to the NaviNetics Resusable (D1) Stereotactic System are substantially equivalent to the predicate and original device, K210700.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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July 14, 2023
NaviNetics, Inc. Danielle Jondal Regulatory Affairs and Quality Specialist 206 S Broadway, Suite 700 Rochester, Minnesota 55904
Re: K231392
Trade/Device Name: NaviNetics Reusable Stereotactic System (NN1000) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 9, 2023 Received: May 12, 2023
Dear Danielle Jondal:
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. Digitally signed by Adam D. Pierce -S Pierce - > 15:20:26 -04'00'
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) K231392
Device Name
NaviNetics Reusable Stereotactic System (NN1000)
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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21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
| K231392 Page 1 of 2 | |
|---|---|
| 510(k) Summary | Prepared on: 2023-05-12 |
| 21 CFR 807.92(a)(1) |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | NaviNetics Inc. |
| Applicant Address | 206 S Broadway STE 700 Rochester MN 55904 United States |
| Applicant Contact Telephone | 5073613576 |
| Applicant Contact | Ms. Danielle Jondal |
| Applicant Contact Email | jondal.danielle@navinetics.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | NaviNetics Reusable Stereotactic System (NN1000) |
| Common Name | Stereotaxic instrument |
| Classification Name | Neurological Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | HAW |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K210700 | NaviNetics D1 Stereotactic System |
| Product Code | |
| HAW | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The NaviNetics Reusable 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 bone anchor screws. The Key serves as the common attachment platform for the Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible instruments. These 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 target from a multitude of directions. Linear adjustments can move the ar-quadrant, medial/ateral (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of surgical planning software provides the target coordinates (X, Y, Z) and the surgical trajectory (CT, AT) which dictate the settings of the stereotactic device.
Intended Use/Indications for Use
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization of the patient head in a coordinate system in order to perform stereotactic neuros, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal
invasive tumor treatments.
Indications for Use Comparison
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted
4
K231392 Page 2 of 2
injections, aspirations and minimal invasive tumor treatments.
Technological Comparison
21 CFR 807.92(a)(6)
There are no technological differences in design, material, chemical composition principle or energy source as shown on the Substantial Equivalence table from the predicate to the subject device, with one minor exception that does not affect device performance, accuracy or effectiveness. The previous working X, Y, and Z axis of 100, 100 is now slightly adjusted to 100, 105, 96.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The performance testing presented demonstrates the design changes to the NaviNetics Resusable (D1) Stereotactic System are substantially equivalent to the predicate and original device, K210700.