(271 days)
Not Found
No
The description focuses on traditional image-guided navigation techniques using optical tracking and landmark/surface registration, with no mention of AI or ML terms or methodologies.
Yes
The device is intended as an aid for precisely locating anatomical structures in neurosurgical procedures, which directly contributes to the treatment of medical conditions.
No
The device is a surgical navigation system that aids in precisely locating anatomical structures and positioning surgical tools during neurosurgical procedures. It uses pre-acquired images (CT, MR) to guide surgery and does not diagnose medical conditions.
No
The device description explicitly lists hardware components such as a computerized main unit, an IR CameraBox, a cart, and accessory sets, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Navient's Function: Navient is a surgical navigation system. It uses pre-operative images (CT, MR) and real-time tracking to guide surgical tools within the patient's body during procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's an aid for precisely locating anatomical structures in neurosurgical procedures. This is an in-vivo (within the body) application.
Therefore, Navient falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.
The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR based model of the anatomy.
Indications:
Example procedures include but are not limited to:
- Cranial Procedures:
- Tumor resections
- Cranial biopsies
- Craniotomies
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
Navient is an image guided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.
Navient's guidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.
Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.
- Cranial Accessory Kit (955-NC-AKC) o
- Biopsy Accessory Kit (955-NC-AKB) O
Disposable tracker instruments are also available based on user preference.
Navient Software Workflow:
Navient software operation proceeds sequentially through 5 stages:
- Images: Load the CT or MR images, review and explore images and perform image fusion.
- Planning: The planning stage, depending on the procedure types
- Set Up: attach the Patient reference, adjust the tracking system position and verify the instruments' tip calibration accuracy.
- Registration: Using Registrator, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.
- Navigation: Navigate the position of the tip of various instruments in the image volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR
Anatomical Site
Cranial (skull)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users: Medical practitioner
Use Environment: Surgical setting
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)
- Reprocessing validation: Reprocessing instructions are available in the user manual. Navient instrument (worst case) was validated for manual and automated cleaning in accordance with AAMI TIR 30: 2011(R) 2016, and steam sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013 for (SAL) of
§ 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). On the left is the Department of Health & 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.
February 5, 2025
ClaroNav Karen Wu Director of Regulatory Affairs 1140 Sheppard Avenue West Unit 10 Toronto, ON M3K2A2 Canada
Re: K241327
Trade/Device Name: Navient Image Guide Navigation System (955-NC-NC) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 3, 2025 Received: January 6, 2025
Dear Karen Wu:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Adam D. Pierce. The date of the signature is 2025.02.05, and the time is 16:57:21 -05'00'.
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
3
Indications for Use
510(k) Number (if known) K241327
Device Name
Navient Image Guided Navigation System, Cranial
Indications for Use (Describe)
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.
The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR based model of the anatomy.
Indications:
Example procedures include but are not limited to:
- Cranial Procedures:
- Tumor resections
- · Cranial biopsies
- · Craniotomies
- · Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
| 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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4
510(K) SUMMARY
ClaroNav Navient
Doc #: 985-05003-IR2025
510(K) SUMMARY NAVIENT IMAGE GUIDED NAVIGATION SYSTEM
| Sponsor: | ClaroNav
1140 Sheppard Avenue West, Unit 10
Toronto, Ontario, M3K 2A2
Canada |
|-------------------------|---------------------------------------------------------------------------------------|
| Contact Person | Karen Wu |
| | Director of Regulatory Affairs |
| Phone | +1 647 552 1489 |
| e-mail | ra@claronav.com |
| Date | February 5, 2025 |
| Device Proprietary Name | Navient Image Guided Navigation System, Cranial |
| Common Name | Navient |
| Product Code | HAW |
| Class | Class II |
| Regulation Number | 21 CFR 882.4560 |
| Regulation Name | Stereotaxic instrument |
| Classification Panel | Neurology |
Predicate Devices
Primary predicate: StealthStation S8 Cranial (K212397)
Indications for Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.
5
510(K) SUMMARY
Doc #: 985-05003-IR2025
The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR based model of the anatomy.
Indications:
Example procedures include but are not limited to: Cranial Procedures:
- Tumor resections .
- . Cranial biopsies
- Craniotomies .
- Pediatric Catheter Shunt Placement •
- . General Catheter Shunt Placement
Technological Characteristics
Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.
Navient's quidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.
Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.
- Cranial Accessory Kit (955-NC-AKC) o
- Biopsy Accessory Kit (955-NC-AKB) O
Disposable tracker instruments are also available based on user preference.
Navient Software Workflow:
Navient software operation proceeds sequentially through 5 stages:
6
Doc #: 985-05003-IR2025
- Images: Load the CT or MR images, review and explore images and perform image fusion. 1.
-
- Planning: The planning stage, depending on the procedure types
- Set Up: attach the Patient reference, adjust the tracking system position and verify the 3. instruments' tip calibration accuracy.
- ধা Registration: Using Registrator, point to the marked landmarks on the actual patient's skin, then trace a path on the patient's face to refine the registration.
-
- Navigation: Navigate the position of the tip of various instruments in the image volume.
Performance Data
Navient's performance testing included:
. Reprocessing validation:
Reprocessing instructions are available in the user manual. Navient instrument (worst case) was validated for manual and automated cleaning in accordance with AAMI TIR 30: 2011(R) 2016, and steam sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013 for (SAL) of