(612 days)
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No
The document describes a hardware system for radiation dose measurement and verification, controlled by software for data display and processing. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is used for quality assurance and verification of treatment planning systems and radiotherapy machines, not for direct treatment or diagnosis of patients.
No
Explanation: The OCTAVIUS System is indicated for collecting beam data for patient plan verification and machine QA in radiotherapy, not for diagnosing patient conditions.
No
The device description explicitly states that the system is comprised of a two-dimensional ion chamber based detector array and a separate detector interface for data acquisition, which are hardware components. While software is mentioned for control, it is part of a larger hardware system.
Based on the provided information, the OCTAVIUS System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for collecting beam data for patient plan verification and machine QA in radiotherapy. This involves measuring radiation output and characteristics, not analyzing biological samples from the human body.
- Device Description: The device description details a system for measuring radiation, including detector arrays, phantoms, and software for data acquisition and processing. There is no mention of components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The OCTAVIUS System does not perform any such analysis.
Therefore, the OCTAVIUS System falls under the category of a medical device used in radiotherapy, specifically for quality assurance and verification of treatment delivery, but it is not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The OCTAVIUS System is comprised of a two-dimensional ion chamber based detector array, uniformly arranged as a matrix and a separate detector interface for data acquisition. The detector array can be placed either in a static cubic or octagonal phantom or in a linear rotational phantom. For the mea-surement of moving radiation sources (e.g. the rotating gantry of a LINAC), the rotational phantom rotates synchronously with the gantry. An inclinometer, fixed to the gantry, delivers the gantry angle values which are used to align the rotating detector to the gantry. The whole system is controlled with software for data display and processing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The OCTAVIUS System must be used only by qualified personnel, usually the medical physicists responsible for the radio-therapy system or an authorized person.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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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
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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3
OCTAVIUS System
510(k) premarket notification
Image /page/3/Picture/2 description: The image shows a logo with the letters PTW in a stylized font. The letters are black and outlined, with a red triangle pointing downwards above the letter T. The logo is contained within a black rectangular border.
510(k) Summary
| 1. | Applicant: | PTW-Freiburg Physikalisch-Technische-Werkstaetten
Dr. Pychlau GmbH |
|-----|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | Loerracher Strasse 7
79115 Freiburg
Germany
www.ptw.de |
| 3. | Contact Person: | Dr. Sándor-Csaba Áts
Tel. +49 (0) 761 49055 896
sandor.ats@ptw.de |
| 4. | Preparation Date: | September 5, 2017 |
| 5. | Device Name: | OCTAVIUS |
| 6. | Proprietary Name: | OCTAVIUS |
| 7. | Common Name: | Dosimetric Quality Assurance for Patient Specific Radiation
Treatment |
| 8. | Classification: | Regulation number: 21 CFR 892.5050
Name: Medical charged-particle radiation therapy system,
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
chamber based detector array, uniformly arranged as a matrix
and a separate detector interface for data acquisition. The detector
array can be placed either in a static cubic or octagonal
phantom or in a linear rotational phantom. For the measure-
ment of moving radiation sources (e.g. the rotating gantry of a
LINAC), the rotational phantom rotates synchronously with the
gantry. An inclinometer, fixed to the gantry, delivers the gantry
angle values which are used to align the rotating detector to the
gantry. The whole system is controlled with software for data
display and processing. |
| 11. | Intended Use: | The PTW OCTAVIUS System is used for dosimetry measure-
ments 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 plan-
ning system (patient plan verification) and/or for periodic quality
assurance procedures according to the QA plan of the respon-
sible medical physicist (e.g. constancy checks). |
| 12. | Indications: | The OCTAVIUS 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 purpos-
es:
– IMRT patient plan verification
– periodic QA procedures, e.g. constancy checks
– beam data analysis according to international therapy do-
simetry protocols
– measurements after repair or replacement of major treat-
ment unit components |
| 13. | Contraindications: | The OCTAVIUS System is for QA purposes and must not be
used while a patient is present.
It must not be used for Diagnostic Radiology.
The resulting measurement data is for data verification of the
patient plan and must not be used to control the radiotherapy
device by importing the data into the therapy patient plan. |
| 14. | Intended User: | The OCTAVIUS System must be used only by qualified per-
sonnel, usually the medical physicists responsible for the radio-
therapy system or an authorized person. |
| 15. | Substantial equivalence | The characteristics of this device are similar to those of the
predicate devices identified on the comparison chart, which is
provided with the premarket notification submission. It is our
opinion that the OCTAVIUS does not have technological char-
acteristics that raise additional types of questions related to
terms of safety and effectiveness. |
| | Differences to the predicate devices: | OCTAVIUS provide ion chambers for radiation detection while
predicate devices utilize semiconductor technology.
Both methods are used since many years and provide equal
performance and accuracy.
No additional safety issue is raised by using different detector
types. |
| 16. | Performance Data: | The FDA has not published any performance standards for this
product. |
| | Biocompatibility: | The device is used for pre-treatment quality assurance while no
patient is present. Since the contact of the operator with the
device occurs only with uninjured skin and the surface of the
device components contains no critical material, the contact
with the operator is biologically uncritical. |
| | Electrical & mechanical
safety and electromagnetic
compatibility (EMC): | Electrical safety and EMC testing were conducted by inde-
pendent test laboratories. OCTAVIUS is certified as in compli-
ance with IEC 61010-1:2010 (with no patient contact of the
product the focus is directed to user safety) and IEC 61326-
1:2012 (emission and immunity) / CISPR 11:2009+A1:2010
(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
Image /page/5/Picture/1 description: The image shows the text "510(k) premarket notification". The text is in bold and is centered in the image. The text is likely a title or heading for a document or presentation.
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