Who is the manufacturer of Zap-X Radiosurgical System?

Zap Surgical Systems, Inc. filed the 510(k) submission for Zap-X Radiosurgical System (K211663).

What is the FDA product code for Zap-X Radiosurgical System?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Zap-X Radiosurgical System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Zap-X Radiosurgical System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Zap-X Radiosurgical System

Q: What are the predicate devices for Zap-X Radiosurgical System?

Zap-X® Radiosurgery System (K183698).

K211663 · Zap Surgical Systems, Inc. · IYE · Jul 29, 2021 · Radiology

Device Facts

Record ID	K211663
Device Name	Zap-X Radiosurgical System
Applicant	Zap Surgical Systems, Inc.
Product Code	IYE · Radiology
Decision Date	Jul 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 Story

The Zap-X Radiosurgery System is a self-shielded, computer-controlled, non-invasive stereotactic radiosurgery device. It utilizes a gantry-mounted linear accelerator (Linac) to deliver therapeutic radiation and a kV imaging system for target localization. During treatment, the system captures X-ray images of patient skeletal anatomy to align the target with the system isocenter. The kV imaging system tracks patient movement in real-time, automatically adjusting the treatment table to compensate for motion. The device is operated by clinicians in a clinical setting. The system provides treatment planning, image guidance, and radiation delivery. By enabling precise, image-guided radiation delivery without the need for a traditional radiation-shielded vault, the device facilitates targeted treatment of brain, head, and neck conditions, potentially improving clinical outcomes through accurate dose delivery and motion management.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, electromagnetic compatibility, software verification/validation, system commissioning, and usability testing.

Technological Characteristics

Self-shielded, gantry-mounted 3MV Linac; kV imaging system for 6D skeletal tracking; 3-degree-of-freedom patient table; 8 beam sizes (4.0-25.0 mm); non-coplanar beam delivery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1, IEC 60825-1, IEC 61217, IEC 62083, IEC 60976, IEC 62304, IEC 62366.

Indications for Use

Indicated for patients requiring treatment planning and image-guided stereotactic radiosurgery or precision radiotherapy for tumors, lesions, and conditions in the brain, head, and neck.

Regulatory Classification

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.

Predicate Devices

Zap-X® Radiosurgery System (K183698)

