MODEL 37-185

K973960 · Victoreen, Inc. · LHN · Jan 14, 1998 · Radiology

Device Facts

• Record ID: K973960
• Device Name: MODEL 37-185
• Applicant: Victoreen, Inc.
• Product Code: LHN · Radiology
• Decision Date: Jan 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

The Model 37-185 provides a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics. The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation. As a quality control tool the use of this product does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use.

Device Story

Model 37-185 is a radiation therapy quality control system consisting of a readout module and a scanner module. The scanner, placed on a treatment couch, uses a stepper motor to move a light-detecting diode and a radiation-detecting diode in a 50 cm straight line to profile radiation and light fields. A fixed central radiation diode acts as a reference to nullify beam amplitude fluctuations. The readout module, located outside the treatment room, contains a microprocessor, LCD, and printer/computer interfaces. It processes data to determine beam flatness, symmetry, and field coincidence per TG-40 guidelines. Operated by qualified personnel, the device provides performance data for therapy machines. It does not contact patients and is not used for treatment planning; the patient is absent during operation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System comprises a scanner module with stepper motor, light-detecting diode, and radiation-detecting diode, connected via 25-meter shielded cable to a microprocessor-based readout module with LCD. Includes leveling mechanism for 90-degree rotation. Connectivity includes RS-232 and parallel printer interface.

Indications for Use

Indicated for use by qualified personnel to perform quality control measurements on radiation therapy machines, including light field/radiation field coincidence, cross-hair centering, and beam flatness/symmetry. Not for patient contact or treatment planning.

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

• Beam Scan, Model 37-201 (K853671A)

Submission Summary (Full Text)

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EXHIBIT A

# Victoreen, Inc.

K973960

Image /page/0/Picture/3 description: The image shows a logo with three horizontal bars. The top bar is black, the middle bar is white, and the bottom bar is white with the word "VICTOREEN" in black, bold, sans-serif font. The logo is simple and clean, with a focus on the text.

Premarket Notification [510k] Summary as required by section 807.92(c)

IAN I 4 1998

# Date Summary was prepared:

September 30, 1997

#### Submitter's Name

Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395

#### Contact Person:

Linda S. Nash Director of Regulatory Affairs and Quality Assurance Phone: [phone] Fax:

## Device Name:

Model 37-185

## Classification Name:

Medical charged - particle radiation therapy system

## Predicate Device:

Beam Scan, Model 37-201, 510(k) #K853671A

# Product Description:

The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable.

The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable.

> 6000 Cochran Road Cleveland, Ohio 44139-3395 [phone] FAX [phone] DATA [phone]

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The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.

#### Intended Use:

The Model 37-185 provides a means of scanning the light field and radiation (Function): field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics. The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation.

As a quality control tool the use of this product does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Linda S.Nash Director of Regulatory Affairs & Quality Assurance Victoreen, Inc. 6000 Cochran Road Cleveland, OH 44139-3395

Dear Ms. Nash:

Re: K973960

Beam Scan Model 37-185 Dated: October 14, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN 1481 / 1000

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 and additionally 809.10 for in vitry diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsmamain.html", ............................................................................................

Sincerely yours,

h. Tiau Yu.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number: K973960

Device Name: Model 37-185

Indications for Use:

Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Leyman

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

Prescription Use
(Per 21 CFR 801.109)

Or

Over-The Counter Use