PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0

{0}------------------------------------------------ ## FEB 2 2 2002 K020436 Page 142 EXHIBIT 2 510(k) Summary of Safety and Effectiveness | SEDECAL SA | SEDECAL USA, Inc. | |--------------------------------------|----------------------------------| | Pelaya 9- Poligono Industrial Rio De | 2910 N. Arlington Heights Rd. | | Janeiro | Arlington Heights Illinois 60006 | | 28110-Algete | Tel 847-394-6960 | | Madrid Spain | Fax 847-394-6966 | | Tel (34) 91-628 0544/91-628 1592 | (Initial Importer) | | Fax (34) 91-628 0574 | Contact: Gary Fromberg | | (Foreign Manufacturer) | | February 5, 2002 510(k) Summary of Safety and Effectiveness - 1. Identification of the Device: Proprietary-Trade Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units Classification Name: Mobile X-ray system, Product Code 90 IZL Common/Usual Name: Portable general purpose diagnostic X-ray Unit. - 2. Equivalent legally marketed devices: This product is similar in function to the MinXray HF100H (a pre-amendments device) - 3. Indications for Use (intended use) Models SP-HF-2.8 and SP-HF-4.0 are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. - 4. Description of the Device: Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held. The usual safety precautions regarding the use of x-rays must be observed by the operator. - 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device. {1}------------------------------------------------ | Characteristic | MinXray HF100H | Models SP-HF-2.8 | Model SP-HF-4.0 | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Intended Use: | Potable general<br>purpose diagnostic<br>X-ray unit | SAME | SAME | | Physical<br>characteristics: | | | | | Size | 8.75"H x 9.5" W x<br>15.35" D. | 8.7 H x 10.4" W x<br>16.5" D | 8.7 H x 10.4" W x<br>16.5" D | | Weight | 40.9 lbs | 33 lb | 33 lb | | Energy Source: | 120 v 50-60~ AC | 90 to 285 VAC (50-<br>60 Hz) | 90 to 285 VAC (50-<br>60 Hz) | | User Interface | Up-Down<br>pushbuttons for<br>three kVp selections<br>and exposure time<br>selections with LED<br>indicators | Up-Down<br>pushbuttons for kVp<br>and mAs. kVp<br>adjustable in 1 kVp<br>steps | Up-Down<br>pushbuttons for kVp<br>and mAs. kVp<br>adjustable in 1 kVp<br>steps | | Exposure times | 0.08-2.00 Sec. In<br>192 steps | 0.002-10 sec 38<br>steps | 0.001-10 sec 41<br>steps | | Ma. | 20 mA | 5, 6.4, 8, 10, 12.5,<br>16, 20, 25, 32, 40,<br>50 | 5, 6.4, 8, 10, 12.5,<br>16, 20, 25, 32, 40,<br>50, 64, 80, 100 | | KvP | 100 KvP | 110 KvP | 115 KvP | | Standards and<br>Safety<br>characteristics: | | | | | Performance<br>Standard | 21 CFR 1020.30 | SAME | SAME | | Electrical safety: | UL 2601, IEC<br>60601-1 | SAME | SAME | Chart, Models SP-HE-2 8 and SP-HF-4.0 ## 7. Conclusion After analyzing both bench and user testing data, it is the conclusion of Sedecal that the Models SP-HF-2.8 and SP-HF-4.0 are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 2 2002 SEDECAL USA, Inc. % Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 DEERFIELD IL 60015 Re: K020436 Trade/Device Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: February 6, 2002 Received: February 8, 2002 Dear Mr. Kamm: 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 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 If you desire specific at one of the following numbers, based on the regulation number at the top of this 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 Additionally, relate at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by received to premained from the Division of Small Manufacturers, Jour responsiblements 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 vours, 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 {4}------------------------------------------------ j) Indications for Use 510(k) Number KD204366 Device Name: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units Indications for Use: Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units are intended financills for Soor Meaned physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ✓ OR Over the Counter Use (Per 21 CFR 801.109) Nancy Srogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K020436