(213 days)
Prowess 2000, Therpac PLUS B3D TUI
Not Found
No
The description focuses on image reconstruction and dose calculation based on user input, with no mention of AI/ML algorithms for analysis or decision support.
No
The device is a treatment planning system that assists clinicians in determining optimal placement of radioisotopes and calculating dose, but it explicitly states it is "not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient," meaning it does not directly treat.
No
The device is described as assisting in determining optimal placement of radioisotopes and calculating dose for treatment planning, not for diagnosing a medical condition.
Yes
The device is described as a "computer system" that processes images and outputs data, with no mention of accompanying hardware components that are part of the regulated device itself. While it interacts with imaging modalities and outputs to a printer, these are external to the core "Strata device" as described.
Based on the provided information, the Strata system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Strata system's intended use and device description clearly state that it uses imaging data (Ultrasound and DICOM) of the patient's anatomy to assist in planning radiation therapy. It does not analyze biological samples like blood, urine, or tissue.
- The purpose of an IVD is to provide information for the diagnosis, monitoring, or treatment of a disease or condition. While the Strata system is used in the treatment planning process, its function is to assist in the physical placement and dosage calculation of radioisotopes based on imaging data, not to diagnose or monitor a disease through the analysis of biological specimens.
The Strata system falls under the category of medical image processing and treatment planning software used in radiation oncology. Its function is to process imaging data and assist clinicians in planning a medical procedure (radiation therapy).
N/A
Intended Use / Indications for Use
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist.
The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
Product codes
90 MUJ
Device Description
The proposed Strata device is a computer system developed for the use of assisting in the placement of anatomical localization and low dose rate isotope implants. This treatment planning procedure is used for lesions, benign or malignant, seated in human tissue. Strata uses multiple two dimensional images including Ultrasound and DICOM (imaging file format) images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices. The information gathered is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound and DICOM (imaging file format) images
Anatomical Site
human tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinician, Medical Physicist or Dosimetrist, the results should then be approved by a licensed Radiation Oncologist.
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)
Prowess 2000 (SSGI, Inc.), Therpac PLUS B3D TUI (Multimedia Medical Systems, Inc.)
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
Image /page/0/Picture/0 description: The image shows the logo for "Rosses Medical" with a shamrock in the middle of the word "Rosses". The logo is in black and white. Above the logo, the date "DEC 11 1998" is printed.
10620 Guilford Road, Suite 201 Jessup, Maryland 20794 (301) 490-2304 · (301) 490-2982 (fax)
510(k) Summary
The 510(k) summary information required by 21 CFR 807.92 is as follows:
Source, Brachytherapy, Radionuclide or Accelerator, Classification Name: Linear, Medical or Other
Common/Usual Name: Brachtherapy Treatment Planning System
Proprietary Name: STRATA
Substantial equivalence: Prowess 2000 (SSGI, Inc.) and Therpac PLUS B3D TUI (Multimedia Medical Systems, Inc.)
Device description: The proposed Strata device is a computer system developed for the use of assisting in the placement of anatomical localization and low dose rate isotope implants. This treatment planning procedure is used for lesions, benign or malignant, seated in human tissue. Strata uses multiple two dimensional images including Ultrasound and DICOM (imaging file format) images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices. The information gathered is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Intended Use: The proposed Strata device is to used only by a qualified clinician, Medical Physicist or Dosimetrist, the results should then be approved by a licensed Radiation Oncologist. Strata is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes. Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
Technological characteristics: The proposed Strata device is similar to predicate devices, and existent methodologies in its intended use.
The proposed device is different than the predicate devices in that it gives the user more flexibility with image acquisition and structure definition.
Submitted,
Rosses Medical Systesm
Rene Spector
Reme Spector Regulatory/SQA Manager Phone/Fax
1
Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Rene Spector Regulatory/SQA Manager Rosses Medical Columbia Gateway Drive Suite 160 Columbia, Maryland 21046 Re: K981678
STRATA ( Brachytherapy RTP System) Dated: September 28, 1998 Received: September 28, 1998 Regulatory class: II 21 CFR 892.5730/Procode: 90 MUJ
Dear Mr. Spector:
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 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, 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 (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/cdrfvdsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (If known):
Device Name:
Indications For Use:
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist.
The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Leggett
Division of Reproductive, Abdominal, El and Radiological 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
OR