(30 days)
Not Found
No
The summary describes a standard image-guided navigation system that uses pre-operative scans and instrument tracking for spatial positioning. There is no mention of AI, ML, or related concepts like image processing that might suggest AI/ML involvement. The performance studies focus on accuracy and human factors, not AI/ML specific metrics.
No.
The device is an image guidance system that assists surgeons with precise positioning of instruments; it does not directly treat or diagnose a disease or condition.
No.
The device is a surgical navigation system, an intraoperative guidance system that assists with the precise positioning of surgical instruments relative to patient anatomy during cranial surgery, rather than diagnosing a condition.
No
The device description explicitly states it is a "system" that assists surgeons with the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans. This implies the system includes hardware components for tracking and displaying instrument position, not just software for planning and image processing. The bench testing also mentions "Dynamic patient motion" and "Other worst-case physical and environmental conditions," which are typically associated with hardware performance testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Zeta Cranial Navigation System Function: The description clearly states that the Zeta Cranial Navigation System is a stereotaxic image guidance system used for the spatial positioning and orientation of neurosurgical instruments during cranial surgery. It assists surgeons in navigating within the patient's body based on pre-operative images.
The system's purpose is to guide surgical procedures on the patient, not to analyze samples from the patient. Therefore, it falls under the category of a surgical navigation or guidance system, not an IVD.
N/A
Intended Use / Indications for Use
The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Zeta Cranial Navigation System is a stereotaxic, image guided planning and intraoperative guidance system enabling computer-assisted cranial interventional procedures. The system assists surgeons with the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Structured light and machine vision
Input Imaging Modality
3D DICOM CT and MRI
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons and neurosurgical procedure staff / Neurosurgical operating room and facilities equipped for interventional cranial procedures
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)
Bench testing was performed to demonstrate substantial equivalence, including:
- Accuracy testing under different conditions, including:
- Simulated clinical procedures using virtual targets that can be located only with the guidance system
- Surgical illumination levels
- Dynamic patient motion
- Other worst-case physical and environmental conditions
- Design validation testing
- Human factors testing, following the FDA Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices"
Software verification and validation testing was conducted.
Electrical safety and electromagnetic compatibility (EMC) testing was conducted; the device passed all tests.
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).
0
January 10, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zeta Surgical Inc Roman Stolyarov, Ph.D. Chief Product Officer 115 Kingston Street, Floor 2 Boston, Massachusetts 02111
Re: K233903
Trade/Device Name: Zeta Cranial Navigation System (ZNS131-US) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 11, 2023 Received: December 11, 2023
Dear Dr. Stolyarov:
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 (the 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/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.
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).
1
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 OS 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.
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-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,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.01.10 Pierce -S 12:34:35 -05'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
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) K233903
Device Name Zeta Cranial Navigation System (ZNS131-US)
Indications for Use (Describe)
The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Zeta Cranial Navigation System is provided below.
1. SUBMITTER
| Applicant: | Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Roman Stolyarov, PhD
Chief Product Officer
Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111
+1 (214) 284-7990
roman.stolyarov@zetasurgical.com |
| Submission Correspondent: | Roman Stolyarov, PhD
Chief Product Officer
Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111
+1 (214) 284-7990
roman.stolyarov@zetasurgical.com |
| Date Prepared: | January 10, 2024 |
2. DEVICE
| Device Trade Name: | Zeta Cranial Navigation System |
|---|---|
| Device Common Name: | Neurological Stereotaxic Instrument |
| Classification Name: | Stereotaxic instrument, 21 CFR 882.4560 |
| Regulatory Class: | Class II |
| Product Code: | HAW |
3. PREDICATE DEVICE
Predicate Device: Zeta Cranial Navigation System [K230661]
5
DEVICE DESCRIPTION 4.
The Zeta Cranial Navigation System is a stereotaxic, image guided planning and intraoperative guidance system enabling computer-assisted cranial interventional procedures. The system assists surgeons with the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans.
