(60 days)
Not Found
No
The summary describes a traditional brachytherapy planning system with standard image processing and dose calculation functionalities. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is a planning and guidance system for brachytherapy, not a device directly applying therapy. Its function is to assist in the planning and localization of radioactive seed implants or HDR afterloader devices, which are the therapeutic agents.
No
This device is described as a 'brachytherapy dose planning and treatment guidance system' used for planning, imaging, and alignment for treating cancer, as well as volume and dose calculations and visualizations. Its primary purpose relates to treatment planning and delivery, not diagnosing a medical condition.
No
The device description explicitly states the system consists of a computer, video capture device, and software tools, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The RadVision system is a brachytherapy dose planning and treatment guidance system. It uses imaging and software to plan and guide the delivery of radiation therapy within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices." This is a therapeutic and planning function, not a diagnostic one based on in vitro analysis.
- Device Description: The description reinforces its role in "dose planning and treatment guidance."
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or performing any tests on specimens outside the body.
Therefore, the RadVision system falls under the category of a medical device used for treatment planning and guidance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Acoustic MedSystems. Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or high dose radiation (HDR) afterloader devices. In addition to planning and treatment, RadVision allows volume and dose calculations. 2D and 3D anatomy and dose visualizations, as well as post treatment seed localization.
RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.
Product codes (comma separated list FDA assigned to the subject device)
MUJ, KXK
Device Description
The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image acquisition, import, display (2D and 3D) from various modalities (ultrasound, MR, CT Fluoroscopy)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room (OR)
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)
Verification and Validation test procedures were prepared considering the technological characteristics of the predicate devices. Non-clinical testing of RadVision was conducted for the following characteristics:
- Computer systems and software .
- Administration, Patient management and Help support .
- Calibration of template positioning and images to template registration
- Equipment set identifications and specifications (associates all . equipment/instrumentation as configured for set up for implants)
- . Image acquisition, import, display (2D and 3D) from various modalities (ultrasound, MR, CT Fluoroscopy)
- . Contouring and anatomical identification
- Identification and loading of radiation source and placement with image quidance (low . dose radiation (LDR) and HDR)
- . Dose calculation (LDR and HDR)
- . Printing reports
Verification and validation testing was performed using RadVision Dose Planning and Treatment System. RadVision passed all the verification and validation tests successfully.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Acoustic Medsystems. The logo consists of a stylized eye-like symbol on the left, with the words "ACOUSTIC" above "MEDSYSTEMS" on the right. A horizontal line runs through the center of the eye symbol and extends to the right, underlining the words.
K131428
Page 1 of 3
208 Burwash Avenue Savoy, IL 61874
JUL 1 6 2013
Section 5 510(k) Summary
| (1) | Date Summary Prepared: | 04/29/2013
Traditional 510(k) Submission | | | |
|-----|------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------|-----------------------------------|
| (2) | Submitter: | Acoustic MedSystems, Inc.
208 Burwash Avenue
Savoy, IL 61874 | | Tel: | 217-239-0900
Fax: 217-239-0905 |
| | | Establishment Registration No.: AMS will register following FDA clearance | | | |
| | | Contact Person: | Jennifer Williams
FDA Official Regulatory
Correspondent
e-mail: jwilliams@acousticmed.com | | |
| (3) | Device Name: | RadVision | | | |
| | Common Name: | Brachytherapy Dose Planning and Treatment System | | | |
| | Classification Name: | 21CFR 892.5050 Medical charged particle radiation therapy system, Class II. | | | |
| | Product Code: | MUJ | | | |
| | Proprietary Name: | RadVision | | | |
Legally Marketed Predicate Devices: (4)
Burdette Medical Systems, Inc. Interplant, 510(k) number K982696 dated 1 April 1999
Varian Medical Systems BrachyVision 6.0, 510(k) number K992762 dated 03 March 2000
Varian Medical Systems VariSeed 7.1, 510(k) number K030534 dated 21 May 2003
Telephone: 217-239-0900 Facsimile: 217-239-0905
1
K131428
Page 2 of 3
Description of Acoustic MedSystems, Inc. RadVision Dose Planning and (5) Treatment System:
The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.
(6) Intended Use:
The intended use of Acoustic MedSystems. Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or high dose radiation (HDR) afterloader devices. In addition to planning and treatment, RadVision allows volume and dose calculations. 2D and 3D anatomy and dose visualizations, as well as post treatment seed localization.
RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.
(6) Performance Testing:
The computer systems that will be used to install RadVision for commercial distribution to customers are required to be tested and meet the following standards:
- IEC 60601-1-1 .
- IEC 60601-1-2 .
- IEC 60601-1-3 .
- IEC 60601-1-4 .
Verification and Validation test procedures were prepared considering the technological characteristics of the predicate devices. Non-clinical testing of RadVision was conducted for the following characteristics:
- Computer systems and software .
- Administration, Patient management and Help support .
- Calibration of template positioning and images to template registration �
- Equipment set identifications and specifications (associates all . equipment/instrumentation as configured for set up for implants)
- . Image acquisition, import, display (2D and 3D) from various modalities (ultrasound, MR, CT Fluoroscopy)
- . Contouring and anatomical identification
- Identification and loading of radiation source and placement with image quidance (low . dose radiation (LDR) and HDR)
- . Dose calculation (LDR and HDR)
- . Printing reports
Verification and validation testing was performed using RadVision Dose Planning and Treatment System. RadVision passed all the verification and validation tests successfully.
2
K131421
Page 3 of 3
Based on verification and validation test results and analysis of similarities and differences between the technological characteristics of the devices, RadVision is substantially equivalent to the stated predicate devices without raising new safety and/or efficacy issues.
Technological Characteristics: (7)
The intended use statement of RadVision is respectfully similar to the intended use statement of the predicate devices. RadVision is a Brachytherapy treatment planning software compatible with both LDR and HDR delivery systems, whereas Interplant and VariSeed 7.1 are for LDR and Varian BrachyVision 6.0 for HDR. There are no substantial differences between RadVision and Interplant and Variseed 7.1 for permanent seed implant functions and between RadVision and Varian BrachyVision for HDR functions.
The level of concern for RadVision software is major: FDA considers software contained in radiation therapy devices to be Major level of concern. RadVision is not intended for diagnostic purposes, nor will it control the delivery of the treatment plan to the patient.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and merge into a single, wavy line at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July, 16, 2013
Acoustic MedSystems, Inc. % Ms. Jennifer Williams Official Regulatory Correspondent 208 Burwash Avenue SAVOY IL 61874
Re: K131428
Trade/Device Name: RadVision Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK. MUJ Dated: April 29. 2013 Received: May 22, 2013
Dear Ms. Williams:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2 - Ms. Williams
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131428
Device Name: RadVision
Indications for Use:
The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices. In addition to planning and treatment, RadVision also allows volume and dose calculations, 2D and 3D analomy and dose visualizations, and post treatment seed localization.
RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.
| Burdette Medical Systems, Inc
Interplant | Varian Medical Systems
BrachyVision 6.0 | Varian Medical Systems
VariSeed 7.1 |
|---------------------------------------------|--------------------------------------------|----------------------------------------|
| K982696 | K992762 | K030534 |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)_K131428
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