(58 days)
Not Found
No
The description focuses on deterministic dose calculations based on established formalisms (AAPM TG-43) and comparisons to primary treatment planning systems. There is no mention of learning, training data, or adaptive algorithms characteristic of AI/ML.
No.
This device is a quality assurance (QA) software for verifying brachytherapy treatment plans; it does not directly deliver or control therapy to a patient.
No
Explanation: The device is described as a "quality assurance tool to verify brachytherapy treatment plans." It compares a calculated dose to a dose predicted by a primary treatment planning system, rather than diagnosing a patient's condition.
Yes
The device is described as a "stand alone software application product" and its description focuses entirely on its software functions (importing files, performing calculations, displaying information, etc.). While it has system requirements (operating system, hardware specs), these are for the platform the software runs on, not components of the medical device itself. The validation and verification also focus on software functionality.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The IMSure Brachy QA Software is a software application used to verify brachytherapy treatment plans. It calculates and compares radiation doses based on treatment planning data. It does not analyze biological samples from a patient.
- Intended Use: The intended use clearly states it's a "quality assurance tool to verify brachytherapy treatment plans." This is a quality control function for a medical procedure, not a diagnostic test performed on a patient sample.
Therefore, the IMSure Brachy QA Software falls under the category of medical device software, specifically for radiation therapy planning and quality assurance, but it is not an IVD.
N/A
Intended Use / Indications for Use
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.
This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.
Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
Product codes
LHN, IYE, JAQ, KXK
Device Description
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.
This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.
IMSure Brachy QA Software independently computes a modeled dose that would be delivered by a high dosc rate (HDR) or low dose (LDR) brachytherapy system to a patient and compares it to the dose predicted by a primary treatment planning system. IMSure Brachy QA Software imports a file produced by a primary HDR or LDR treatment planning system (TPS), in the format of an industry standard Dicom-RT™ or vendor specific file, which contains information about a treatment. The files contain information about applicators or catheters and the associated source information in each catheter, such as source type, source strength, source location and source duration. The files may also contain information about specific calculation points and the dose predicted by the primary planning system, as well as patient specific information. The dose computation algorithm used is a superposition of point or line sources, incorporating 3-D geometrical features of the source construction, as well as radiological features of the source composition. Dosc modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results.
After importing a TPS plan, a user may edit the information, adding or modifying source positions, durations (or dwell times), type, or activity strength. Calculation point information may be edited as well. A 3-D view of the applicators, source positions, and calculation point positions is provided. A paper or electronic record can be stored including the final dose computation for each calculation point compared to the dose computed by the TPS, as well as relevant patient information for long term documentation. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
IMSure Brachy QA Software is provided to the customer on a CD. It requires the Microsoft Windows Operating System 2000 with service pack 2 or better, or XP. Computer system requirements include Pentium III or equivalent, a minimum of 256 MB RAM and 100 MB available hard drive space. Display requirements include 1024 x 768 minimum resolution and an OpenGL compatible video card meeting OpenGL 1.1 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical physicians, or dosimetrists.
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)
The Standard Imaging IMSure Brachy QA Software has been verified and validated at Standard Imaging, and addressed the following functional areas:
- Installation .
- . Import Tool Module
- . User Preferences Module
- . QA Module
- Source Library Module .
- User Management Module .
- . Simple 1 strand +xyz to -xyz.
- . Dual IR-192 dwl
- 24 channels .
- . Xoft
- . 4 I125 point
- Line 1D aniso .
- Line scalar aniso
Additionally, the IMSure Brachy QA Software was successfully cvaluated by the following beta sites: - . UCSD Hospital, San Diego, CA
- . Grant Methodist Hospital, Columbus OH
- Memorial Hospital, South Bend, IN .
- Edward Hospital, Naperville, IL .
- . Texas Oncology Hospital, Klabzuba, TX
The Standard Imaging IMSure Brachy QA Software has met its predetermined design specifications, risk analysis and validation objectives.
