(166 days)
ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The goal of this system is to provide a tool that will provide consistent results using well documented algorithms. This system does not provide direct or indirect control over any treatment delivery device or system in any form. The device only provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
ROCS Ultraseed is software that executes well known and documented algorithms to produce radiation dose estimations for prostate ultrasound-guided brachytherapy. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. The software is designed to run on a PC platform utilizing the Microsoft® Windows® operating systems. All dates are four digit numbers so the system is able to handle the year 2000.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for the ROCS Ultraseed™ device, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It lacks the specifics requested regarding a study proving the device meets acceptance criteria.
{0}------------------------------------------------
MAY 1 2 1999
K984241
510(k) SUMMARY
| Submitter: | Radiation Oncology Computer Systems, Inc.6190 Corte Del CedroCarlsbad, CA 92009(760) 929-1811 |
|---|---|
| Contact: | Charlene Neblett, Manager, Quality Assurance |
| Date Prepared: | November 25, 1998 |
| Device Name: | ROCS Ultraseed™ |
| Common Name: | Prostate Ultrasound-guided Brachytherapy PlanningSystem |
| Classification Name:Number: | Accelerator, Linear, Medical, Accessory90 IYE (892.5050) |
| Predicate Device: | Radiation Oncology Computer Systems TreatmentPlanning System510(k) notification K862643 |
Device Description:
ROCS Ultraseed is software that executes well known and documented algorithms to produce radiation dose estimations for prostate ultrasound-guided brachytherapy. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. The software is designed to run on a PC platform utilizing the Microsoft® Windows® operating systems. All dates are four digit numbers so the system is able to handle the year 2000.
Intended Use:
ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The goal of this system is to provide a tool that will provide consistent results using well documented algorithms. This system does not provide direct or indirect control over any treatment delivery device or system in any form. The device only provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
{1}------------------------------------------------
Technological Characteristics:
ROCS Ultraseed™ is designed to run on the Microsoft® Windows 95®, Windows 98ºor Microsoft® Windows NT® operating system. The user interface has been based upon the standard Microsoft® Windows® graphical user interface providing ease of use for anyone familiar with windows products. This differs from the predicate device in that the operating system is now Microsoft® Windows®; whereas, the predicate device utilized the DOS operating system. Additionally, ROCS Ultraseed™ is designed for ultrasound image input.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1999
Charlene Neblett Manager, Quality Assurance Radiation Oncology Computer System 6190 Corte Del Cedro Carlsbad, CA 92009
Re:
K984241 ROCS UltraSeed Dated: March 5, 1999 Received: March 8, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Neblett:
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). 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 (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 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) 594-4613. 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
{3}------------------------------------------------
INDICATIONS FOR USE
ROCS ULTRASEED™
ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The device provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. lt is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
Thind h. Sezson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological I 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.