(293 days)
No
The summary does not mention AI or ML, and the device description focuses on hardware and traditional treatment planning software.
Yes
The device is described as a "CygneX I Treatment Delivery Subsystem" comprised of a "Therapeutic X-ray Generation Part" that generates X-ray beams for planned treatment. Its intended use is to "provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS)".
No
This device is designed for treatment planning and delivery of radiotherapy, not for diagnosing medical conditions. It uses CT data for planning but its primary function is therapeutic.
No
The device description explicitly details hardware components like a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part, indicating it is not software-only.
Based on the provided information, the CygneX I System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions... tumors and conditions of the brain and base of skull (BOS)." This describes a therapeutic device that delivers radiation treatment directly to the patient.
- Device Description: The description details a system that generates and delivers X-ray beams for treatment. It includes components like a linear accelerator, manipulator, and control console. This is consistent with a radiotherapy device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The CygneX I System does not perform any such analysis of biological samples.
Therefore, the CygneX I System is a therapeutic device, specifically a radiotherapy system, and not an IVD.
N/A
Intended Use / Indications for Use
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
Product codes
IYE
Device Description
The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energize (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data. The device uses a commercially available (510K cleared) positioning device for monitoring the patient's body surface movement, such as AlignRT PLUS, and a mobile C-Arm imaging or fluoroscopic system to confirm the target position, such as the Philips Veradius Neo System, K133819, or equivalent.
Anatomical Site
Brain and base of skull (BOS).
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)
Comprehensive nonclinical testing in accordance with FDA Recognized Consensus Standards (TAB 8-2 and TAB-14), and testing in accordance with internal performance specifications (TAB-15) were performed. The nonclinical testing included essential performance and basic safety testing, electromagnetic compatibility testing, functional performance characteristics testing, and software verification and validation testing. All testing confirmed that the CygneX I System performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Accuray CyberKnife System, K984563
Reference Device(s)
Philips Veradius Neo System, K133819
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2015
Accuthera, Inc. % Mr. Robert Morton CEO Ouality and Regulatory Services, Inc. 1244 Fairway Valley Court LINCOLN CA 95648
Re: K143560 Trade/Device Name: CygneX I System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 3, 2015 Received: September 8, 2015
Dear Mr. Morton:
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'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
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Indications for Use
510(k) Number (if known) K143560
Device Name CygneX I System
Indications for Use (Describe)
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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ACCUTHERA
510(k) Summary
The following information is provided following the format of 21 CFR 807.92.
Submitter: Accuthera Inc. 2-8-22 Kurigi, Asao-ku, Kawasaki-shi Kanagawa, 215-0033 Japan
| Contact Name: Eiji Tanabe, Ph.D. | |
|---|---|
| President & CEO | |
| Phone: | +81-44-980-1511 |
| Fax: | +81-44-980-1522 |
| Email: | etanabe@accuthera.com |
Date Summary was prepared: 10 December 2014
Name of the Device:
| Trade/Proprietary Name: | CygneX I System |
|---|---|
| Common or Usual Name: | Medical Linear Accelerator |
| Classification Name: | Medical charged-particle radiation therapy system |
| 21 CFR 892.5050, Class II | |
| Product Code: IYE |
Predicate Device: Accuray CyberKnife System, K984563
Description of Device:
The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energized (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides
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ACCUTHERA
Accuthera Inc. Head Office 2-8-22 Kurigi, Asao-ku, Kawasaki-Shi, 215-0033 Japa TFI : +81-44-980-1511 FAX: +81-44-980-1522 E-mail: info@accuthera.com URL: http://www.accuthera.com
from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
Statement of Intended Use:
The CygneX I System is a medical charged-particle radiation therapy system accelerating electrons intended to provide photon radiation for treatment.
Statement of Indications For Use:
The CygneX I System is intended to provide treatment planning and surfaceguided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
Summary of the Technological Characteristics:
The CygneX I System has same Intended Use, principles of operation, and major technological characteristics and a similar Indication For Use as the predicate device, the CyberKnife System For Stereotactic Radiosurgery/Radiotherapy, K984563, manufactured by Accuray, Inc.
A comparison table summarizing the similarities and differences between the CygneX I System and the predicate device is provided in Table ES-1.
