OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

K160405 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten · IYE · Oct 20, 2017 · Radiology

Device Facts

• Record ID: K160405
• Device Name: OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
• Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
• Product Code: IYE · Radiology
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The PTW OCTAVIUS System is used for dosimetry measurements in the context of a radiotherapy system, e.g. a medical linear accelerator (LINAC), electron or photon beams, a particle therapy system or a Cobalt-60 treatment machine. The device is intended for the measurement of dose distributions and the comparison with the data as calculated by the treatment planning system (patient plan verification) and/or for periodic quality assurance procedures according to the QA plan of the responsible medical physicist (e.g. constancy checks).

Device Story

OCTAVIUS system performs dosimetric quality assurance for radiotherapy. Input: radiation beam data collected via 2D ion chamber matrix array. Operation: detector array placed in static (cubic/octagonal) or linear rotational phantom; rotational phantom synchronizes with LINAC gantry using inclinometer data. Output: dose distribution measurements displayed and processed via software. Used in clinical radiotherapy environments by medical physicists/authorized personnel. Output used for patient plan verification and machine QA; does not control radiotherapy device. Benefits: ensures accuracy of treatment planning systems and radiotherapy machine performance.

Clinical Evidence

Bench testing only. No clinical data. Electrical safety and EMC testing performed per IEC 61010-1:2010, IEC 61326-1:2012, CISPR 11:2009+A1:2010, and 47 CFR Part 15 Subpart B. Software verification and validation conducted per FDA 2005 guidance.

Technological Characteristics

2D ion chamber matrix detector array; separate detector interface for data acquisition. Static (cubic/octagonal) or linear rotational phantom configurations. Inclinometer for gantry angle synchronization. Compliant with IEC 61010-1:2010 (electrical safety) and IEC 61326-1:2012 (EMC).

Indications for Use

Indicated for medical physicists or authorized personnel to perform IMRT patient plan verification, periodic QA/constancy checks, beam data analysis per international dosimetry protocols, and post-repair/replacement measurements on radiotherapy systems. Contraindicated for use while a patient is present or for diagnostic radiology.

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

• Sun Nuclear's “MapCHECK2” and “ArcCHECK” (K131466)

Submission Summary (Full Text)

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PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Dr. Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Str.7 Freiburg, 79115 BW GERMANY

October 20, 2017

Re: K160405

Trade/Device Name: OCTAVIUS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 29, 2017 Received: October 2, 2017

Dear Dr. Ats:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Ochs

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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#### Indications for Use

510(k) Number (if known) K160405

Device Name OCTAVIUS

Indications for Use (Describe)

The OCTA VIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:

- IMRT patient plan verification
- periodic QA procedures, e.g. constancy checks
- beam data analysis according to international therapy dosimetry protocols
- measurements after repair or replacement of major treatment unit components