Reference Devices

CyberKnife M6 Systems (K150873)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-----------------------------------------------------------------------------------------------| | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 {4}------------------------------------------------ ## 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ # 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 {7}------------------------------------------------ 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. {8}------------------------------------------------ # SUBSTANTIAL EQUIVALENCE TABLE ## Table 12.1. Substantial Equivalence Table | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None | | Regulation Number | 21 CFR 892.5050 Medical charged-particle radiation therapy system | 21 CFR 892.5050 Medical charged-particle radiation therapy system | 21 CFR 892.5050 Medical charged-particle radiation therapy system | None | | Regulatory Class | II | II | II | None | | Classification Product Code | IYE | IYE | IYE | None | | Indications for Use | Identical to the primary predicate device | 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 Cyberknife M6 Systems are indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | Reference device treats entire body while subject and predicate devices treat the head, neck and brain only | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None | | Product Description/ Design | Identical to the primary predicate device | The zap-X Radiosurgery Systems (Zap-X System) is a robotic radiosurgery system consisting of a compact Linac mounted on a dual axis rotational gantry. The gantry parts also serve as radiation shields enabling the system to operate without a bunker. The Zap-x positions with patient with the target at the isocenter by moving the patient table under kV image guidance. The source is then rotated isocentrically around the patient to deliver radiation from various angles. | The CyberKnife M6 System utilizes a compact X- bancd Linac mounted on a robotic manipulator arm. The patient is positioned by a couch under kV image guidance and the source is moved around the patient and radiation is delivered from various angles. | Subject and predicate devices treat patient within shielded system while reference device treats patient within shielded vault or bunker (radiation exposure to the user and general public are equivalent for all three systems) | | Safety Features | Identical to the primary predicate device | The Zap-x has been designed to include the following: -E-stop buttons to enable the user to stop machine motion and radiation -Interlocks to prevent | -Contact detection sensor at the distal end of the secondary collimator housing on the linac and on the back of robot arm. | None | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None | | | | improper system usage -Password and physical key access/radiation control -Proximity scanners that ensure system motion and radiation only occur when the area around the system is clear -A laser scanning proximity detector to detect and prevent collisions with the collimator -A software collision predication model that utilizes a standard patient envelope to predict potential collisions prior to system movement. | -Contact with the sensor causes an Emergency Stop (E-STOP) condition halting all motion of the system. -Safety Zones: There is a safety zone around the patient and the treatment couch; size is user selectable based on individual patient sizes (small, medium, or large). The dynamic safety zone is designed to encompass the entire patient body and always lies within the fixed safety zone. | | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife 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 Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System | Image: Cyberknife M6 Systems | None | | Occurrence of Side Effects | Identical to the primary predicate device and reference device. | During or shortly after radiation treatment or in the months and years following radiation. | During or shortly after radiation treatment or in the months and years following radiation. | None | | Treatment Site | Identical to the primary predicate device | Brain, head, and neck | Brain, head, and neck, all other anatomical regions in the body | Reference device treats entire body while subject and predicate devices treat head, neck and brain only | | Accelerator (treatment beam) | Identical to the primary predicate device | 3MV nominal photon beam energy | 6 MV nominal photon beam energy | Higher energy required for reference device to treat other anatomical locations deeper in the body | | Dose rate (in MU/min) | Identical to the primary predicate device | $1500\pm10$ % MU/min at 450 mm | $1000\pm10$ % MU/min at 800 mm | None | | Depth at Maximum Dose (Dmax) | Identical to the primary predicate device | $7\pm1$ mm | $15\pm2$ mm | None | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System (K183698) | Image: Cyberknife M6 Systems (K150873) | None | | Treatment Beam | Identical to the primary predicate device | 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 the Source to Axis distance of 450 mm | 5, 7.5, 10, 12.5, 15, 20, 25, 30, 35, 40, 50 and 60 mm diameter field sizes at 800 mm SAD (with Iris Aperture Collimator) | None | | Moveable Treatment Beam | Identical to the primary predicate device | Yes - Two degree of freedom gantry | Yes - Six degree of freedom robotic arm | None | | Patient Table/Couch | Identical to the primary predicate device | Yes | Yes | None | | Treatment Table | Identical to the primary predicate device | Movable table with 3 degrees of freedom | Moveable table with 5 degrees of freedom | None | | Number of Treatment sessions | Identical to the primary predicate device | Single or a short course of hypofractionation (2-5 sessions) for larger lesions (>3 cm) | Single or a short course of hypofractionation (2-5 sessions) for larger lesions (>3 cm) | None | | Overall treatment duration | Identical to the primary predicate device | 1-2 weeks | 1-2 weeks | None | | Treatment Beam Technology | Identical to the primary predicate device | Linac system | Linac System | None | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698) | Reference Device Cyberknife M6 Systems (K150873) | Analysis of Differences | | Product Image | Image: Zap-X Radiosurgery System | Image: Zap-X Radiosurgery System | Image: Cyberknife M6 Systems | None | | Photon Radiation Source | Identical to the primary predicate device | X-ray Photons | X-ray Photons | None | | Beam Crossfire | Identical to the primary predicate device | Non-coplanar | Non-coplanar | None | | Shielding for ionizing radiation | Identical to the primary predicate device | Self-shielded | Treatment Vault | None | | Treatment Beam Energy | Identical to the primary predicate device | 3 MeV nominal photon beam energy (1.0MeV mean photon energy) | 6 MeV nominal photon beam energy (2.0MeV mean photon energy) | None | | Dose Rate | Identical to the primary predicate device | 1500±10% MU/min at 450mm | 1000±10% MU/min at 800 mm | None | | Real-Time Dosimetry | Identical to the primary predicate device | Yes | Yes | None | | Safety subsystem | Identical to the primary predicate device | Yes | Yes | None | | System console (operating panel) and user interface software | Identical to the primary predicate device | Yes | Yes | None | | Feature | Subject Device Zap-X Radiosurgery System | Primary Predicate Device Zap-X Radiosurgery System (K183698)…

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