(86 days)
No
The summary describes standard image processing, contouring, and planning functions common in radiotherapy planning software, without mentioning AI, ML, or related concepts. The "auto seed placement and dose optimization routines" and "automatic seed identification" are likely based on traditional algorithms rather than AI/ML.
No.
This device is a software application for pre-operative planning and post-operative evaluation of brachytherapy procedures, which assists in the planning and evaluation of a therapeutic procedure but does not directly perform therapy.
No
The device is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for prostate cancer. It assists physicians in planning and evaluating procedures, but it does not directly diagnose a condition or disease.
No
The device description explicitly states that the application runs on a "standard Intel PCs" and is available on an "OR-safe hardware platform." It also interfaces with various hardware peripherals like digitizers, video capture cards, printers, and scanners. This indicates the device includes or requires specific hardware components beyond just the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic or monitoring purposes.
- Device Function: The MMS . TherpacPLUS B3DTUI is a software application used for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures. It processes medical images and assists in planning and evaluating a medical procedure performed directly on the patient.
- Lack of Specimen Handling: The description does not mention the device interacting with or analyzing any specimens taken from the human body. Its inputs are clinical imaging modalities, not biological samples.
Therefore, the device falls under the category of medical devices used for treatment planning and evaluation based on imaging data, rather than in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MMS·TherpacPLUS B3DTUI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-planning the patient's implant procedure and evaluating the actual post-operative results of the procedure.
Product codes
90 MUJ
Device Description
Hardware Platform and Operating System: The application runs on standard Intel PCs under Microsoft Windows® 32-bit operating systems.
The application is available on an OR-safe hardware platform. This hardware platform has electrical safety, emission control and cleaning provisions.
Peripherals and Accessories: The application interfaces with an electromagnetic digitizer, video capture cards, printers, film scanners, as well as DICOM and other image importer and data drives and external sources.
Software Features: The application supports image capture and importation from clinical imaging modalities sources, structure contouring and template registration, seed placement and dosimetry display for procedure planning and post-plan evaluation. Planning functions are supported by auto seed placement and dose optimization routines. The application supports post-procedure evaluation through automatic seed identification. Both planning and evaluation functions allow plans to be printed on reports, support visualization in 2D and 3D views. The applications has two user support modules - seed source specification and database manager.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians and medical physicists
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
Summary of 510(k) Safety and Effectiveness Data for MMS-TherpacPLUS B3DTUI
| Prepared: | August 6, 1998 |
|---|---|
| Submitter: | Multimedia Medical Systems, Inc. |
| Address: | 400 Ray C. Hunt Drive, Suite 380 |
| Charlottesville, VA 22903 | |
| Phone: | 804/977-8710 |
| Contact: | Alexander Crosby |
| Vice President of Quality | |
| Common Name: | Transperineal ultrasound-guided implant prostate |
| brachytherapy planning system | |
| Device Name: | MMS-TherpacPLUS B3DTUI, version 6.7 |
| Classification Name: | Treatment planning computer, CFR 892.5050 |
| Predicate Devices: | Multimedia Medical Systems “Therpac Radiotherapy |
| Treatment Planning System”, K930506 | |
| SSGL “Prowess 2000”. K924240 |
Device Description:
Hardware Platform and Operating System: The application runs on standard Intel PCs under Microsoft Windows® 32-bit operating systems.
The application is available on an OR-safe hardware platform. This hardware platform has electrical safety, emission control and cleaning provisions.
Peripherals and Accessories:
The application interfaces with an electromagnetic digitizer, video capture cards, printers, film scanners, as well as DICOM and other image importer and data drives and external sources.
Software Features:
The application supports image capture and importation from clinical imaging modalities sources, structure contouring and template registration, seed placement and dosimetry display for procedure planning and post-plan evaluation. Planning functions are supported by auto seed placement and dose optimization routines. The application supports post-procedure evaluation
Section 6 Page 1 of 2
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through automatic seed identification. Both planning and evaluation functions allow plans to be printed on reports, support visualization in 2D and 3D views. The applications has two user support modules - seed source specification and database manager.
Intended Use
The MMS·TherpacPLUS B3DTUI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-planning the patient's implant procedure and evaluating the actual post-operative results of the procedure.
2
Image /page/2/Picture/0 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" arranged around the perimeter. In the center of the seal is a stylized design featuring three profiles that appear to be connected, possibly representing people or the concept of health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 NOV
Alexandria Crosby Vice President of Quality Multimedia Medical Systems 400 Rav C. Hunt Drive, S380 Charlottesville, VA 22903
Re:
MMS-TherapacPLUS B3DTUI Dated: August 7, 1998 Received: August 11, 1998 Regulatory class: II 21 CFR 892,5730/Procode: 90 MUJ
Dear Mr. Crosby:
We have reviewed your Section 510%) 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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 ritto 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/cdr/dsmarnain.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
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| 5 0(k) Number (if known): | K982821 |
|---|---|
| Device Name: | MMS THERPAC PLUS B3D TUI |
| Indications For Use: |
··
The MMS . TherpacPLUS B3DTUI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-olanning the patient's implant procedure and evaluating the actual post-operative results of the procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K982821
Prescription Use
(Per 21 CFR 801.109)
O
OR
Over-The-Counter Use
بخ
(Optional Format 1-2-96)
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