NOMOS CORVUS 5.0M

K032209 · Nomos Corp. · MUJ · Aug 21, 2003 · Radiology

Device Facts

• Record ID: K032209
• Device Name: NOMOS CORVUS 5.0M
• Applicant: Nomos Corp.
• Product Code: MUJ · Radiology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist. The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

Device Story

CORVUS 5.0M is a radiation therapy treatment planning system. It processes treatment machine-specific data to generate conformal external beam photon radiation therapy plans. Used by medical physicists, dosimetrists, and radiation oncologists in clinical settings to guide radiation delivery to target volumes defined by oncologists. The system assists in clinical decision-making by providing a roadmap for radiation therapy, potentially improving treatment conformity to the target volume. This version represents a platform migration from the NextStep operating system to Macintosh OS X (Mac OSX).

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing demonstrating that the modified device produces clinically equivalent results to the predicate.

Technological Characteristics

Radiation therapy treatment planning software. Operates on Macintosh OS X (Mac OSX) hardware. Fundamental scientific technology and performance specifications remain unchanged from the predicate system.

Indications for Use

Indicated for use by medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans for external beam photon (x-ray) radiation therapy. Contraindicated for electron therapy and intracavitary (brachytherapy) sources.

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

• NOMOS CORVUS System (K940663, K963258, K972451)

Submission Summary (Full Text)

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AUG 2 1 2003

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# Section 2 - 510(k) Summary

# Summary of Safety and Effectiveness NOMOS Motorized CRANE® II

Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act

## A. General Information:

| Classification Name: | Medical charged-particle radiation therapy<br>system accessory: Treatment Planning<br>System<br>(Sec. 892.5050) |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
|----------------------|-----------------------------------------------------------------------------------------------------------------|

Common/Usual Name: Radiation Therapy Treatment Planning System

Trade/Proprietary Name: CORVUS® 5.0M System

Applicant's Name and Address: Francis X. Dobscha Director of Quality

> NOMOS Corporation 200 West Kensinger Drive Cranberry Township, PA 16066

| Phone: | 724-741-8242 |
|--------|--------------------|
| FAX: | 724-741-0778 |
| Email: | [e-mail] |

- B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451)
- Class II C. Classification:
- None established D. Performance Standards:

## E. Intended Use and Device Description:

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon

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K03209
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treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.

## F. Summary of Substantial Equivalence

### Indications for Use:

The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

### Materials:

The materials used in the CORVUS 5.0M are equivalent to those used in the currently marketed device. The only difference is the use of computer hardware and peripherals supporting the Mac OSX operating system (versus hardware supporting the NextStep operating system).

### Manufacturing:

The manufacturing processes used in the production of the CORVUS 5.0M System has not changed from that used to produce the currently-marketed predicate device. The device is manufactured at the same facility under the same process controls.

### Specifications and Fundamental Scientific Technology:

The performance specifications of the CORVUS 5.0M System are the same as the currently-marketed CORVUS System. The design and the fundamental scientific technology upon which the CORVUS System operates have not changed.

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## Design Controls:

The modification to the CORVUS System were developed, tested, and implemented following NOMOS Corporation's established processes for design control. NOMOS Corporation's design control processes conform to all applicable requlatory and industry requirements. A hazard analysis and testing were performed to assess the impact of the modification, which resulted in a determination that the modification does not raise any new issues of safety or efficacy for the device.

#### Conclusions:

Based on the above information, and on NOMOS Corporation's commitment to provide safe, reliable, and effective products, NOMOS considers the CORVUS 5.0M Radiation Therapy Planning System to be substantially equivalent to the currently-marketed CORVUS System.

#### Note:

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be legally marketed according to FDA regulations and is not relevant evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. (1977).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Ms. Francis X. Dobscha VP, Quality and Regulatory Affairs NOMOS Corporation 200 West Kensinger Drive CRANBERRY TOWNSHIP PA 16066 Re: K032209

Trade/Device Name: CORVUS Radiation Therapy 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 14, 2003 Received: July 22, 2003

Dear Ms. Dobscha:

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 (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.

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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, 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 the 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" (21CFR Part 807.97) you may obtain. 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. 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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510(k) Number: Not Assigned

K032209

Page 1 of 1

CORVUS® 5.0M Radiation Therapy Planning System Device Name:

Indications for Use:

The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

*Nancy C. Brogdon*
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K032209 |
|---------------|---------|
|---------------|---------|

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