HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
Device Facts
| Record ID | K072256 |
|---|---|
| Device Name | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL |
| Applicant | Hill Laboratories Co. |
| Product Code | PFW · Physical Medicine |
| Decision Date | Mar 12, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. 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; joint contractures. This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary). 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.
Device Story
HF54 is a combination system providing ultrasound, interferential, and premodulated electrical stimulation; optional infrared probe (HF023) provides topical heating. Device used in clinical settings by qualified therapists. Ultrasound applicators (one or two) deliver therapeutic deep heat; can be operated in manual scanned mode or stationary hands-free mode. System monitors treatment parameters; operator must remain present to ensure patient safety and prevent overheating. Output affects clinical decision-making by providing physical therapy modalities for pain management and tissue heating. Benefits include non-invasive pain relief and muscle relaxation.
Clinical Evidence
Bench testing only. Thermal measurements confirmed that ultrasound applicator surface temperature does not exceed 45 °C during stationary use. Thermal index calculations and measurements verified that tissue and bone temperatures remain below 45 °C at intensities ≤ 10W. No clinical data provided.
Technological Characteristics
Combination system for ultrasonic diathermy, interferential/premodulated stimulation, and infrared therapy. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, and IEC 60601-2-10. Ultrasound output is pulsed. Features optional hands-free stationary ultrasound application. Materials and display parameters are identical to predicate K062256.
Indications for Use
Indicated for patients requiring symptomatic relief of chronic intractable pain, traumatic or post-surgical pain, relief of pain and joint contractures via deep heat, and topical heating for muscle/joint aches, stiffness, spasms, and arthritis-related pain.
Regulatory Classification
Identification
An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Predicate Devices
- HF 54 (K062256)
Submission Summary (Full Text)
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K072256
# 510(k) SUMMARY
For
## Hill Laboratories
## HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation
#### l. Submitter's Name and Address
| Submitter's Name: | Hill Laboratories | MAR 12 2008 |
|-----------------------|-------------------|-------------|
| 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 |
#### 4. Establishment Registration Number
Establishment Registration 2510425 Number:
#### 5. Reason for Submission
Expanded Indications for Use
#### 6. Device Details
| Proprietary or Trade<br>Name: | HF54 Combination Ultrasound Interferential and<br>Premodulated Stimulation System with optional<br>hands-free operation |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasonic Diathermy |
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### 7. Device Common Name, Classification, Product Code & CFR No.
| Common Name | Class | ProCode | CFR |
|--------------------------------|-------|---------|----------|
| Ultrasonic Diathermy | 2 | IMI | 890.5300 |
| Interferential Current Therapy | 2 | LIH | |
| Infrared lamp | 2 | ILY | 890.5500 |
#### 8. Classification Name
- (i) diathermy, ultrasonic, for use in applying therapeutic deep heat
- (ii) interferential current therapy
- lamp, infrared, therapeutic heating (iii)
#### 9. Device Classification Panel
Physical Medicine & Neurology
#### 10. Indications for Use
#### Interferential and Premodulated Modes 10.1
- Pain relief for:
- Symptomatic relief of chronic intractable pain and/or management of traumatic . or post surgical pain.
#### 10.2 Ultrasound Therapy
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
- . Joint contractures
This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional.
Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary).
#### 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
December 10, 2007
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#### 11. Standards
#### 11.1 Mandatory Standards
21 CFR 1050.10 is applicable to therapeutic ultrasound. The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with ontional hands-free operation complies with this mandatory standard.
#### 11.2 Consensus Standards
The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is designed to comply with the following Consensus Standards:
| STANDARD NO. | TITLE |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 +A1, +A2 | Medical Electrical Equipment- Part 1: General Requirements for<br>Safety |
| UI. 60601-1 | Medical Electrical Equipment- Part 1: General Requirements for<br>Safety |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for<br>safety - Collateral standard: Electromagnetic compatibility -<br>Requirements and tests |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for<br>the safety of ultrasonic physiotherapy equipment |
| IEC 60601-2-10 | Medical electrical equipment. Part 2: Particular requirements for the<br>safety of nerve and muscle stimulators |
#### 12. Predicate Devices
| 510(k) Number | Trade or Proprietary or Model<br>Name | Manufacturer | Class |
|---------------|---------------------------------------|-------------------|-------|
| K062256 | HF 54 | Hill Laboratories | 2 |
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#### Substantial Equivalence (SE) Rationale 12.1
## 12.1.1 Technology
The HF54 with optional hands-free operation offers the same electrical stimulation, ultrasonic therapy and/or combination of the two and shares the same characteristics including waveforms, operating frequencies and the same use in physical medicine and neurology as the predicate device. The device with its proposed extended indications for use is intended to be used only by a qualified therapist.
