(90 days)
No
The summary describes a traditional radiotherapy treatment planning system using established algorithms (convolution/superposition, collapsed cone, Gaussian pencil beam) and does not mention any AI or ML components.
No.
The device is a treatment planning system for calculating radiation dose, not a device that directly delivers therapy or treatment to a patient.
No
Explanation: The Helax-TMS is a radiotherapy treatment planning system, which is used for planning radiation doses, not for diagnosing diseases or medical conditions. Its function is to prepare for treatment, not to identify a condition.
No
The device description explicitly states "The system software is designed to lead the user through a logical flow planning process," implying that the software is part of a larger system, likely including hardware components for data input, processing, and output in a clinical setting. The export capabilities also suggest interaction with hardware like block-cutting devices and milling machines.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Helax-TMS Function: Helax-TMS is a radiotherapy treatment planning system. Its purpose is to plan the delivery of radiation therapy to a patient's body based on imaging data and other clinical information. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "radiation dose planning" for patients undergoing external beam or brachytherapy treatment. This is a planning tool for a therapeutic procedure, not a diagnostic test performed on a sample.
Therefore, based on the provided information, Helax-TMS falls under the category of a medical device used in the treatment planning process, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process.
Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 (i) to 50 MeV, proton energies from 1 to 275 MeV* as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus.
- Brachytherapy units for patients undergoing interstitial or intracavitary treatment in (ii) the oncology clinic.
Export capabilities exists as part of Helax-TMS to verify beam and patient data, to provide dose planning results, and to provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, and record and verify systems.
Product codes
90 MUJ
Device Description
Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and brachytherapy treatment in the Oncology clinic. Helax-TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, a Gaussian pencil beam model for electrons, and a proton dose calculation. A brachytherapy module is integrated into Helax-TMS for treatment modeling of interstitial and intracavity brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oncology clinic
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993766, K962892, K953391, K002312
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
510(k) Summary
613-592-3400 x2372 Tel: MDS Nordion 1.1 Submitter: 613-592-2006 Fax: 447 March Road Kanata, Ontario K2K 1X8 CANADA
Contact Person:
E. S. Martell, Vice President Quality & Regulatory Affairs 447 March Road Kanata, Ontario K2K 1X8 CANADA
- MDS Nordion AB 1.2 Device Manufacturer: Box 1704 SE-75147 Uppsala SWEDEN
- Helax-TMS Proton Functionality 1.3 Device Name:
- Medical Charged-Particle Radiation Therapy System Classification Name: 1.4 (892.5050)
- Radiation Therapy Treatment Planning System 1.5 Common or Usual Name:
Legally Marketed Predicate Device: 1.6
Helax-TMS v 5.0 (K993766), Helax-TMS v 3.0 (K962892) and Helax-TMS v 2.10 (K953391), Varian Proton Vision 7.0 (K002312)
Description of Helax-TMS Proton Functionality: 1.7
Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and brachytherapy treatment in the Oncology clinic. Helax-TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, a Gaussian pencil beam model for electrons, and a proton dose calculation. A brachytherapy module is integrated into Helax-TMS for treatment modeling of interstitial and intracavity brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.
1
Intended use of Helax-TMS Proton Functionality: 1.8
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process.
Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 (i) to 50 MeV, proton energies from 1 to 275 MeV* as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus.
- Brachytherapy units for patients undergoing interstitial or intracavitary treatment in (ii) the oncology clinic.
Export capabilities exists as part of Helax-TMS to verify beam and patient data, to provide dose planning results, and to provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, and record and verify systems.
*Note: Underlined sentence added due to new proton algorithm.
1.9 Technological Characteristics
The Helax-TMS v 5.1 is a modification of the Helax-TMS v 5.0/v 3.0/v 2.10 Radiation Therapy Treatment Planning System. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. There are no differences between the Helax TMS v 5.1 and Helax-TMS v 5.0/v 3.0/v 2.10 that adversely affect the safety or effectiveness of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2001
Mr. E.S. Martell Vice President, Quality & Regulatory Affairs MDS Nordion, Inc. 447 March Road KANATA, ONTARIO, CANADA K2K 1X8
Re: K010682
Helax TMS v.5.1 Photon Functionality RTTPS Dated: February 27, 2001 Received: March 7, 2001 Regulatory Class: II 21 CFR §892.5050/Procode: 90 MUJ
Dear Mr. Martell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 (s)
3
Indications for Use 6.0
010682 510 (k) Number:_
Device Name: Helax-TMS, v.5.1 Proton Functionality
Indications For Use:
Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process.
Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 (i) to 50MeV, proton energies from 1 to 275 MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus.
- Brachytherapy units for patients undergoing interstitial or intracavitary treatment in (ii) the Oncology clinic.
Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.
(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 801.109) |
OR
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| 510(k) Number | K010682 |
|---|---|
| --------------- | --------- |
MDS Nordion Inc.