STELLAR MODEL HS-04

{0}------------------------------------------------ K973223 ## 510(k) Summary FEB 1 8 1998 # Stellar Model HS-04 Common/Classification Name: Powered Electrical Stimulator/ Powered Heating Pad, 21 CFR 890.5850 and 890.5740 > Stellar Medical Corporation 1800 Second Street, Suite 705 Sarasota, FL 34236 Contact: B. C. James, M.D., Prepared: August 26, 1997 #### LEGALLY MARKETED PREDICATE DEVICES A. The Stellar Model HS-04 is substantially equivalent to the RS Medical Model RS-4M (K953136) and the Staodyn EMS + 2 (K926510) electrical stimulators with respect to its stimulation functions and is substantially equivalent to the PT-PAC Portable Heating Pad (K963887)with respect to its heating functions. #### B. DEVICE DESCRIPTION The Stellar Model HS-04 is a device that combines the functionality of two devices that have been classified by FDA, the powered muscle stimulator and the powered heating pad. Heat and muscle stimulation are often used at the same time by physical therapists and others to treat patients, and the HS-04 provides both therapies with a single combination device for convenience. The heating elements are contained in the same applicators that hold the stimulation electrodes. #### C. INTENDED USE The Stellar Model HS-04 is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, and prevention of venous thrombosis. #### D. SUBSTANTIAL EQUIVALENCE SUMMARY The HS-04 is a medical device, and it combines the indications for use {1}------------------------------------------------ of the legally marketed predicate devices. The HS-04 has the same technological characteristics as the predicate devices and these characteristics are precise enough to ensure equivalence. This premarket notification describes the characteristics of the HS-04 in sufficient detail to assure substantial equivalence. #### TECHNOLOGICAL CHARACTERISTICS ய் The system is powered through an AC power adaptor which can accept voltages in the range 90-132 VAC and 46-63 Hz and it draws a maximum of 0.7 Amperes. The stimulator section only (no heat) can be powered temporarily with an alkaline battery. The HS-04 uses solid state electronics to generate the stimulation waveforms and resistive DC-powered heating elements to produce the heating effect. These characteristics are the same as those of the predicate devices. The pulse rate and intensity are settable on the controller. In the muscle stimulator mode, the pulse rate may be varied between 1 and 150 pulses per second. The stimulator pulses for five seconds and then is off for five seconds. The pulse width of the biphasic pulses may range from 1 to 415 microseconds according to the "intensity" setting. The second of the biphasic pair of pulses follows the first by 1 millisecond. The number of pulses per second may be adjusted from 1 to 150 by adjusting a potentiometer on the back of the controller box. Each applicator pad is rectangular in shape (3 x 3.5 inches) with a thin profile. The heating component forms the back of the pad and the stimulation electrode forms the front surface. The stimulation electrodes have a conductive solid gel which sticks to the pad and the electrical contacts on one side and to the treatment area of the patient on the other. #### ட் TESTING ﻨﺔ The Stellar Model HS-04 is being tested for electrical safety by an independent laboratory. Tests are being carried out to assure compliance with UL-2601. KMC Systems will not market the device until the electrical safety certifications have been successfully completed. {2}------------------------------------------------ #### G. CONCLUSIONS This pre-market submission demonstrates Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 8 1998 T. Whit Athey, Ph.D. ·Senior Consultant C.L. McIntosh Associates, Inc. Representing Stellar Medical Corporation 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 K973223 Re : Stellar Model HS-04 Requlatory Class: II IPF, IRT, and LIH Product Codes: December 9, 1997 Dated: December 9, 1997 Received: Dear Dr. Athey: 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 Device Amendments, or to 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 The general controls provisions of the Act __ _ 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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. {4}------------------------------------------------ Page 2 - T. Whit Athey, Ph.D. 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 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/cdrh/dsmamain.html". Sincerely yours, a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): Device Name: Stellar Model HS-04 Indications For Use: ### Stimulator Mode The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf. ## Interferrential Mode The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms. ### Heating Mode The Stellar Model HS-04 heating mode is indicated for heating of a body region for the relief of minor muscular or joint pain. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluatio (Division Sign-Off) Division of General Restorative Devices Prescription Use (Per 21 CFR 801.109) OR .. . Over-The-Counter Use . . . . . . . . . . . . . . . .