MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER

{0}------------------------------------------------ # Victoreen, LLC Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string is "K982937". The handwriting is somewhat stylized, with some characters connected and others distinct. ## EXHIBIT A Image /page/0/Picture/4 description: The image shows the word "VICTOREEN" in bold, black letters. The letters are capitalized and evenly spaced. The word is set against a white background and is enclosed in a black border. # Premarket notification [510(k)] Summary as required by section 807.92 (c) ## Date Summary was prepared: August 18, 1998 ### Submitter's Name: Victoreen, LLC 6000 Cochran Road Cleveland, OH 44139-3395 ### Contact Person: Mary Jo Nero Quality Assurance Associate Phone: (440) 248-9300 ext. 215 Fax: (440) 248-9301 #### Device Name: Model 580-006 Radiation Therapy Ionization Chamber #### Classification Name: Medical Charged-Particle Radiation Therapy System #### Predicate Device Name: Model 500-6 Radiation Therapy Ionization Chamber 510(k) Number: K932342 > 6000 Cochran Road Cleveland. Ohio 44139-3395 (440) 248-9300 FAX (440) 248-9301 (800) 850-4608 {1}------------------------------------------------ Performance Standards Under Section 514: Labeling: Label: Advertising Brochure: (Product Data Sheet) Model 580-006 New Device No Performance Standard established for this device Reference Exhibit C #### Model 500-6 Predicate Device No Performance Standard established for this device 500-6 Reference Exhibit B #### Intended Use: This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines. 580-006 #### Product Description The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case. {2}------------------------------------------------ # Specification Comparison Table | Feature | New Device<br>Model 580-006 | Predicate Device<br>Model 500-6 | |--------------------------------------------------------|----------------------------------------------|---------------------------------| | Volume | 0.61 cm³ | 0.6 cm³ | | Sensitivity | 2.0 x 10⁻⁸ cGy⁻¹ | 2 x 10⁻¹⁰ A/R/s | | Leakage | <4 x 10⁻¹⁵ A | < 10⁻¹⁵ A | | Wall Material | PMMA acrylic with<br>graphite layer | Tissue equivalent plastic | | Wall area material density | 78.5 mg/cm² | 58 mg/cm² | | Collector | Pure aluminum, 1mm<br>diameter x 20.0mm long | Tissue equivalent plastic | | Cable length | 1 meter | 15 meters | | Range of Temperature | +10°C to +40°C | +10°C to +40°C | | Relative air humidity | 75%, non-condensing | 20% to 75%, non-<br>condensing | | Build-up cap material | PMMA for ⁶⁰Co | Acrylic 1.2 g/cm³ | | Chamber length | 23.6 mm | 24.4 mm | | Chamber diameter | 5.95 mm | 7.1 | | Build-up cap diameter | 16.3 mm | 13.3 mm | | Probe length | 157 mm | 124 mm | | Energy Range without build-<br>up cap | 21keV to 662 keV | 70keV to 662 keV | | Energy Range with build-up<br>cap | 662 keV to 1.5 MeV | 1.2 MeV to 1.5 MeV | | Maximum exposure range for<br>99.5% efficiency @ 300 V | 3.0Gy s⁻¹ | 4000 R/min | {3}------------------------------------------------ #### Similarities to predicate device (500-6) The 580-006 and the predicate device are similar. Both units are an air filled ionization chamber that produce a current when exposed to ionizing radiation produced by a medical therapy machine. The 580-006 and the 500-6 are connected to an approved electrometer by a triaxial BNC connector. #### Differences to predicate device The 580-006 uses a pure aluminum electrode while the 500-6 uses a tissue equivalent plastic electrode. Also the 580-006 uses a PMMA acrylic chamber material coated with a graphite material while the 500-6 uses a tissue equivalent plastic for it's chamber material. The 580-006 has a wider energy response range ( 21 keV to 662 keV) than the 500-6. (70 keV to 662 keV) #### Possible Customer Use and Misuse The customer may use this devise as a quality assurance or a absolute dosimetry measurement of a medical therapy machine, with the appropriate electrometer, when calibrated by the necessary approved calibration lab. A misuse may occur if the user forgets or does not use the appropriate build-up material for the energy of the radiation that they are measuring. ### Fail Safe / Safety The 580-006 will not produce the appropriate current if it is not connect properly to an electrometer. The 300-500VDC bias voltage is present only on the inside of the chamber and can not be touched by the operator. ### Risk / Hazard Analysis A Risk / Hazard Analysis has been conducted on this product per Victoreen product development procedures. This product is used to measure the absolute dose outputs from medical therapy machines. The device is not used to monitor the dose delivered to the patient during treatment. Since the devise is used only by a qualified medical physicist and must be calibrated on a periodic cycle, by a qualified calibration lab, it does not affect the administration of radiation to the patient or the performance of the therapy machine. {4}------------------------------------------------ #### Failure Mode The 580-006 triaxial connector may fail electrically. This failure will be evident to the user by either physically touching the connector or the electrometer failure to measure the correct current. #### Labeling. Warnings, Standard Identification Product marking will include: Victoreen. Model Number and serial number. All advertising, brochures, sales literature, etc. will conform to FDA and Victoreen Standards. Warning: This device is intended to be used for the detection and measurment of ionizing radiation. It should be used only by persons who have been trained in the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation. Although the equipment was designed and manufactured in compliance with all applicable safety standards, certain hazards are inherent in the use of electronic and radiometric equipment. ### Calibration Factory calibration of the product will, at a minimum, consist of a calibration factor for the following NIST techniques M50, M250, Cesium 137 and Cobalt 60, This calibration will not be used as a substitute for an approved calibration facility for the measurement of absolute dose. ### Storage Needs / Shelf Life / Disposability Shelf life is indefinite. Storage shall be in a cool, dry environment free of corrosive materials, fluctuation in temperature and humidity, or vibration and shock. There are no disposability restrictions. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 9 1000 Edward W. Siurek III Director of Regulatory Affairs & Quality Assurance Victoreen, LLC 6000 Cochran Road Cleveland, Ohio 44139 #### Re: K982937 Model 580-006 Radiation Therapy Ionization Chamber Dated: August 19, 1998 Received: August 21, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN Dear Mr. Siurek: 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 indications for use 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 resided 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 Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 riting diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmadsmamain.html". Sincerely yours, William Yin Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # INDICATION FOR USE STATEMENT Page 1 of 1 _ 510(k) Number (if known): __Unknown ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: This instrument is intended for the purpose of calibrating and measuring the ionizating radiation outputs for medicas therapy machines. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE) David L. Bryson Revision Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number _ Prescription Use X (Per 21CFR801.109) Over-the-Counter Use____________ OL