(58 days)
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.
The subject device, a modification to the previously cleared Zap-X Radiosurgery System, is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is selfshielded for ionizing radiation. A gantry-mounted linear accelerator provides the modified Zap-X System with a therapeutic radiation source, and a kV imaging system is used to locate the treatment target accurately. At the start of treatment, X-ray images of the 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.
The subject device for which this submission is being made improves the patient tracking/alignment throughout treatment. This is the only new feature which has been implemented on the subject device differentiating it from the predicate device. There is no change to the system specifications as a result of this improvement in patient alignment - the overall system patient positioning is still within 1 mm as with the predicate device.
The provided document is an FDA 510(k) clearance letter and summary for the Zap-X® Radiosurgery System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a standalone study with defined acceptance criteria and performance metrics.
Therefore, the document does not contain the following information typically found in a study designed to prove a device meets specific acceptance criteria:
- A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy).
- Sample size used for a test set in a performance study, or data provenance for such a set.
- Number of experts used to establish ground truth for a test set, or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor its effect size.
- Standalone (algorithm only without human-in-the-loop performance) study results.
- Type of ground truth used for a performance study (e.g., pathology, outcomes data).
- Sample size for a training set (as this is a medical device, not an AI/ML algorithm in the traditional sense, though it uses software).
- How ground truth for a training set was established.
What the document does describe is that the modified Zap-X Radiosurgery System was evaluated through non-clinical bench testing to demonstrate that it performed as intended and was substantially equivalent to its predicate device.
Here's an overview of the "acceptance criteria" and "study" as presented in this 510(k) submission:
1. Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are primarily conformance to established design specifications and relevant industry standards, as well as demonstration of substantial equivalence to a predicate device. The "reported device performance" is that these specifications and standards were met.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance (as stated in the document) |
|---|---|
| Meets design specifications for the modified Zap-X System (including the new patient alignment feature). | "Internal testing performed confirmed that the modified Zap-X System meets all design specifications." |
| Validation of bug fixes and minor enhancements. | "Those changes have also been validated following internal design validation procedures." |
| Conformance to electrical safety and electromagnetic compatibility standards. | Non-clinical bench testing included "Electrical safety and electromagnetic compatibility testing." |
| Conformance to software verification and validation standards. | Non-clinical bench testing included "Software verification and validation testing." |
| Conformance to system and subsystem verification testing standards. | Non-clinical bench testing included "System and subsystem verification testing." |
| Conformance to system validation testing for commissioning, treatment planning, and treatment delivery. | Non-clinical bench testing included "System validation testing of system commissioning, treatment planning, and treatment delivery." |
| Conformance to usability testing requirements. | Non-clinical bench testing included "Usability testing." |
| Conformance to specific radiotherapy and radiographic equipment standards (as listed by IEC standards). | "Standards conformance testing related to radiotherapy systems and radiographic equipment." The document lists several IEC standards (e.g., 60601-1, 60601-2-1, 62083, etc.). |
| Demonstrates substantial equivalence to the predicate device Zap-X Radiosurgery System (K183698). | "The collective bench testing demonstrates that the subject device is substantially equivalent to the predicate device." |
| Overall system patient positioning within 1 mm (same as predicate device). | "the overall system patient positioning is still within 1 mm as with the predicate device." |
| Meets requirements for radiation leakage and protection (identical to predicate and reference devices). | "the subject device 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 predicate Zap-X Radiosurgery System as well as the reference CyberKnife device within a radiation-shielded vault." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of clinical data for performance evaluation. The "tests" refer to engineering bench tests and validations of device components and software.
- Data Provenance: Not applicable for a typical "test set" as defined for clinical performance. The testing was internal ("Internal testing performed confirmed...") and focused on engineering validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission doesn't describe a study involving expert-established ground truth for a clinical test set. The validation was against engineering specifications and industry standards.
