2 BASIC

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for CAPINTEC, INC. with the letters "CII" in a black box. Above the logo is the text "K Φ3 Φ1 7 5". The date "APR 1 7 2003" is on the right side of the image. January 15, 2003 RE: Summary of Safety and Effectiveness Information for the Capintec 2 Basic | Manufacturing and Service Center | | |----------------------------------|--------------| | Capintec, Inc. | | | 540 Alpha Drive | | | Pittsburgh, PA 15238 | | | Phone | 412-963-1988 | | FAX | 412-963-0610 | Corporate Office Capintec, Inc. Arrow Road amsey, NJ 07446 hone 201-825-9500 AX 201-825-1336 Establishment Registration Number 2518443 Contact information Mary Anne Dell, M.S. VP and General Manager Phone 412-963-1099 412-963-0610 FAX Email madell@capintec.com Trade name or common name 2 Basic Type of Submission Traditional 510(k) Classification of Device Class II, Accessory to Linear Accelerator, Radiology Panel Intended Use The 2 Basic is intended to be used by trained medical physicist to measure the radiation output from radiation therapy machines for verification of patient treatment plan, quality assurance, or beam characteristics. It is not intended to function as a primary calibration device. The 2 Basic can be used in direct surface contact with patients or in a phantom material. {1}------------------------------------------------ K\$\phi\$ 3\$\phi\$175 Product Description: The Capintec 2 Basic system consists of 2 diode detectors permanently attached to a precision electrometer and application software. The detectors are solid state silicon diodes with a hemispherical shape optimized for direct patient contact. They provide high sensitivity, excellent linearity, and uniform output vs. gantry angle. The diodes are completely water resistant and enclosed in biocompatible molded epoxy. The high precision electrometer measures the current from the detector and converts the value into a displayed dose and provides automatic zero compensation. Application software controls the system and stores measurement data for each detector, and associated beam parameters such as energy, MU, and patient demographic data. Data can be stored on the PC or printed for hard copy record. Customer must supply a UL recognized PC to be used with application software. Predicate Device: Predicate Devices submitted by Theta Systems, Inc. Model PDM/2 Patient Dose Monitor 510(k) Number K912249 and Isorad Integral Buildup Photon Diodes 510(k) Number K912250. The 2 Basic uses the Equidose Diode Detector Design submitted by MasTek DEM, Inc. 510(k) Number K980826 The 2 Basic meets the following Safety Standards Medical Electrical Equipment, Part 1 General Requirements - UL2601-1:2nd Medical Electrical Equipment, Part 1 General Requirements - IEC60601-1: Collateral standard: Electromagnetic Compatibility-IEC 60601-1-2 Medical Electrical Equipment, Part 1 General Requirements for Safety Medical Electrical Equipment, Part 1 General Requirements-Can/CSA C22.2 No.606101-M90 Medical Electrical Systems-IEC 606601-1-1:1993+A1 IEC 60601-2-9 Patient Contact Dosimeters Used in Radiation Therapy with Electrically Connected Radiation Detectors. The risk analysis, safety testing and verification and validation testing has addressed patient contact hazards, software hazards, and operator hazards and concluded that the unit is safe and fully meets the intended use and stated specifications of the product. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged to follow the curve of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MID 20850 Ms. Mary Anne Dell Vice President and General Manager Capintec, Inc. 540 Alpha Drive PITTSBURG PA 15241 Re: K030175 APR 1 7 2003 Trade/Device Name: 2 Basic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: January 15, 2003 Received: January 17, 2003 Dear Ms. Dell 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. {3}------------------------------------------------ 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 | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion 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" (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 (800) 638-2041 or (301) 443-6597 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 Page 2 {4}------------------------------------------------ ## Appendix 2 Indications for Use Form Page 510(k) Number K030175 Device Name: 2 Basic Indications For Use: The 2 Basic is a solid state diode detector system coupled with a precision electrometer and PC for radiation measurement, data storage and display. It is intended to be used by trained medical physicists for the measurement of radiation output from radiation therapy treatment machines. The 2 Basic can be used with direct patient contact for entrance skin measurements, or in air, water, or other suitable phantoms materials for beam output measurements. Measurement data is used to verify and document the beam characteristics of radiation therapy treatment machines for quality assurance programs and to very therapeutic doses delivered to patients during treatments. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) David A. Sypm (Division Sign-Off) Division of Reproductive. A and Radiological Device 510(k) Numb