The Zap-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.

Device Description

The modified Zap-X Radiosurgery System ("Zap-X System") is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. A gantry-mounted linear accelerator provides the modified Zap-X System with a source of therapeutic radiation and a kV imaging system is used to accurately locate the treatment target. At the start of treatment, X-ray images of patient skeletal anatomy serve to align the treatment target with respect to the system isocenter. During radiosurgical treatment, the kV imaging system of the modified Zap-X System tracks patient movement and adjusts the table precisely to compensate for such movement.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Zap-X Radiosurgery System. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to establish acceptance criteria for de novo performance or to report on a study directly proving such criteria.

Therefore, the information requested about acceptance criteria and a study proving the device meets them, particularly regarding AI performance metrics, is largely not present in this document. This document focuses on demonstrating that the modified Zap-X System is equivalent to an existing device and thus does not require new acceptance criteria to be established or proven in the same way an entirely novel device might.

However, I can extract information related to the device's performance characteristics, safety, and testing methods that would implicitly serve as "acceptance criteria" for a substantial equivalence determination.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met by demonstrating similarity to the predicate device and conforming to relevant standards. The performance data is primarily bench testing and compliance with recognized standards.

Feature/Criterion	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance
Regulation Number	21 CFR 892.5050 (Medical charged-particle radiation therapy system)	21 CFR 892.5050 (Medical charged-particle radiation therapy system)
Regulatory Class	Class II	Class II
Product Code	IYE	IYE
Indications for Use	Treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated. (Same as predicate)	Same as predicate device
Accelerator (treatment beam)	3MV nominal photon beam energy (Same as predicate)	Same as primary predicate device
Dose rate (in MU/min)	1500 ± 10% MU/min at 450 mm (Same as predicate)	Same as primary predicate device
Depth at Maximum Dose (Dmax)	7 ± 1 mm (Same as predicate)	Same as primary predicate device
Treatment Beam Sizes	8 available beam sizes: diameters of 4.0 mm, 5.0 mm, 7.5 mm, 10.0 mm, 12.5 mm, 15.0 mm, 20.0 mm and 25.0 mm at 450 mm SAD (Same as predicate)	Same as primary predicate device
Moveable Treatment Beam	Yes – Two degree of freedom gantry (Same as predicate)	Same as primary predicate device
Patient Table/Couch	Yes (Same as predicate)	Same as primary predicate device
Shielding for ionizing radiation	Self-shielded (Same as predicate)	Self-shielded
Real-Time Dosimetry	Yes (Same as predicate)	Same as primary predicate device
Safety subsystem	Yes (Same as predicate)	Same as primary predicate device
System console & user interface software	Yes (Same as predicate)	Same as primary predicate device
Treatment target tracking software	Yes (Same as predicate)	Same as primary predicate device
Treatment planning software	Yes (Same as predicate), with new features (pre-generated dose volume selection, optimize workflow for multiple metastatic tumors)	Same as primary predicate device, with addition of two features. (Demonstrated to not raise new safety/effectiveness questions.)
Treatment delivery software	Yes (Same as predicate)	Same as primary predicate device
Electrical safety and electromagnetic compatibility	Conformance to IEC 60601-1:2005, IEC 60601-1-2:2007	Testing performed to these standards.
Electron accelerators safety	Conformance to IEC 60601-2-1:2014	Testing performed to this standard.
Laser safety	Conformance to IEC 60825-1:2014	Testing performed to this standard.
Radiotherapy equipment coordinates, movements, scales	Conformance to IEC 61217:2011-12	Testing performed to this standard.
Safety of radiotherapy treatment planning systems	Conformance to IEC 62083:2009-09	Testing performed to this standard.
Software verification and validation	Meets established specifications for consistent performance and does not raise different safety/effectiveness questions.	Performed.
System and subsystem verification	Meets established specifications for consistent performance and does not raise different safety/effectiveness questions.	Performed.
System validation (commissioning, treatment planning, delivery)	Meets established specifications for consistent performance and does not raise different safety/effectiveness questions.	Performed.
Usability testing	Meets established specifications for consistent performance and does not raise different safety/effectiveness questions.	Performed.
Radiation Leakage and Protection	Meet requirements and provide protection identical to predicate and reference CyberKnife.	Demonstrated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided for clinical data. The document explicitly states: "No clinical testing was performed to support this premarket notification." The testing performed was "nonclinical, bench testing." Therefore, there is no clinical test set, sample size, or data provenance in the context of human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Since no clinical testing was performed, there was no clinical ground truth established by experts for human patient data. The ground truth for bench testing would be based on engineering specifications and physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set or human expert review/adjudication was conducted as part of this submission.

