HCMI X-RAY

{0}------------------------------------------------ OCT 2 2 2002 Image /page/0/Picture/1 description: The image shows a document with the title "510(k) Summary of Safety and Effectiveness". The document includes the logo and contact information for Health Care MFG., INC. The address is listed as 2146 East Pythian St., Springfield, MO 65802. The phone number is 417-864-6511, and the fax number is 417-864-7394. The document also includes the number K022667. EXHIBIT 2 August 9, 2002 Contact: Katrina Moulder, Official Correspondent - 1. Identification of the Device: Proprietary-Trade Name: "HCMI X-Ray" High Frequency Radiographic System Classification Name: Stationary X-Ray System, Product Code 90 KPR Common/Usual Name: Stationary X-Ray System - 2. Equivalent legally marketed devices This product is similar in function to the Bennett X-Ray Radiographic System K952672 - 3. Indications for Use (intended use) : "HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations 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: The "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied. | HCMI 100 kHz Generators with Anatomical Programming | | | | |-----------------------------------------------------|----------|-----------|--------| | Model | mA Range | kVp Range | Max KW | | HF-300 | 25-300 | 40-125 | 30 | | HF-600 | 25-600 | 40-125 | 37.5 | | HF-3SE | 25-300 | 40-125 | 30 | | HF-3SEE | 25-300 | 40-125 | 30 | {1}------------------------------------------------ - 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 devices. | Characteristic | Bennett X-Ray<br>Radiographic System<br>K952672 | "HCMI X-Ray"<br>High Frequency<br>Radiographic<br>System | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest, abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position. | SAME | | Performance<br>Standard | 21 CFR 1020.30 | SAME | | Electrical safety | Electrical Safety per<br>Underwriters Laboratories<br>Standard UL-2601(IEC-<br>60601) and IEC 60601,<br>Underwriters Laboratories<br>Standard UL187: UL<br>Standard for Safety for X-<br>Ray Equipment. | SAME, | - 6. Substantial Equivalence Chart, "HCMI X-Ray" High Frequency Radiographic System ## 7. Conclusion After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Health Care Manufacturing, Inc. that the "HCMI X-Ray" High Frequency Radiographic System is as safe and effective as the predicate device, has 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 shows a black and white seal of the Department of Health & Human Services. The seal features a stylized eagle with three lines emanating from its head, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 2 2 2002 Health Care MFG., Inc. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015 USA Re: K022667 Trade/Device Name: "HCMI X-Ray" High Frequency Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: August 9, 2002 Received: August 12, 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 contact the Office of Compliance 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 Office of Compliance 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 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. Snigdon 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 KU22667 510(k) Number Device Name: "HCMI X-Ray" High Frequency Radiographic System Indications for Use: "HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations 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. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over the Counter Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number -