RAYAUTOPLAN 1.0

K083264 · Raysearch Laboratories AB · MUJ · Jan 22, 2009 · Radiology

Device Facts

• Record ID: K083264
• Device Name: RAYAUTOPLAN 1.0
• Applicant: Raysearch Laboratories AB
• Product Code: MUJ · Radiology
• Decision Date: Jan 22, 2009
• 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

Ray Autoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI Among the generated plans, the user selects and climically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the pattent The intended users of RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

Device Story

RayAutoplan is a standalone software program for radiation treatment planning. It takes patient descriptions (CT images, regions of interest) and a reference dose distribution from a TomoTherapy treatment planning system as input. The system generates a family of individually optimized IMRT plans using a three-dimensional collapsed cone dose engine. The software displays 2D/3D dose distributions, dose difference maps, dose-volume histograms (DVHs), and dose statistics in a GUI. Clinically qualified staff (physicians, physicists, dosimetrists) review these plans, select one for approval, and export the final plan via DICOM to an R&V system for patient treatment. The device assists clinicians in efficient plan generation and selection, potentially improving treatment planning workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Standalone software; runs on Windows XP or Vista. Uses a three-dimensional collapsed cone dose engine for IMRT plan calculation. Features GUI for plan visualization (2D/3D dose, DVHs, statistics). Connectivity via DICOM for data import/export. No specific hardware materials or energy sources as it is a software-only device.

Indications for Use

Indicated for use by clinically qualified staff (medical physicists, doctors, dosimetrists) to generate and optimize IMRT treatment plans based on reference dose distributions from a TomoPlan system for subsequent patient treatment.

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

• Oncentra MasterPlan v3.1 (K081281)

Submission Summary (Full Text)

{0}------------------------------------------------

| Title | Document ID | Version |
|----------------------------------|-------------|---------|
| 510(k) Application - RayAutoplan | RSL-D-58-10 | 1.0 |

# 5. 510(k) Summary RayAutoplan

- 5 1 510(k) owner
RaySearch Laboratories AB Sveavägen 25, plan 9 111 34 Stockholm Sweden

[phone] Tel Fax [phone]

- 5 2 Contact person
Anders Murman

- 5 3 Preparation date
09/01/2008

# 5 4 Trade name

RayAutoplan, alias t-RayAutoplan, alias SharePlan

RayAutoPlan is the product name RaySearch will use moving this device into the world market

t-RayAutoplan was the name of the product during the development project, and when seen in the documentation related to this application, it is the same as RayAutoplan, by definition

SharePlan is the trade name TomoTherapy Inc will use on the world market, as being the exclusive distributor of this device This name is not further used in the documentation of this application

## 5 5 Common name

Radiation treatment planning system

## 5 6 Classification name

Medical charged-particle radiation therapy system (21 CFR 892 5050, Product Code MUJ)

#### 5 7 Predicate devices

Oncentra MasterPlan v3 1 510(k) number K081281

# 5 8 Device description

RayAutoplan is a stand-alone software program that generates a number of treatment plans, based on the dose distribution exported from a TomoTherapy treatment planning system

Detailed information of RayAutoplan can be found in reference 1, Customer requrement specifications

However, the most important workflow is described below

| Flow of Events | | |
|----------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | User | System |
| 1 | The user launches RayAutoplan | 3 The system imports the data and checks<br>consistency of in-data |
| 2 | The user selects the transferred<br>TomoTherapy case from a list of<br>TomoTherapy cases | |
| 4 | The user selects machine and treatment<br>energy | |
| 5 | The user selects MLC delivery mode<br>(SMLC/DMLC) | |
| 6 | The user specifies beam configuration | |
| 7 | The user specifies which plan family or<br>families that should be generated | |

KOB3uey

JAN 2 2 2009

{1}------------------------------------------------

| Title | Document ID | |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| 510(k) Application - RayAutoplan | RSL-D-58-10 | 10 |
| 8 The user starts the automatic plan generation | 9 The system generates plans<br>10 The system displays plans as<br>- 2D and 3D dose and patient displays<br>- Dose difference maps<br>- DVHs (several overlaid in same graph)<br>- Dose statistics<br>- Plan data (machine, beams, segments and so on) | |
| 11 The user reviews the Linac plans<br>12 The user selects a plan for approval and generates plan documentation | 13 The system creates a report containing<br>- Patient info<br>- Plan info<br>- Dose info | |
| 14 The user approves the plan for delivery | 15 Prints plan documentation and exports | |

Alternative workflows exist, including automatic plan generation and beam commissioning

To execute, RayAutoplan needs the following unput

- . A patient description, normally CT images and regions of interests
- A dose distribution serving as a reference dose, which should be benchmarked ●

As output, RayAutoplan produces a inac IMRT treatment plan and the corresponding dose distribution from an accurate calculation of the dose engine

plan to DICOM archive or R&V system

The software runs on a Windows XP or Windows Vista platform

## 5 9 Intended use

Ray Autoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI Among the generated plans, the user selects and climically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the pattent

The intended users of RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

## 5 10 Technological characteristics summary

The technological characteristics are the same for Ray Autoplan as for Oncentra MasterPlan v3 1 Both devices produce IMRT treatment plans with corresponding dose distributions computed using a firee dimensional collapsed cone dose engine Both devices have a function of electronic clinical approval of treatment plans by trained and authorized staff, and finally export in DICOM format for commencing treatment or archiving

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird-like symbol with three curved lines representing its wings. The bird is oriented towards the right. Encircling the bird is text that reads "DEPARTMENT OF HUMAN SERVICES (USA)" in a circular arrangement. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RaySearch Laboratories AB % Mr Jay Y Kogoma Senior Staff Engineer Intertek Testing Services 2307 E Aurora Rd . Unit B7 TWINSBURG OH 44087

JAN 2 2 2009

Re K083264

Trade/Device Name RayAutoplan 1 0 Regulation Number 21 CFR 892 5050 Regulation Name Medical charged-particle radiation therapy system Regulatory Class II Product Code: MUJ Dated January 5, 2008 Received January 6, 2008

# Dear Mr Kogoma

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 adulteratıon

If your device is classified (see above) into etther 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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892 xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry suppor/index.html

Sincerely yours,

Lamme M. Morre

anıne M N Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| Title | Document ID | Version |
|----------------------------------|-------------|---------|
| 510(k) Application - RayAutoplan | RSL-D-58-10 | 1.0 |

# 4. Indications for Use Statement

510(k) Number (if known) - Device Name RayAutoplan 1 0

2083264

Indications For Use

RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the pattent

The intended users of RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

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)

Hales Reem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number