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

No. This is not an AI-assisted diagnostic or interpretation device that would involve human readers performing tasks. It is a radiosurgery system. The document does not mention any MRMC studies or AI assistance in the context of human interpretation improvement.

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

This refers to the performance of the system itself, which is what the "nonclinical, bench testing" covers. The device, being a radiosurgery system, operates as a standalone system (with human planning and oversight, but the delivery itself is automated based on the plan). The performance data cited from bench testing (electrical safety, software V&V, system validation, standards conformance) demonstrates the standalone performance of the device's components and integrated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the nonclinical testing, the "ground truth" would be established through:
- Engineering specifications and design requirements: To which the system and its components were verified and validated.
- Physical measurements and dosimetry: For characteristics like dose rate, beam sizes, and depth at maximum dose.
- Standard compliance: Verification against the requirements of international and national standards (e.g., IEC 60601 series).

8. The sample size for the training set

Not provided/Not applicable in a clinical sense. This document pertains to a medical device for radiation therapy delivery, not an AI/ML algorithm that requires a "training set" of patient data in the typical sense. While the software within the system would have undergone development and testing (software V&V), the document does not specify a "training set" size for any internal algorithms.

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

Not provided/Not applicable. As above, a "training set" in the context of AI/ML is not discussed. The "ground truth" for the device's operational parameters would be established by physics principles, engineering design, and quality control processes.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zap Surgical Systems, Inc. % Mr. Jim Talbot Vice President RA/QA 590 Taylor Way, Suite A SAN CARLOS CA 94070 February 25, 2019

Re: K183698

Trade/Device Name: Zap-X Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: December 27, 2018 Received: December 31, 2018

Dear Mr. Talbot:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Enclosure

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Indications for Use

510(k) Number (if known)

K183698 Device Name

Zap-X Radiosurgery System

Indications for Use (Describe)

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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GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Zap Surgical Systems, Inc. 590 Taylor Way, Suite A San Carlos, CA 94070 USA Phone: (650) 793-8250 FAX: (650) 832-1038

Contact Person:

Jim Talbot Vice President RA/Q A Phone: (650) 793-8250 FAX: (650) 832-1038

Date Prepared: December 21, 2018

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Zap-X™ Radiosurgery System

Generic/Common Name:

Medical charged-particle radiation therapy system

Regulation Number/Classification:

21 CFR 892.5050, Class II

Classification Product Code:

IYE

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PREDICATE DEVICE(S) [807.92(a)(3)]

Zap Surgical Systems, Inc. asserts that the modified Zap-X Radiosurgery System ("Zap-X System") is substantially equivalent to the predicate device, Zap-X Radiosurgery System, cleared under 510(k) K171804. The modified Zap-X System and the predicate device are medical charged-particle radiation therapy systems, falling within 21 CFR 892.5050, Product Code IYE. The proposed modified Zap-X Radiosurgery System is comparable to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics, and safety characteristics. The modified Zap-X System is also appropriately comparable to Accuray Cyberknife M6 System (reference device) cleared under 510(k) 150873.

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

The modified Zap-X Radiosurgery System is intended to provide treatment planning and image- guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

With regard to technological characteristics, the modified Zap-X Radiosurgery System, originally cleared Zap-X device and reference device all have similar features and components. All three systems utilize a Linac system to generate the treatment beam.