## 12.1.2 Standards
The ultrasound output and electrical stimulation currents are consistent with FDA guidance and international standards. The new device is in compliance to the same standards.
## 12.1.3 Materials
The materials used in construction of the device and the method of information display are identical. The measured parameters for the proposed HF54 are the identical to those displayed on the device cleared under K062256. The software has not been changed from the cleared device.
## 12.1.4 Risk Analysis
The expanded indications for use (stationary ultrasound) needed a review of the risks posed by a stationary technique. The primary risks were identified as:
- a) Temperatures in tissues above 45 °C
- b) Temperature rise in bone
- Standing waves c)
- d) Self-heating of the ultrasound applicator
- The patient falling asleep during hands-free operation possibly leading to e) overheating of tissues.
#### Temperatures in Tissues and In Bone 12.1.4.1
From Measurement and Thermal Index Calculations, it was shown that with an intensity of ≤ 10W, the temperature of Tissue or Bone would not rise above 45 °C when used as directed. See Attachment C-1. There is no new safety issue.
#### 12.1.4.2 Standing Waves
The ultrasound output is pulsed and will not support standing waves. There is no new safety issue.
#### 12.1.4.3 Self Heating of the Ultrasound Applicator
Measurements made during the original submission for the HF54 included thermal measurements of the ultrasound applicator surface. The tests demonstrated that the applicator surface temperature did not exceed 45 °C when stationary, over the whole treatment time. Measurements were made at equal distances across the surface of the treatment surface. There is no new safety issue.
HF54 With Optional Hands-free operation
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#### Patient falling asleep during treatment 12.1.4.4
The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep.
There are no new treatment modes, identical circuitry and software are used. The changes therefore do not change the effectiveness of the device.
## 12.2 Conclusion
The proposed HF54 with Optional Hands-free operation when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the current version of the HF54 cleared under K062256.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2014
Hill Laboratories c/o Mr. Brady Aller 3 Bacton Hill Rd. Frazer, PA 19355
Re: K072256
Trade/Device Name: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: II Product Code: PFW; ILY; LIH Dated: December 10, 2007 Received: December 13, 2007
Dear Mr. Aller:
This letter corrects our substantially equivalent letter of March 12, 2008.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{6}------------------------------------------------
Page 2 - Mr. Brady Aller
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Joyce M. Whang -S
for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) No. If known
## Indications For Use statement - Interferential and Premodulated Modes
Device Name:
HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation
Indications For Use:
The HF54 interferential therapy and premodulated therapy 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 ×
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart 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)
Nelke Dsl for nxm
Division Size: 18
**Division of General Restorative**
and Neurological Devices
510(1) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
HF54 With Optional Hands-free operation
December 10, 2007
Page 14 of 70
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510(k) No. If known
## Indications For Use statement - Ultrasound Therapy
| Device Name: | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Ultrasound therapy is available from the HF54 and indicated for:<br>Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as:<br>Relief of pain<br>joint contractures<br>This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional.<br>Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary). |
Continued on next page
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|------------------|---|--------|----------------------|
|------------------|---|--------|----------------------|
Prescription Use X Over-The-Counter Use
(Per 21 CFR 801 Subpart 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**)
Nilpeaglh formxm
Division of General, Restorative, and Neurological Devices
510(k) Number: K072256
HF54 With Optional Hands-free operation
December 10, 2007
{9}------------------------------------------------
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 | X | AND/OR |
|---------------------------|---|--------|
| (Per 21 CFR 801 Subpart D | | |
Over-The-Counter Use
(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)
Neil Ogden for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** K072256
HF54 With Optional Hands-free operation
December 10, 2007
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