OPTIRAD

K993895 · Permedics, Inc. · MUJ · Jun 2, 2000 · Radiology

Device Facts

• Record ID: K993895
• Device Name: OPTIRAD
• Applicant: Permedics, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jun 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

To be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

Device Story

OptiRad is a 3D radiation therapy treatment planning software system. It processes user-controlled inputs to compute and estimate radiation doses. The system generates displays and hardcopy reports to assist clinicians—radiation oncologists, medical physicists, radiation therapists, and dosimetrists—in selecting optimal patient treatment plans. It does not control treatment delivery devices. The software operates on the Microsoft Windows NT platform. Output is intended for independent clinical review and verification by a physicist or physician before implementation. The device benefits patients by providing structured dose estimations to guide clinical decision-making in radiation therapy.

Technological Characteristics

Software-based 3D radiation therapy treatment planning system. Operates on Microsoft Windows NT operating system. Provides dose computation, display, and documentation. No hardware components described.

Indications for Use

Indicated for use by radiation oncologists, medical physicists, radiation therapists, or dosimetrists to compute, display, evaluate, and document radiation dose estimations for patient treatment planning. Requires independent clinical review and verification by a physicist or physician prior to use.

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

• ROCS TPS

Submission Summary (Full Text)

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

## 510(k) SUMMARY

K993895
page 1 of 2

Submitter: PerMedics Inc.

1475 S. Victoria Ct. Address: San Bernardino, CA 92408

909-799-8300 Phone number: 909-799-8348 Fax Number:

Caroline Huff Name of Contact Person:

- November 11, 1999 Date Prepared:
- OptiRad Device Name:
- 3d Radiation Therapy Treatment Planning System Common Name:
- System, Planning, Radiation Therapy Treatment Classification Name:
- CFR 892.5050 Classification Number:
- ROCS TPS Predicate Name:

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

Summary Continued:

K993895
Page 2 of 2

## Description Of Device:

The OptiRad 3D-radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). Input is user controlled. This treatment planning system does not provide direct or indirect control over any treatment delivery device or system in any form.

The OptiRad software application is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.

The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. Ît is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, dosimetrist, or radiation treatment planner.

## Intended Use Of Device:

To be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

## Technological Characteristics:

The OptiRad and the predicate ROCS TPS are the same in that they both are intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations and are to be submitted for independent clinical review and verification by a physicist or physician prior to use.

The OptiRad is designed to work in Microsoft® Windows NT® operating system as is the ROCS TPS.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2000

PerMedics, Inc. C/O Greg Holland Regulatory Consultant Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606

Re:

K993895 OptiRad (3D Radiation Therapy Treatment Planning System) Dated: March 17, 2000 Received: March 20, 2000 Regulatory class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Mr. Holland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Occion of received in the enclosure) to legally marketed predicate devices device is substantially equivalent (for the macked of the Medical Device Amendments, or to device that mankeed in millerslate conninces phor to the Federal Food, Drug, and Cosmetic Act (Act (Act (Act). You may, therefore, tiave been reclassified in accordance with the provisions of the Act. The general controls provisions of the Activals manter the device, subject to the general series, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

lf your device is classified (see above) into either class III (Premarket Approval), it may be subject to If your device is Gassined (sec above) and battler one of the Code of Federal Regulations , Title 21, ട്ടിൾ additional controls. Exemination assumes compliance with the Current Good Manufacturing Practice (10) Prodice Parts oo to oos. A Substition Pequation (QS) for Medical Devices: General regulation (21 CFR Part 820) and requirements, as sections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with that, through penone as mapourily, the rocking, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might the Edgar register. Todal noter 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 This letter will allow you to begilly 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 and additionally 809.10 for in vitro if you desire action article for your dones of Carles of [phone]. Additionally, for questions on the promotion and diagnosic devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, advonaling of your device onemarket notification" (21CFR 807.97). Other general information on your responsibilities under the Misbanining by lectifice to promation (Schurces Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{3}------------------------------------------------

Premarket Notification - PerMedics, Inc. -- OptiRad

1 __of_ l_ Page_

510(k) Number (if known):

K993895

OptiRad Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The OptiRad software is to be used for the computation, display, evaluation and The Optimal Soltware is to be "documents to be submitted for independent output documentation or radiation account of the device provides output data in the clinkal review and judgement phort of a suide a physician in selecting the optimum form of displays and of narded to provide a report to be used by a competent pattern plan. It is intended to provide a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

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

..............................................................................................................................................................................

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Janis G. Seegson

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