(78 days)
Unknown
The document mentions "autosegmentation capability" in the description of the "FOCAL Fusion" release. While autosegmentation can be implemented using traditional image processing techniques, it is also a common application of AI/ML in medical imaging. Without further details on the implementation of this feature, it is not possible to definitively determine if AI/ML is used. The document does not explicitly mention AI, DNN, or ML.
No
The device is a software package that assists in radiation treatment planning by allowing users to identify patient isocenters, place treatment beams, and identify beam modifiers. It does not directly provide a therapeutic effect to the patient.
No
The FOCAL workstation software is used for radiation treatment planning, including identifying patient isocenters, placing treatment beams, and identifying beam modifiers. While it uses CT and MR images, its purpose is to plan treatment, not to diagnose a disease or condition. It is described as an "accessory to a radiation treatment planning system" and its functionality is related to optimizing and delivering radiation therapy, not initial diagnosis.
Yes
The device is described as a "computer software package" and "software" throughout the document, and its function is to process data and provide tools for radiation treatment planning on a Personal Computer, without mentioning any specific hardware components included in the submission.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the FOCAL workstation software is an accessory to a radiation treatment planning system. Its purpose is to facilitate tasks within the radiation therapy planning process, such as identifying isocenters, placing beams, and identifying beam modifiers. It does not involve the examination of specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details the software's evolution from remote contouring to viewing treatment planning results and now to CT simulation. All these functions are related to the planning and delivery of radiation therapy, not in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any activities typical of IVD devices, such as analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro tests.
The device is a software accessory for a medical device (radiation treatment planning system) used in the planning phase of radiation therapy.
N/A
Intended Use / Indications for Use
The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system.
FOCAL Sim is intended to permit CT simulation to be performed on the FOCAL workstation. The CT scan is read into the radiation treatment planning system and then sent to the FOCAL workstation. On FOCAL, the user is able to identify patient isocenters, place treatment beams and identify beam modifiers (blocks, wedges, etc.). This information is then passed back to the radiation treatment planning system for storage and documentation of the resultant treatment plan and calculation of patient dose based on this information. The resultant plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
Product codes
90 MUJ
Device Description
The FOCAL Workstation was initially cleared for marketing under K981535. The initial release of the product had, as its intended use, the remote contouring of patient outlines, structures and tumors as part of radiation therapy planning. The FOCAL Workstation was designed to work with our FOCUS Radiation Treatment Planning (RTP) System. The task of contouring, typically performed by the Radiation Oncologist, is the most time-consuming task in radiation therapy planning. The goal was to free up the higher powered UNIX-based RTP Computer Capacity from performing calculation-intensive activities of treatment planning by moving the contouring to a remote device. This remote device was a personal Computer loaded with the FOCAL contouring software running on common Microsoft products (Windows 95, 98, NT). Once contouring was complete, the information was returned to the RTP System to continue the treatment planning process.
The first release of FOCAL contained only manual contouring capability and was given the trade name of "FOCAL Ease". The second release enhanced the user's ability to view of CT and MR images as well as providing an autosegmentation capability. This added functionality was given the trade name "FOCAL Fusion".
A later release of FOCAL software provided the capability to view the results of treatment planning performed earlier on the FOCUS RTP System. This included the ability to view isodose contours and Dose Volume Histograms (DVH's) as well as Digitally Reconstructed Radiographs (DRR's). This was given the name "FOCAL Vue" and provided the user with a remote capability to view and compare alternate treatment plans and select the one which best satisfied her/his prescription.
The subject of this Premarket Notification is the addition of the ability to perform CT simulation, a feature called "FOCAL Sim". This addition moves the contouring of patient targets or viewing of treatment planning results into a more active role in the treatment planning process. The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be used for the performance of CT simulations and forward this information to the RTP System for dose calculation.
The CT Simulation capability described in this 510(k) will be a software module "added-on" to the existing FOCAL Workstation previously cleared under K981535 in April, 1999. The FOCAL System with CT Simulation capability incorporates no technological characteristics not currently in the predicate CT Simulation devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel / Radiation therapy planning
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)
Clinical testing was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness. This software merely takes some of the tasks previously performed on the RTP System and allows them to be performed on the FOCAL Workstation.
