PRECISEPLAN 2.0

K022411 · Precision Therapy Intl., Inc. · MUJ · Sep 20, 2002 · Radiology

Device Facts

• Record ID: K022411
• Device Name: PRECISEPLAN 2.0
• Applicant: Precision Therapy Intl., Inc.
• Product Code: MUJ · Radiology
• Decision Date: Sep 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

Device Story

PrecisePLAN® 2.00 is a software-based treatment planning system for radiation therapy. It accepts user-defined treatment parameters to perform 2D and 3D dosimetry planning. The system includes optional weight optimization functionality to support Intensity Modulated Radiation Therapy (IMRT), enabling the creation of geometric apertures to target tumors while sparing surrounding organs at risk. The device processes clinical inputs to calculate radiation dose distributions, which are then transferred to a radiation therapy delivery system. It is intended for use by healthcare professionals in a clinical setting to assist in treatment decision-making and dose delivery optimization.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and risk analysis to demonstrate safety and effectiveness.

Technological Characteristics

Software-based treatment planning system; supports 2D/3D conformal planning and IMRT weight optimization; operates under a Quality Management System compliant with ISO 9001 and 21 CFR 820; software level of concern is Major.

Indications for Use

Indicated for radiation therapy patients requiring dosimetry planning, including 2D, 3D conformal, and Intensity Modulated Radiation Therapy (IMRT) planning to define treatment parameters and minimize exposure to organs at risk.

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

• PrecisePLAN® 1.00 (K002240)

Submission Summary (Full Text)

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

## RO22411

## SEP 2 0 2002

## SUMMARY OF SAFETY & EFFECTIVENESS

Precision Therapy International Inc. (PTI) hereby provides the following material summarizing safety and effectiveness information for PrecisePLAN® 2.00. This information is summarized as follows:

- 1) PrecisePLAN® 2.00 is an enhancement to the PrecisePLAN® 1.00, which has previously been cleared for commercial distribution (K002240 8/23/2000). This enhancement to PrecisePLAN® does not raise additional types of safety or effectiveness considerations.
- 2) The accompanying documents provided for the user contain comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.
- It is our opinion that PrecisePLAN® 2.00 does not have technological 3) characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing PrecisePLAN®.
- PrecisePLAN® 2.00 is designed to bear the CE mark affirming 4) compliance with all relevant European Directives in force, in particular the European Medical Device Directive. As a result of this, products may be sold freely without restriction throughout the entire European Union.
- PTI is a registered medical device establishment of assessed capability ર) against the requirements of ISO 9001 and the Medical Device Directive 93/42/EEC Annex II.
- PTI Quality System has been established to satisfy the requirements of 6) ISO 9001, the Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820. PTI has developed the Precise Plan 2.00 using an established and documented Quality Management System.
- In accordance with the above requirements, all parts of the Quality 7) System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.

| REF .:<br>DRC-170-2029-01 | Premarket Notification Section 510(k) for the<br>Precision Therapy International Inc.<br>PrecisePLAN® 2.00 | | | |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------|------------|--|
| | Summary of Safety & Effectiveness<br>Information | Page 1 of 2 | 07/22/2002 | |
| © 2002 Precision Therapy International Inc. All rights reserved | | | | |
| PRECISION THERAPY INTERNATIONAL INC. NORCROSS, GA USA | | | | |

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

- PTI has conducted risk analysis on PrecisePLAN® 2.00 and has 8) concluded that it does not introduce hazards that raise new types of safety or effectiveness considerations. After considering the Guidance for the Content of Pre-Market Notification Submissions of Medical Devices Containing Software PTI has concluded the level of concern appropriate to the device is "Major".
- The Quality System is subject to regular, planned and documented 9) quality system audits conducted by external auditors from BSI (UK Notified Body) and the FDA.

Peter Stegagno

Signature

Mark Symons

President

Signature

July 22, 20

1/22/02

Director, Regulatory Affairs & Quality Assurance

| REF.:<br>DRC-170-2029-01 | Premarket Notification Section 510(k) for the<br>Precision Therapy International Inc.<br>PrecisePLAN® 2.00<br>Summary of Safety & Effectiveness<br>Information | Page 2 of 2 | 07/22/2002 |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------|
| © 2002 Precision Therapy International Inc. All rights reserved<br>PRECISION THERAPY INTERNATIONAL INC, NORCROSS, GA USA | | | |

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

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle.

Food and Drug Administration i 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2002

Mr. Peter Stegagno Director, Regulatory Affairs & Quality Assurance Precision Therapy International, Inc. 3155 Northwoods Parkway NW NORCROSS GA 30071

Re: K022411

Trade/Device Name: PrecisePLAN® Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ

Dated: July 22, 2002 Received: July 24, 2002

Dear Mr. Stegagno:

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 fimited 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.

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

This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snigdin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

510(k) Number (if known): KO22411

Device Name:

Indication for Use:

The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

PrecisePLAN® Treatment Planning System

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

David C. Knapp

Division Sign-Off Division of Reproductive, Ab and Radiological Devic 510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)