NOMOSSTAT, VERSION 1.0

K060895 · Nomos Corp. · IYE · Jul 21, 2006 · Radiology

Device Facts

• Record ID: K060895
• Device Name: NOMOSSTAT, VERSION 1.0
• Applicant: Nomos Corp.
• Product Code: IYE · Radiology
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.

Device Story

nomoSTAT is an accessory for external beam photon therapy systems; provides 3-dimensional conformal radiation treatment planning/delivery. Used in clinical radiation oncology settings by radiation therapists and oncologists. Device facilitates precise radiation dose distribution to target volumes while sparing surrounding healthy tissue. Output assists clinicians in treatment planning and delivery; enhances therapeutic accuracy for cancer patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Accessory for external beam photon therapy systems; enables 3-dimensional conformal radiation delivery. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring 3-dimensional conformal radiation therapy using an external beam photon therapy system.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 21 2006

Mr. Leigh Spotten Director of Quality and Regulatory Affairs NOMOS Corporation 200 West Kinsinger Drive CRANBURY TOWNSHIP PA 16066

Re: K060895

Trade/Device Name: nomoSTAT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IXE Dated: June 21, 2006 Received: June 21, 2006

## Dear Mr. Spotten:

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 (Premarket Approval), 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. 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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely vours,

Nancy C. Hogdon

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

510(k) Number (if known): K060895

Device Name: __nomoSTAT

Indications for Use:

The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David W. Simpson

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

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