The proposed device, as well as the predicate and reference devices all use a collimator to control the treatment beam size. The treatment beam sizes offered with the modified Zap-X System are identical to the predicate device and within the ranges offered by the reference CyberKnife. Moreover, all three systems deliver treatment beams from a variety of

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directions. In addition, all three systems have a patient table to support and position the patient during treatment. The proposed device, predicate device and reference device Accuray CyberKnife all have an imaging system to accurately deliver radiation to the treatment target. All systems have control consoles and interface software to control and monitor the systems for treatment planning and treatment delivery. All systems include capabilities for patient tracking. The modified Zap-X System, like the primary predicate and CyberKnife, use patient skeletal anatomy to align the treatment target with respect to the system isocenter. All three systems use the kV imaging system to track patient movement and adjust the table precisely to compensate for such movement during treatment. All three systems were extensively tested for electrical safety and electromagnetic compatibility per the relevant standards for medical electrical equipment, electron accelerators and radiotherapy equipment.

The primary difference in technological features between the predicate Zap-X System and the modified Zap-X System is that the latter has implemented a number of minor design changes. The modified Zap-X System is identical to the original Zap-X device with respect to design in that both systems are intended to treat lesions of the head. Finally, the modified Zap-X System was demonstrated to meet the requirements for radiation leakage and provide protection from radiation to the operator and general public identical to that of the original Zap-X System as well as the reference CyberKnife device within a radiation shielded vault.

SUBSTANTIAL EQUIVALENCE

With regard to a primary predicate device, the modified Zap-X System is identical to the original Zap-X System cleared on September 21, 2017 (K171804). Both devices share the same general intended use, i.e., the planning and performance of image guided stereotactic radiosurgery and precision radiotherapy. In addition, the proposed brain, head and neck targets to be treated by the modified Zap-X System are identical to the treatment targets of the originally cleared Zap-X System and are a subset of the reference Accuray CyberKnife device.

Detailed comparisons of the proposed Zap-X Radiosurgery System to the primary predicate Zap-X System as well as the reference CyberKnife device are provided in the following table.

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Substantial Equivalence Table

Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceZap-X RadiosurgerySystem(K171804)	Reference DeviceCyberKnife M6Systems(K150873)	Analysis ofDifferences
RegulationNumber	21 CFR 892.5050	21 CFR 892.5050	21 CFR 892.5050	None
	Medical charged-particle radiationtherapy system	Medical charged-particleradiation therapy system	Medical charged-particle radiationtherapy system	None
RegulatoryClass	II	II	II	None
ClassificationProduct Code	IYE	IYE	IYE	None
Indications forUse	Same as primarypredicate device	The Zap-X RadiosurgerySystem is intended toprovide treatmentplanning and image-guided stereotacticradiosurgery andprecision radiotherapyfor tumors, lesions andconditions in the brain,head and neck whenradiation treatment isindicated.	The CyberKnife M6Systems areindicated fortreatment planningand image guidedstereotacticradiosurgery andprecisionradiotherapy forlesions, tumors andconditionsanywhere in thebody when radiationtreatment isindicated.	None
Accelerator(treatmentbeam)	Same as primarypredicate device	3MV nominal photonbeam energy	6 MV nominalphoton beam energy	None
Dose rate (inMU/min)	Same as primarypredicate device	$1500±10%$ MU/min at450 mm	$1000±10%$ MU/minat 800 mm	None
Depth atMaximumDose (Dmax)	Same as primarypredicate device	$7±1$ mm	$15±2$ mm	None
TreatmentBeam	Same as primarypredicate device	8 available beam sizes:diameters of 4.0 mm, 5.0mm, 7.5 mm, 10.0 mm,12.5 mm, 15.0 mm, 20.0mm and 25.0 mm at theSource to Axis distance	5, 7.5, 10, 12.5, 15,20, 25, 30, 35, 40,50 and 60 mmdiameter field sizesat 800 mm SAD(with Iris Aperture)	None
Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceZap-X RadiosurgerySystem(K171804)	Reference DeviceCyberKnife M6Systems(K150873)	Analysis ofDifferences
		of 450 mm	Collimator)
MoveableTreatmentBeam	Same as primarypredicate device	Yes – Two degree offreedom gantry	Yes – Six degree offreedom robotic arm	None
PatientTable/Couch	Same as primarypredicate device	Yes	Yes	None
Shielding forionizingradiation	Same as primarypredicate device	Self-shielded	Treatment Vault	None
Real-TimeDosimetry	Same as primarypredicate device	Yes	Yes	None
Safetysubsystem	Same as primarypredicate device	Yes	Yes	None
System console(operatingpanel) and userinterfacesoftware	Same as primarypredicate device	Yes	Yes	None
Treatmenttarget trackingsoftware	Same as primarypredicate device	Yes	Yes	None
Treatmentplanningsoftware	Same as primarypredicate devicewith addition of twofeatures:1.Allow user toselect pre-generated dosevolume fortreatment2.Optimize userworkflow ofmultiplemetastatictumors	Yes	Yes	Same aspredicatewith theexceptionof two newfeatures
Feature	Proposed DeviceZap-XRadiosurgerySystem	Primary PredicateDeviceZap-X RadiosurgerySystem(K171804)	Reference DeviceCyberKnife M6Systems(K150873)	Analysis ofDifferences
Treatmentdeliverysoftware	Same as primarypredicate device	Yes	Yes	None

