RAYDOSE

K082221 · Raysearch Laboratories AB · MUJ · Oct 22, 2008 · Radiology

Device Facts

• Record ID: K082221
• Device Name: RAYDOSE
• Applicant: Raysearch Laboratories AB
• Product Code: MUJ · Radiology
• Decision Date: Oct 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

RayDose is software that computes dose (energy per volume deposited by ionizing radiation) threedimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts. Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities: - Symmetric and asymmetric rectangular fields - Multileaf collimated fields - Coplanar and non-coplanar fields - Intensity modulated fields using Step-and-shoot technique - Intensity modulated fields using Sliding Window technique

Device Story

RayDose is a software-based radiation therapy dose calculation engine. Inputs include patient/phantom geometry (CT images, regions-of-interest), treatment plan parameters, and dose grid settings. It utilizes a three-source fluence algorithm (modeling primary, scatter/transmitted, and electron contributions) and a collapsed cone (CC) algorithm to compute 3D dose distributions. Used in radiation oncology clinics by clinicians for treatment planning and quality assurance. Output consists of calculated dose values in a 3D grid, assisting providers in clinical decision-making for radiation therapy. Benefits include accurate dose calculation for complex treatment modalities, including intensity-modulated fields.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based dose calculation engine. Physics-based three-source fluence algorithm; collapsed cone (CC) algorithm for 3D dose computation. Supports 6-18 MV X-ray energies. Compatible with symmetric/asymmetric fields, multileaf collimators, coplanar/non-coplanar fields, and intensity-modulated (step-and-shoot/sliding window) techniques. Runs on Windows XP platform.

Indications for Use

Indicated for patients undergoing external beam radiation therapy in an oncology clinic. Used to compute 3D radiation dose distributions for linear accelerators (6-18 MV) using various collimation and modulation techniques. No specific contraindications listed.

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

• DCM 1.0 (K011246)
• Pinnacle3 Radiation Therapy Planning System (K041577)

Submission Summary (Full Text)

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KOS2221 0.10+2

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Title: | Document ID: | version: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------|
| 15100k)<br>Application - RayDose | 13 Q<br>-1)-54-30 | |

# 5. 510(k) Summary RayDose

#### 5.1 510(k) owner

RaySearch Laboratories AB Sveavägen 25, plan 9 111 34 Stockholm Sweden Tel: [phone] [phone] Fax:

OCT 2 2 2008

## 5.2 Contact person

Anders Murman

# 5.3 Preparation date

03/29/2007

## 5.4 Trade name

RayDose

# 5.5 Common name

Radiation therapy dose calculation engine

## 5.6 Classification name

Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)

## 5.7 Predicate devices

| DCM 1.0 | 510(k) number K011246 |
|---------------------------------------------|-----------------------|
| Pinnacle3 Radiation Therapy Planning System | 510(k) number K041577 |

## 5.8 Device description

RayDose is a software program, which offers dose calculation, either as a separate unit or as a service to other software programs.

In short, RayDose needs the following input:

- A patient or phantom description, normally CT images and regions-of-interest 0
- A treatment plan 0
- Settings needed for the dose calculation (such as dose grid and algorithm) 0

RayDose computes dose to all points in the chosen dose grid, by means of applying the beams of the treatment plan onto the patient or phantom geometry. This dose computation uses the following algorithms:

- For fluence, a first principle physics based three-source fluence algorithm exists, where the first 0 source models the collimated primary fluence, the second source models scattered and transmitted fluence from all parts of the treatment head and the third source models electron contributions to the photon fluence.
- A collapsed cone algorithm (CC) for calculating bulk doses given impinging fluence exists. This 0 algorithm has a high accuracy also for inhomogeneities in the patient or phantom geometry.

As output, RayDose produces dose values in the chosen dose grid.

The software runs on a Windows XP platform.

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#### 5.9 Intended use

RayDose is software that computes dose (energy per volume deposited by ionizing radiation) threedimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts.

Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:

- 0 Symmetric and asymmetric rectangular fields
- Multileaf collimated fields 0
- Coplanar and non-coplanar fields 0
- Intensity modulated fields using Step-and-shoot technique 0
- 0 Intensity modulated fields using Sliding Window technique

#### 5.10 Technological characteristics summary

The technological characteristics are the same for RayDose as for DCM 1.0 and Pinnacle3 Radiation Therapy Planning System. All three devices compute fluence for external photon beams using a physicsbased algorithm modeling both the primary and scatter fluence and electron contributions. All three devices compute dose in three dimensions from the fluence using a collapsed cone algorithm.

DCM 1.0 and RayDose support symmetric and asymmetric fields, multileaf collimators, coplanar and noncoplanar fields and intensity modulated step-and-shoot fields.

Pinnacle Radiation Therapy Planning System and RayDose support intensity modulated sliding window fields, also known as dynamic multileaf collimated fields.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

RaySearch Laboratories AB % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K082221

Trade/Device Name: RayDose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: П Product Code: MUJ Dated: October 3. 2008 Received: October 7, 2008

#### Dear Mr. Lehtonen:

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.

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#### Page 2

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jorque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

510(k) Number (if known): - Ko82221

Device Name: RayDose 1.0

Indications For Use:

RayDose is software that computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts.

Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:

- Symmetric and asymmetric rectangular fields O
- Multileaf collimated fields 0
- Coplanar and non-coplanar fields O
- Intensity modulated fields using Step-and-shoot technique O
- 0 Intensity modulated fields using Sliding Window technique

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use NO (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)

Hubert Leuner

Division of Reproductive, Abdomi Radiological Devices 510(k) Number