(72 days)
Not Found
No
The summary describes a dose calculation engine based on established radiotherapy physics principles and input data, with no mention of AI/ML techniques for dose calculation or planning.
No.
The device is a dose calculation module used for planning radiation treatment, not for directly delivering or performing the therapeutic action itself.
No
The device is described as a "radiotherapy dose engine for radiation dose planning," which means it calculates radiation doses for treatment, not for diagnosing a condition.
Yes
The device is described as a "three-dimensional radiotherapy dose engine" and its function is to "calculate dose plans" based on input data. The description focuses solely on the software's computational function and its interaction with a treatment planning system and DICOM objects. There is no mention of any associated hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that DCM is a "three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment." It calculates radiation doses for treatment, not for analyzing biological samples.
- Intended Use: The intended use is for "plan[ning] radiation treatment," which is a therapeutic process, not a diagnostic one based on in vitro analysis.
- Input Data: The input data is based on "DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system," which are related to patient anatomy and treatment parameters, not biological sample analysis.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics. It is a radiotherapy planning software.
N/A
Intended Use / Indications for Use
DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.
Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
- . Cobalt-60 units
DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
Product codes
90 MUJ
Device Description
DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system.
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)
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
| JUN | 6 2002 | Section 1 | | | K020971
1 of 2 |
|----------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------|------|--------------------|-------------------|
| 510(k) Summary | | | | | |
| 1.1 | Submitter: | MDS Nordion
447 March Road
Ottawa, Ontario K2K 1X8
CANADA | Tel: | 613-592-3400 x2372 | |
| | | | Fax: | 613-592-2006 | |
| | Contact Person: | E. S. Martell
Vice President
Quality & Regulatory Affairs
447 March Road
Ottawa, Ontario K2K 1X8
CANADA | | | |
| 1.2 | Device Manufacturer: | MDS Nordion AB
Box 1704
SE-75147 Uppsala
SWEDEN | | | |
| 1.3 | Device Name: | DCM 2.0 | | | |
| 1.4 | Classification Name: | Medical Charged-Particle Radiation Therapy System
(892.5050) | | | |
| 1.5 | Common or Usual Name: | Radiation Therapy Treatment Planning System | | | |
| 1.6 | Legally Marketed Predicate Device: | | | | |
Helax-TMS v 5.1 (K010682) and DCM 1.0 (K011246)
1.7 Description of Dose Calculation Module (DCM):
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DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system.
1.8 Intended use of DCM:
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DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.
1
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Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
- . Cobalt-60 units
DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
Note: This intended use is a direct subset of the Intended Use of the predicate device, DCM with the addition of electron dose calculations for electron beams from 6 to 25 MeV.
1.9 Technological Characteristics
DCM 2.0 has the same technological characteristics as DCM 1.0 and introduces the capability of performing electron calculations using the Voxel Monte Carlo, (VCM++) algorithm, supported by the electron Beam Model, EBM.
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three parallel lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6-2002 JUN
MDS Nordion AB % Mr. E. S. Martell Vice President, Quality & Regulatory Affairs MDS Nordion 447 March Road Kanata, Ontario CANADA K2K1X8
Re: K020971
Trade/Device Name: DCM 2.0 Radiation Therapy Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: March 20, 2002
Dear Mr. Martell:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Received: March 26, 2002
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
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
4
Section 12
Indications for Use
510 (k) Number: K020971
Device Name: DCM version 2.0
Indications For Use:
DCM is a three-dimensional radiotherapy dose engine for radiation dose plaming of patients undergoing external beam treatment in oncology clinic.
Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with:
- Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
- Cobalt-60 units .
DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators;
motorized and dynamic wedges; customized blocking and bolus.
David h. hyam
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020971
(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
Over-The-Counter Use_
(Optional Format 1-2-96)
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