ODYSSEY

K042861 · Permedics, Inc. · MUJ · Jan 12, 2005 · Radiology

Device Facts

• Record ID: K042861
• Device Name: ODYSSEY
• Applicant: Permedics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

Device Story

Odyssey is a software-based radiation treatment planning system (RTPS) used by clinicians to prepare radiation therapy. It ingests imaging data to perform target and non-target delineation; executes algorithms to compute radiation dose estimations; and supports beam planning, verification, and quality assurance. The system offers forward planning and an optional inverse planning module for Intensity Modulated Radiation Treatment (IMRT). Outputs are displayed for independent clinical review and judgment by a physician to inform radiation therapy decisions. The device is intended for use in clinical settings where radiation treatment planning is performed.

Clinical Evidence

No clinical data. Substantial equivalence and safety/effectiveness were demonstrated through bench testing, including software verification and validation, Hazard Analysis, and Failure Modes and Effects Analysis.

Technological Characteristics

Software-based radiation treatment planning system. Features include imaging, target/non-target delineation, beam planning, verification, and quality assurance modules. Supports forward planning and inverse planning (IMRT). No hardware components described.

Indications for Use

Indicated for use in radiation treatment planning to compute, display, and evaluate radiation dose estimations for clinical review prior to radiation therapy. No specific patient population, age, or gender restrictions stated.

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

• ADAC P3MRT™ (K002237)
• OptiRad (K993895)

Submission Summary (Full Text)

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JAN 1 2 2005

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K042861

## 510(k) Summary

#### Submitter:

PerMedics, Inc. 1475 S. Victoria Ct. San Bernardino, CA. 92408 Phone: [phone] Fax: [phone]

#### Contact Person:

Jessica Connor Quality Assurance Manager

### Date Prepared:

October 12, 2004

# Device Name:

Odyssey

#### Common Name:

Radiation Treatment Planning System

#### Classification Name:

System, Planning, Radiation Treatment

#### Predicate Devices:

ADAC P3MRT™ - K002237 OptiRad - K993895

#### Device Description:

The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.

#### Intended Use:

Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

PerMedics, Inc. ♦ 1475 S. Victoria Ct., San Bernardino, CA 92408 909.478.5000 ♦ Fax [phone] ♦ Email: [e-mail]

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## Summary of Technological Characteristics Compared to Predicate Devices:

Odyssey contains no technological characteristics not currently contained in the predicate devices, ADAC P3 MRT inverse planning option (K002237) and OptiRad (K993895).

## Summary of Non-Clinical Testing:

The performance and results of Verification and Validation demonstrate Odyssey to be safe and effective. A Hazard Analysis and Failure Modes and Effects Analysis were completed, with all hazards and failure modes mitigated to acceptable levels.

## Summary of Clinical Testing:

Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of Odyssey.

#### Conclusion:

Odyssey is as safe, as effective, and is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

Ms. Jessica Connor Quality Assurance Manager PerMedics, Inc. 1475 S. Victoria Ct. SAN BERNARDINO CA 92408

Re: K042861

Trade/Device Name: Odyssey Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: December 9, 2004 Received: December 10, 2004

Dear Ms. Connor:

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 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms iction will and in your of substantial equivalence of your device to a legally prematication: "The PDF maning on 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 If you done spoorne at one 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" (21 CFR Also, process not regulation eeneral information on your responsibilities under the Act from the 801:57). " Ou may oount ourers, International and Consumer Assistance at its toll-free number (800) DIVISION of of othern handracters, its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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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Indications for Use

Page 1 of 1

510(k) Number (if known): Ko42861

Device Name: Odyssey

Indications for Use:

Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

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(Division Signature)
Division of Banks

Prescription Use

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