4. Adjudication method for the test set:
- Not applicable, as there was no clinical test set requiring expert adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a radiosurgery system for treatment delivery, not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone system for radiosurgery. The "study" described is the non-clinical bench testing of this system. It is not an algorithm being assessed in isolation from a human-in-the-loop context. The enhancement is an "improvement in patient alignment during treatment" within the system itself.
7. The type of ground truth used:
- The "ground truth" for the non-clinical testing was defined by engineering design specifications, performance metrics derived from the predicate device, and the requirements of various industry standards (e.g., IEC 60601-1, IEC 62304).
8. The sample size for the training set:
- Not applicable. This is not a submission for an AI/Machine Learning algorithm that requires a "training set" in the common sense. The system is a medical device incorporating software and hardware.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set in the context of an AI/ML algorithm.
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July 29, 2021
Image /page/0/Picture/1 description: The image contains 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
Re: K211663
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: May 28, 2021 Received: June 1, 2021
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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2
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 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 medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K211663
Device Name Zap-X® Radiosurgery System
Indications for Use (Describe)
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.
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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510(k) Notification K211663
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:
Contact Person:
Jim Talbot Vice President RA/QA Phone: (650) 793-8250 FAX: (650) 832-1038
Date Prepared: May 28, 2021
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
Company: Zap Surgical Systems, Inc. Zap-X® Radiosurgery System (K183698) Device:
REFERENCE DEVICE
Company: ACCURAY INCORPORATED Device: CyberKnife M6 Systems (K150873)
INDICATIONS FOR USE [807.92(a)(5)]
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 [807.92(a)(4)]
The subject device, a modification to the previously cleared Zap-X Radiosurgery System, is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is selfshielded for ionizing radiation. A gantry-mounted linear accelerator provides the modified Zap-X System with a therapeutic radiation source, and a kV imaging system is used to locate the treatment target accurately. At the start of treatment, X-ray images of the 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.
The subject device for which this submission is being made improves the patient tracking/alignment throughout treatment. This is the only new feature which has been implemented on the subject device differentiating it from the predicate device. There is no change to the system specifications as a result of this improvement in patient alignment - the overall system patient positioning is still within 1 mm as with the predicate device.
PREDICATE DEVICE(S) [807.92(a)(3)]
Zap Surgical Systems, Inc. asserts that the subject device, Zap-X Radiosurgery System ("Zap-X System"), is substantially equivalent to the predicate device Zap-X Radiosurgery System, cleared under 510(k) K183698. The subject device and the predicate device are medical charged-particle radiation therapy systems, falling within 21 CFR 892.5050, Product Code IYE. The subject
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device 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 subject device is also appropriately comparable to Accuray Cyberknife M6 System (reference device) cleared under 510(k) K150873.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The technological characteristics of the subject device and the predicate device cleared under Zap-X Radiosurgery System (K183698) and reference device all have similar features and components. All three systems utilize a Linac system to generate the treatment beam.
The subject device and the predicate, and the reference device all use a collimator to control the treatment beam size. The treatment beam sizes offered with the subject device are identical to the predicate device and within the ranges offered by the reference device, CyberKnife. Moreover, all three systems deliver treatment beams from a variety of directions. In addition, all three systems have a patient table to support and position the patient during treatment. The subject device, predicate device, and reference device Accuray CyberKnife have a KV imaging system to monitor patient movements allowing accurate delivery of radiation to the treatment target. All systems have control consoles and interface software to control and monitor treatment planning and treatment delivery systems. All systems include capabilities for patient tracking. Like the primary predicate and CyberKnife, the subject device uses the 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, electromagnetic compatibility and other applicable state-of-the-art standards for medical electrical equipment, electron accelerators, and radiotherapy equipment.
The primary difference in technological features between the predicate Zap-X System and the subject device is that the latter has implemented a number of minor design changes. While none of the minor design changes implemented in the subject device would require a new 510(k) submission, the multitude of changes that have been implemented since the clearance of the predicate device warrant a submission at this time. The subject device is identical to its predicate with respect to design in that both systems are intended to treat lesions of the head. Finally, the subject device 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 predicate Zap-X Radiosurgery System as well as the reference CyberKnife device within a radiation-shielded vault.