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
Image /page/0/Picture/0 description: The image shows the logo for Standard Imaging. The logo consists of the word "STANDARDIMAGING" in a stylized font. To the right of the text is a circular graphic with a jagged, abstract design, possibly representing a burst or explosion. The overall design is simple and modern.
September 17, 2008
Ko82773
NOV 1 9 2008
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the
Standard Imaging IMSure Brachy QA Software | | |
|----------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|
| Proprietary Name: | Standard Imaging IMSure Brachy QA Software | | |
| Common Name: | Dose Validation Software | | |
| Classification Name: | Primary: | Medical Charged-Particle Radiation Therapy System
(accessory to) | |
| | Secondary: | Remote Controlled Radionuclide Applicator System
(accessory to)
Radionuclide Brachytherapy Source
(accessory to) | |
| Classification: | Primary: | Class II - 21CFR892.5050 - LHN, IYE | |
| | Secondary: | Class II - 21CFR892.5700 - JAQ
Class II - 21CFR892.5730 - KXK | |
| Panel: | Radiology | | |
| Predicate Devices: | Primary: | Standard Imaging (Prodigm), IMSure QA Software
510(k) Number K031975 | |
| | Secondary: | Oncology Data Systems, MU Check v7.0 (Brachy Check-
510(k) Number K061152 | |
| Contact Person: | Raymond Riddle, PE, RAC
Chief Regulatory Officer | | |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Standard Imaging IMSure Brachy QA Software was designed to comply with the applicable portions of the following voluntary standard:
- IEC 60601-1-4 (Edition 1.1 2000-04) Collateral standard for programmable medical . systems
/3
STANDARDING, INC. 3120 Deming Way, Middleton, W 53562-1461 800-261-0446 608-31-025 PH 608-831-202 FAX www.standardimaging.com
Assurance is confidence™
1
Image /page/1/Picture/0 description: The image shows the logo for Standard Imaging. The text "STANDARD IMAGING" is displayed in a stylized font, with the word "STANDARD" in a thinner font than "IMAGING". To the right of the text is a circular graphic with a burst-like design.
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.
This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.
Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
The Standard Imaging IMSure Brachy QA Software has been verified and validated at Standard Imaging, and addressed the following functional areas:
- Installation .
- . Import Tool Module
- . User Preferences Module
- . QA Module
- Source Library Module .
- User Management Module .
- . Simple 1 strand +xyz to -xyz.
- . Dual IR-192 dwl
- 24 channels .
- . Xoft
- . 4 I125 point
- Line 1D aniso .
- Line scalar aniso �
Additionally, the IMSure Brachy QA Software was successfully cvaluated by the following beta sites:
- . UCSD Hospital, San Diego, CA
- . Grant Methodist Hospital, Columbus OH
- Memorial Hospital, South Bend, IN .
- Edward Hospital, Naperville, IL .
- . Texas Oncology Hospital, Klabzuba, TX
The Standard Imaging IMSure Brachy QA Software has met its predetermined design specifications, risk analysis and validation objectives.
14
STANDARDIMAGING, INC. 3120 Deming Way, Middleton, WI 53562-1461 800-261-4466 608-831-0025 PH 608-831-2202 FAX www.standardimaging.com
Assurance is confidence™
2
General Information
| Device Name - Proprietary: | IMSure Brachy QA Software - During development, the name has evolved, resulting in
many of the documents in this 510(k) having slightly different names. Upon 510(k)
clearance, all documents, including manuals, advertisements, labeling and software
supplied to the marketplace and/or users will use the name IMSure Brachy QA Software. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name - Common: | Dose Validation Software |
| Device Name - Classification(s): | |
| Primary: | Medical Charged-Particle Radiation Therapy System (accessory to) |
| Secondary: | Remote Controlled Radionuclide Applicator System (accessory to)
Radionuclide Brachytherapy Source (accessory to) |
| Device Panel: | Radiology |
| Device Classification(s): | |
| Primary: | Class II - 21CFR892.5050 -- LHN, IYE |
| Secondary: | Class II - 21CFR892.5700 - JAQ, Class II - 21CFR892.5730 - KXK |
| Predicate Devices: | |
| Primary: | Standard Imaging (Prodigm), IMSure QA Software
510(k) Number K031975 |
| Secondary: | Oncology Data Systems, MU Check v7.0 (Brachy Check)
510(k) Number K061152 |
| Performance Standards: | To the best of Standard Imaging's knowledge, performance standards have not been
promulgated by FDA for this device. |
| Establishment Registration Number: | 2184007 |
| Owner/Operator Number: | 9003193 |
| Facility Information: | Standard Imaging, Inc.
