(16 days)
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 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.
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.
The provided text describes a medical device, the TomoTherapy HI-ART System®, which is a radiation therapy system. However, the document primarily focuses on regulatory approval (510(k) submission for substantial equivalence) and does not contain specific acceptance criteria or an in-depth study proving the device meets those criteria in the manner typically expected for AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, the "Validation" section describes a more general approach, focusing on system functionality and compliance with safety standards rather than quantitative performance metrics against a defined ground truth for a diagnostic or AI-driven task.
Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample size for the test set," "Number of experts for ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Sample size for training set," and "How ground truth for training set was established," the provided document does not contain this information.
It is important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance principles, rather than presenting detailed clinical trial results or AI/ML performance metrics.
Here's a summary of what can be extracted or inferred from the provided text, along with the information that is not present:
Acceptance Criteria and Study for TomoTherapy HI-ART System® (modified)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Functionality Validation: - Planning - Imaging - Delivery - Database Management - DICOM Communications | "The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc." (Evaluation against IMRT phantoms, ion chambers, and other test phantoms.) |
| Safety Compliance: - IEC 60601-1 (Medical electrical equipment - General requirements for safety) - IEC 60601-2-1 (Medical electrical equipment - Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV) - IEC 60601-1-2 (Medical electrical equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests) - IEC 60601-1-4 (Medical electrical equipment - Collateral standard: Programmable electrical medical systems) - EN ISO 14971:2000 (Medical devices - Application of risk management to medical devices) | "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 and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use." |
| Intended Use Fulfillment: - Integrated system for planning and delivery of IMRT. - Precise radiation delivery to tumors/targeted tissues. - Minimizing radiation delivery to vital healthy tissue. - Physician/oncologist prescribes plan; system calculates; physician approves. - Therapist selects/implements plan. - TomoImage (MVCT) scan for patient positioning confirmation and repositioning assist (not for diagnostic use). - Delivers radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery in helical tomographic pattern. | The conclusion states: "Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use." This implicitly means it meets the stated intended uses. |
| Substantial Equivalence: | "The HI-ART System with modifications is substantially equivalent to the HI-ART system [Predicate Device: K042739]." (As determined by the FDA.) |
Note: The document provides high-level statements about meeting safety standards and demonstrating safety/effectiveness for intended use, rather than specific numerical performance metrics for acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not present in the document. The validation section mentions "IMRT phantoms, ion chambers and other test phantoms," which are physical objects rather than patient data. There is no mention of a test set of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not present in the document. Since there is no mention of a patient-related test set or
ground truth establishment using experts, this information is not applicable.
4. Adjudication method for the test set
- Not present in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not present in the document. This type of study is not mentioned. The device is a radiation therapy system, not an AI diagnostic tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present in the document. The device is an integrated system (planning, imaging, delivery) that is always used with human operators (physicians/oncologists and therapists). The concept of "standalone algorithm performance" (e.g., for a diagnostic AI) does not directly apply here. The system's imaging component (MVCT) is explicitly stated "is not for diagnostic use."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not present in the document in the context of patient data. For the system's "functionality validation," the ground truth seems to be derived from physical measurements using tools like "IMRT phantoms, ion chambers and other test phantoms" against expected physical radiation dose distributions and system behaviors.
8. The sample size for the training set
- Not present in the document. The document describes a radiation therapy delivery system, not a machine learning model that would typically have a "training set" of data.
9. How the ground truth for the training set was established
- Not present in the document. (See point 8).
In conclusion, the provided FDA 510(k) summary focuses on regulatory compliance, system functionality, safety standards, and substantial equivalence to a predicate device for a radiation therapy system. It does not include the detailed performance metrics, patient data study designs, or AI/ML-specific validation information that would be expected for a diagnostic AI device.
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(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. BurokerTomoTherapy Incorporated1240 Deming WayMadison, 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 TherapySystem |
| Predicate Device: | TomoTherapy Hi-Art SystemK042739 |
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
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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
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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.
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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 .
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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
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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
§ 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.