(107 days)
Not Found
No
The summary describes a hardware device for radiation dose measurement and comparison, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a quality assurance tool for radiation delivery systems and treatment plans (IMRT, VMAT, 4DRT) and does not directly treat or diagnose a disease.
No
The device is used for quality assurance of treatment delivery and the radiation system, not for diagnosing patient conditions, diseases, or injuries.
No
The device description explicitly states it consists of "matrices of semiconductors embedded in a phantom" which are 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 focused on quality assurance of patient-specific treatment delivery and the radiation delivery system in radiotherapy. This involves measuring and verifying the physical delivery of radiation, not analyzing biological samples from a patient.
- Device Description: The device measures the interaction of radiation with semiconductors embedded in a phantom. This is a physical measurement of radiation dose, not a test performed on biological specimens.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) to provide information about a patient's health status. This device does not interact with or analyze any biological samples.
The device described is a quality assurance tool for radiotherapy equipment and treatment delivery, which falls under the category of medical devices used in the treatment process, but not as an in vitro diagnostic.
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 (from 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.
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 non-clinical 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
Image /page/0/Picture/1 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 image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2015
ScandiDos AB % Mr. Thomas Matzen Product Manager Dag Hammarskjölds väg 52A SE-75237 Uppsala SWEDEN
Re: K151180
Trade/Device Name: Delta" Phantom+ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 22, 2015 Received: July 22, 2015
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. 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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.'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
D017 04 008 07
-001061
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151180
Device Name Delta4 Phantom+
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| ScandiDos | © ScandiDos AB | ||
|---|---|---|---|
| This document may not be copied without the written consent of ScandiDos AB. | |||
| Document Title: | Confidential | ||
| FDA 510(k) - Summary - Delta4 | Document ID: | ||
| D017 04 010 02 | |||
| Phantom+ | |||
| Subject: | Delta4 Phantom+ | Page | |
| a-007_01_1 | |||
| (a-007_01_6) | |||
| Author: | Signature | Date | |
| Thomas Matzen |
D017 04 010 02 FDA 510(k) - Summary - Delta4 Phantom+.docx
| Version | Comment | Author | Description |
|---|---|---|---|
| 01.01 | 2015-04-27 | Thomas Matzen | First Draft |
| 01 | Released | Thomas Matzen | No changes |
| 02 | Released | Thomas Matzen | Corrected Spelling mistake in IEC standard |
| Added non-clinical test comparison |
APPLICANT 1
| 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 | 2015-07-17 |
| was prepared (yyyy-mm-dd) |
2 DEVICE
| Trade Name | Delta4 Phantom+ |
|---|---|
| Common Name | Pre-treatment Verification System (for Quality Assurance) |
| Classification Name | Medical charged-particle radiation therapy system, |
| §892.5050, Product code: IYE |
3 PREDICATE DEVICE
| Predicate Device | Delta4 |
|---|---|
| Listing Number | D002954 |
| 510(k) Premarket submission | |
| number | K052920 |
4
| Document Title: | Document ID: | Page |
|---|---|---|
| FDA 510(k) - Summary - Delta4 Phantom+ | D017 04 010 02 | a- 007_01_2 |
| (a-007_01_6) |
DESCRIPTION 4
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 (from 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.
5 COMPARISON
5.1 General
The Delta Phantom+ dosimetry system is an improved version of its predicate device Delta4.
The most obvious improvement is that the Delta4 Phantom+ dosimetry system is wireless: no power cables, no trig cable and no data cables.
Otherwise the principal design is left unchanged.
| Area | Delta4 (predicate
device) | Delta4 Phantom+ | Comment |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
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). | 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. | The intended use
definitions are almost
identical. However, the
text had been changed
slightly to ease
understanding.
VMAT is just a special
form of intensity
modulated treatment
and is by definition
included in "IMRT".
However, sometimes
"VMAT" is used as if it
was something
different. For
clarification VMAT is
named in the intended
use of Phantom+
explicitly. pre treatment delivery
quality assurance
includes quality
assurance of machine
parameters. For
clarification QA of the
radiation delivery system
is named explicitly in the
intended use of. |
5.2 Use context
5
| ScandiDos | |
|---|---|
| Document Title: |
|---|
| FDA 510(k) - Summary - Delta4 Phantom+ |
| Document ID:
D017 04 010 02 | Page
a- 007_01_3
(a-007_01_6) |
| -------------------------------- | ------------------------------------- |
|---|
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| 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 | N/A |
5.3 Energy
| Area | Delta4 (predicate
device) | Delta4 Phantom+ | Comment |
|---------------------|----------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power
supply | AC power socket | Battery powered.
