(16 days)
Not Found
No
The description focuses on the system's integrated planning, imaging (MVCT), and helical radiation delivery capabilities. It mentions dose calculation and plan optimization but does not describe any features or processes that explicitly utilize AI or ML algorithms for tasks like image analysis, treatment planning optimization beyond standard algorithms, or adaptive therapy based on learned patterns. The validation described is for system functionality and dose delivery accuracy using phantoms, not for performance metrics typically associated with AI/ML models.
Yes
The device is intended for the delivery of intensity modulated radiation therapy (IMRT) for the treatment of tumors or other targeted tissues, which is a therapeutic purpose.
No.
The TomoImage (MVCT image) obtained from the system is explicitly stated as "not for diagnostic use." The primary purpose of the device is for planning and delivering intensity modulated radiation therapy (IMRT), not for diagnosis.
No
The device description explicitly details hardware components such as a linear accelerator, gantry, couch support, primary collimator, multi-leaf collimator (MLC), detector, control devices, and power supplies, indicating it is a physical radiation therapy system, not software-only.
Based on the provided information, the TomoTherapy HI-ART System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the planning and delivery of intensity modulated radiation therapy (IMRT) to treat tumors or other targeted tissues. It is a therapeutic device, not a diagnostic one.
- Device Description: The description details a radiation therapy system with components like a linear accelerator, gantry, and couch, all designed for delivering radiation treatment. While it has imaging capabilities (MVCT), the description explicitly states the MVCT image is not for diagnostic use.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The TomoTherapy HI-ART System operates in vivo (within the body) and its primary function is therapeutic.
The imaging capabilities (MVCT) are used for patient positioning and verification prior to treatment, which is a function related to the delivery of the therapy, not for diagnosing a condition.
N/A
Intended Use / Indications for Use
The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.
The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.
When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
Product codes (comma separated list FDA assigned to the subject device)
IYE, MUJ
Device Description
The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning, and helical radiation therapy treatment capabilities into a single comprehensive IMRT system.
The HI-ART System's planning station or operator station is used by the physician to prescribe and enter the radiation therapy plan. A diagnostic CT image imported via a DICOM protocol from another diagnostic CT device or a TomoImage (MVCT) scan is used as the basis for the plan. The regions of interest, regions to avoid, and other prescribing information are entered in a manner that is similar to other commercially available planning systems.
The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The linear accelerator along with the primary collimator, multi-leaf collimator (MLC), detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.
The primary collimator and the MLC control the beam dimensions during radiation delivery so that the range of collimated beam size can vary from 0 to 400 mm wide by 5 to 50 mm at the isocenter. The MLC is constructed of 64 tungsten leaves that open and close as determined by the radiation therapy plan. The intensity of the radiation beam is proportional to the length of time that a particular leaf is open. The opening and closing of various leaves as the radiation is delivered in this helical pattern allows for an IMRT plan to be delivered with precise control. The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue.
Because the HI-ART System is operating in a helical mode similar to CT systems, it inherently has the ability to obtain a CT image. The system utilizes the linear accelerator to obtain a megavoltage (MVCT) scan of the region of interest prior to the delivery of radiation therapy. This MVCT image is then used to ascertain that the patient is correctly positioned prior to treatment. The radiation dose to the patient from an MVCT scan is comparable to diagnostic CT or portal imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT (TomoImage™ (MVCT)) scan; diagnostic CT image imported via DICOM protocol
Anatomical Site
tumors or other targeted tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician/oncologist, therapist
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)
The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc. Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image is a black and white photograph that appears to be of low quality. The image is grainy and has a lot of noise, which makes it difficult to see any details. The image is mostly black, with some white areas. The black areas are concentrated in the upper left corner of the image, while the white areas are concentrated in the lower right corner.
(page 1/3)
Image /page/0/Picture/2 description: The image shows the logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol appears to be a circular shape with a section removed, creating a dynamic and somewhat incomplete form. Below the symbol, the word "TomoTherapy" is prominently displayed in a bold, sans-serif font, with the trademark symbol to the right. Underneath "TomoTherapy", the word "INCORPORATED" is written in smaller, uppercase letters.