Summary of Non-Clinical Testing: The testing performed by CMS and our results can be found in Section 9 of this submittal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
DEC 0 5 2001
510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM)
| 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: | September, 2001 |
| Device Trade Name: | FOCAL Workstation |
| Device Common Name: | Accessory to Radiation Treatment Planning System |
| Device Classification: | System, Simulation, Radiation Therapy per |
| 21CFR892.5840 | |
| Substantial Equivalence: | Picker International Acqsim Simulator/Localizer - |
| K923851 | |
| GE Advantage Sim - K951830 | |
| ADAC Advantage Sim - K993923 |
Device Description: (See Section 7 of this submittal for a more detailed Device Description). The FOCAL Workstation was initially cleared for marketing under K981535. (At that time, the device was referred to as the FOCUS Pilot Contouring Workstation. However, by the time the Premarket Notification was cleared, the CMS Marketing Department had selected another trade name.)
The initial release of the product had, as its intended use, the remote contouring of patient outlines, structures and tumors as part of radiation therapy planning. The FOCAL
1
510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM) Page 2 of 3
Workstation was designed to work with our FOCUS Radiation Treatment Planning (RTP) W orkstation was designed to work while of the same of the most recently under System willer was intraily ordains repically performed by the Radiation Oncologist, is K002147. The task of contouring, typediation therapy planning and requires a minimum of the most thing consuming task in rad to free up the higher powered UNIX-based RTP Computer Capaonity. It was our goal goal calculation-intensive activities of treatment Workstation for performing the ing to a remote device. This remote device was a prailing by moving the contourning to a common Microsoft products (Windows 95, Fersonal Computer fouded with the FOCAL contouring software running on that While was 20, While was complete, the information was returned to the RTP System to continue the treatment planning process.
The first release of FOCAL contained only manual contouring capability and was given The first ferease of FOCAL Ease". The second release enhanced the users ability to the trade hame of 'I OCAL Lase ' - I vision of CT and MR images as well as providing an autosegmentation capability. This added functionality was given the trade name "FOCAL Fusion".
A later release of FOCAL software provided the capability to view the results of treatment planning performed earlier on the FOCUS RTP System. This included the treatment planning perfermed vans as well as Dose Volume Histograms (DVH's) and abinty to view isodose assations (DRR's). This was given the name "FOCAL Vue" Dighany Roconsalation at a remote capability to view and compare alternate treatment plans and select the one which best satisfied her/his prescription.
All of these development efforts were performed per the CMS software development An of these de relopment of the Premarket Notification clearance. This included inhouse validation testing to assure clinical efficacy and safety.
The subject of this Premarket Notification is the addition of the ability to perform CTV The subject of this Promation, a feature we call "FOCAL Sim". This addition simulation off the contouring of patient targets or viewing of treatment planning results into a more active role in the treatment planning process. For a description of the CT simulation process, refer to Section 7 of this submittal.
2
510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM) Page 3 of 3
Device Intended Use: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be econtring and for the mations and forward this information to the RTP System for dose calculation.
Summary of Technological Characteristics Compared to Predicate Devices: The CT Simulation capability described in this 510(k) will be a software module "added-on" to the existing FOCAL Workstation previously cleared under K981535 in April, 1999. The FOCAL System with CT Simulation capability incorporates no technological characteristics not currently in the predicate CT Simulation devices.
The FOCAL System supports the most popular CT Scanners as well as the three most common linear accelerators (Varian, Siemens and Philips/Elekta).
Summary of Clinical Testing: Clinical testing was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness. This software merely takes some of the tasks previously performed on the RTP System and allows them to be performed on the FOCAL Workstation.
Summary of Non-Clinical Testing: The testing performed by CMS and our results can be found in Section 9 of this submittal.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2001
Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc. TM 1145 Corporate Lake Drive ST. LOUIS MO 63132
Re: K013112
Trade/Device Name: FOCAL CT Simulation (CT Sim) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 MUJ Dated: September 14, 2001 Received: September 18, 2001
Dear Mr. Parsons:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one review 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 (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.
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: K013112
Device Name: FOCAL Workstation with CT Simulation Capability
Indication for use: The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system.
FOCAL Sim is intended to permit CT simulation to be performed on the FOCAL workstation. The CT scan is read into the radiation treatment planning system and then sent to the FOCAL workstation. On FOCAL, the user is able to identify patient isocenters, place treatment beams and identify beam modifiers (blocks, wedges, etc.). This information is then passed back to the radiation treatment planning system for storage and documentation of the resultant treatment plan and calculation of patient dose based on this information. The resultant plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
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 _________________________________________________________________________________________________________________________________________________________
Dave Brion
(Division Sign Off)
Division of Reprodustila, Abdominal,
and Radioteland Daviess K013112
510(k) Number...