(87 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on hardware and standard quality assurance procedures.
No
The device is used for quality assurance of treatment delivery, not for treating patients directly. Its purpose is to verify the accuracy of IMRT and 4DRT treatments before they are administered to patients, making it a measurement and quality control tool rather than a therapeutic device.
No.
The device is used for quality assurance of treatment delivery in IMRT and 4DRT (respiratory gating and tumor tracking) and does not diagnose a disease or condition.
No
The device description explicitly lists hardware components such as a phantom, detector arrays, electrometer, and connection cables, in addition to software.
Based on the provided information, the Delta4 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT". This describes a quality control or verification process for a medical treatment delivery system (radiotherapy), not a diagnostic test performed on biological samples from a patient.
- Device Description: The components (software, phantom, detector arrays, electrometer, cables) are consistent with a system designed to measure radiation dose distribution in a physical phantom, not to analyze biological samples.
- Input Imaging Modality: While a CT scan is used to image the phantom, the CT itself is not part of the device, and the device's function is not to process or interpret patient images for diagnostic purposes.
- Anatomical Site/Patient Age/Patient Data: There is no mention of analyzing patient-specific biological samples or data related to anatomical sites or patient demographics.
- User/Care Setting: The typical user is a "Physicist or other dosimetry expert" in a "Radiotherapy Department," which aligns with a quality assurance role in radiation therapy, not a clinical diagnostic setting.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Delta4 device's function is to verify the accuracy of a radiation treatment plan and delivery system using a physical phantom.
N/A
Intended Use / Indications for Use
The intended use of the product is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).
The intended use of Delta4 is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The new device consists out of:
- software .
- . phantom
- Detector arrays. .
- Multi-channel electrometer .
- Connection cables .
When measurements are to be performed the device is typically put on the patient table (or couch). Then the device is exposed typically from different angles.
The detector arrays are mounted inside the phantom. The software and connection cables are not shown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (computer tomograph) - The CT is not part of the new device.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment: Radiotherapy Department
Typical user: Physicist or other dosimetry expert
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)
Non-clinical tests were performed. The technology uses semiconductors which is widely used in dosimetry in radiation therapy. The new device is designed for conformance with IEC 601-1 (electrical isolation, leakage current) and IEC 601-1-2 (electromagnetic compatibility). Each unit is subject to final performance testing.
Clinical tests were not necessary; however, the device has been tested in a clinical environment.
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
© ScandiDos AB
JAN 1 2 2006
Document Title: 510(k):Summary Document ID: D001 04 003 02
Page
92(96)
PREDICATE DEVICES 3
| OmniPro I'mRT | |
|---|---|
| 510(k) number | K031634 |
| Trade name | OmniPro I'mRT |
| Intended Use | The intended use of the OmniPro I'mRT system is to: |
| Verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment Verify the intensity maps during IMRT delivery prior to treatment Verify the absolute dose in given points for IMRT fields. | |
| Company | Scanditronix Wellhöfer GmbH |
| Bahnhofstraße 5 | |
| D-90592 Schwarzenbruck | |
| Germany | |
| http://www.scanditronix-wellhofer.com/ |
| MapCheck | |
|---|---|
| 510(k) number | unknown |
| Trade Name | MapCheck |
| Intended Use | "The MapCHECK™ is a 2-dimensional therapy beam measurement system intended for quick and precise verification of the dose distribution resulting from an IMRT plan. Beam measurement is accomplished using a grid of 445 diode detectors that are housed between two sheets of solid acrylic. The MapCHECK measures the integrated ABSOLUTE dose at all detector locations, each of which has been corrected to the central detector sensitivity. This measured dose map is then automatically normalized and compared to a normalized imported treatment plan dose map, all in less than one minute." |
| (citet from the company's homepage: http://www.sunnuclear.com, MapCHECK Model 1175) | |
| Company | Sun Nuclear Corporation |
| 425-A Pineda Court | |
| Melbourne, FL 32940 | |
| USA | |
| www.sunnuclear.com |
| Dynamic Thorax Phantom | |
|---|---|
| 510(k) number | unknown |
| Trade Name | CIRS Model 008 Dynamic Thorax Phantom |
| Intended Use | "The CIRS Model 008 Dynamic Thorax Phantom is designed to investigate and minimize the |
| impact of organ motion and patient positioning errors in radiation therapy. It is the first | |
| commercially available dynamic QA phantom, developed for image acquisition, treatment | |
| planning and dose delivery." |
1
Document Title: 510(k):Summary
Document ID: 2920 D001 04 003 02 Page 9 3 (9 6)
| Dynamic Thorax Phantom | |
|---|---|
| (citet from the company's homepage http://www.cirsinc.com/, IMRT/IGRT | |
| 4D QA Phantom) | |
| Company | CIRS, Inc. |
| 2428 Almeda Avenue, Suite 212 | |
| Norfolk, VA 23513 | |
| USA | |
| http://www.cirsinc.com |
DESCRIPTION OF THE NEW DEVICE 4
The intended use of the new device is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumour tracking).
The new device consists out of:
- software .
- . phantom
- Detector arrays. .
- Multi-channel electrometer .
- Connection cables .
When measurements are to be performed the device is typically put on the patient table (or couch). Then the device is exposed typically from different angles.
Below the device is shown schematically in a typical environment. Note that the detector arrays are barely visible, since they are mounted inside the phantom. The software and connection cables are not shown.
Image /page/1/Picture/15 description: The image shows a medical device with several labeled components. The labels identify the 'Detector array', 'Electrometer', and 'Phantom' as parts of the device. The 'Accelerator gantry' and 'Patient couch' are explicitly noted as not being part of the device. The device appears to be used for medical imaging or treatment, possibly involving radiation.
