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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zeta Cranial Navigation System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (Zeta Cranial Navigation System, K233903) rather than explicitly stating quantitative performance acceptance criteria in an easily digestible table. However, it implicitly uses various testing results to show the device meets safety and effectiveness requirements.

Below is an attempted table based on the provided information, where "Acceptance Criteria" are implied by successful test completion and "Reported Device Performance" is the outcome of those tests.

Acceptance Criteria (Implied)	Reported Device Performance
Adherence to Biocompatibility Standards	Patient contact information is not needed as there are no direct or indirect patient-contacting components of the device.
Adherence to Electrical Safety Standards (IEC 60601-1)	The device passed all tests.
Adherence to Software Lifecycle Standards (IEC 62304)	The device passed all tests.
Adherence to Electromagnetic Compatibility (EMC) Standards (IEC 60601-1-2)	The device passed all tests.
Adherence to Usability Standards (IEC 60601-1-6)	The device passed all tests.
Software Verification and Validation	Testing was conducted, and documentation provided as recommended by FDA guidance. The software was considered a Major level of concern.
Cybersecurity Management	Documentation was provided as recommended by FDA guidance.
Cleaning and Sterilization Efficacy	The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling.
Shelf Life (Stability)	Shelf-life is not applicable due to the low likelihood of time-dependent product degradation.
Accuracy under various conditions (simulated clinical procedures, surgical illumination, dynamic patient motion, worst-case physical/environmental conditions)	Tested and demonstrated substantial equivalence (implied satisfactory accuracy).
Design Validation	Performed to demonstrate substantial equivalence.
Human Factors and Usability	Testing was performed following FDA guidance.
Navigation Frames Per Second	Uncapped (mean 21fps) - Note: This is a performance metric, not an explicit acceptance criterion, but it implies meeting a functional requirement.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of image data or patient studies for the subject device. The performance data provided is primarily from bench testing, electrical safety, software validation, and human factors testing.

Specifically, for accuracy testing, it mentions:

"Simulated clinical procedures using virtual targets"
"Surgical illumination levels"
"Dynamic patient motion"
"Other worst-case physical and environmental conditions"

However, the document does not provide details on:

The sample size of virtual targets, simulated procedures, or specific cases used for accuracy testing.
The provenance of any data (e.g., country of origin, retrospective/prospective) for these bench tests.

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 document describes bench testing and simulated environments rather than expert-adjudicated clinical data sets.

4. Adjudication method for the test set

This information is not provided as the testing described does not involve expert adjudication of a test set. The accuracy testing was likely measured against pre-defined virtual targets or established physical ground truths in a bench setting.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done, nor any data regarding human reader improvement with AI assistance. The Zeta Cranial Navigation System is described as an image guidance system for surgeons, not an AI-assisted diagnostic or interpretative tool for human readers of medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly state "standalone performance" in the context of an algorithm. However, the accuracy testing and other bench tests (e.g., electrical safety, software validation) would inherently assess the device's functional performance independent of human interaction beyond operating the device. The "Navigation Frames Per Second" (mean 21fps) is a standalone performance metric for the system's real-time tracking capability.

7. The type of ground truth used

For the accuracy testing, the ground truth appears to be:

Virtual targets: For simulated clinical procedures.
Established physical ground truths: For accuracy measurements under various physical and environmental conditions.

The document does not mention pathology, outcomes data, or expert consensus as ground truth for the performance evaluations described.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This is consistent with the device being primarily a navigation system, where the software's role is real-time tracking and display based on established principles, rather than a machine learning model that requires extensive training data for image interpretation or diagnosis.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not provided.

Summary

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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).

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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).

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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

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Indications for Use

510(k) Number (if known) K242351

Device Name Zeta Cranial Navigation System (ZNS131-US)

Indications for Use (Describe)

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.

