(56 days)
No
The summary describes a computer-controlled system for image-guided radiosurgery with motion tracking and compensation, but it does not mention or imply the use of AI or ML for any function, including image processing, treatment planning, or motion tracking. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to perform stereotactic radiosurgery and precision radiotherapy, which are forms of treatment, making it a therapeutic device.
No.
The Zap-X Radiosurgery System is described as a treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy system; it is used for treatment rather than diagnosis.
No
The device description clearly outlines hardware components such as a linear accelerator, gantry, and kV imaging system, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Zap-X Radiosurgery System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Zap-X Function: The Zap-X Radiosurgery System is described as a system for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy. It uses radiation to treat tumors and lesions directly within the body.
- No Specimen Analysis: The description focuses on delivering radiation therapy and using imaging to guide this treatment. There is no mention of analyzing biological specimens taken from the patient.
Therefore, the Zap-X Radiosurgery System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV imaging system, X-ray images
Anatomical Site
brain, head and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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. No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known)
K183698 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
4
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)]
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.
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
5
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 Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
Zap-X Radiosurgery
System
(K171804) | Reference Device
CyberKnife M6
Systems
(K150873) | Analysis of
Differences |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 892.5050 | 21 CFR 892.5050 | 21 CFR 892.5050 | None |
| | Medical charged-
particle radiation
therapy system | Medical charged-particle
radiation therapy system | Medical charged-
particle radiation
therapy system | None |
| Regulatory
Class | II | II | II | None |
| Classification
Product Code | IYE | IYE | IYE | None |
| Indications for
Use | Same as 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. | None |
| Accelerator
(treatment
beam) | Same as primary
predicate device | 3MV nominal photon
beam energy | 6 MV nominal
photon beam energy | None |
| Dose rate (in
MU/min) | Same as primary
predicate device | $1500±10%$ MU/min at
450 mm | $1000±10%$ MU/min
at 800 mm | None |
| Depth at
Maximum
Dose (Dmax) | Same as primary
predicate device | $7±1$ mm | $15±2$ mm | None |
| Treatment
Beam | Same as 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 | 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) | None |
| Feature | Proposed Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
Zap-X Radiosurgery
System
(K171804) | Reference Device
CyberKnife M6
Systems
(K150873) | Analysis of
Differences |
| | | of 450 mm | Collimator) | |
| Moveable
Treatment
Beam | Same as primary
predicate device | Yes – Two degree of
freedom gantry | Yes – Six degree of
freedom robotic arm | None |
| Patient
Table/Couch | Same as primary
predicate device | Yes | Yes | None |
| Shielding for
ionizing
radiation | Same as primary
predicate device | Self-shielded | Treatment Vault | None |
| Real-Time
Dosimetry | Same as primary
predicate device | Yes | Yes | None |
| Safety
subsystem | Same as primary
predicate device | Yes | Yes | None |
| System console
(operating
panel) and user
interface
software | Same as primary
predicate device | Yes | Yes | None |
| Treatment
target tracking
software | Same as primary
predicate device | Yes | Yes | None |
| Treatment
planning
software | Same as primary
predicate device
with addition of two
features:
Allow user to
select pre-
generated dose
volume for
treatment
Optimize user
workflow of
multiple
metastatic
tumors | Yes | Yes | Same as
predicate
with the
exception
of two new
features |
| Feature | Proposed Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
Zap-X Radiosurgery
System
(K171804) | Reference Device
CyberKnife M6
Systems
(K150873) | Analysis of
Differences |
| Treatment
delivery
software | Same as primary
predicate device | Yes | Yes | None |
Table 12.1. Substantial Equivalence Table
7
8
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
9
- . 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.