2
C ScandiDos AB
Document Title: 510(k):Summary
KUS2920
Document ID: D001 04 003 02
General Challenge 4.1
The physicist wants to verify the dose-distribution in a patient.
However, in most cases it is not possible to measure the dose directly in the patient.
The principal solution is to substitute the patient with a phantom similar to the human body regarding size and physical properties like density or electron-density. Inside this phantom detectors are mounted. These detectors can measure the dose distribution when exposing the phantom to a patient specific treatment scheme.
Typical workflow in IMRT 4.2
-
- The phantom is scanned in a CT (computer tomograph). This needs to be done only once. The CT is not part of the new device.
- A plan for a specific patient is applied onto the phantom. This is done in a TPS (Treatment 2. Planning System). The TPS is not part of the new device.
- The dose distribution in the phantom is calculated by the TPS. 3.
- The calculated dose distribution is exported from the TPS to the new device's software. 4.
-
- The phantom - with the detector matrix mounted inside the phantom - is exposed with the patientspecific plan. The dose is measured and ready for analysis in the device's software.
- The calculated and the measured dose are compared inside the device's software. 6.
-
- A report is printed.
4.3 Typical workflow in 4DRT
The workflow is the same as for IMRT with the following exceptions:
- Not only one dose plan is calculated and applied. Two or more dose plans may be calculated per . patient. For example for respiratory gating two plans may be calculated representing two phases in the respiratory cycle; during one phase the beam shall be ON, during the other OFF..
- When exposing the phantom with the patient specific plan(s) trigger signals may be used to flag . the phase (e.g. beam on or beam off in the above example). The dose distribution is saved individually for the different phases and can be compared with the calculated dose distribution planned for the respective phase.
Scientific concept 4.4
The detectors in the detector array are semiconductors, no external voltage (as necessary for ion-chambers) is applied.
When irradiating semiconductors a current is created; this current is measured in the electrometer.
4.5 Material used
The phantom material is a plastic material that is
- . similar to human tissue regarding density and electron density
- non toxic (approved for food contact) .
ਦ INTENDED USE
The intended use of the product is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).
3
Document Title: 510(k):Summary Document ID: D001 04 003 02
Environment: Radiotherapy Department
Typical user: Physicist or other dosimetry expert
KOS2920
Contact with patient: No.
Note: Only one of the predicate devices, the dynamic thorax phantom, is explicitly intended for quality assurance in 4D RT.
It is an advantage that the new device not only can be used for quality assurance in IMRT but also in 4DRT.
- . The customer can automatically perform quality assurance in one single session. This avoids two exposures only because the IMRT measurement instruments must be substituted with a 4DRT measurement instrument.
TECHNOLOGICAL CHARACTERISTICS. 6
6.1 Detector(s)
The new device like one of the predicate devices use semiconductors as detectors, two predicate devices use other technologies like ionization chambers, TLDs or film (among others).
The advantages of semiconductors compared to ionization chambers are:
- . Small volume (The smaller the detector volume the better is the spatial resolution.)
- . No external high voltage
The advantages of semiconductors compared to films or TLD are:
- Readout with high time resolution possible .
- . Readout online
6.2 Phantom Material
The density and the electron density are all in the range of human tissue (between fat and bone).
6.3 Energy source
The energy source is the same for all devices (normal power outlet)
None of the devices delivers energy to the patient or the user.
NON-CLINICAL TESTS 7
The technology used is the same as used as in one of the predicate devices. This technology (semiconductors) is widely used in the field of dosimetry in radiation therapy, especially when measurements are to be performed on or in a patient (in vivo dosimetry). The most important reason for the latter is that this technology is seen as inherently safe due to the absence of high voltage. This technology is well known and explicit tests in laboratories are not necessary to show equivalence.
The following is done to minimize potential electrical risks:
- . The new device is designed for conformance with IEC 601-1 (electrical isolation, leakage current) and IEC 601-1-2 (electromagnetic compatibility)
- . Each unit is subject to final performance testing.
4
© ScandiDos AB
Document Title: 510(k):Summary
Kosz920
Document ID: D001 04 003 02
CLINICAL TESTS 8
Clinical tests are not necessary; however, the device has been tested in a clinical environment.
9 CONCLUSION
The new device is partly better, partly equivalent and in some cases identical with the predicate devices regarding safety, design and performance.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three abstract, curved shapes that resemble a stylized caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Matzen Diplom Physiker ScandiDos AB Dag Hammarskjölds väg 52A4 Uppsala Science Park Uppsala, SE-752 37 SWEDEN
Re: K052920
JAN 1 2 2006
Trade/Device Name: Delta4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 16, 2005 Received: December 19, 2005
Dear Mr. Matzen:
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.
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 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); 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.
6
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97): 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Higdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
© ScandiDos AB
| Document Title: | 510(k): Indication for Use | Document ID: | Page |
|---|---|---|---|
| Subject: | Pre-treatment System | K052920 | |
| D001 04 002 01 | 7_1 | ||
| Author: | Signature | Date | |
| Thomas Matzen | 2005-04-07 |
| Applicant | ScandiDos AB |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | Delta4 |
| Indications for Use: | The intended use of Delta4 is quality assurance of patient |
| specific treatment delivery prior to the treatment in IMRT and | |
| 4DRT (respiratory gating and tumor tracking). |
Prescription Use X (Part 21 CFR 801 Subpart D)
Image /page/7/Picture/3 description: The image shows the text "AND/OR". The word "AND" has a line drawn through it, indicating it is being crossed out or negated. The "OR" part of the text is not crossed out, suggesting it is the intended option.
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
management of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of
David R. Leggmm
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number