Kobo912
Safety and Effectiveness Summary 1.4
GENERAL INFORMATION
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Person: | Kenneth D. Buroker
TomoTherapy Incorporated
1240 Deming Way
Madison, WI 53717-1954 |
|----------------------|---------------------------------------------------------------------------------------------|
| Phone: | (608) 824-2811 |
| Fax: | (608) 824-2991 |
| Date: | March 31, 2006 |
| Device Trade Name: | HI-ART System (modified) |
| Common Name: | Radiation Therapy System |
| Classification Name: | Medical Charged Particle Radiation Therapy
System |
| Predicate Device: | TomoTherapy Hi-Art System
K042739 |
INTENDED USE
The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.
The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.
When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
1240 Deming Way
Madison, WI 53717-1954
608.824.2800
fax 608.824.2996
.tometherapy.com
012
1
DESCRIPTION
(page 2/3)
The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning, and helical radiation therapy treatment capabilities into a single comprehensive IMRT system.
The HI-ART System's planning station or operator station is used by the physician to prescribe and enter the radiation therapy plan. A diagnostic CT image imported via a DICOM protocol from another diagnostic CT device or a TomoImage (MVCT) scan is used as the basis for the plan. The regions of interest, regions to avoid, and other prescribing information are entered in a manner that is similar to other commercially available planning systems.
The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The linear accelerator along with the primary collimator, multi-leaf collimator (MLC), detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.
The primary collimator and the MLC control the beam dimensions during radiation delivery so that the range of collimated beam size can vary from 0 to 400 mm wide by 5 to 50 mm at the isocenter. The MLC is constructed of 64 tungsten leaves that open and close as determined by the radiation therapy plan. The intensity of the radiation beam is proportional to the length of time that a particular leaf is open. The opening and closing of various leaves as the radiation is delivered in this helical pattern allows for an IMRT plan to be delivered with precise control. The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue.
Because the HI-ART System is operating in a helical mode similar to CT systems, it inherently has the ability to obtain a CT image. The system utilizes the linear accelerator to obtain a megavoltage (MVCT) scan of the region of interest prior to the delivery of radiation therapy. This MVCT image is then used to ascertain that the patient is correctly positioned prior to treatment. The radiation dose to the patient from an MVCT scan is comparable to diagnostic CT or portal imaging.
SAFETY CONSIDERATIONS
The HI-ART System has several characteristics that promote its safety - no beam blocks are used that can fall off onto the patient; the rotating gantry is covered so that the patient cannot contact moving gantry parts; the linear accelerator operates in photon mode only so inadvertent electron exposure is virtually eliminated; MVCT allows for reliable pattent positioning.
Also, the HI-ART System consists of components similar to those already commercially marketed, including the 6 MV linear accelerator, rotating gantry, patient couch and CT imaging devices.
013
2
STANDARDS COMPLIANCE
Kobo9112 (page 3/3)
The HI-ART System is designed to comply with relevant sections of the IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4 safety standards and EN ISO 14971:2000.
VALIDATION
The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc. Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms.
CONCLUSION
Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use. The HI-ART System with modifications is substantially equivalent to the HI-ART system.
3
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 9 2006
Mr. Kenneth D. Buroker Vice President of Regulatory Affairs TomoTherapy, Inc. 1240 Deming Way MADISON WI 53717-1954
Re: K060912
Trade/Device Name: TomoTherapy HI-ART System® (modified) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: March 31, 2006 Received: April 3, 2006
Dear Mr. Buroker:
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 cither class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
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ting Public .
4
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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
5
1.3 Indications for Use Form
- 510(k) Number (if known)
K040912
Page 1 of 1
Device Name:
TomoTherapy HI-ART System® (modified)
- Indications for use:
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.
The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This Tomolmage (MVCT) will confirm that the patient's position is correct for the radiation therapy. as nell as assist in patient re-positioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.
When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy treatment, stereotactic radiotherapy, or stereotactic radiosurgery in accordance with the physician approved plan delivered in a helical tomographic pattern.
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 810.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
arbological Devices
Number K060912