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# OCTAVIUS System

### 510(k) premarket notification

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### 510(k) Summary

| 1. | Applicant: | PTW-Freiburg Physikalisch-Technische-Werkstaetten<br>Dr. Pychlau GmbH |
|-----|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | Loerracher Strasse 7<br>79115 Freiburg<br>Germany<br>www.ptw.de |
| 3. | Contact Person: | Dr. Sándor-Csaba Áts<br>Tel. [phone]<br>[e-mail] |
| 4. | Preparation Date: | September 5, 2017 |
| 5. | Device Name: | OCTAVIUS |
| 6. | Proprietary Name: | OCTAVIUS |
| 7. | Common Name: | Dosimetric Quality Assurance for Patient Specific Radiation<br>Treatment |
| 8. | Classification: | Regulation number: 21 CFR 892.5050<br>Name: Medical charged-particle radiation therapy system,<br>Product Code: IYE |
| 9. | Predicate Device: | Sun Nuclear's “MapCHECK2” and “ArcCHECK” (K131466) |
| 10. | Device Description: | The OCTAVIUS System is comprised of a two-dimensional ion<br>chamber based detector array, uniformly arranged as a matrix<br>and a separate detector interface for data acquisition. The detector<br>array can be placed either in a static cubic or octagonal<br>phantom or in a linear rotational phantom. For the measure-<br>ment of moving radiation sources (e.g. the rotating gantry of a<br>LINAC), the rotational phantom rotates synchronously with the<br>gantry. An inclinometer, fixed to the gantry, delivers the gantry<br>angle values which are used to align the rotating detector to the<br>gantry. The whole system is controlled with software for data<br>display and processing. |
| 11. | Intended Use: | The PTW OCTAVIUS System is used for dosimetry measure-<br>ments in the context of a radiotherapy system, e.g. a medical<br>linear accelerator (LINAC), electron or photon beams, a particle<br>therapy system or a Cobalt-60 treatment machine. The device<br>is intended for the measurement of dose distributions and the<br>comparison with the data as calculated by the treatment plan-<br>ning system (patient plan verification) and/or for periodic quality<br>assurance procedures according to the QA plan of the respon-<br>sible medical physicist (e.g. constancy checks). |
| 12. | Indications: | The OCTAVIUS System is intended to collect beam data for<br>patient plan verification of a treatment planning system (TPS)<br>and under the aspect of machine QA for the following purpos-<br>es:<br>– IMRT patient plan verification<br>– periodic QA procedures, e.g. constancy checks<br>– beam data analysis according to international therapy do-<br>simetry protocols<br>– measurements after repair or replacement of major treat-<br>ment unit components |
| 13. | Contraindications: | The OCTAVIUS System is for QA purposes and must not be<br>used while a patient is present.<br>It must not be used for Diagnostic Radiology.<br>The resulting measurement data is for data verification of the<br>patient plan and must not be used to control the radiotherapy<br>device by importing the data into the therapy patient plan. |
| 14. | Intended User: | The OCTAVIUS System must be used only by qualified per-<br>sonnel, usually the medical physicists responsible for the radio-<br>therapy system or an authorized person. |
| 15. | Substantial equivalence | The characteristics of this device are similar to those of the<br>predicate devices identified on the comparison chart, which is<br>provided with the premarket notification submission. It is our<br>opinion that the OCTAVIUS does not have technological char-<br>acteristics that raise additional types of questions related to<br>terms of safety and effectiveness. |
| | Differences to the predicate devices: | OCTAVIUS provide ion chambers for radiation detection while<br>predicate devices utilize semiconductor technology.<br>Both methods are used since many years and provide equal<br>performance and accuracy.<br>No additional safety issue is raised by using different detector<br>types. |
| 16. | Performance Data: | The FDA has not published any performance standards for this<br>product. |
| | Biocompatibility: | The device is used for pre-treatment quality assurance while no<br>patient is present. Since the contact of the operator with the<br>device occurs only with uninjured skin and the surface of the<br>device components contains no critical material, the contact<br>with the operator is biologically uncritical. |
| | Electrical & mechanical<br>safety and electromagnetic<br>compatibility (EMC): | Electrical safety and EMC testing were conducted by inde-<br>pendent test laboratories. OCTAVIUS is certified as in compli-<br>ance with IEC 61010-1:2010 (with no patient contact of the<br>product the focus is directed to user safety) and IEC 61326-<br>1:2012 (emission and immunity) / CISPR 11:2009+A1:2010<br>(RF technology) and 47 CFR Part 15 Subpart B. |

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# OCTAVIUS System

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#### 510(k) premarket notification

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## OCTAVIUS System

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effectiveness.

Image /page/5/Picture/2 description: This document excerpt discusses software verification and validation testing, as well as bench and non-clinical testing. It mentions that software verification and validation testing results were conducted and submitted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). The document also states that verification and validation testing demonstrated that OCTAVIUS fulfills the design specification and its intended use. The document concludes that the PTW OCTAVIUS System is as safe and effective as the predicate device and that the application is as well or better.

to the use the device do not raised new questions of safety and