INDICATIONS FOR USE ર.
The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.
6. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
| Subject Device | Predicate Device |
|---|---|
| The Zeta Cranial Navigation System is a stereotaxic | The Zeta Cranial Navigation System is a stereotaxic |
| image guidance system intended for the spatial | image guidance system intended for the spatial |
| positioning and orientation of neurosurgical | positioning and orientation of neurosurgical |
| instruments used by surgeons. The device is indicated | instruments used by surgeons. The device is indicated |
| only for cranial surgery where reference to a rigid | only for cranial surgery where reference to a rigid |
| anatomical structure can be identified, does not | anatomical structure can be identified, does not |
| require rigid fixation of the patient, and does not | require rigid fixation of the patient, and does not |
| require fixation of a navigated instrument guide to the | require fixation of a navigated instrument guide to the |
| patient. The system is intended to be used in operating | patient. The system is intended to be used in operating |
| rooms and in less acute surgical settings such as | rooms and in less acute surgical settings such as |
| interventional procedure suites. | interventional procedure suites. |
Technological Comparisons
The table below compares the key technological features of the subject device to the predicate device (Zeta Cranial Navigation System, K230661).
| Cleared Device | Subject Device | |
|---|---|---|
| General | ||
| 510(k) | ||
| Number | K230661 | K233903 |
| Device Name | Zeta Cranial Navigation System | Zeta Cranial Navigation System |
| Classification | ||
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW |
| Cleared Device | Subject Device | |
| Classification | Class II | Class II |
| Indications | ||
| For Use | The Zeta Cranial Navigation System is a | |
| stereotaxic image guidance system intended for | ||
| the spatial positioning and orientation of | ||
| neurosurgical instruments used by surgeons. | ||
| The device is indicated only for cranial surgery | ||
| where reference to a rigid anatomical structure | ||
| can be identified, does not require rigid fixation | ||
| of the patient, and does not require fixation of a | ||
| navigated instrument guide to the patient. The | ||
| system is intended to be used in operating | ||
| rooms and in less acute surgical settings such | ||
| as interventional procedure suites. | The Zeta Cranial Navigation System is a | |
| stereotaxic image guidance system intended for | ||
| the spatial positioning and orientation of | ||
| neurosurgical instruments used by surgeons. | ||
| The device is indicated only for cranial surgery | ||
| where reference to a rigid anatomical structure | ||
| can be identified, does not require rigid fixation | ||
| of the patient, and does not require fixation of a | ||
| navigated instrument guide to the patient. The | ||
| system is intended to be used in operating rooms | ||
| and in less acute surgical settings such as | ||
| interventional procedure suites. | ||
| Intended | ||
| User | Neurosurgeons and neurosurgical procedure | |
| staff | Neurosurgeons and neurosurgical procedure | |
| staff | ||
| Intended Use | ||
| Environment | Neurosurgical operating room and facilities | |
| equipped for interventional cranial procedures | Neurosurgical operating room and facilities | |
| equipped for interventional cranial procedures | ||
| Anatomical | ||
| Site | Head | Head |
| Principle of | ||
| Operation | Preoperative image upload, Surgical planning, | |
| Patient registration, and Instrument guidance | Preoperative image upload, Surgical planning, | |
| Patient registration, and Instrument guidance | ||
| Technology | ||
| Accepted | ||
| Imaging | ||
| Modalities | 3D DICOM CT and MRI | 3D DICOM CT and MRI |
| Data Input | USB and CD-ROM | USB and CD-ROM |
| Instrument | ||
| Tracking | ||
| Technology | Optical tracking of wireless, unpowered | |
| instruments | Optical tracking of wireless, unpowered | |
| instruments | ||
| Instrument | ||
| Compatibility | Brainlab Disposable Stylet only | Brainlab Disposable Stylet only |
| Registration | ||
| Technology | Structured light and machine vision | Structured light and machine vision |
