(103 days)
Not Found
No
The description focuses on hardware (semiconductors, phantom) and basic signal analysis and comparison, with no mention of AI/ML terms or concepts.
No
The device is used for quality assurance of radiation delivery systems and patient-specific treatment delivery, not for direct therapeutic intervention on a patient.
No
Explanation: The device is used for quality assurance of treatment delivery and radiation systems, not for diagnosing patient conditions. It compares actual dose distribution with intended dose distribution, which is a quality control function.
No
The device description explicitly states it consists of "matrices of semiconductors embedded in a phantom" which are physical hardware components. The software is used to analyze the signal from these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "quality assurance of patient specific treatment delivery" and "quality assurance of the radiation delivery system." This is focused on verifying the accuracy and performance of a medical device (the linear accelerator) and the treatment plan, not on analyzing biological samples from a patient to diagnose or monitor a medical condition.
- Device Description: The device measures radiation hitting semiconductors embedded in a phantom. This is a physical measurement of radiation dose distribution, not an analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts with radiation, not with patient samples.
Therefore, this device falls under the category of a medical device used for quality assurance in radiotherapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device is
- quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).
- quality assurance of the radiation delivery system.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation firom a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.
The new device Delta4 Phantom+ MR is equivalent in form and function to the cleared device Delta4 Phantom+, but has been verified as an MR-conditional product.
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
The intended user is a health care professional in the field of radiotherapy like a medical physicist or a dosimetrist who have been educated in the safe use of the device.
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)
Comparison tests have been performed with the predicate device in clinical and nonclinical situations.
Among others pre-treatment verification measurements of numerous treatment plans have been performed with both the new device and the predicate device. The results were compared with each other and it was determined that the results had very good correlation.
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
K183606
Confidential
This document may not be copied without the written consent of ScandiDos AB.
| Document Title: | FDA 510(k) - Summary - Delta4
Phantom+ MR | |
|-----------------|------------------------------------------------------|------|
| Subject: | Delta4 Phantom+ MR | |
| Document ID: | D017 04 074 01 | |
| Page | 002_06_1
(002_06_5) | |
| Author: | Signature | Date |
| Thomas Matzen | | |
D017 04 074 01 FDA 510(k) - Summary - Delta4 Phantom+ MR.docx
| Version | Comment | Author | Description |
|---|---|---|---|
| 01 | released | Thomas Matzen | First Version |
1 APPLICANT
| 510(k) owner's Name | ScandiDos AB |
|---|---|
| Street address | Dag Hammarskjölds väg 52A |
| Postal Code, City | SE-75237 Uppsala |
| Country | Sweden |
| Phone Number | +46-18-472 30 30 |
| Fax Number | +46-18-10 74 02 |
| Name of official correspondent | Thomas Matzen |
| Date the summary | |
| was prepared (yyyy-mm-dd) | 2018-11-21 |
2 DEVICE
| Trade Name | Delta4 Phantom+ MR |
|---|---|
| Common Name | Pre-treatment Verification System (for Quality Assurance) |
| Classification Name | Medical charged-particle radiation therapy system, |
| 8892.5050. Product code: IYE |
3 PREDICATE DEVICE
| Predicate Device | Delta4 |
|---|---|
| 510(k) Premarket submission number | K151180 |
1
| Document Title: | FDA 510(k) - Summary - Delta4 Phantom+ MR |
|---|---|
| Document ID: | D017 04 074 01 |
| Page | 002_06_2 |
| (002_06_5) |
4 DESCRIPTION
The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation firom a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.
The new device Delta4 Phantom+ MR is equivalent in form and function to the cleared device Delta4 Phantom+, but has been verified as an MR-conditional product.
5
COMPARISON WITH THE PREDICATE DEVICE
| Area | Delta4 Phantom+
(predicate device) | Delta4
Phantom+ MR
(new device) | Comparison |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------|
| Intended
Use | The intended use of the device is
• quality assurance of patient specific
treatment delivery prior to the
treatment in IMRT (including
VMAT) and 4DRT (e.g.
respiratory gating and tumour
tracking).
• quality assurance of the radiation
delivery system. | Same as
predicate
device. | Both the new and the
predicate device have
the same intended use. |
| Intended
User | The intended user is a health care
professional in the field of
radiotherapy like a medical physicist
or a dosimetrist who have been
educated in the safe use of the device. | Same as
predicate
device. | Both the new and the
predicate device have
the same intended
User. |
5.1 Use context
5.1.1 Identical for both devices
The use context regarding
- patient contact (no patient contact)
- spatial use (professional healthcare environment)
- . social use (users are only health care professionals who have been educated in the safe use of the device)
- Hygienic use (clean but not sterile)
- general physical use (controlled environmental conditions, no sharp accelerations) o
- activity use (set up, power on, treatment plan delivery for QA purpose) ●
are identical for the new and the predicate device.
5.1.2 Differences
There are differences regarding physical use context regarding strong magnetic fields: The predicate device is MR unsafe and is never used in strong magnetic fields. The new device is MR conditional and can be used in strong magnetic fields (typically between 0.35T and 1.5T). The
2
| © ScandiDos AB | |
| Document Title: | FDA 510(k) - Summary - Delta4 Phantom+ MR |
| Document ID: | D017 04 074 01 |
| Page | 002_06_3 |
| (002 06 5) |
new device uses non-ferromagnetic materials (like aluminium) instead of ferromagnetic material (as found in the predicate device).