SUBSTANTIAL EQUIVALENCE
The subject device is identical to the primary predicate device previously cleared on February 25, 2019 (K183698). The two devices have identical intended use, i.e., the planning and performance of image-guided stereotactic radiosurgery and precision radiotherapy. In
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addition, the proposed brain, head, and neck targets to be treated by the subject device are identical to the treatment targets in the primary predicate device and 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
Table 12.1. Substantial Equivalence Table
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
|---|---|---|---|---|
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None |
| RegulationNumber | 21 CFR 892.5050Medical charged-particle radiationtherapy system | 21 CFR 892.5050Medical charged-particle radiationtherapy system | 21 CFR 892.5050Medical charged-particle radiationtherapy system | None |
| RegulatoryClass | II | II | II | None |
| ClassificationProduct Code | IYE | IYE | IYE | None |
| Indications forUse | Identical to theprimary predicatedevice | The Zap-XRadiosurgery Systemis intended to providetreatment planning andimage-guidedstereotacticradiosurgery andprecision radiotherapyfor tumors, lesions, andconditions in the brain,head, and neck whenradiation treatment isindicated. | The CyberknifeM6 Systems areindicated fortreatment planningand image-guidedstereotacticradiosurgery andprecisionradiotherapy forlesions, tumors,and conditionsanywhere in thebody whenradiation treatmentis indicated. | Referencedevice treatsentire bodywhile subjectand predicatedevices treat thehead, neck andbrain only |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None |
| ProductDescription/Design | Identical to theprimary predicatedevice | The zap-XRadiosurgery Systems(Zap-X System) is arobotic radiosurgerysystem consisting of acompact Linacmounted on a dual axisrotational gantry. Thegantry parts also serveas radiation shieldsenabling the system tooperate without abunker. The Zap-xpositions with patientwith the target at theisocenter by movingthe patient table underkV image guidance.The source is thenrotated isocentricallyaround the patient todeliver radiation fromvarious angles. | The CyberKnifeM6 System utilizesa compact X-bancd Linacmounted on aroboticmanipulator arm.The patient ispositioned by acouch under kVimage guidanceand the source ismoved around thepatient andradiation isdelivered fromvarious angles. | Subject andpredicatedevices treatpatient withinshielded systemwhile referencedevice treatspatient withinshielded vaultor bunker(radiationexposure to theuser and generalpublic areequivalent forall threesystems) |
| SafetyFeatures | Identical to theprimary predicatedevice | The Zap-x has beendesigned to include thefollowing:-E-stop buttons toenable the user to stopmachine motion andradiation-Interlocks to prevent | -Contact detectionsensor at the distalend of thesecondarycollimator housingon the linac and onthe back of robotarm. | None |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None |
| improper system usage-Password and physicalkey access/radiationcontrol-Proximity scannersthat ensure systemmotion and radiationonly occur when thearea around the systemis clear-A laser scanningproximity detector todetect and preventcollisions with thecollimator-A software collisionpredication model thatutilizes a standardpatient envelope topredict potentialcollisions prior tosystem movement. | -Contact with thesensor causes anEmergency Stop(E-STOP)condition haltingall motion of thesystem.-Safety Zones:There is a safetyzone around thepatient and thetreatment couch;size is userselectable based onindividual patientsizes (small,medium, or large).The dynamic safetyzone is designed toencompass theentire patient bodyand always lieswithin the fixedsafety zone. | |||
| Feature | Subject DeviceZap-X RadiosurgerySystem | Primary Predicate DeviceZap-X Radiosurgery System(K183698) | Reference DeviceCyberknife M6 Systems(K150873) | Analysis of Differences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System | Image: Cyberknife M6 Systems | None |
| Service Life | Identical to the primary predicate device | With proper care and maintenance, the expected service life of the system is 10 years. | With proper care and maintenance, the expected operating life of the system is 10 years. | None |
| Side Effects | Identical to the primary predicate device and reference device. | Mild and temporary, often involving fatigue, nausea, and skin irritation. Side effects can be severe, leading to pain, alterations in normal body functions (for example, salivary function), deterioration of quality of life, permanent injury, and even death. | Mild and temporary, often involving fatigue, nausea, and skin irritation. Side effects can be severe, leading to pain, alterations in normal body functions (for example, salivary function), deterioration of quality of life, permanent injury, and even death. | None |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary Predicate DeviceZap-X Radiosurgery System(K183698) | Reference DeviceCyberknife M6 Systems(K150873) | Analysis of Differences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System | Image: Cyberknife M6 Systems | None |
| Occurrence ofSide Effects | Identical to theprimary predicatedevice andreference device. | During or shortly afterradiation treatment orin the months andyears followingradiation. | During or shortlyafter radiationtreatment or in themonths and yearsfollowingradiation. | None |
| Treatment Site | Identical to theprimary predicatedevice | Brain, head, and neck | Brain, head, andneck, all otheranatomical regionsin the body | Referencedevice treatsentire bodywhile subjectand predicatedevices treathead, neck andbrain only |
| Accelerator(treatmentbeam) | Identical to theprimary predicatedevice | 3MV nominal photonbeam energy | 6 MV nominalphoton beamenergy | Higher energyrequired forreference deviceto treat otheranatomicallocations deeperin the body |
| Dose rate (inMU/min) | Identical to theprimary predicatedevice | $1500\pm10$ % MU/min at450 mm | $1000\pm10$ %MU/min at 800mm | None |
| Depth atMaximumDose (Dmax) | Identical to theprimary predicatedevice | $7\pm1$ mm | $15\pm2$ mm | None |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None |
| TreatmentBeam | Identical to theprimary predicatedevice | 8 available beam sizes:diameters of 4.0 mm,5.0 mm, 7.5 mm, 10.0mm, 12.5 mm, 15.0mm, 20.0 mm, and25.0 mm at the Sourceto Axis distance of 450mm | 5, 7.5, 10, 12.5, 15,20, 25, 30, 35, 40,50 and 60 mmdiameter field sizesat 800 mm SAD(with Iris ApertureCollimator) | None |
| MoveableTreatmentBeam | Identical to theprimary predicatedevice | Yes - Two degree offreedom gantry | Yes - Six degreeof freedom roboticarm | None |
| PatientTable/Couch | Identical to theprimary predicatedevice | Yes | Yes | None |
| TreatmentTable | Identical to theprimary predicatedevice | Movable table with 3degrees of freedom | Moveable tablewith 5 degrees offreedom | None |
| Number ofTreatmentsessions | Identical to theprimary predicatedevice | Single or a short courseof hypofractionation(2-5 sessions) for largerlesions (>3 cm) | Single or a shortcourse ofhypofractionation(2-5 sessions) forlarger lesions (>3cm) | None |
| Overalltreatmentduration | Identical to theprimary predicatedevice | 1-2 weeks | 1-2 weeks | None |
| TreatmentBeamTechnology | Identical to theprimary predicatedevice | Linac system | Linac System | None |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System | Image: Cyberknife M6 Systems | None |
| PhotonRadiationSource | Identical to theprimary predicatedevice | X-ray Photons | X-ray Photons | None |
| BeamCrossfire | Identical to theprimary predicatedevice | Non-coplanar | Non-coplanar | None |
| Shielding forionizingradiation | Identical to theprimary predicatedevice | Self-shielded | Treatment Vault | None |
| TreatmentBeam Energy | Identical to theprimary predicatedevice | 3 MeV nominal photonbeam energy (1.0MeVmean photon energy) | 6 MeV nominalphoton beamenergy (2.0MeVmean photonenergy) | None |
| Dose Rate | Identical to theprimary predicatedevice | 1500±10% MU/min at450mm | 1000±10%MU/min at 800mm | None |
| Real-TimeDosimetry | Identical to theprimary predicatedevice | Yes | Yes | None |
| Safetysubsystem | Identical to theprimary predicatedevice | Yes | Yes | None |
| Systemconsole(operatingpanel) anduser interfacesoftware | Identical to theprimary predicatedevice | Yes | Yes | None |
