(57 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard image-guided navigation techniques.
No
The device is an image guidance system that assists surgeons with instrument positioning; it does not directly treat or diagnose a disease or condition.
No
The Zeta Cranial Navigation System is an image guidance system used for the spatial positioning and orientation of neurosurgical instruments during cranial surgery. It assists surgeons with precise instrument placement relative to patient anatomy by displaying instrument positions on 3D preoperative medical scans. It does not generate medical diagnoses or analyze physiological data for diagnostic purposes.
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 guidance. The bench testing also includes accuracy testing under physical and environmental conditions, further suggesting hardware is involved.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of 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 in vivo (within the living body), not to perform diagnostic tests on samples in vitro.
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
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
Not Found
Input Imaging Modality
3D DICOM CT, MRI
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons, neurosurgical procedure staff; Neurosurgical operating room, 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:
- 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.
No clinical testing was required for the subject device.
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
October 4, 2024
Image /page/0/Picture/1 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zeta Surgical Inc. Raahil Sha Chief Technology Officer 115 Kingston Street, Floor 2 Boston, Massachusetts 02111
Re: K242351
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: September 4, 2024 Received: September 4, 2024
Dear Raahil Sha:
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.
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-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).
2
Sincerely,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.10.04 Pierce -S 09:57:13 -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
3
Indications for Use
510(k) Number (if known) K242351
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) |
|---|
| ------------------------------------------------- |
| ☑ 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: | Raahil M. Sha
Chief Technology Officer
Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111
+1 (972) 992-8834
raahil.sha@zetasurgical.com |
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
Zeta Cranial Navigation System [K233903]
4. 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.
5. 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.
5
6. SUBSTANTIAL EQUIVALENCE
The table below compares the key technological features of the subject device to the predicate device (Zeta Cranial Navigation System, K233903).
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| 510(K) NUMBER | K233903 | K242351 |
| DEVICE NAME | Zeta Cranial Navigation System | Zeta Cranial Navigation System |
| CLASSIFICATION | ||
| REGULATION | 21 CFR 882.4560 | 21 CFR 882.4560 |
| PRODUCT CODE | HAW | HAW |
| 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, neurosurgical procedure staff | Neurosurgeons, neurosurgical procedure staff |
| INTENDED USE | ||
| ENVIRONMENT | Neurosurgical operating room, facilities equipped | |
| for interventional cranial procedures | Neurosurgical operating room, facilities equipped | |
| for interventional cranial procedures | ||
| ANATOMICAL SITE | Head | Head |
| PRINCIPLE OF | ||
| OPERATION | Preoperative image upload, Surgical planning, | |
| Patient registration, Instrument guidance | Preoperative image upload, Surgical planning, | |
| Patient registration, Instrument guidance | ||
| ACCEPTED IMAGING | ||
| MODALITIES | 3D DICOM CT, MRI | 3D DICOM CT, MRI |
| DATA INPUT | USB, CD-ROM | USB, CD-ROM, PACS |
| INSTRUMENT | ||
| TRACKING | Optical tracking of unpowered wireless | |
| instruments | Optical tracking of unpowered wireless | |
| instruments | ||
| INSTRUMENT | ||
| COMPATIBILITY | Brainlab Disposable Stylet | Brainlab Disposable Stylet, IZI Disposable Passive |
| Blunt Probe | ||
| PREDICATE DEVICE | SUBJECT DEVICE | |
| 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 | ||
| FEATURES | Target point projection, instrument rendering, | |
| instrument extended trajectory, physical distance | ||
| measurement, multiple perspectives | Target point projection, instrument rendering, | |
| instrument extended trajectory, physical distance | ||
| measurement, multiple perspectives | ||
| REGISTRATION | ||
| METHOD | Automatic, pinless and markerless | Automatic, pinless and markerless |
| NAVIGATION FRAMES | ||
| PER SECOND | Uncapped (mean 21fps) | Uncapped (mean 21fps) |
6
7. PERFORMANCE DATA
7.1. 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.
7.2. Electrical safety and electromagnetic compatibility (EMC)
The Zeta Cranial Navigation System was tested in accordance with the following standards:
- . IEC 60601-1:2005 Ed. 3 + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, except 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.
7
- . 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, Ed. 3.2 2020-07, Medical electrical equipment - Part 1-6: General reguirements for basic safety and essential performance - Collateral standard: Usability. The device passed all tests.
7.3. 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 and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
7.4. Sterilization, Cleaning, and Shelf Life
The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling. Shelf-life is not applicable due to the low likelihood of time-dependent product degradation.
7.5. 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 ●
- 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.
7.6. Clinical Testing
No clinical testing was required for the subject 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.