Table 12.1. Substantial Equivalence Table

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PERFORMANCE DATA [807.92(b)]

Zap Surgical Systems has performed bench testing to ensure that the modified Zap-X Radiosurgery System performs as intended.

[807.92(b)(1)] Nonclinical Testing Summary:

The nonclinical, bench testing included:

Electrical safety and electromagnetic compatibility testing ●
Software verification and validation testing .
System and subsystem verification testing ●
System validation testing of system commissioning, treatment planning and . treatment delivery
. Usability testing
Standards conformance testing related to radiotherapy systems and radiographic . equipment

The standards used in the development and testing of the Zap-X System include the following:

IEC 60601-1:2005. Medical electrical equipment Part 1: General requirements for . basic safety and essential performance

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. IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-1:2014, Medical electrical equipment - Part 2-1: Requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60825-1, 2014: Safety of laser products Part 1: Equipment classification and ● requirements
IEC 61217, 2011-12: Radiotherapy equipment - Coordinates, movements and scales
IEC 62083, 2009-09: Medical electrical equipment Requirements for the safety of ● radiotherapy treatment planning systems

The collective results of the nonclinical testing demonstrate that the design, the manufacturing and commissioning processes, safety controls, treatment planning and treatment delivery of the modified Zap-X Radiosurgery System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the modified Zap-X Radiosurgery System does not raise different questions of safety or effectiveness for image guided stereotactic radiosurgery and precision radiotherapy when compared to the predicate devices.

[807.92(b)(2)] Clinical Testing Summary:

This section is not applicable. No clinical testing was performed to support this premarket notification.

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical safety and performance testing has been performed on the modified Zap-X Radiosurgery System to evaluate the overall performance of the device. The collective results confirm that the modified Zap-X Radiosurgery System is safe and effective, meets its specifications, exhibits the required mechanical and functional characteristics for its intended use and demonstrate that the device is safe, effective and performs as safely and effectively as the legally marketed predicate device.

The proposed Zap-X Radiosurgery System was compared to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. Based on this comparison, there were only minor differences in the technological characteristics between the devices which do not raise any different questions of safety or effectiveness. In addition, the modified Zap-X System is similar to the reference device with regard to treatment energy, indications for use and other system features. By virtue of the above analysis, the modified Zap-X System is considered to be substantially equivalent to the primary predicate device.

SUMMARY

The Zap-X Radiosurgery System is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.