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 to 50MeV 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 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.

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. 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, and a Gaussian pencil beam model for electrons. A Brachytherapy module is integrated into 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Helax-TMS v5.0, a 3D Radiotherapy Treatment Planning (RTP) system. However, it does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets said criteria.

The document primarily focuses on:

Submitter and Contact Information: Basic administrative details.
Device Name and Classification: Identifies Helax-TMS as a Medical Charged-Particle Radiation Therapy System.
Legally Marketed Predicate Devices: Lists similar devices already on the market.
Description of Helax-TMS v5.0: Explains its functionality as a 3D RTP system for both external beam and Brachytherapy, highlighting its algorithms and treatment planning capabilities.
Intended Use: Specifies the scenarios in which Helax-TMS is used, including various X-ray and electron energies, treatment approaches, and integration with other medical devices.
Technological Characteristics: States that v5.0 is a modification of previous versions and that these modifications do not adversely affect safety or effectiveness.
FDA Clearance Letter: A letter from the FDA indicating that the device has been reviewed and found substantially equivalent to legally marketed predicate devices.
Indications for Use Statement: Reiterates the intended use and capabilities of the device, similar to the description.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission for a device, confirming its substantial equivalence, but it does not detail the technical performance evaluation studies or specific acceptance criteria.

Summary

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Attachment C

510(k) Summary

Submitter:	MDS Nordion447 March RoadKanata, Ontario K2K 1X8CANADA	Tel:	613-592-3400 x2372
		Fax:	613-592-2006
Contact Person:	E. S. Martell, Vice PresidentQuality & Regulatory Affairs
Date Prepared:	October 29, 1999
Device Name:	Helax-TMS
Classification Name:	Medical Charged-Particle Radiation Therapy System (892.5050)
Common or Usual Name:	Radiation Therapy Treatment Planning System

Legally Marketed Predicate Device:

TMS v 3.0 (K962892) and TMS v 2.10 (K953391), CadPlan Helios Option 6.0 (K984532) NOMOS Peacock Plan (K940663) and identified as NOMOS CORVUS (K963258)

Description of Helax-TMS v 5.0:

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Intended use of Helax-TMS v 5.0:

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 to (i) 50MeV 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.
(ii) Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the Oncology clinic.

Technological Characteristics

The Helax-TMS v 5.0 is a modification of the TMS 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 5.0 and TMS v 3.0/v 2.10 that adversely affect the safety or effectiveness of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 1999

E. S. Martell Vice President Quality & Regulatory Affairs MDS Nordion 447 March Road Kanata, Ontario K2K 1X8 CANADA

Re:

K993766 Helax-TMS V5.0 Dated: November 4, 1999 Received: November 8, 1999 Regulatory class: II 21 CFR 892.5900/Procode: 90 MVJ

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, 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 (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 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 requlation (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) 594-4613. 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 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page i of 1

Labels	Values
510(k) NUMBER (IF KNOWN)	K993766
DEVICE NAME	HELAX- TMS V5.0

INDICATIONS FOR USE:

Based on quality assured radiation therapy input data Hclax-TMS is used to plan radiation treatments with:

linear accelerators with X-ray cncrgics from 4 to 50MV and electron energies (i) from 4 to 50MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar ficids; total body irradiation; multi-leal collimators; motorized and dynamic wedges; customized blocking; compensating filters; and bolus.
Brachytherapy units for patients undergoing interstitial or intracavitary treatment (ii) in the Oncology clinic.

(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)

Over-The-Counter-Use (Optional Format 1-2-

Vamil G. Symm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological 510(k) Number

** TOTAL PAGE.002 **

Regulation Number and Section

§ 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.