BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6

K070611 · Nomos Corp. · IYE · Jul 11, 2007 · Radiology

Device Facts

• Record ID: K070611
• Device Name: BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
• Applicant: Nomos Corp.
• Product Code: IYE · Radiology
• Decision Date: Jul 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

Device Story

BAT is an ultrasound imaging system used for patient positioning during external beam radiation therapy and general diagnostic imaging. The device captures ultrasound images of organs to assist clinicians in verifying patient alignment prior to radiation delivery. It functions as an ultrasonic pulsed echo imaging system. Operated by clinicians in a clinical setting, the device provides real-time visualization of internal anatomy. By identifying organ position, the system enables precise patient setup, potentially increasing the accuracy of radiation dose delivery to the target area while sparing surrounding healthy tissue. The output is displayed for the clinician to make adjustments to the patient's position before treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Ultrasonic pulsed echo imaging system. Operates under 21 CFR 892.5050 (Medical charged-particle radiation therapy system) and 21 CFR 892.1560 (Ultrasonic pulsed echo imaging system). Product codes IYE and IYO.

Indications for Use

Indicated for patient positioning during external beam radiation therapy for organs identifiable via ultrasound; also indicated for general diagnostic ultrasound imaging of small organs (breast, thyroid, testes), abdominal, trans-esophageal (non-cardiac), trans-rectal, trans-vaginal, and musculoskeletal structures.

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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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "U.S. HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and tail feathers.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## .JUL 1 1 2007

Ms. Marita Brust Vice President Quality Assurance NOMOS Corporation 200 West Kensinger Dr. CRANBERRY TOWNSHIP PA 16066

Re: K070611

Trade/Device Name: BAT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYE and IYO Dated: June 14, 2007 Received: June 15, 2007

## Dear Ms. Brust:

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.

Image /page/0/Picture/10 description: The image shows a logo with the letters FDA in the center, surrounded by the words "Centennial" and "1906-2006". Below the logo is the text "Protecting and Promoting Public Health". The text is written in a decorative font. The image appears to be a scan of a document.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast oc advised that I Dris assume of that your device complies with other requirements of the Act that IDA has made a decemmandings administered by other Federal agencies. You must of any I Citial satures and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK in the quality systems (QS) regulation (2) 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) I ms letter will anow you to begin mainer of substantial equivalence of your device to a legally premits the lineadon: The PDF inishingssification 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 desire specific advice for your are 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 (21CFN I all 807.77). Tountal Security of Small Status 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 yours,

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): _K070611

Device Name: BAT

Indications for Use:

BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

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)

Nancy Brogdon

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

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