ATLAS-BASED AUTOSEGMENTATION

K080799 · Computerized Medical Systems, Inc. · LHN · Aug 7, 2008 · Radiology

Device Facts

• Record ID: K080799
• Device Name: ATLAS-BASED AUTOSEGMENTATION
• Applicant: Computerized Medical Systems, Inc.
• Product Code: LHN · Radiology
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.

Device Story

Standalone software application; automates contouring of radiation therapy targets and anatomical structures. Inputs: user-provided medical images. Processing: uses atlas-based autosegmentation via deformable registration algorithms to map pre-segmented atlas images to new patient images. Outputs: estimated anatomy boundary contours. Usage: clinical environment; operated by radiation oncology staff. Workflow: software generates initial contours; clinician exports output to a separate treatment planning system for manual editing, dose calculation, and review. Benefit: increases efficiency in radiotherapy treatment planning by providing a starting point for contouring, reducing manual workload.

Clinical Evidence

No clinical data. Bench testing only. Verification tests were performed in-house to ensure system functionality against design requirements. Clinically oriented validation test cases were executed by customer support personnel to confirm fitness for clinical use.

Technological Characteristics

Standalone software application. Uses deformable registration algorithms for image segmentation. Communicates via DICOM standard. Atlas library is user-expandable. No hardware components; software-only device.

Indications for Use

Indicated for use by clinicians to generate estimated anatomy boundary contours for radiotherapy treatment planning. Not for direct clinical use; requires export to a treatment planning system for editing, review, and approval by qualified clinicians.

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

• BrainLAB iPlan RT Dose (K053584)
• Pinnacle3 (K041577)
• IKOEngelo (K061006)

Submission Summary (Full Text)

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1080799

AUG - 7 2008

## 510(k) Summary of Safety & Efficacy Atlas-Based Autosegmentation 510(k)

Submitter Name: Computerized Medical Systems, Inc. Submitter Address: 1145 Corporate Lake Drive St. Louis, MO 63132-1716 Submitter Phone: [phone] Submitter Fax: [phone] Contact Person: Kathryn Stinson - Regulatory Affairs Associate Date Summary Prepared: Device Trade Name: Atlas-Based Autosegmentation Device Common Name: Autosegmentation Software Device Classification: System, Simulation, Radiation Therapy per 21CFR892.5840 Substantial Equivalence: BrainLAB iPlan RT Dose (K053584) Pinnacle3 (K041577); IKOEngelo (K061006);

Level of Concern & Rationale*: Major

*Per FDA document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.

4b of Table 1, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " Atlas-Based Autosegmentation (abbreviated "ABAS") does not directly control the linear accelerator that delivers the radiation. Once completed, contours are sent to a treatment planning system where dose is calculated and contours are adjusted. reviewed, approved by qualified clinicians and subject to quality assurance practices before treatment actually takes place. There is no automatic link between the ABAS software and the linear accelerator. ABAS is not a full treatment planning system and performs only an initial contouring function. However, because previous guidance has held that radiation treatment planning systems are devices of major concern, and because we believe ABAS falls under the larger category of software programs associated with treatment planning, we have assumed a "major" level of concern for the purposes of this submission.

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Device Description: Contouring of radiation therapy targets and surrounding anatomical structures (also known as image segmentation) is a critical part of radiation treatment planning that can be extremely time consuming. Atlas-Based Autosegmentation (ABAS) is a software application that automates the contouring process using atlas-based autosegmentation. This method uses an already-segmented image set (atlas) to segment a set of new, user-input images using deformable registration algorithms. The contours ABAS generates are not usable for treatment as-is; they must be exported to a treatment planning system for editing. However, Atlas-based Autosegmentation provides a good starting point from which minimal editing is required, enabling the clinician to create a high quality treatment plan more efficiently.

Device Intended Use: Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.

Summary of Technological Characteristics Compared to Predicate Devices: ABAS is unique compared to substantially equivalent products in that it performs only autosegmentation. BrainLAB's iPlan RT Dose and Phillips/ADAC's Pinnacle are fully functioning treatment planning systems that include autosegmentation, contour editing, dose calculation and plan review. IKOEngelo allows the user to edit contours in addition to providing autosegmentation capability. ABAS's sole function is to automatically generate estimated contours generated are not clinically usable as-is, and ABAS does not offer the tools necessary to edit them. The user must export the segmented image sets to a treatment planning system for contour editing, dose calculation, plan review and other necessary treatment planning activities.

ABAS uses an altas-based approach to autosegmentation. like iPlan and IKOEngelo, and allows the user to expand its library of atlases just as Pinnacle3 allows the user to save new models and templates. Like all of the predicate devices, ABAS uses deformable registration and communicates with other treatment planning applications using DICOM.

A detailed comparison can be found in section 12 of this submittal.

Summary of Clinical Testing: Clinical trials were not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. ABAS was deemed fit for clinical use.

Summary of Non-Clinical Testing: Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the ABAS Verification Test Report, which is included in section 18 of this submittal. ABAS successfully passed verification testing.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG - 7 2008

Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Mcdical Systems, Inc. 1145 Corporate Lake Drive ST. LOUIS MO 63132

Re: K080799

Trade/Device Name: Atlas-Based Autosegmentation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN and MUJ Dated: July 18, 2008 Received: July 20, 2008

Dear Ms. Stinson:

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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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. Youngers of Your of t 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 100-1050.

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, pervoits 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 Compliari) produce 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 CDRF 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 Reportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may othing 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) 633-241 or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/industry/support/indox.2011 or

Sincerely yours,

Nancy 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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K080799

## Statement of Indication for Use Atlas-Based Autosegmentation 510(k)

Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.

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Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)

Prescription Use

OR per 21 CFR 801.109

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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

Atlas-Based Autosegmentation 510(k) Computerized Medical Systems, Inc.

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