(90 days)
OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.
The Scanditronix & Wellhöfer OmniDos is a General Dosimetry System similar to Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997. OmniDos and the marketed predicated products are radiotherapy quality assurance measuring devices designed to measure dose distribution. Using appropriate detectors and servo/scanners, the dose distribution can be accurately measured to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking and linear scans. These devices are designed to function in conjunction with a PC, which controls the relative position of the detectors while measuring and storing dose information of the radiotherapy beam. Each device is designed to provide two or more channels from electrometers which have their results converted into digital information for storage, display, or transfer to other systems for radiation therapy treatment planning using data formats suitable for the other system. Depending on configuration the devices offer several options for use of the detector system, including film scanning, TMR measurements, and other options.
The provided text describes the Scanditronix Medical AB OmniDos General Dosimetry System, a device for measuring radiation dose distribution in radiotherapy quality assurance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.
| Acceptance Criterion (Described Conceptually) | Reported Device Performance |
|---|---|
| Operational Characteristics | "Comparison of operational characteristics for the Scanditronix Medical OmniDos General Dosimetry System and the predicate product show similar results that are suitable for their intended purpose." |
| Electrical Safety (IEC 601-1) | "The Scanditronix Medical OmniDos General Dosimetry System is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current and meets electrical performance standards for CSA and UL." |
| Electromagnetic Compatibility (IEC 601-1-2) | "The electrometers of Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH for OmniDos, General Dosimetry System has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2." |
| Safety | "Testing of operational parameters indicates that the Scanditronix Medical OmniDos General Dosimetry System is safe..." |
| Intended Use Fulfillment | "...it fulfils the intended use..." |
| Performance Equivalence | "...and performs as well as or better than the previously released product RFA-300plus." (Implies meeting or exceeding the performance of the predicate device. The predicate devices are listed as WP700 (FDA K945321/S1), RFA-300 (FDA K934303/S1), and RFA-300 LDA Utility (FDA K961400), with the RFA-300plus likely being an updated version of one of these.) |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "final tests" performed on the "whole system consisting of software and hardware." However, it does not specify the sample size for these tests (e.g., number of measurements, number of devices tested).
- Sample Size: Not specified.
- Data Provenance: The tests are described as "Non-Clinical tests" and performed by the manufacturer ("Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH"). The origin of the data (country) is not explicitly stated beyond the company's location in Sweden. It is presumably prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is for quality assurance measurement, not diagnostic interpretation. The testing involved comparing operational characteristics and adherence to technical standards, not expert-derived ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable as the testing did not involve human interpretation or subjective assessments requiring adjudication. The performance was assessed against objective characteristics and technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a measurement system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The evaluation described is essentially a standalone performance assessment of the system (software + hardware) against its intended function and established technical standards. There isn't an "algorithm only" component separate from the hardware in the context of this dosimetry system. The "Non-Clinical tests" section details this standalone evaluation of the system's operational characteristics, electrical safety, and electromagnetic compatibility.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Predicate device performance: The OmniDos system was compared to and declared "similar" or "as well as or better than" previously released predicate devices (WP700, RFA-300, RFA-300 with LDA Utility).
- Established industry practice and standards: Adherence to "recognized and established industry practice" for electrical hazards, and conformance with IEC 601-1 (electrical isolation, leakage current), CSA, UL (electrical performance), and IEC 601-1-2 (electromagnetic compatibility) standards.
- Intended use fulfillment: The device's ability to accurately measure dose distribution for quality assurance, calibration, input to treatment planning systems, acceptance testing, beam tuning, and research.
8. Sample Size for the Training Set
This is not applicable. The OmniDos is a dosimetry system, not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would be inherent in its design and engineering based on physics and metrology principles, rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8. The "ground truth" for its development would be the fundamental principles of radiation dosimetry and engineering standards, not a labeled dataset for a machine learning algorithm.
