(87 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its modifications do not mention any AI/ML capabilities. The "Fast Optimizer" modification is described as using "modified hardware and software" for increased efficiency, not AI/ML.
Yes.
The device delivers radiation therapy to treat tumors, which is a therapeutic intervention.
No
Explanation: The device description explicitly states, "The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use."
No
The device description explicitly states it is a "radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging... and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system," indicating it includes significant hardware components for imaging and radiation delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the planning and precise delivery of radiation therapy to treat tumors or targeted tissues. This is a therapeutic application, not a diagnostic one.
- Device Description: The description explicitly states that the device does not diagnose disease. While it includes megavoltage CT imaging, this is for IGRT (Image-Guided Radiation Therapy) functionality and is not intended for diagnostic use.
- Nature of IVDs: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.
The TomoTherapy Treatment System is a radiation therapy delivery system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
The TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software. The device name remains unchanged as "TomoTherapy Treatment System", and the modification itself is referred to as TomoTherapy Treatment System Fast Optimizer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT imaging
Anatomical Site
tumors or other targeted tissues
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)
The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device.
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.
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Image /page/0/Picture/2 description: The image contains the logo for TomoTherapy. The logo consists of a stylized image to the left of the company name. The company name is written in a bold, sans-serif font. A period follows the company name.
DEC 2 2 2011
"S"T" "#S&I" AI LES IVA "WORKS IVA "WORKS" THE NE
Section 2 510(k) Summary
Applicant:
TomoTherapy, Inc. 1209 Deming Way Madison, WI 53717-1954 Phone: 608.824.2800 Fax: 608.824.2981
Contact:
Gregory G. Bange gbange@accuray.com
Date Prepared:
October 25, 2011 (with corrected device name)
Device Identification:
| Device Name: | TomoTherapy Treatment System |
|---|---|
| Trade Names | Hi-Art® and TomoHD™ |
| Common Name: | Radiation Therapy System |
| Classification: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Description: | Medical charged particle radiation therapy system |
Predicate Device:
TomoTherapy Hi-Art System (modified) K082005
Description:
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
The TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software. The device name remains unchanged as "TomoTherapy Treatment System", and the modification itself is referred to as TomoTherapy Treatment System Fast Optimizer.
Intended Use:
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is
1
TomoTherapy.
delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Technological Characteristics:
The technological characteristics of the TomoTherapy Treatment System Next Generation Fast Optimizer are substantially equivalent to the predicate. The TomoTherapy Treatment System Next Generation Fast Optimizer introduces new hardware, a Graphics Processing Unit (GPU), and revised software to accommodate this new hardware to allow for substantially increased speed and efficiency during the performance of optimization and dose calculation processes. All other primary subassemblies remain unchanged, and therefore this modification is comparable in key safety and effectiveness features, utilizes substantially similar design, construction, materials, energies, and it has an intended use that is identical to that of the predicate device.
As the modification is limited to faster operation of the Planning sub-system with unchanged dose accuracy constraints, and the changes do not affect the radiation delivery system, this modification does not alter the performance claims for the product. These technological enhancements do not raise new types of safety or effectiveness questions.
Performance Data:
The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device.
Summary:
The TomoTherapy Treatment System Next Generation Fast Optimizer is substantially equivalent to the predicate device. The intended use, major technological characteristics, and principles of operation of the TomoTherapy Treatment System Fast Optimizer are identical to those of the predicate device. Minor technological differences do not raise new types of safety or effectiveness questions. Performance data demonstrate the TomoTherapy Treatment System Fast Optimizer is as safe, as effective, and performs as well as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles a human figure embracing or protecting something, often interpreted as representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory Bange Manager of Regulatory Submissions and Standards TomoTherapy, Inc. 1209 Deming Way MADISON WI 53717-1954
DEC 2 2 2011
Re: K112776
Trade/Device Name: TomoTherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 10, 2011 Received: November 14, 2011
Dear Mr. Bange:
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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to eonimered processified 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r roase be active and in that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-lefated adverse events) (21 CFR Part 820), and 2010 (21 CFR Part 820). This letter requirements as set form in the quality by with (