(58 days)
No
The description focuses on improved patient tracking and alignment using a kV imaging system and precise table adjustments, without mentioning AI/ML algorithms for image analysis or decision-making.
Yes.
The device uses a linear accelerator to provide therapeutic radiation for treating tumors, lesions, and conditions in the brain, head, and neck.
No
The Zap-X Radiosurgery System is a therapeutic device that delivers radiation treatment. While it uses imaging to guide treatment, its primary function is therapy, not diagnosis.
No
The device description clearly states it is a computer-controlled system with a linear accelerator, kV imaging system, and a table, indicating it is a hardware system with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Zap-X Radiosurgery System is a therapeutic device. It uses radiation to treat tumors and lesions within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's 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 treatment function, not a diagnostic function performed on a sample.
- Device Description: The description focuses on the delivery of radiation and imaging for targeting and tracking, not on analyzing biological samples.
Therefore, based on the provided information, the Zap-X Radiosurgery System is a therapeutic device, not an In Vitro Diagnostic.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV imaging system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
No clinical testing was performed to support this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zap-X® Radiosurgery System (K183698)
Reference Device(s)
CyberKnife M6 Systems (K150873)
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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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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
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.
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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) | 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
target tracking
software | Identical to the
primary predicate
device | Yes | Yes | None |
| Treatment
planning
software | Identical to the
primary predicate
device with the
added feature:
1.Enhancement
made to the patient
alignment during
treatment. | Yes | Yes | Same as the
predicate device
except for one
new feature |
| Treatment
delivery
software | Identical to the
primary predicate
device | Yes | Yes | None |
| Method | Identical to the
primary predicate
device | 6D skeletal Tracking
System using planar
Cranial Imaging and
algorithmic comparison
real-time bony anatomy
with DRRs, at the
initiation of and during
patient treatment | 6D skeletal
Tracking System
using planar
Cranial Imaging
and algorithmic
comparison real-
time bony anatomy
with DRRs, at the
initiation of and
during patient
treatment | None |
| Control | Identical to the
primary predicate
device | Treatment Console
Pendant | Remote
Workstation Local
Hand Pendant | None |
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SECTION 5. 510(K) SUMMARY
16
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.