5.2 Energy
5.2.1 Identical for both devices
- Neither the new nor the predicate device deliver energy to the patient. .
- Both the new and the predicate device have the same software functionality regarding power supply operation:
- o The software recognizes if the device is powered on and displays information about the connected hardware.
- If the connected device is powered OFF the software informs the user that there o is no working hardware connected.
5.2.2 Differences
The predicate device can be battery powered via a power supply unit. The battery is not MR conditional. Therefore the battery powered option is NOT available for the new device. The new device is always powered via the power supply unit (the same unit as used by the predicate device). Moreover the power cable has been prolonged in the new device so that the power supply unit can be placed outside the strong magnetic field of the MR-linac, e.g. outside the treatment room.
For obvious reasons battery status is not available for the new device in the software.
5.3 Design, Dimensions, Material
5.3.1 Identical for both devices
The parameters regarding
- Measurement phantom shape and dimension (cylinder, 22cm x 40cm)
- Phantom length including electronics (about 71cm)
- Phantom weight (about 27 kg)
- o Phantom material (PMMA or Plastic Water)
- Detector placement (two 2D arrays, perpendicular to each other)
- . Default detector array orientation (sagittal/coronal)
are identical for the new and the predicate device.
5.3.2 Differences
The new device has an additional housing with some electronic parts, which in the predicate device are found within the same housing as the rest of the additional housing in the new device contains components that work more satisfactorily when placed outside the strong magnetic field.
5.4 Performance, technology, communication
5.4.1 Identical for both devices
The following parameter are identical for both the new and the predicate device:
3
| ScandiDos | © ScandiDos AB |
|---|---|
| Document Title: | FDA 510(k) - Summary - Delta4 Phantom+ MR |
| Document ID: | D017 04 074 01 |
| Page | 002_06_4 |
| (002_06_5) |
- operating principal (detectors creating a signal in the radiation field of a medical linear ● accelerator, signal is transferred to computer program where it is analysed)
- o Detector technology (semiconductors)
- Measured quantity (Dose)
- . Software analysis (comparing measured with calculated dose)
- Main analysis parameters (Dose difference, distance to agreement, gamma index)
- communication between PC and router (ethernet cable)
5.4.2 Differences
- The predicate device software supports the predicate device. The software of the new device supports in addition also the new device. The new device is treated in the same way as the predicate device in the software. All functionality available for the predicate hardware is now available for the new device, no software functionality had to been added. The use of the software in combination with the new hardware is as efficient and as safe as with the predicate hardware.
- Communication between measuring hardware and accesspoint/router: The predicate device uses Wi-Fi 802.11n communication. To allow a stable communication between hardware and PC in areas with strong magnetic fields the new device relies on standard ethernet cables instead.
5.5 Standards met
5.5.1 Identical for both devices
Both devices meet IEC 61010-1 and IEC 60601-1-2.
5.5.2 Differences
Additionally the device is conform to ASTM F2052. The predicate has not been designed to be MR conditional. Small modifications (like substituting ferromagnetic parts with non-magnetic parts) made it possible to create the new (MR conditional) device.
5.6 Biocompatibility
5.6.1 Identical for both devices
Neither of the devices is in contact with patient or body fluids.
5.7 Compatibility with the environment and other devices, safety (mechanical, chemical, physical, thermal, radiation)
5.7.1 Identical for both devices
Neither of the devices is an accessory to another medical device.
Both devices work according to their intended use without being connected to other medical devices.
5.7.2 Differences
The predicate device is MR unsafe. The new device is MR conditional. This has been achieved by substituting some ferromagnetic materials in the predicate device with non-ferromagnetic materials.
4
| ScandiDos | ||
|---|---|---|
Document Title:
5.8 Sterility
5.8.1 Identical for both devices
Neither of the devices is intended to be sterile.
5.9 Performance: comparison with Predicate
Comparison tests have been performed with the predicate device in clinical and nonclinical situations.
Among others pre-treatment verification measurements of numerous treatment plans have been performed with both the new device and the predicate device. The results were compared with each other and it was determined that the results had very good correlation.
SUMMARY 6
The new device is equivalent, in most cases identical with the predicate devices regarding safety, design and performance.
Whereas the predicate device is MR unsafe the new device is MR conditional. This has been achieved by substituting the few existing ferromagnetic parts with non-magnetic parts (like aluminium). This change does in no way effect the safety, usability or effectiveness in a negative way.
5
0020401
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183606
Device Name Delta4 Phantom+ MR
Indications for Use (Describe)
The intended use of the device is
· quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).
· quality assurance of the radiation delivery system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
6
April 8, 2019
Image /page/6/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
ScandiDos AB Thomas Matzen Manager QA, RA Dag Hammarskjölds väg 52A Uppsala, 752 37 Se
Re: K183606
Trade/Device Name: Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: February 21, 2019 Received: February 25, 2019
Dear Thomas 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 you, 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 of medical device-related adverse events) (21 CFR 803) for
7
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure