HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM

{0}------------------------------------------------ K062256 FEB 26 2007 # 510(k) SUMMARY For ### Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System #### 1. Submitter's Name and Address | Submitter's Name: | Hill Laboratories | |-----------------------|-------------------| | Address: | 3 Bacton Hill Rd | | City, State, and Zip: | Frazer, PA 19355 | #### 2. Contact Person | Name: | Brady Aller | |------------|-------------------------| | Title: | Sales/Service Manager | | Telephone: | ( 610 ) 644-2867 | | Facsimile: | ( 610 ) 647-6297 | | E-mail: | bradyaller@hilllabs.com | #### 3, Manufacturing Facility Address | Manufacturer: | Hill Laboratories | |-----------------------|-------------------| | Address: | 3 Bacton Hill Rd | | City, State, and ZIP: | Frazer, PA 19355 | #### Establishment Registration Number 4. Establishment 2510425 Registration Number: #### 5. Reason for Submission New Device #### 6. New Device Details | Proprietary or Trade<br>Name: | HF54 Combination Ultrasound Interferential<br>and Premodulated Stimulation System | |-------------------------------|-----------------------------------------------------------------------------------| | Common Name: | Ultrasonic Diathermy | {1}------------------------------------------------ ### Device Common Name, Classification, Product Code & 7. CFR No. | Common Name | Class | ProCode | CFR | |--------------------------------|-------|---------|----------| | Ultrasonic Diathermy | 2 | IMI | 890.5300 | | Interferential Current Therapy | 2 | LIH | | | Infrared lamp | 2 | ILY | 890.5500 | #### Classification Name 8. diathermy, ultrasonic, for use in applying therapeutic deep heat interferential current therapy lamp, infrared, therapeutic heating #### 9. Device Classification Panel Physical Medicine & Neurology #### Indications for Use 10. #### Interferential and Premodulated Modes 10.1 Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. #### Ultrasound Therapy 10.2 Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: - Relief of pain Muscle Spasms Joint contractures The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using one or two ultrasound applicators. The second ultrasound applicator is optional. The intended Use/Indications For Use stated herein are consistent with the cleared indications for use for the predicate devices. {2}------------------------------------------------ #### Infrared Therapy 10.3 An Infrared light probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or with an optional external medical grade, isolated power supply. It is used to provide topical heating for: - . Temporary increases in local blood flow and circulation - . Temporary relief of minor muscle and joint aches - . Temporary relief of pain and stiffness - . Relaxation of muscles - . Temporary relief (or relaxation) of muscle spasms - Temporary relief of minor pain and stiffness associated with arthritis #### Standards 11. #### Mandatory Standards 11.1 21 CFR 1050.10 is applicable to therapeutic ultrasound. The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System complies with this mandatory standard. #### 11.2 Consensus Standards The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System is designed to comply with the following Consensus Standards: | STANDARD NO. | | |--------------|--| |--------------|--| | | TITLE | | |--|-------|--| | | | | | IEC 60601-1 +A1, +A2 | Medical Electrical Equipment- Part 1: General Requirements<br>for Safety | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | UL 60601-1 | Medical Electrical Equipment- Part 1: General Requirements<br>for Safety | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements<br>for safety - Collateral standard: Electromagnetic compatibility -<br>Requirements and tests | | IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements<br>for the safety of ultrasonic physiotherapy equipment | | IEC 60601-2-10 | Medical electrical equipment. Part 2: Particular requirements<br>for the safety of nerve and muscle stimulators | #### 12. Predicate Devices | 510(k) Number | Trade or Proprietary or Model<br>Name | Manufacturer | Class | |---------------|---------------------------------------|--------------|-------| | K031329 | Solaris Model 708 and 709 | Dynatronics | 2 | {3}------------------------------------------------ #### Substantial Equivalence (SE) Rationale 12.1 The HF54 offers electrical stimulation, ultrasonic therapy and/or combination of the two and shares the same or similar basic characteristics including waveforms, operating frequencies and the same use in physical medicine and neurology as the predicate device. The new device and the predicate device are intended to be used by a qualified therapist. The light wavelengths (visible and infrared) and output intensities for the HF023 Infrared therapy probe are the same as the predicate device's Infrared therapy probe cleared under K031239. The methods of application and intended use/indications for use are the same and the same patient population is intended to be treated by the new device and the predicate device. The ultrasound output and electrical stimulation currents are consistent with FDA guidance and international standards. The predicate device claims compliance to the same standards. The materials used in construction of the device and the method of information display are similar. The measured parameters for the proposed HF54 are the same as those displayed on the predicate devices. #### Conclusion 12.2 The proposed HF54 including HF023 Infrared Therapy probe is Substantially Equivalent to the Dynatronics Solaris device cleared under K031329. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 - EE29 28 2837 Hill Laboratories % Mr. Brady Aller Sales/Service Manager 3 Bacton Hill Road Frazer, Pennsylvania 19355 Re: K062256 Trade/Device Name: HF54 Combination Ultrasound Interferential and Premodulate Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, IL Y, LIH Dated: January 8, 2007 Received: January 10, 2007 Dear Mr. Aller: 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 such 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. {5}------------------------------------------------ Page 2 - Mr. Brady Aller 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 (240) 276-0210 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Miy Hh Osta Mark N. Molkerson Mark N. Melkerson J Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ | 510(k) No. | | |------------|--| | If known | | ### Indications For Use statement – Interferential and Premodulated Modes HF54 Combination Ultrasound Interferential and Premodulated Device Name: Stimulation System Indications For Use: The HF54 is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. : Continued on next page . . | Prescription Use | X | AND/OR | Over-The-Counter Use | | |--------------------------|---|----------------------------|----------------------|--| | (Per 21 CFR 801 Subpa D) | | (Per 21 CFR 801 Subpart C) | | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | 510(k) Number | K062256 | |---------------|---------| |---------------|---------| . {7}------------------------------------------------ | 510(k) No. | | |------------|--| | lf known | | ## Indications For Use statement - Ultrasound Therapy | Device Name: | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use: | Ultrasound therapy is available from the HF54 and indicated for: | | | Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: | | | Relief of pain | | | Muscle Spasms | | | joint contractures | | | The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using One or two ultrasound applicators. The second ultrasound applicator is optional. | | Continued on next page | | | Prescription Use<br>(Per 21 CFR 801 Subpart D) | X | |----------------------------------------------------|---| | AND/OR | | | Over-The-Counter Use<br>(Per 21 CFR 801 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) • : . : {8}------------------------------------------------ | 510(k) No. If known | | |---------------------|--| |---------------------|--| ### Indications For Use statement -Infrared Applicator Device Name: Infrared Therapy (using optional HF023) Indications For Use: An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: . Temporary increases in local blood flow and circulation . Temporary relief of minor muscle and joint aches � Temporary relief of pain and stiffness � Relaxation of muscles . Temporary relief (or relaxation) of muscle spasms . Temporary relief of minor pain and stiffness associated with arthritis Prescription Use AND/OR Over-The-Counter Use メ (Per 21 CFR 801 Subpa (Per 21 CFR 801 D) Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)