ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

K151426 · Scandidos AB · IYE · Jan 29, 2016 · Radiology

Device Facts

• Record ID: K151426
• Device Name: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
• Applicant: Scandidos AB
• Product Code: IYE · Radiology
• Decision Date: Jan 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

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.

Device Story

Device is a 2D semiconductor detector matrix for radiotherapy quality assurance (QA). Detector matrix is placed in the radiation field of a medical linear accelerator; radiation exposure generates signals; signals are transferred to a computer for analysis. Software compares measured dose distributions against planned treatment distributions. Used by medical physicists/technicians in clinical radiotherapy settings to verify treatment plan delivery and accelerator performance. Provides quantitative and subjective assessments of dose distribution; enables verification of respiratory gating and tumor tracking. Benefits include improved accuracy of radiation therapy delivery and validation of treatment planning systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing of performance characteristics.

Technological Characteristics

2D semiconductor detector matrix; acquisition, display, and analysis software. Designed to IEC 60601-1 and IEC 60601-1-2 standards. Operates by detecting radiation-induced signals in the linear accelerator field. Connectivity via computer interface for data processing.

Indications for Use

Indicated for quality assurance of patient-specific external radiotherapy treatment delivery (IMRT, VMAT, 4DRT) and radiation delivery system performance verification.

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

• PTW DAVID IMRT QC verification system (K062817)
• IBA Compass (K072374)

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

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.

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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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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) | <span> <span style="padding-right: 5px;">☒</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="padding-left: 20px;"> <span style="padding-right: 5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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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 | [phone] |
| Fax Number | [phone] |
| Name of official correspondent | Thomas Matzen |
| Date the summary<br>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<br>treatment plans |
| Device Classification Name | Medical charged-particle radiation therapy system<br>(§892.5050) |
| Product code | IYE |

## 3 PREDICATE DEVICES

| Predicate Devices | Registered<br>Establishment Number | 510(k) Premarket submission<br>number |
|------------------------------------------|------------------------------------|---------------------------------------|
| PTW DAVID IMRT QC<br>verification system | 9681124 | K062817 |
| IBA Compass | 9614952 | K072374 |

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| | ScandiDos | © ScandiDos AB | |
|-----------------|----------------------------------------|----------------|------------------------|
| Document Title: | FDA 510(k) - Summary - Delta4 Discover | Document ID: | Page |
| | | D012 04 016 01 | 002_06_2<br>(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.