3120 Deming Way
Middleton, WI 53562
Telephone: (608) 831-0025
Fax: (608) 831-2202
Webpage: www.standardimaging.com |
3
Device Background
Standard Imaging acquired the IMSure QA Software from Prodigm, Inc. in 2005. Since that time the company has made minor incremental improvements to the product. Since Standard Imaging had a strong market presence with brachytherapy quality assurance products, a simple standalone software product in the IMSure mold was an obvious development choice.
Device Description
IMSurc Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.
This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimetric accuracy is adequate for a particular patient.
IMSure Brachy QA Software independently computes a modeled dose that would be delivered by a high dosc rate (HDR) or low dose (LDR) brachytherapy system to a patient and compares it to the dose predicted by a primary treatment planning system. IMSure Brachy QA Software imports a file produced by a primary HDR or LDR treatment planning system (TPS), in the format of an industry standard Dicom-RT™ or vendor specific file, which contains information about a treatment. The files contain information about applicators or catheters and the associated source information in each catheter, such as source type, source strength, source location and source duration. The files may also contain information about specific calculation points and the dose predicted by the primary planning system, as well as patient specific information. The dose computation algorithm used is a superposition of point or line sources, incorporating 3-D geometrical features of the source construction, as well as radiological features of the source composition. Dosc modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results.
After importing a TPS plan, a user may edit the information, adding or modifying source positions, durations (or dwell times), type, or activity strength. Calculation point information may be edited as well. A 3-D view of the applicators, source positions, and calculation point positions is provided. A paper or electronic record can be stored including the final dose computation for each calculation point compared to the dose computed by the TPS, as well as relevant patient information for long term documentation. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
IMSure Brachy QA Software is provided to the customer on a CD. It requires the Microsoft Windows Operating System 2000 with service pack 2 or better, or XP. Computer system requirements include Pentium III or equivalent, a minimum of 256 MB RAM and 100 MB available hard drive space. Display requirements include 1024 x 768 minimum resolution and an OpenGL compatible video card meeting OpenGL 1.1 specifications.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Raymond T. Riddle, PE, RAC Chief Regulatory Officer Standard Imaging, Inc. 3120 Deming Way MIDDLETON WI 53562-1461
NOV 1 9 2008
Re: K082773
. Trade/Device Name: IMSure Brachy QA Software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 18, 2008 Received: September 22, 2008
Dear Mr. Riddle:
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. Iisting 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 such 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.
5
Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arque In Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Usc
K08z773
510(k) Number (if known):
Device Name:
IMSure Brachy QA Software
Indications For Use:
IMSure Brachy QA Software is a stand alone software application product intended for use as a quality assurance tool to verify brachytherapy treatment plans developed on a radiation therapy treatment planning system with the appropriate transfer format. It may also be used as a segregated standalone application in the IMSure QA Software suite of software products.
This product is intended for use by trained medical physicians, or dosimetrists. The calculation results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physician or dosimetrist to determine whether the dosimctric accuracy is adequate for a particular patient.
Dose modeling of a source is based on the AAPM TG-43 formalism, and may be adjusted by a qualified user to match measured or published results. IMSure Brachy QA Software does not control any radiation delivery devices and does not allow the export of calculated information.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-the-Counter-Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Helene
ivision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1
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