(277 days)
No
The description focuses on the addition of proton therapy planning and the implementation of a dose calculation algorithm provided by MGH. There is no mention of AI or ML.
No
The device is a treatment planning system and does not directly deliver therapy. Its intended use is to plan radiation treatment, not to administer it.
No
This device is a treatment planning system that uses diagnostic imaging data to create radiation treatment plans, but it does not perform diagnosis itself.
Yes
The device description focuses entirely on the software's functionality in processing imaging data, calculating dose distributions, and generating treatment plans. There is no mention of any accompanying hardware components that are part of the device itself. While it interacts with external hardware (linear accelerators, CT/MR scanners), the device being cleared is the software system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist." This is a planning tool for therapeutic procedures, not a diagnostic test performed on samples taken from the body.
- Device Description: The device accepts patient imaging data and source dosimetry data to create a treatment plan. It calculates and displays radiation dose distribution within the patient. This is a simulation and planning process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
Therefore, the FOCUS RTP System, as described, is a medical device used for radiation therapy planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons)..
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.
Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The FOCUS system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one which maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file.
Previously, for situations where external beam therapy was to be used, either Electron and/or Photon radiation beams could be selected.. These were delivered by a linear accelerator whose output characteristics are input to the treatment planning system prior to beginning planning.
This Premarket Notification addresses the addition of a third type of radiation beam -Proton. The algorithm for calculating dose was provided by the Massachusetts General Hospital (MGH), based on their years of experience at the Harvard Cyclotron Lab. In addition to providing the algorithm, MGH also worked with CMS in its implementation. Software developers at MGH were trained on the CMS software development process to permit them to create code directly for use in FOCUS. As the final step, MGH provided the verification testing to assure the algorithm had been implemented correctly, measuring calculated dose against measures. A FOCUS RTP System with proton planning capability is now in clinical use at the Northeast Proton Therapy Center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR scans, or from films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dosimetrist or Medical Physicist
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)
Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device.
Summary of Non-Clinical Testing: Algorithm test cases were written and executed to assure the system is calculating dose correctly for proton treatment plans. The results of testing on the Proton Algorithm feature can be found in the Validation of the CMS Proton Treatment Planning System for Treatments In Large Field Beam Line at the Harvard Cyclotron Laboratory (HCL) authored by Skip Rosenthal of MGH. This document is included in Tab 15 of this 510(k).
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.
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.
0
K 020027 FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness
| Submitter Name: | Computerized Medical Systems, Inc. |
|---|---|
| Submitter Address: | 1145 Corporate Lake Drive |
| St. Louis, MO 63132-1716 | |
| Submitter Phone: | 314 993 0003 |
| Submitter Fax: | 314 993-0075 |
| Contact Person: | Michael A. Parsons - Director - Quality Assurance |
| and Regulatory Affairs | |
| Date Summary Prepared: | December, 2001 |
| Device Trade Name: | FOCUS Radiation Treatment Planning System |
| Device Common Name: | Radiation Treatment Planning System |
| Device Classification: | System, Simulator, Radiation Therapy per |
| 21CFR892.5840 | |
| Substantial Equivalence: | Varian ProtonVision (K000922 & K002312) |
Device Description: The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.
1
Kozoozz
FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness Page 2 of 3
Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The FOCUS system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one which maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file.
Previously, for situations where external beam therapy was to be used, either Electron and/or Photon radiation beams could be selected.. These were delivered by a linear accelerator whose output characteristics are input to the treatment planning system prior to beginning planning.
This Premarket Notification addresses the addition of a third type of radiation beam -Proton. The algorithm for calculating dose was provided by the Massachusetts General Hospital (MGH), based on their years of experience at the Harvard Cyclotron Lab. In addition to providing the algorithm, MGH also worked with CMS in its implementation. Software developers at MGH were trained on the CMS software development process to permit them to create code directly for use in FOCUS. As the final step, MGH provided the verification testing to assure the algorithm had been implemented correctly, measuring calculated dose against measures. A FOCUS RTP System with proton planning capability is now in clinical use at the Northeast Proton Therapy Center.
Device Intended Use: The FOCUS RTP System with will continue to be used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan sct-up.
Summary of Technological Characteristics Compared to Predicate Devices: The Proton Planning algorithm described in this 510(k) consists of modules "added-on" to the existing FOCUS Radiation Treatment Planning System previously cleared under K915691 in February, 1995, K973936 in June, 1998 and K002147 in October, 2000.
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Kozouzą FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness Page 3 of 3
Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device.
Summary of Non-Clinical Testing: Algorithm test cases were written and executed to assure the system is calculating dose correctly for proton treatment plans. The results of testing on the Proton Algorithm feature can be found in the Validation of the CMS Proton Treatment Planning System for Treatments In Large Field Beam Line at the Harvard Cyclotron Laboratory (HCL) authored by Skip Rosenthal of MGH. This document is included in Tab 15 of this 510(k).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol resembling an abstract human figure or a caduceus, composed of three curved lines.
Public Health Service
OCT 0 8 2002
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc.™ 1145 Corporate Lake Drive ST LOUIS MO 63132
- Re: K020027 Trade/Device Name: FOCUS Radiation Treatment Planning System with Proton Planning Capability Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: August 22, 2002 Received: August 23, 2002
Dear Mr. Parsons:
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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 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
5
Statement of Indication for Use
510(k) Number: Ko20027
Device Name: FOCUS Radiation Treatment Planning System with Proton Planning Canability
Indication for use: The FOCUS RTP System consists of CMS-developed software running on UNIX-based operating systems and off the shelf hardware including computers and various computer peripherals (digitizing tablet, printer/plotter, etc.).
The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons)..
Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)
Prescription Use
OR per 21 CFR 801.109 Over the Counter Use
David A. Heymann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Computerized Medical Systems Inc. - FOCUS RTP System with Proton Planning - Indications For Use Statement