OMNIDOS

K011763 · Scanditronix Medical AB · IYE · Sep 5, 2001 · Radiology

Device Facts

• Record ID: K011763
• Device Name: OMNIDOS
• Applicant: Scanditronix Medical AB
• Product Code: IYE · Radiology
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

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.

Device Story

OmniDos is a general dosimetry system for radiotherapy quality assurance; measures radiation dose distribution using water phantoms, air scanners, film scanners/digitizers, and single/array detectors. System connects to a PC to control detector positioning and acquire dose data via electrometers. Software converts analog signals to digital information for storage, display, or transfer to treatment planning systems. Used by medical physicists/technicians in clinical settings for beam tuning, isodose tracking, and linear scans. Provides quantitative analysis of radiation beams to ensure accurate treatment delivery; benefits patients by verifying radiotherapy equipment performance and calibration.

Clinical Evidence

No clinical data. Device is a quality assurance tool not involved in direct patient treatment delivery. Safety and performance established via bench testing of operational parameters and electrical/electromagnetic compatibility (IEC 601-1, IEC 601-1-2).

Technological Characteristics

System includes water phantoms, air/film scanners, and radiation detectors. Electrometers convert signals to digital data. Connectivity via PC. Conforms to IEC 601-1 (electrical safety/leakage) and IEC 601-1-2 (EMC). CSA and UL compliant.

Indications for Use

Indicated for quality assurance, calibration of radiation devices, acceptance testing, beam tuning, and research analysis of radiation dose distribution in clinical radiotherapy environments.

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

• WP700 (Wellhöfer Dosimetrie) (K945321/S1)
• RFA-300 (Scanditronix Medical) (K934303/S1)
• RFA-300, LDA Utility (Scanditronix Medical) (K961400)

Submission Summary (Full Text)

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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 [phone]

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.

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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

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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:

> [phone] 8xx.1xxx [phone] 876.2xxx, 3xxx, 4xxx, 5xxx 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx [phone] [phone] 892.2xxx, 3xxx, 4,xxx, 5xxx [phone] 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 [phone] or [phone] 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)