(84 days)
Not Found
No
The description details a system that establishes and updates a correspondence between surface movement and lesion movement based on acquired x-ray images. This process, while involving real-time monitoring and compensation, is described as a direct correspondence mapping and estimation, not explicitly utilizing AI or ML algorithms for learning or prediction from complex data patterns. The lack of mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML further supports this conclusion.
Yes
The device is described as an option to the CyberKnife System, which is used for stereotactic radiosurgery and precision radiotherapy of lesions, tumors, and conditions. These are therapeutic interventions designed to treat medical conditions.
No
This device is designed to facilitate the precision delivery of radiation therapy by tracking tumor motion during respiration, not to diagnose medical conditions or identify the presence of diseases. Its function is to enable more accurate treatment, not to identify problems.
No
The device description explicitly states that the Motion Tracking System includes hardware components such as a sensor assembly, tracking targets, a cable junction box, and a controller.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a Motion Tracking System that is an option for the CyberKnife System. Its purpose is to track the movement of lesions within the body during respiration to facilitate targeted radiation therapy. It uses external surface tracking and internal x-ray imaging to achieve this.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a system that interacts with the patient externally and uses imaging to guide a treatment delivery system.
Therefore, the device's function and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Product codes
90 IYE
Device Description
Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.
During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images
Anatomical Site
lesions that move during breathing, such as those located in the lung or near the diaphragm
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
APR 2 2 2002
Korozay
Tab 4
Premarket Notification [510(k)] Summary
January 25, 2002
| Trade Name: | Motion Tracking System |
|---|---|
| Common Name: | Linear Accelerator for Radiation Therapy |
| Classification Name: | Medical Linear Accelerator Accessory, 90 IYE (per 21 |
| CFR section 892.5050) | |
| Manufacturer's Name: | |
| Address: | Accuray Incorporated |
| 570 Del Rey Avenue | |
| Sunnyvale, CA 94085 | |
| Corresponding Official: | |
| Title: | |
| Telephone: | |
| Fax: | Donald E. Caddes |
| President and COO | |
| 408-522-3740 | |
| 408-522-3749 |
Accuray CyberKnife® System, K011024 and Varian Predicate Devices: Medical Systems RPM Respiratory Gating System, K983629.
Device Description: Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.
During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for
1
the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.
Intended Use: The Motion Tracking System is an option to the CyberKnife System and is intended to enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Technological Characteristics: Refer to Tab 9.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Donald E. Caddes President and COO Accuray Incorporated 570 Del Rey Avenue SUNNYVALE CA 94085 Re: K020294
Trade/Device Name: Motion Tracking System Respiratory Tracking Accessory Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation system
Regulatory Class: II Product Code: 90 IYE Dated: January 25, 2002 Received: January 28, 2002
Dear Mr. Caddes:
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.
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); 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,
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific across at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Accuray Motion Tracking System Traditional 510(k)
Tab 3
Indications For Use
510(k) Number: K020294
Device Name: Motion Tracking System
Indications for Use:
To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use_
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdomis and Radiological Devices 510(k) Numbe
OR