| Feature | Subject DeviceZap-XRadiosurgerySystem | Primary PredicateDeviceZap-X RadiosurgerySystem(K183698) | Reference DeviceCyberknife M6Systems(K150873) | Analysis ofDifferences |
| Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None |
| Treatmenttarget trackingsoftware | Identical to theprimary predicatedevice | Yes | Yes | None |
| Treatmentplanningsoftware | Identical to theprimary predicatedevice with theadded feature:1.Enhancementmade to the patientalignment duringtreatment. | Yes | Yes | Same as thepredicate deviceexcept for onenew feature |
| Treatmentdeliverysoftware | Identical to theprimary predicatedevice | Yes | Yes | None |
| Method | Identical to theprimary predicatedevice | 6D skeletal TrackingSystem using planarCranial Imaging andalgorithmic comparisonreal-time bony anatomywith DRRs, at theinitiation of and duringpatient treatment | 6D skeletalTracking Systemusing planarCranial Imagingand algorithmiccomparison real-time bony anatomywith DRRs, at theinitiation of andduring patienttreatment | None |
| Control | Identical to theprimary predicatedevice | Treatment ConsolePendant | RemoteWorkstation LocalHand Pendant | None |
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SECTION 5. 510(K) SUMMARY
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SECTION 5. 510(K) SUMMARY
PERFORMANCE DATA [807.92(b)]
Zap Surgical Systems has performed bench testing to ensure that the modified Zap-X Radiosurgery System performs as intended.
There was one new feature added to the Zap-X System, which is described in the Device Description. That new feature is an improvement in the patient alignment during treatment. Internal testing performed confirmed that the modified Zap-X System meets all design specifications.
This submission also includes a number of less significant changes - primarily bug fixes and also minor enhancements to address user requests and minor technical enhancements. Those changes have also been validated following internal design validation procedures.
NONCLINICAL TESTING SUMMARY [807.92(b)(1)]
The non-clinical 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 60601-1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2014 Electromagnetic disturbances - Requirements and tests
- IEC60601-2-1:2014 Basic safety and essential performance of linear accelerators in ● the range of 1 MeV to 50 MeV
- IEC60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
- IEC61217:2011 Radiotherapy equipment - Coordinates, movements, and scales
- IEC62083:2009 Medical electrical equipment Requirements for the safety of ● radiotherapy treatment planning systems
- . IEC60976:2007 Medical electrical equipment - Medical electron accelerators -Functional performance characteristics
- IEC62304:2015 Medical device software Software life-cycle processes ●
- IEC62366:2015 Medical devices Application of usability engineering to medical ● devices
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SECTION 5. 510(K) SUMMARY
The collective results of the nonclinical testing demonstrate that the design, 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 subject device is substantially equivalent to the predicate device.
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SECTION 5. 510(K) SUMMARY
CLINICAL TESTING SUMMARY [807.92(b)(2)]
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 have been performed on the subject device to evaluate the device's overall performance. The collective results confirm that the subject device is substantially equivalent to the predicate device. The subject device meets its specifications, exhibits the required mechanical and functional characteristics for its intended use, and demonstrates that it is substantially equivalent to the legally marketed predicate device.
The subject device 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. In addition, the modified Zap-X System is similar to the reference device with regard to indications for use, and other system features. By virtue of the above analysis, the subject device is substantially equivalent to the primary predicate as well as the reference device.
SUMMARY
The Zap-X Radiosurgery System is considered substantially equivalent to the predicate device.
§ 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.