| Guidance | ||
| Technology | Image based, provides real-time display of | |
| instrument position relative to patient anatomy | Image based, provides real-time display of | |
| instrument position relative to patient anatomy | ||
| Major | ||
| System | ||
| Components | Cart, Sensor head, Sensor head positioning | |
| arm, Monitor, Monitor positioning arm, | ||
| Tracked instruments, Software | Cart, Sensor head, Sensor head positioning arm, | |
| Monitor, Monitor positioning arm, Tracked | ||
| instruments, Software | ||
| User | ||
| Interface | Non-sterile touchscreen monitor that is covered | |
| with a transparent sterile cover during the | ||
| procedure | Non-sterile touchscreen monitor that is covered | |
| with a transparent sterile cover during the | ||
| procedure | ||
| Workflow | ||
| Components | Upload, Segmentation, Planning, | |
| Staging/Positioning, Registration, Instrument | ||
| Calibration, Navigation | Upload, Segmentation, Planning, | |
| Staging/Positioning, Registration, Instrument | ||
| Calibration, Navigation | ||
| Planning | ||
| Features | Multiple target point selection, multiple | |
| instrument selection | Multiple target point selection, multiple | |
| instrument selection | ||
| Navigation | Target point projection, instrument rendering, | Target point projection, instrument rendering, |
| Cleared Device | Subject Device | |
| Features | instrument extended trajectory, physical | |
| distance measurement, multiple perspectives | instrument extended trajectory, physical | |
| distance measurement, multiple perspectives | ||
| Registration | ||
| Method | Automatic, pinless, and markerless | Automatic, pinless, and markerless |
| Navigation | ||
| Frames per | ||
| Second | 5Hz | Uncapped (mean 21fps) |
| Component and accessory modifications | ||
| Instrument | ||
| Tracker | NDI Polaris Vicra | NDI Polaris Lyra |
| 3D Camera | Ensenso N35-804-16-IR | Ensenso N36-804-16-IR |
| Suggested | ||
| draping | ||
| accessories | Welmed Protect5 Fenestrated Drape | Welmed Protect5 Fenestrated Drape and Exact |
| Cranial Drape | ||
| Other modification | ||
| Instrument | ||
| calibration | Required | Recommended for Brainlab Disposable Stylet |
Table 1: Technological Comparison
6
510(k) Summary
7
510(k) Summary
8
PERFORMANCE DATA 7.
Biocompatibility Testing
There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.
Electrical safety and electromagnetic compatibility (EMC)
The Zeta Cranial Navigation System was tested in accordance with the following standards:
- . IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, with the exception of Clause 11.7 regarding biocompatibility. The device passed all tests.
- IEC 62304:2006+ Amd 1:2015, Medical device software Software life cycle . processes. The device passed all tests.
- IEC 60601-1-2:2014+A1:2021, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests. The device passed all tests.
- IEC 60601-1-6, Edition 3.2 2020-07, Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability. The device passed all tests.
Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was considered a Major level of concern.
Cybersecurity documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Sterilization, Cleaning, and Shelf Life
Sterilization and Cleaning
The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling.
Shelf-Life
Shelf-life is not applicable due to the low likelihood of time-dependent product degradation.
Bench Testing
The following bench testing was performed to demonstrate substantial equivalence:
- Accuracy testing under different conditions, including: ●
- . Simulated clinical procedures using virtual targets that can be located only with the guidance system
- Surgical illumination levels .
9
- Dynamic patient motion ●
- Other worst-case physical and environmental conditions
- . Design validation testing
- Human factors testing, following the FDA Guidance Document, "Applying . Human Factors and Usability Engineering to Medical Devices"
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
8. CONCLUSION
The results of testing described above demonstrate that the Zeta Cranial Navigation System is as safe and effective as the predicate device and supports a determination of substantial equivalence.