(Rechargeable) Battery
is embedded in device. | While the predicate device
must be connected to the a
socket-outlet is the Delta4
Phantom+ dosimetry
system battery powered.
This makes it much more
convenient to set up the
device. |
| Energy
delivered | No energy is delivered to
user or patient | Same as predicate
device | N/A |
5.4 Performance, technology, materials
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| Operating principal | The device consists out of matrixes of semiconductors embedded in a phantom. These matrixes are inserted into the radiation field of a medical linear accelerator. If radiation (from 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. | Same as predicate device | N/A |
| Detector technology | Semiconductors | Same as predicate device | N/A |
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
| Detector placement | Two 2D arrays; the arrays are mounted in a 3D phantom | Same as predicate device | N/A |
| Shape: | |||
| Dimensions | |||
| Phantom | Cylinder, 22x40cm | Same as predicate device | N/A |
| Dimension phantom | |||
| including electronics | |||
| housings | Length: About 72cm Total height when in lowest position: about 36cm Center height when in lowest position: about 18cm | Length: About 71cm Total height when in lowest position: about 28cm Center height when in lowest position: about 15.5cm | Practically and from the safety and effectiveness point of view there is no difference between the devices regarding overall length. The new device has lower phantom supports. The new phantom supports do not block the longitudinal alignment laser at all. Therefore the set up and the alignment of the new device is more convenient, safer and more effective compared to the predicate device. The center height has been lowered by some centimeters in the new device. This increases the clearance between the linac and the treatment couch for beams from beneath the couch with reduced risk for collision between linac and couch - the set up of the new device is therefore safer, more convenient and more effective compared to the predicate device. |
| Weight | About 27kg | Same as predicate device | N/A |
| Main | |||
| Analysis | |||
| parameters | Dose Difference Distance to agreement Gamma index | Same as predicate device | N/A |
6
Document Title:
FDA 510(k) - Summary - Delta4 Phantom+
| Document ID: | D017 04 010 02 |
|---|---|
| Page | a- 007_01_4 (a-007 01 6) |
7
| Document Title: |
|---|
| FDA 510(k) - Summary - Delta4 Phantom+ |
| Document ID: | Page |
|---|---|
| D017 04 010 02 | a- 007_01_5 |
| (a-007_01_6) |
5.5 Communication
| Area | Delta4 (predicate
device) | Delta4 Phantom+ | Comment |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication
software ←→
access point/
router | Via an ethernet cable
connected the PC is
connected directly with
the access point/router. | Same as predicate device | N/A |
| Communication
Access point/
router ←→
measuring
hardware | Via Ethernet cables. | Wi-Fi 802.11n | By eliminating the
ethernet cable to the
hardware the risk for
entangling (rotating
gantry) has been
eliminated. This makes
the usage both safer and
also more convenient
and effective (set up is
much faster).
The communication
protocol used is a widely
spread standard protocol
(used in hospitals,
homes, offices)
guaranteeing a safe and
effective use of the new
device. |
5.6 (Safety) Standards met
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| Standards met | • IEC 61010-1 | ||
| • IEC 60601-1-2 | Same as predicate device | N/A |
5.7 Biocompatibility
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| General | Device is never in contact with patients | Same as predicate device | N/A |
| Compatibility of Phantom material | Good, see | ||
| 21CFR886.1385 | |||
| (PMMA) | Same as predicate device | N/A |
8
| © ScandiDos AB | |||
|---|---|---|---|
| Document Title: | |||
| FDA 510(k) - Summary - Delta4 Phantom+ | Document ID: | ||
| D017 04 010 02 | Page | ||
| a- 007_01_6 | |||
| (a-007_01_6) |
5.8 Compatibility with the environment and other devices, safety (mechanical, chemical, physical, thermal, radiation)
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| General | Device fulfils the essential requirements as defined in the “Council Directive 93/42/EEC of 14 June 1993 concerning medical devices” (MDD) | Same as predicate device | N/A |
5.9 Sterility
| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---|---|---|---|
| General | Device is not intended to be sterile | Same as predicate device | N/A |
5.10 Comparison with predicate
Comparison tests have been performed with the predicate device in clinical and non-clinical 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.
6 SUMMARY
The new device is superior or at least equivalent, in many cases identical with the predicate devices regarding safety, effectiveness, design and performance.