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| Feature | Accuray CyberKnife System For
Stereotactic
Radiosurgery/Radiotherapy
K984563 | Accuthera CygneX I System
(CygneX I with CygPlan I) | Consideration of the
difference(s) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CyberKnife System (K984563) is a medical charged-particle radiation
therapy system accelerating
electrons intended to provide photon
radiation for treatment. | The CygneX I System is a medical
charged-particle radiation therapy
system accelerating electrons intended
to provide photon radiation for treatment. | Same |
| Indication for use | To provide treatment planning and
image-guided stereotactic
radiosurgery and precision
radiotherapy for lesions (e.g.
arteriovenous malformations), tumors
and conditions of the brain, base of
skull (BOS), cervico-thoracic spine
(CTS), head and neck. | The System is intended to provide
treatment planning and surface-guided
stereotactic radiosurgery and precision
radiotherapy for lesions (e.g.
arteriovenous malformations), tumors
and conditions of the brain and base of
skull (BOS). | No, but while it is less, it is
included by the predicate. |
| Principles of
Radiation
delivery | The System is a type of stereotactic
radiotherapy, a non-invasive
treatment in which high doses of
focused radiation beams are
delivered from multiple locations
outside of the body to destroy a
tumor or lesion within the body. This
minimizes radiation exposure to
healthy tissue surrounding the tumor.
The system uses a linear accelerator
(Linac), producing the radiation while
mounted on a robotic arm. | The System is a type of stereotactic
radiotherapy, a non-invasive treatment in
which high doses of focused radiation
beams are delivered from multiple
locations outside of the body to treat a
tumor or lesion within the body. This
minimizes radiation exposure to healthy
tissue surrounding the tumor.
The system uses a linear accelerator
(Linac), producing the radiation while
mounted on a robotic arm. | Same |
| Patient
position
monitoring | The predicate incorporates a
fluoroscopic imaging device. | CygneX I uses commercially available
(510K cleared) positioning device for
monitoring of the patient's body surface
movement, such as AlignRT PLUS and a
mobile C-Arm imaging or fluoroscopic
system be used to confirm the target
position, such as the Philips Veradius
Neo System, K133819, or equivalent. | No, but same safety can be
achieved by confirmation of the
patient position using a device
which can image the position of
the target inside the patient. |
| Technical characteristic | | | |
| Single dose
and
fractionated
treatment | YES | YES | Same |
| X-band
Accelerator | YES | YES | Same |
| X-ray energy | 6MV(Standing wave Linac) | 6MV(Standing wave Linac) | Same |
| Dose rate | 300 cGy/min (maximum BUILD UP) | 300 cGy/min (maximum BUILD UP) | Same |
| Isocenter
floor height
SAD | 127cm (nominal isocenter, system is
not isocentric)
80cm | 130cm (nominal isocenter, system is not
isocentric)
60cm | No, but it is only 3 cm higher.
No, but it still treats the target to
the prescribed dose. |
| Source Target
positioning | Six-axis manipulator | Six-axis manipulator | Same |
| Patient
Positioning
device
(Treatment
Couch) | Stationary/Adjustable | CygneX I System does not include a
Treatment Couch. It uses commercially
available Adjustable Treatment Couch
which complies with conditions specified
by Accuthera Inc. | No, but same level of safety &
effectiveness can be achieved
by using a specified 510K
cleared treatment couch. |
| Mechanical
Isocenter
accuracy | Less than 0.05cm radius | Sphere less than 0.05cm radius | Same |
| Dosimetry
system
reproducibilit
y
position | ±3% or 3MU whichever is greater at
any fixed treatment node | ±2% or 1 MU whichever is greater at any
fixed treatment node | No, but has improved
specification. |
| Beam
collimation | Fixed secondary collimators
delivering circular field sizes of 5, 7.5,
10, 12.5, 15, 20, 25, 30, 35, 40, 50
and 60 mm diameter at SAD | Variable secondary collimator delivering
regular hexagonal fields sizes, the
distances between the two opposite
sides are 5, 7.5, 10, 12.5, 15, 20, 25 and
30 mm at SAD | Comparable field sizes up to 30
mm. |
| Target
location
reference | Patient's skull | Patient's skull | Same |
| Treatment
Planning
System | YES | YES | Same |
| Safety
Interlocks | YES | YES | Same |
| Emergency
Stop | YES | YES | Same |
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8
Table ES-1: Comparison of major feature of CygneX I System and the Predicate Device
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Summary of Performance Testing:
There are some minor differences. However, comprehensive nonclinical testing in accordance with FDA Recognized Consensus Standards as shown in the TAB 8-2 and in the TAB-14, and testing in accordance with our internal performance specifications as shown in the TAB-15 demonstrates that the minor differences do not adversely impact performance of the device for its intended use nor do the differences raise new safety concerns. The nonclinical testing performed includes essential performance and basic safety testing, electromagnetic compatibility testing, functional performance characteristics testing and software verification and validation testing. All of these testing confirmed that the CygneX I System performs as intended.
Thus the CygneX I System is substantially equivalent to the Accuray CyberKnife System For Stereotactic Radiosurgery/Radiotherapy (K984563).