(246 days)
Not Found
No
The summary describes a hardware device with associated software for comparing planned and measured dose distributions, but there is no mention of AI or ML techniques being used for this comparison or analysis.
No
The device is described as a "quality assurance (QA) device" used to "check delivered treatment plans" and "mapping of therapeutic radiation dose distributions." It does not directly treat or diagnose a disease.
No
The device is described as a "quality assurance (QA) device" used to check the delivery of radiation therapy, not to diagnose a patient's medical condition. It evaluates the performance of the treatment system and planning, rather than providing information about a disease or health state.
No
The device description explicitly states it consists of a "2-dimensional matrix of semiconductors" which is a hardware component, in addition to the 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is used for quality assurance of radiation therapy equipment and treatment delivery. It measures radiation dose distributions externally to the patient, within the radiation field of a medical linear accelerator. It does not analyze biological samples from a patient.
- Intended Use: The intended use clearly states "quality assurance of patient specific treatment delivery during and before external radiotherapy treatment" and "quality assurance of the radiation delivery system." This is focused on the performance of the medical equipment and the accuracy of the delivered radiation, not on diagnosing or monitoring a patient's health condition through biological samples.
Therefore, this device falls under the category of a medical device used for quality control and assurance in radiation therapy, 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 during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (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 is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes.
The device consists of a 2-dimensional matrix of semiconductors and associated acquisition, display and analysis computer programs. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used in both quantitative and subjective assessments of the performance of radiation therapy treatment planning systems and therapeutic radiation delivery systems.
The detector matrix is inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the detectors a signal is created and transferred to a computer where it is evaluated (e.g. by comparing planned with measured dose distributions).
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
Not Found
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)
Not Found
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 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2016
ScandiDos AB % Mr. Thomas Matzen Product Manager Dag Hammarskjolds vag 52A Uppsala, SE-75237 Uppsala Lan SWEDEN
Re: K151426
Trade/Device Name: "Delta Discover, and "Delta" Discover+" Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 28, 2015 Received: December 28, 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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a sequence of handwritten numbers and letters. The sequence starts with "D012", followed by "04", then "045", and ends with "01". All the characters are written in blue ink and appear to be on a white background.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151426
Device Name "Delta4 Discover" and "Delta4 Discover+"
Indications for Use (Describe)
The intended use of the device is
· quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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.
Confidential
| Document Title: | FDA 510(k) - Summary - Delta4 Discover | Document ID: | Page |
|---|---|---|---|
| Subject: | Delta4 Discover | D012 04 016 01 | 002_06_1 (002_06_2) |
| Author: | Signature | Date | Thomas Matzen |
D012 04 016 01 FDA 510(k) - Summary - Delta4 Discover.docx
| Version | Comment | Author | Description |
|---|---|---|---|
| 01 | Released | Thomas Matzen | First release |
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) | 2015-05-20 |
2 DEVICE
| Trade Name | "Delta4 Discover" and "Delta4 Discover+" |
|---|---|
| Common/Usual Name | QA device for verification of radiotherapy treatments and |
| treatment plans | |
| Device Classification Name | Medical charged-particle radiation therapy system |
| (§892.5050) | |
| Product code | IYE |
3 PREDICATE DEVICES
| Predicate Devices | Registered
Establishment Number | 510(k) Premarket submission
number |
|------------------------------------------|------------------------------------|---------------------------------------|
| PTW DAVID IMRT QC
verification system | 9681124 | K062817 |
| IBA Compass | 9614952 | K072374 |
4
| ScandiDos | © ScandiDos AB | ||
|---|---|---|---|
| Document Title: | FDA 510(k) - Summary - Delta4 Discover | Document ID: | Page |
| D012 04 016 01 | 002_06_2 | ||
| (002 06 2) |
4 DESCRIPTION OF THE DEVICE
The device is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes.
The device consists of a 2-dimensional matrix of semiconductors and associated acquisition, display and analysis computer programs. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used in both quantitative and subjective assessments of the performance of radiation therapy treatment planning systems and therapeutic radiation delivery systems.
The detector matrix is inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the detectors a signal is created and transferred to a computer where it is evaluated (e.g. by comparing planned with measured dose distributions).
5 INTENDED USE OF THE DEVICE
The intended use of the device is
- o quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)
- quality assurance of the radiation delivery system. .
6
SAFETY AND ESSENTIAL PERFORMANCE
The new device is designed in full accordance with the applicable sections of the following standards:
- IEC 60601-1
- . IEC 60601-1-2
7
TECHNOLOGICAL COMPARISON WITH THE PREDICATE DEVICES
All devices are intended for quality assurance of patient specific treatment delivery and quality assurance of the radiation delivery system.
Based on the technological characteristics, the intended use, safety and effectiveness, essential performance, performance the new device is substantially equivalent to the predicate devices.
The documentation submitted for review supports this claim.
8 SUMMARY
The new device is superior or at least equivalent with the predicate devices regarding safety, design and performance.