(94 days)
No
The document describes a computer-controlled system for radiosurgery with image guidance and motion tracking, but it does not mention AI or ML in the device description, intended use, or performance studies. The image processing described is for alignment and motion tracking, which are standard functions in such systems and do not necessarily imply AI/ML.
Yes
The device is intended to provide treatment for tumors, lesions, and conditions, and it uses a linear accelerator to provide a source of therapeutic radiation.
No
Explanation: The device is described as a "Radiosurgery System" intended to "provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions." This indicates it is a therapeutic device, not a diagnostic one. It uses imaging for guiding treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation" and includes a "gantry-mounted linear accelerator" and a "kV imaging system," which are hardware components.
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 about a person's health.
- Zap-X Function: The Zap-X Radiosurgery System is a therapeutic device. Its purpose is to deliver radiation treatment directly to tumors and lesions within the body. It uses imaging for guidance and planning, but it does not analyze biological samples taken from the patient.
The description clearly states its intended use is for "treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck". This is a therapeutic application, not a diagnostic one based on in vitro analysis.
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 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 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 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
standard healthcare facility
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
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
- 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 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 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.
Clinical Testing Summary:
This section is not applicable. No clinical testing was performed to support this premarket notification.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing, ribbon-like design connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2017
Zap Surgical Systems % Ms. Darlene Crockett-Billig. Regulatory Consultant Experien Group, LLC 224 Airport Parkway, Suite 250 SAN JOSE CA 95110
Re: K171804
Trade/Device Name: Zap-X Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 15, 2017 Received: June 19, 2017
Dear Ms. Crockett-Billig:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 201 Subpart D) | Own-Use The County Use (21 CFR 201 Subpart C) |
|---|---|
| ☑ | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Notification K__171804
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Zap Surgical Systems, Inc. 590 Taylor Way, Suite A San Carlos, CA 94070 USA Phone: (650) 796-5302 FAX: (650) 832-1038
Contact Person:
Darlene Crockett-Billig Co-Founder and President Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: (408) 400-0856 FAX: (408) 400-0865
Date Prepared: June 15, 2017
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 Zap-X Radiosurgery System ("Zap-X System") is substantially equivalent to the predicate device. Accuray CyberKnife M6 Systems, cleared under 510(k) K150873. The 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 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 Zap-X System is also appropriately comparable to another device (i.e., reference device), the Leksell Gamma Knife Icon (K151561). The Gamma Knife Icon is classified as a radionuclide radiation therapy system per 21 CFR 892.5750, Product Code IWB. This reference device is included as it is similar to the Zap-X System with respect to treatment energy, indications for use and other features.
DEVICE DESCRIPTION [807.92(a)(4)]
The 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 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 Zap-X System tracks patient movement and adjusts the table precisely to compensate for such movement.
INDICATIONS FOR USE [807.92(a)(5)]
The Zap-X Radiosurgery System is intended to provide treatment planning and imageguided 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 Zap-X Radiosurgery System, predicate device and reference device all have similar features and components. The Zap-X System and the CyberKnife utilize a Linac system to generate the treatment beam. Because the CyberKnife, a whole-body radiosurgery system, operates at a somewhat higher energy compared to the Zap-X System (6MV vs. 3MV. respectively), the Leksell Gamma Knife Icon (K151561) device, manufactured by Elekta Instruments AB, has been included as a reference device. Specifically, the Gamma Knife Icon, the indications for which include the treatment of head structures, operates at an energy of 1.17MV and 1.33MV by virtue of its 60 Cobalt irradiation sources. The energy of these photon beams is quite comparable to the average 1MV photons produced by the Zap-X System 3MV Linac.
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 Zap-X System are within the ranges offered by the CyberKnife, as well as the Gamma Knife reference device. Moreover, all three systems deliver treatment beam from a variety of
5
510(k) SUMMARY
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 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 Zap-X System, like the CyberKnife, uses patient skeletal anatomy to align the treatment target with respect to the system isocenter. As with the CyberKnife, the Zap-X System uses the kV imaging system to track patient movement and adjust the table precisely to compensate for such movement during treatment. The Zap-X System, like the predicate and references devices, was 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 CyberKnife and the Zap-X System is that the latter is more compact and self-shielded, enabling it to be installed and used in a standard healthcare facility without a specialized shielded vault. The Zap-X System is comparable to the Gamma Knife Icon reference device with respect to design in that both systems are intended to treat lesions of the head. Although the Gamma Knife Icon does include some self-shielding that limits radiation exposure outside the treatment device, a specialized treatment vault is still required to protect both system operators and general public. Finally, the Zap-X System was demonstrated to meet the requirements for radiation leakage and provide protection from radiation to the operator and general public similar to that of CyberKnife within a radiation shielded vault.
SUBSTANTIAL EQUIVALENCE
With regard to a primary predicate device, the Zap-X System is most like the CyberKnife M6 System (K150873) manufactured by Accuray. 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 Zap-X System are inclusive within the CyberKnife's indications for use, i.e., "for treatment of lesions, tumors and conditions anywhere in the body". Furthermore, the CyberKnife and Zap-X System have comparable major system components. A minor difference in the energy of the treatment beam (6MV vs. 3MV) does not raise any new issues in terms of either the safety or effectiveness of treatment.
The Zap-X System is also appropriately comparable to another device (i.e., reference device), the Leksell Gamma Knife Icon (K151561) manufactured by Elekta Instruments AB. Notably, the intended use of the Gamma Knife for "stereotactic irradiation of structures in the head" closely matches that being proposed for the Zap-X System. Moreover, a heavily shielded design intended to minimize the extent of ionizing radiation leakage, albeit to differing extents, results in both the Gamma Knife and Zap-X System sharing a rather similar shape. Finally, the energy of the ionizing radiation beams generated by the Gamma Knife's radionuclide Cobalt is quite similar to the average energy produced by the Zap-X System.
Detailed comparisons of the proposed Zap-X Radiosurgery System to the CyberKnife predicate device and Gamma Knife Icon reference device are provided in the following table.
6
| Feature | Proposed Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
CyberKnife M6
Systems
(K150873) | Reference Device
Gamma Knife
Icon
(K151561) | Analysis of
Differences |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 892.5050
Medical charged-
particle radiation
therapy system | 21 CFR 892.5050
Medical charged-
particle radiation
therapy system | 21 CFR 892.5750
Radionuclide
radiation therapy
system | Broadly all three
devices fall
within the
general category
of radiotherapy
systems. |
| Classification
Product Code | IYE | IYE | IWB | -- |
| 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. | 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. | Leksell Gamma
Knife® Icon™ is a
teletherapy device
intended for
stereotactic
irradiation of head
structures ranging
from very small
target sizes of a
few millimeters to
several
centimeters, e.g.
metastatic tumors,
arteriovenous
malformations,
trigeminal
neuralgia,
medically
refractory
essential tremor,
meningiomas,
vestibular
schwannomas,
post-surgical
pituitary
adenomas and
recurrent
glioblastomas. | Zap-X System
Indications falls
within broad
indication of
CyberKnife and
has same
intended use as
the Gamma
Knife Icon for
treatment of
lesions in the
head. |
| Accelerator
(treatment
beam) | 3MV nominal
photon beam
energy | 6 MV nominal
photon beam
energy | Not Applicable.
Irradiation Source
is 60Cobalt with
emission at 1.17
and 1.33MV | Energy level of
Zap-X falls
within range of
CyberKnife and
Gamma Knife
Icon. |
| Feature | Proposed Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
CyberKnife M6
Systems
(K150873) | Reference Device
Gamma Knife
Icon
(K151561) | Analysis of
Differences |
| Dose rate (in
MU/min) | 1500±10%
MU/min at
450 mm | 1000±10%
MU/min at
800 mm | 300 cGy/min
(in comparing
isotopes to
Linacs:
1 cGy~1MU) | Zap-X System
dose rate is
similar to the
CyberKnife. |
| Depth of Dose
Maximum
(Dmax) | 7 ±1 mm | 15±2 mm | ~5 mm | Depth at
maximum dose
for Zap-X
System is very
comparable to
Gamma Knife
Icon which is
appropriate,
given its similar
intended use. |
| Treatment
Beam | 8 available beam
sizes: diameters
of 4.0, 5.0, 7.5,
10.0, 12.5, 15.0,
20.0 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) | System uses 3
different sets of
fixed collimator
apertures (4 mm,
8mm and 16 mm) | Zap-X System
treatment beam
sizes fall within
available sizes of
the predicate and
reference
devices. |
| Moveable
Treatment
Beam | Yes - Two degree
of freedom gantry | Yes - 6 degree of
freedom robotic
arm | No - 192 60Co
source arranged in
'hemisphere' to
treat intracranial
lesions | All systems
deliver treatment
beam from a
variety of
directions. |
| Patient
Table/Couch | Yes | Yes | Yes | All systems have
a patient table or
couch to support
patient during
treatment. |
| Shielding for
ionizing
radiation | Self-shielded | Treatment Vault | Partial Self-
shielding and
Treatment Vault | All three systems
protect the
operator and the
general public
from the
radiation from
the machine. |
| Real-Time
Dosimetry | Yes | Yes | No | Like the
predicate, the
Zap-X System
includes real-
time dosimetry. |
| Feature | Proposed Device
Zap-X
Radiosurgery
System | Primary Predicate
Device
CyberKnife M6
Systems
(K150873) | Reference Device
Gamma Knife
Icon
(K151561) | Analysis of
Differences |
| Safety
subsystem | Yes | Yes | Yes | All systems
provide safety
control
subsystems. |
| System console
(operating
panel) and user
interface
software | Yes | Yes | Yes | All systems
provide control
consoles. |
| Treatment
target
tracking
software | Yes | Yes | Yes | All systems
allow for patient
tracking during
therapy. |
| Treatment
planning
software | Yes | Yes | Yes | All systems
include treatment
planning
software. |
| Treatment
delivery
software | Yes | Yes | Yes | All systems
provide
treatment
delivery
software. |
Substantial Equivalence Table
7
510(k) SUMMARY
8
510(k) SUMMARY
PERFORMANCE DATA [807.92(b)]
Zap Surgical Systems has performed bench testing to ensure that the 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 ●
- o 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 o 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 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 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 Zap-X Radiosurgery System to evaluate the overall performance of the device. The collective results confirm that the 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 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 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.