ScandiDos Delta4 Phantom+

K151180 · Scandidos AB · IYE · Aug 19, 2015 · Radiology

Device Facts

• Record ID: K151180
• Device Name: ScandiDos Delta4 Phantom+
• Applicant: Scandidos AB
• Product Code: IYE · Radiology
• Decision Date: Aug 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

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.

Device Story

Delta4 Phantom+ is a dosimetry system for radiotherapy quality assurance. It consists of semiconductor detector matrices embedded in a cylindrical PMMA phantom. The device is placed in the radiation field of a medical linear accelerator. When radiation hits the semiconductors, they generate signals that are transmitted via Wi-Fi (802.11n) to a computer. The system analyzes the data, comparing measured dose distributions against intended treatment plans. It is operated by medical physicists or dosimetrists in a clinical setting. The device is battery-powered and wireless, eliminating cables to improve safety by preventing entanglement with the gantry and reducing setup time. Lowered phantom supports increase clearance between the linac and treatment couch, reducing collision risks. Output allows clinicians to verify treatment delivery accuracy, ensuring the radiation delivery system functions correctly before patient treatment, thereby enhancing patient safety.

Clinical Evidence

Bench testing and comparative clinical performance evaluations were conducted. Pre-treatment verification measurements of numerous treatment plans were performed using both the Delta4 Phantom+ and the predicate Delta4 device. Results showed very good correlation between the two systems, confirming that the new device is equivalent in performance and effectiveness.

Technological Characteristics

Semiconductor detector matrices embedded in a PMMA phantom (22x40cm cylinder). Battery-powered with wireless Wi-Fi 802.11n communication. Complies with IEC 61010-1 and IEC 60601-1-2. Non-sterile device.

Indications for Use

Indicated for quality assurance of patient-specific radiotherapy treatment delivery (IMRT, VMAT, 4DRT) and radiation delivery system performance. Intended for use by healthcare professionals, such as medical physicists or dosimetrists, trained in the device's safe operation.

Regulatory Classification

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.

Predicate Devices

• Delta4 (K052920)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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D017 04 008 07

-001*06*1

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)

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| ScandiDos | | © ScandiDos AB | |
|--------------------------------------|-----------------|------------------------------------------------------------------------------|------------------------------------|
| | | This document may not be copied without the written consent of ScandiDos AB. | |
| Document Title: | | | Confidential |
| <b>FDA 510(k) - Summary - Delta4</b> | | | Document ID:<br>D017 04 010 02 |
| <b>Phantom+</b> | | | |
| Subject: | Delta4 Phantom+ | | Page<br>a-007_01_1<br>(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<br>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 | [phone] |
| Fax Number | [phone] |
| | |
| 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,<br>§892.5050, Product code: IYE |

# 3 PREDICATE DEVICE

| Predicate Device | Delta4 |
|---------------------------------------|---------|
| Listing Number | D002954 |
| 510(k) Premarket submission<br>number | K052920 |

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| Document Title: | Document ID: | Page |
|----------------------------------------|----------------|-----------------------------|
| FDA 510(k) - Summary - Delta4 Phantom+ | D017 04 010 02 | a- 007_01_2<br>(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<br>device) | Delta4 Phantom+ | Comment |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The intended use of<br>Delta4 is<br><br>quality assurance of<br>patient specific treatment<br>delivery prior to the<br>treatment in IMRT and<br>4DRT (respiratory gating<br>and tumor tracking). | The intended use of<br>the device is<br>quality assurance of<br>patient specific<br>treatment delivery<br>prior to the<br>treatment in IMRT<br>(including VMAT)<br>and 4DRT (e.g.<br>respiratory gating<br>and tumour<br>tracking). quality assurance of<br>the radiation<br>delivery system. | The intended use<br>definitions are almost<br>identical. However, the<br>text had been changed<br>slightly to ease<br>understanding.<br>VMAT is just a special<br>form of intensity<br>modulated treatment<br>and is by definition<br>included in "IMRT".<br>However, sometimes<br>"VMAT" is used as if it<br>was something<br>different. For<br>clarification VMAT is<br>named in the intended<br>use of Phantom+<br>explicitly. pre treatment delivery<br>quality assurance<br>includes quality<br>assurance of machine<br>parameters. For<br>clarification QA of the<br>radiation delivery system<br>is named explicitly in the<br>intended use of. |

#### 5.2 Use context

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| ScandiDos | |
|-----------|--|
| | |

| Document Title: |
|----------------------------------------|
| FDA 510(k) - Summary - Delta4 Phantom+ |

| Document ID:<br>D017 04 010 02 | Page<br>a- 007_01_3<br>(a-007_01_6) |
|--------------------------------|-------------------------------------|
|--------------------------------|-------------------------------------|

| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------|
| <b>Intended User</b> | 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<br>device) | Delta4 Phantom+ | Comment |
|---------------------|----------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power<br>supply | AC power socket | Battery powered.<br>(Rechargeable) Battery<br>is embedded in device. | While the predicate device<br>must be connected to the a<br>socket-outlet is the Delta4<br>Phantom+ dosimetry<br>system battery powered.<br>This makes it much more<br>convenient to set up the<br>device. |
| Energy<br>delivered | No energy is delivered to<br>user or patient | Same as predicate<br>device | N/A |

# 5.4 Performance, technology, materials

| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Operating principal</b> | 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 |
| <b>Detector technology</b> | 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:<br>Dimensions<br>Phantom | Cylinder, 22x40cm | Same as predicate device | N/A |
| Dimension phantom<br>including electronics<br>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<br>Analysis<br>parameters | Dose Difference Distance to agreement Gamma index | Same as predicate device | N/A |

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# Document Title:
FDA 510(k) - Summary - Delta4 Phantom+

| Document ID: | D017 04 010 02 |
|--------------|--------------------------|
| Page | a- 007_01_4 (a-007 01 6) |

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| 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<br>device) | Delta4 Phantom+ | Comment |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication<br>software ←→<br>access point/<br>router | Via an ethernet cable<br>connected the PC is<br>connected directly with<br>the access point/router. | Same as predicate device | N/A |
| Communication<br>Access point/<br>router ←→<br>measuring<br>hardware | Via Ethernet cables. | Wi-Fi 802.11n | By eliminating the<br>ethernet cable to the<br>hardware the risk for<br>entangling (rotating<br>gantry) has been<br>eliminated. This makes<br>the usage both safer and<br>also more convenient<br>and effective (set up is<br>much faster).<br>The communication<br>protocol used is a widely<br>spread standard protocol<br>(used in hospitals,<br>homes, offices)<br>guaranteeing a safe and<br>effective use of the new<br>device. |

# 5.6 (Safety) Standards met

| Area | Delta4 (predicate device) | Delta4 Phantom+ | Comment |
|---------------|----------------------------------|--------------------------|---------|
| Standards met | • IEC 61010-1<br>• 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<br>21CFR886.1385<br>(PMMA) | Same as predicate device | N/A |

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| | © ScandiDos AB | | |
|-----------------------------------------------------------|----------------|--------------------------------|-------------------------------------|
| Document Title:<br>FDA 510(k) - Summary - Delta4 Phantom+ | | Document ID:<br>D017 04 010 02 | Page<br>a- 007_01_6<br>(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.