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Section 6
SEP = 5 2001
510(k) Summary
This summery is submitted in compliance with 21 CFR 807.92
Scanditronix Medical AB Submitted by: (a) (1) Stålgatan 14, S-754 50 Uppsala Sweden
Trade name of the company: Scanditronix Wellhöfer
Contact persons:
Sten Larsson or Alf Öhman +46 18 18 07 00
31 May -2001
General Dosimetry System
Date of preparation:
(2)
OmniDos Trade name of device:
Common name:
Classification name:
Identification of predicate (3) marketed device:
WP700 (Wellhöfer Dosimetrie) FDA K945321/S1, 1995, 29th of March. RFA-300 (Scanditronix Medical) FDA K934303/S1, 510(k) Aug 1994, RFA-300, LDA Utility (Scanditronix Medical) FDA K961400: Jan. 1997
(Accessory to) Radionuclide radiation therapy
system, §892,5750; X-ray radiation therapy system, §892,5900; and Medical charged-particle
radiation therapy system, §892.5050.
(4) . Description of the device:
The Scanditronix & Wellhöfer OmniDos is a General Dosimetry System similar to
Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997.
OmniDos and the marketed predicated products are radiotherapy quality assurance measuring devices designed to measure dose distribution.
{1}------------------------------------------------
Using appropriate detectors and servo/scanners, the dose distribution can be accurately measured to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking and linear scans. These devices are designed to function in conjunction with a PC, which controls the relative position of the detectors while measuring and storing dose information of the radiotherapy beam. Each device is designed to provide two or more channels from electrometers which have their results converted into digital information for storage, display, or transfer to other systems for radiation therapy treatment planning using data formats suitable for the other system. Depending on configuration the devices offer several options for use of the detector system, including film scanning, TMR measurements, and other options.
-
Intended use: (5)
OmniDos is a system software utilising hardware components to measure radiation dose distribution. The hardware consists of water phantoms, air scanners, film scanners/ digitizers and single or array detectors. The hardware comes from Scanditronix Medical, the sister company Wellhöfer Dosimetry and from 3'd party vendors. OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research. -
(6) Technological comparison:
The Scanditronix Medical AB OmniDos is a General Dosimetry System similar to
Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997.
Non-Clinical tests: (b) (1)
The OmniDos system consists of the OmniDos software and hardware. The hardware consists of the same devices as the hardware of the above systems (WP700, RFA-300, RFA-300 with LDA Utility). The final tests have been performed for the whole system consisting of software and hardware.
Comparison of operational characteristics for the Scanditronix Medical OmniDos General Dosimetry System and the predicate product show similar results that are suitable for their intended purpose. To minimize potential electrical hazards, Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH adheres to recognized and established industry practice, and all devices are subject to final performance testing. The Scanditronix Medical OmniDos General
{2}------------------------------------------------
Dosimetry System is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current and meets electrical performance standards for CSA and UL. The electrometers of Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH for OmniDos, General Dosimetry System has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2.
-
Clinical tests: (2)
Due to the fact that the system is a quality assurance device in radiation treatment not directly involved in the delivery of the treatment radiation, no clinical testing was performed. -
Test conclusions: (3)
Testing of operational parameters indicates that the Scanditronix Medical OmniDos General Dosimetry System is safe, it fulfils the intended use and performs as well as or better than the previously released product RFA-300plus.
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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right.
SEP = 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alf Öhman Quality Manager Scanditronix Medical AB Stalgatan 14 S-754 50 Uppsala SWEDEN
Re: K011763
Omnidos General Dosimetry System Version 6.0 Dated: May 31, 2001 Received: June 7, 2001 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Öhman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have is we marked your beatler of the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate substantially uqur and the medical be as each and the Medical Device Amendments, or to devices that have been reclassified in commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, the general of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to succh 11 your device to existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts additional controls. "Existing mayor regaliation assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 875. A subsamians equation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administation (FDA) will verify such assumptions. Failure to comply with the GMP regulation may Qu it in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 31 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
(301) 594-4591 8xx.1xxx (301) 594-4616 876.2xxx, 3xxx, 4xxx, 5xxx 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4616 (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx (301) 594-4692 Other
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-669. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frée number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
OmniDos General Dosimetry System
Indications for Use:
OmniDos is a system software utilising hardware components to measure radiation dose distribution. The hardware consists of water phantoms, nicasure ruditation associets/ digitizers and single or array detectors. The all scannors, from Scanditronix Medical, the sister company Wellhöfer Dosimetry and from 3'd party vendors.
Dosmietry and from accurately analyse and handle the measured dose Onlinevos is assuratery and of assurance purposes, for calibration of radiation devices, distribution in quality assurance in the Systems, for acceptance testing, beam tuning and in research.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
K011763
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011763
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The -Counter Use__
(Optional Format 1-2-96)
§ 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.