1. SUBMITTER

Applicant:	Zeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111
Contact:	Raahil M. ShaChief Technology OfficerZeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111+1 (972) 992-8834raahil.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

5. INDICATIONS FOR USE

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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
CLASSIFICATIONREGULATION	21 CFR 882.4560	21 CFR 882.4560
PRODUCT CODE	HAW	HAW
CLASSIFICATION	Class II	Class II
INDICATIONSFOR USE	The Zeta Cranial Navigation System is astereotaxic image guidance system intended forthe spatial positioning and orientation ofneurosurgical instruments used by surgeons. Thedevice is indicated only for cranial surgery wherereference to a rigid anatomical structure can beidentified, does not require rigid fixation of thepatient, and does not require fixation of anavigated instrument guide to the patient. Thesystem is intended to be used in operating roomsand in less acute surgical settings such asinterventional procedure suites.	The Zeta Cranial Navigation System is astereotaxic image guidance system intended forthe spatial positioning and orientation ofneurosurgical instruments used by surgeons. Thedevice is indicated only for cranial surgery wherereference to a rigid anatomical structure can beidentified, does not require rigid fixation of thepatient, and does not require fixation of anavigated instrument guide to the patient. Thesystem is intended to be used in operating roomsand in less acute surgical settings such asinterventional procedure suites.
INTENDED USER	Neurosurgeons, neurosurgical procedure staff	Neurosurgeons, neurosurgical procedure staff
INTENDED USEENVIRONMENT	Neurosurgical operating room, facilities equippedfor interventional cranial procedures	Neurosurgical operating room, facilities equippedfor interventional cranial procedures
ANATOMICAL SITE	Head	Head
PRINCIPLE OFOPERATION	Preoperative image upload, Surgical planning,Patient registration, Instrument guidance	Preoperative image upload, Surgical planning,Patient registration, Instrument guidance
ACCEPTED IMAGINGMODALITIES	3D DICOM CT, MRI	3D DICOM CT, MRI
DATA INPUT	USB, CD-ROM	USB, CD-ROM, PACS
INSTRUMENTTRACKING	Optical tracking of unpowered wirelessinstruments	Optical tracking of unpowered wirelessinstruments
INSTRUMENTCOMPATIBILITY	Brainlab Disposable Stylet	Brainlab Disposable Stylet, IZI Disposable PassiveBlunt Probe
	PREDICATE DEVICE	SUBJECT DEVICE
REGISTRATIONTECHNOLOGY	Structured light and machine vision	Structured light and machine vision
GUIDANCETECHNOLOGY	Image based, provides real-time display ofinstrument position relative to patient anatomy	Image based, provides real-time display ofinstrument position relative to patient anatomy
MAJOR SYSTEMCOMPONENTS	Cart, Sensor head, Sensor head positioning arm,Monitor, Monitor positioning arm, Trackedinstruments, Software	Cart, Sensor head, Sensor head positioning arm,Monitor, Monitor positioning arm, Trackedinstruments, Software
USER INTERFACE	Non-sterile touchscreen monitor that is coveredwith a transparent sterile cover during theprocedure	Non-sterile touchscreen monitor that is coveredwith a transparent sterile cover during theprocedure
WORKFLOWCOMPONENTS	Upload, Segmentation, Planning,Staging/Positioning, Registration, InstrumentCalibration, Navigation	Upload, Segmentation, Planning,Staging/Positioning, Registration, InstrumentCalibration, Navigation
PLANNINGFEATURES	Multiple target point selection, multiple instrumentselection	Multiple target point selection, multiple instrumentselection
NAVIGATIONFEATURES	Target point projection, instrument rendering,instrument extended trajectory, physical distancemeasurement, multiple perspectives	Target point projection, instrument rendering,instrument extended trajectory, physical distancemeasurement, multiple perspectives
REGISTRATIONMETHOD	Automatic, pinless and markerless	Automatic, pinless and markerless
NAVIGATION FRAMESPER SECOND	Uncapped (mean 21fps)	Uncapped (mean 21fps)

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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.

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. 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.

Regulation Number and Section

§ 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).