(182 days)
Not Found
No
The summary describes a standard image-guided navigation system without mentioning AI or ML capabilities.
No.
The device is an image guidance system that assists surgeons in positioning instruments; it does not directly treat or diagnose a disease or condition.
No
The device aids in surgical navigation and instrument positioning but does not diagnose diseases or conditions.
No
The device description explicitly states it is a "stereotaxic, image guided planning and intraoperative guidance system" that assists 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 functionality inherently requires hardware components for tracking the instruments and displaying the information, going beyond software alone. The bench testing also mentions "Dynamic patient motion" and "worst-case physical and environmental conditions," which are typically associated with hardware performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Zeta Cranial Navigation System Function: The description clearly states that the Zeta system is a stereotaxic image guidance system used for the spatial positioning and orientation of neurosurgical instruments during cranial surgery. It helps surgeons navigate within the patient's body based on pre-operative images.
The system's function 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 only indicated 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
Yes
Mentions AI, DNN, or ML
Yes (machine vision)
Input Imaging Modality
3D CT / MRI (max slice thickness 2mm)
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:
- 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"
The device passed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Maximum Tracking Speed (cm/s): 0.88
Effective Navigation Latency (c): 0.17
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
September 8, 2023
Zeta Surgical Roman Stolyarov, Ph.D. Vice President of Product 2 Park Plaza. Suite 400 Boston, Massachusetts 02116
Re: K230661
Trade/Device Name: Zeta Cranial Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 9, 2023 Received: August 9, 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 (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
1
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 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 (OS) 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,
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Adam D. Pierce -S" is written on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" and "Date: 2023.09.08 19:01:29-04'00'".
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
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Indications for Use
510(k) Number (if known) K230661
Device Name Zeta Cranial Navigation System
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 only indicated 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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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.
SUBMITTER 1.
| Applicant: | Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Roman Stolyarov, PhD
Vice President of Product
Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111
+1 (214) 284-7990
roman.stolyarov@zetasurgical.com |
| Submission Correspondent: | Roman Stolyarov, PhD
Vice President of Product
Zeta Surgical Inc.
115 Kingston Street, Floor 2
Boston, MA 02111
+1 (214) 284-7990
roman.stolyarov@zetasurgical.com |
| Date Prepared: | September 7, 2023 |
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 |
PREDICATE DEVICE 3.
Predicate Device: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application [K192945]
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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.
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.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
| Subject Device | Predicate Device |
|---|---|
| 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 7D Surgical System is a stereotaxic image |
| guidance system intended for the spatial positioning | |
| and orientation of neurosurgical instruments used by | |
| surgeons. The system is also intended to be used as the | |
| primary surgical luminaire during image guided | |
| surgery. The device is indicated for cranial surgery | |
| where reference to a rigid anatomical structure can be | |
| identified. |
Technological Comparisons
The table below compares the key technological features of the subject device to the predicate device (7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, K192945).
| Table 1: | Technological Comparison |
|---|---|
| ---------- | -------------------------- |
| | Proposed Device
(K230661) | Predicate Device
(K192945) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K230661 | K192945 |
| Applicant | Zeta Surgical | 7D Surgical |
| | Proposed Device
(K230661) | Predicate Device
(K192945) |
| Device Name | Zeta Cranial Navigation System | 7D Surgical System Cranial Biopsy and
Ventricular Catheter Placement Application |
| Classification Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW |
| Classification | Class II | Class II |
| 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 |
| Principal of Operation | Preoperative image upload
• Surgical planning
• Patient registration
• Instrument guidance | Preoperative image upload
• Surgical planning
• Patient registration
• Instrument guidance |
| Technology | | |
| Imaging Modalities | 3D CT / MRI (max slice thickness 2mm) | 3D CT / MRI (max slice thickness 2mm) |
| Data Format | DICOM | DICOM |
| CD-ROM Input | Yes | Yes |
| USB Input | Yes | Yes |
| DICOM Compliance | Yes | Yes |
| Instrument Tracking
Technology | Optical | Optical |
| Registration Technology | Structured light and machine vision | Structured light and machine vision |
| 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 |
| Workflow Components | Upload
• Segmentation
• Planning
• Staging/Positioning
• Registration
• Instrument Calibration
• Navigation | Upload
• Segmentation
• Planning
• Instrument Calibration
• Registration (includes Staging/Positioning)
• Navigation |
| | Proposed Device
(K230661) | Predicate Device
(K192945) |
| 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 |
| Image Guided | Yes | Yes |
| Real-time Display of the
Instrument Position | Yes | Yes |
| Provide Guidance for
Surgical Instruments | Yes | Yes |
| Instrument Technology | Wireless and unpowered | Wireless and unpowered |
| Instrument
Compatibility | Brainlab Disposable Stylet | 7D instruments |
| Initial Registration
Method | Automatic | Manual (requires user defined features) |
| Continuous Registration
Method | Automatic and pinless | Patient is pinned |
| Markerless Registration | Yes | Yes |
| Network Connectivity | No | Yes |
| User Interface | Non-sterile touchscreen monitor that is covered
with a transparent sterile cover during the
procedure | Non-sterile workstation with foot pedal
controls for use during the procedure |
| Performance | | |
| Maximum Tracking
Speed (cm/s) | 0.88 | N/A - pinned system |
| Effective Navigation
Latency (c) | 0.17 | Unknown |
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7. PERFORMANCE DATA
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
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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 o the guidance system
- Surgical illumination levels O
- Dynamic patient motion O
- о 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"
8
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.