(106 days)
Not Found
No
The description focuses on dose calculation and quality assurance based on measurements and treatment plans, without mentioning AI or ML algorithms.
No
The device is used for quality assurance and plan verification in radiation therapy, calculating dose and measuring radiation fields, not for directly treating a patient.
No
COMPASS is used for quality assurance and plan verification in radiation therapy, calculating dose distribution and performing QA tests on the radiation delivery system. It does not diagnose medical conditions.
No
The device description explicitly mentions the use of "electronic 2D devices, including transmission detector" and "electronic 2D devices, preferably with transmission detector," which are hardware components used for measuring radiation fields. While the system performs calculations and analysis (software functions), it relies on and integrates with physical measurement hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states that COMPASS is used for quality assurance and plan verification in external beam radiation therapy. It computes dose distributions based on treatment plans and measurements of radiation fields. It also performs QA tests on the radiation delivery system.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from a patient. Its function is related to the delivery and verification of radiation therapy, not the analysis of patient samples for diagnostic purposes.
Therefore, based on the intended use and device description, COMPASS falls under the category of a radiation therapy quality assurance and verification device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
COMPASS is used for quality assurance and plan verification in external beam radiation therapy for multileaf collimated fields and intensity modulated fields.
It computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom. The calculation is based on read-in treatment plans, and additionally on online or offline measurements of radiation fields with radiation-transparent or non-transparent, 2 dimensional multi-element ionization chamber arrays.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The system is intended to be used with intensity modulated radiation therapy, delivered with high energy x-ray beams from an isocentric gantry linear accelerator. The modulation of these beams shall be accomplished by means of MLCs and Jaws.
The aim is to measure the fluences of the applied fields by means of electronic 2D devices, including transmission detector which can be used during patient irradiation. Alternatively the fluences can be calculated from a computation independent from the original TPS, using segmentation data from the TPS or a delivery log file.
Furthermore, the intention of the system is to recalculate the resulting dose distribution in a phantom or, using patient anatomy data, in a patient.
Moreover, the system allows performing QA tests on the radiation delivery system. When the system is used together with electronic 2D devices, preferably with transmission detector, it can also provide sensitivity calibration and performance tests on EPID systems.
Finally, the system will provide online information about the quality of the delivery, both on a delivery system level (e.g. leaf positioning accuracy, dose per segment accuracy) as on the patient level (resulting dose distribution). In case of discrepancies, corrective action (adjusted plan for further fractions) shall be proposed.
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
Prescription Use
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.
K062817 David (PTW), K031634 OmniPro I'mRT (Scanditronix Wellhöfer), K012227 muCheck (Oncology Data Systems, Inc.), Delta4 (Scandidos AB)
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
5.1 510(k) owner
Scanditronix Wellhöfer GmbH Bahnhofstrasse 5 90592 Schwarzenbruck Germany
Tel: +49 9128 607 0 Fax: +49 9128 607 10
5.2 Contact person
Martin Arold
5.3 Preparation date
15/08/2007
5.4 Trade name
Compass
5.5 Common name
Accelerator, linear, medical
5.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code IYE)
5.7 Predicate devices
K062817 David (PTW), K031634 OmniPro I'mRT (Scanditronix Wellhöfer), K012227 muCheck (Oncology Data Systems, Inc.), Delta4 (Scandidos AB)
5.8 Device description
The system is intended to be used with intensity modulated radiation therapy, delivered with high energy x-ray beams from an isocentric gantry linear accelerator. The modulation of these beams shall be accomplished by means of MLCs and Jaws.
The aim is to measure the fluences of the applied fields by means of electronic 2D devices, including transmission detector which can be used during patient irradiation. Alternatively the fluences can be calculated from a computation independent from the original TPS, using segmentation data from the TPS or a delivery log file.
Furthermore, the intention of the system is to recalculate the resulting dose distribution in a
DEC 0 7 2007
1
| Compass | FDA Report 510(k) Submission | P-05-008-531-001 | |
|---|---|---|---|
| Annual Property Comments of the Call of Children and Children and |
phantom or, using patient anatomy data, in a patient.
Moreover, the system allows performing QA tests on the radiation delivery system. When the system is used together with electronic 2D devices, preferably with transmission detector, it can also provide sensitivity calibration and performance tests on EPID systems.
Finally, the system will provide online information about the quality of the delivery, both on a delivery system level (e.g. leaf positioning accuracy, dose per segment accuracy) as on the patient level (resulting dose distribution). In case of discrepancies, corrective action (adjusted plan for further fractions) shall be proposed.
5.9 Intended use
COMPASS is used for
quality assurance and plan verification in external beam radiation therapy for multileaf collimated fields and intensity modulated fields.
It computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom. The calculation is based on read-in treatment plans, and additionally on online or offline measurements of radiation fields with radiation-transparent or non-transparent, 2 dimensional multi-element ionization chamber arrays.
5.10 Technological characteristics summary
On principle, all devices allow performing QA tests on the radiation delivery system. Based upon the technological characteristics, intended use, and non-clinical tests, Compass is substantially equivalent to the predicate devices. The documentation submitted for review supports this claim.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three wavy lines representing the body and arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2007
Mr. Martin Arold Quality Manager IBA Dosimetry GmbH Bahnhoftrasse 5, 90592 Schwarzenbruck GERMANY
Re: K072374
Trade/Device Name: Compass Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy device Regulatory Class: II Product Code: IYE Dated: November 15, 2007 Received: November 20, 2007
Dear Mr. Arold:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072374
Device Name: COMPASS
Indications For Use:
COMPASS is used for
quality assurance and plan verification in external beam radiation therapy for multileaf collimated fields and intensity modulated fields.
It computes dose (energy per volume deposited by ionizing radiation) threedimensionally in a geometrical representation of a patient or a phantom. The calculation is based on read-in treatment plans, and additionally on online or offline measurements of radiation fields with radiation-transparent or nontransparent, 2 dimensional multi-element ionization chamber arrays.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lami Thi Thien
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(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072374
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