(182 days)
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.
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.
The provided document, a 510(k) Premarket Notification for the Zeta Cranial Navigation System, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
However, based on the information provided, we can infer the types of performance aspects tested and the general conclusion of the submitter.
Here's an attempt to structure the information based on your request, highlighting where the document provides details and where it lacks them for a comprehensive answer:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance numbers. Instead, it describes general testing categories. We can infer the "acceptance criteria" were implicit in passing these tests.
| Performance Aspect (Inferred Acceptance Criteria) | Reported Device Performance (from "Bench Testing" section) |
|---|---|
| Accuracy | Demonstrated accuracy under different conditions, including: - Simulated clinical procedures using virtual targets - Surgical illumination levels - Dynamic patient motion - Other worst-case physical and environmental conditions |
| - Maximum Tracking Speed | 0.88 cm/s |
| - Effective Navigation Latency | 0.17 s |
| Electrical Safety and EMC Compliance | Passed all tests according to IEC 60601-1, IEC 62304, IEC 60601-1-2, and IEC 60601-1-6. |
| Software Verification and Validation | Verified and validated software as recommended by FDA guidance for "Major level of concern" software. |
| Cybersecurity | Documentation provided as recommended by FDA guidance. |
| Usability (Human Factors) | Passed all tests following FDA Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices." |
| Sterilization & Cleaning Effectiveness | Cleaning instructions provided in labeling; device is reusable and non-sterile. Implies cleaning is effective if instructions are followed. |
| Shelf-Life | Not applicable; low likelihood of time-dependent product degradation. |
Important Note: The document states "The device passed all tests" for electrical safety, EMC, software, and human factors. It also states that accuracy testing was performed and implies successful demonstration of accuracy under various conditions. However, specific quantifiable acceptance thresholds or detailed results (e.g., actual accuracy measurements in mm) are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The "Bench Testing" section mentions "Simulated clinical procedures using virtual targets" and testing under "Dynamic patient motion" and "Other worst-case physical and environmental conditions," but does not provide the number of simulations, patients, or instances.
- Data Provenance: The nature of the testing (bench testing, simulations) suggests a controlled laboratory environment. The country of origin for the data is not specified, but the applicant (Zeta Surgical Inc.) is based in Boston, Massachusetts, USA. The testing appears to be retrospective as it was conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is primarily technical bench testing and simulations, and does not appear to involve human expert ground truth for interpretation of medical images or surgical outcomes in the way a clinical study would.
4. Adjudication method for the test set
This information is not provided. Given that the testing focuses on technical performance and simulations, an adjudication method in the context of expert review (e.g., 2+1, 3+1) is unlikely to be applicable or described for these types of tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Was an MRMC study done? No. The document explicitly states under "Clinical Data": "Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
- Effect Size: Not applicable, as no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a "stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons." It is an intraoperative guidance system that assists surgeons. Therefore, its performance is inherently tied to human use (human-in-the-loop). While its component technologies (like tracking accuracy or latency) are tested in a standalone manner, the overall device function is not a standalone "algorithm only" product in the sense of an AI diagnostic tool. The performance metrics provided (maximum tracking speed, effective navigation latency) are for the system's technical operation.
7. The type of ground truth used
For the bench tests, the ground truth would be:
- Engineering/Physical Measurements: Precision instruments and known physical parameters (e.g., for accuracy testing against virtual targets, illumination levels, simulated motion).
- Standard Compliance: Adherence to the requirements of the referenced IEC and other standards (e.g., for electrical safety, EMC, software, human factors).
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a navigation system, not a machine learning model that would typically have a "training set" for image interpretation or diagnosis. It uses pre-operative 3D CT/MRI scans and machine vision for patient registration and instrument tracking, but the document does not describe a separate machine learning training phase for its core image guidance functionality. The "machine vision" mentioned for registration technology typically refers to computer vision algorithms, but not necessarily a "deep learning" or "AI" model trained on a large dataset in the way a diagnostic AI would be.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. (See point 8).
In summary, the 510(k) submission focuses on demonstrating the technical performance and safety of the device through bench testing and compliance with recognized standards, arguing for substantial equivalence to a predicate device, rather than providing a clinical effectiveness study with human readers or AI performance metrics.
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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
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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 2Boston, MA 02111 |
|---|---|
| Contact: | Roman Stolyarov, PhDVice President of ProductZeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111+1 (214) 284-7990roman.stolyarov@zetasurgical.com |
| Submission Correspondent: | Roman Stolyarov, PhDVice President of ProductZeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111+1 (214) 284-7990roman.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 stereotaxicimage guidance system intended for the spatialpositioning and orientation of neurosurgicalinstruments used by surgeons. The device is indicatedonly for cranial surgery where reference to a rigidanatomical structure can be identified, does notrequire rigid fixation of the patient, and does notrequire fixation of a navigated instrument guide to thepatient. The system is intended to be used in operatingrooms and in less acute surgical settings such asinterventional procedure suites. | The 7D Surgical System is a stereotaxic imageguidance system intended for the spatial positioningand orientation of neurosurgical instruments used bysurgeons. The system is also intended to be used as theprimary surgical luminaire during image guidedsurgery. The device is indicated for cranial surgerywhere reference to a rigid anatomical structure can beidentified. |
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 andVentricular 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 procedurestaff | Neurosurgeons and neurosurgical procedurestaff |
| Intended UseEnvironment | Neurosurgical operating room and facilitiesequipped for interventional cranial procedures | Neurosurgical operating room and facilitiesequipped 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 TrackingTechnology | Optical | Optical |
| Registration Technology | Structured light and machine vision | Structured light and machine vision |
| Major SystemComponents | 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, multipleinstrument selection | Multiple target point selection, multipleinstrument selection |
| Navigation Features | Target point projection, instrument rendering,instrument extended trajectory, physicaldistance measurement, multiple perspectives | Target point projection, instrument rendering,instrument extended trajectory, physicaldistance measurement, multiple perspectives |
| Image Guided | Yes | Yes |
| Real-time Display of theInstrument Position | Yes | Yes |
| Provide Guidance forSurgical Instruments | Yes | Yes |
| Instrument Technology | Wireless and unpowered | Wireless and unpowered |
| InstrumentCompatibility | Brainlab Disposable Stylet | 7D instruments |
| Initial RegistrationMethod | Automatic | Manual (requires user defined features) |
| Continuous RegistrationMethod | Automatic and pinless | Patient is pinned |
| Markerless Registration | Yes | Yes |
| Network Connectivity | No | Yes |
| User Interface | Non-sterile touchscreen monitor that is coveredwith a transparent sterile cover during theprocedure | Non-sterile workstation with foot pedalcontrols for use during the procedure |
| Performance | ||
| Maximum TrackingSpeed (cm/s) | 0.88 | N/A - pinned system |
| Effective NavigationLatency (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"
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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.
§ 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).