MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300

K060669 · Healthonics, Inc. · GZJ · Oct 13, 2006 · Neurology

Device Facts

• Record ID: K060669
• Device Name: MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
• Applicant: Healthonics, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For Prescription Use Model SE-100: - Relief of chronic intractable pain. - Adjunctive treatment of post-surgical or post-traumatic acute pain. For Prescription Use Models ST-150, ST-200 and ST-300: - Relief of chronic intractable pain. - Adjunctive treatment of post-surgical or post-traumatic acute pain. - Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee. - Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand.

Device Story

MedRelief ST Series (ST-100, ST-150, ST-200, ST-300) provides subthreshold electrical stimulation for pain relief. Device inputs: battery power; user-selected settings (frequency, burst timing). Principle: hard-wired solid-state electronics generate biphasic, subthreshold electrical pulse trains (20 Hz–20 kHz) applied via skin-contact electrodes. No microprocessor or software used. Output: electrical pulses to skin. Used in home (ST-100, ST-150, ST-200) or clinical (ST-300) settings. Healthcare providers prescribe; patients apply electrodes and operate controls. Subthreshold stimulation acts at cellular level without causing sensation or muscle contraction, potentially relieving pain.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on comparative analysis of electrical output characteristics (current, pulse shape, frequency, charge) and intended use against legally marketed predicate devices.

Technological Characteristics

Battery-powered (9V lithium) TENS device; flame-retardant ABS plastic housing. Solid-state, hard-wired circuitry (no software/microprocessor). Biphasic pulse output; frequencies 20 Hz–20 kHz. Applied via self-adhesive/gelled electrodes. Complies with AAMI NS4 safety standards. Dimensions vary by model (1.7 oz to 8 oz).

Indications for Use

Indicated for patients requiring relief of chronic intractable pain, adjunctive treatment of post-surgical or post-traumatic acute pain, and adjunctive therapy for pain associated with osteoarthritis of the knee or rheumatoid arthritis of the hand. Prescription use only.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Healthonics MedRelief SE-50 (K030998)
• Bionicare Model BIO-1000 (K030332, K983228)

Submission Summary (Full Text)

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K060669

Applicant: Healthonics, Inc. MedRelief®® ST Series Microcurrent TENS Traditional 510(k) Premarket Notification

Page 1:4

# OCT 1 3 2006 Biophysics Health Co

510(k) Summary:

| 510(k) Owner: | Healthonics, Inc.<br>903 Main Street South<br>New Ellenton, SC 29803 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James W. Kronberg<br>Chief Engineer<br>Phone [phone]<br>Fax [phone] |
| Date Prepared: | March 10, 2006 - Revised September 13, 2006 |
| Device Name: | MedRelief ST ("Sub-Threshold") Series, consisting<br>of models ST-100, ST-150, ST-200 and ST-300. |
| Common or Usual Name: | TENS device. |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain<br>Relief. 21 CFR 882.5890, Class II, Product Code<br>84GZJ (prescription) or Stimulator, Electrical,<br>Transcutaneous, for Arthritis. 21 CFR 882.5890,<br>Class II, Product Code NYN (prescription). |
| Predicate Devices: | Healthonics MedRelief® SE-50 for acute and chronic<br>pain indications (K030998).<br>Bionicare Model BIO-1000 for osteoarthritis<br>(K030332) and rheumatoid arthritis (K983228)<br>indications. |

#### Description of the Device:

The MedRelief" ST Series™, consisting of models ST-100, ST-150, ST-200 and ST-300, is designed to provide subthreshold electrical stimulation for acute and chronic pain, including pain, including pain from osteoarthritis and rheumatoid arthritis, in a single compact, lightweight and user-friendly package. "Subthreshold" stimulation does not normally cause sensation or muscle contraction, but acts at a cellular level to relieve pain.

Each device in the ST Series is comprised of the following main components.

- A power section consisting of battery, switch, test and conditioning components; .
- A dosing timer, initialized at power-on and providing a choice of treatment times; .
- A control oscillator, providing pulse-burst timing; .
- A pulse oscillator, providing timing for individual pulses; and .
- An output section, providing filtering, DC blocking and intensity control.

While some components are digital, all functions are hard-wired and there is no microprocessor or software used. Output is by means of lead wires and skin-contact electrodes already commercially available and legally sold by others.

The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.

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Indications and Intended Use:

- . Relief of chronic intractable pain. (All modelse) ;
- . Adjunctive treatment of post-surgical or post-traumatic acute pain. {{{#=====================================================================================================
- Adjunctive therapy in reducing the level of pain and symptoms associated with . osteoarthritis of the knee. (ST-150, ST-200 and ST-300 and ST-300 and ST-300 coment
- . Adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand. (ST-150, ST-200 and ST-300 and ST-300 ember

The indications are the same as for the predicate devices listed. All units are for prescription use only. The ST-100 is a simplified unit meant for home use, with one output channel and a minimal set of signal options, closely similar to the SE-50 predicate device. Other devices in the ST Series™ are meant for a wider range of indications by including a signal modeled on that of the Bionicare BIO-1000 predicate device. The ST-150 is otherwise identical with the ST-100. The ST-200 offers two output channels and more user options. The ST-300 offers four channels, even more options, and is meant for use in a clinical setting only.

#### Technological Characteristics:

The technological characteristics of the MedRelief® ST Series™ are the same as those of the predicate devices. Each device is battery-powered with no provisions for line power or AC adapters. Each uses solid-state electronics to produce trains of subthreshold electrical pulses, at frequencies within the human audible range (~20 Hz to ~20 KHz), which are applied to the body through self-adhesive or gelled electrodes placed on the skin. Pulses have zero net charge and may be applied either continuously, or divided into pulse bursts alternating with quiet periods. All signal characteristics comply with the safety requirements of AAMI NS4.

#### Comparison of Features of MedRelief® ST Series™ Models

(s) - user switch selected. (c) - user adjustable through continuous range.

| Characteristic or Feature | ST-100 | ST-150 | ST-200 | ST-300 |
|---------------------------------|-------------------------------------------------------------------------------------|-----------------------------|----------------------------------------------|-------------------------|
| Intended use | Intractable chronic, postsurgical / posttraumatic acute and arthritis-related pain. | | | |
| Intended sale | Prescription only | | | |
| Number of output<br>channels | 1 | 1 | 2 | 4 |
| Pulse frequency | 700, 1800 or<br>4150 Hz (s) | 100, 700 or<br>4150 Hz (s) | 100, 230, 700,1800, 4150<br>Hz or 12 KHz (s) | 100 Hz to 20<br>KHz (c) |
| Pulse (short phase) length | 1/7 of long phase or 20 microseconds, whichever is greater | | | |
| Burst frequency | 15 Hz in pulse burst mode; N/A in continuous mode. | | | |
| Burst duty cycle | 15% or 100%* (s) | 5% up to 100%* (c) | | |
| Timer | None (runs whenever turned on) | 30 min., 8 hrs or cont. (s) | | |
| Dimensions, in. | 2.5 x 2.1 x 0.63 | 3.5 x 2.5 x 1 | 7 x 5 x 2.5 | |
| Weight including battery | 1.7 oz. | 2.5 oz. | 8 oz. | |
| Charger, AC cord or<br>adapter? | None | | | |

* Burst duty cycle of 100% = continuous operation.

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y 3. 4

#### Comparison of General and Technical Characteristics to Predicates.

Electrical output measurements assume a 500-ohm load. Timing values cited below are accurate to ±20% or 10 microseconds, whichever is larger. Other cited values are accurate to ±20% unless otherwise stated.

For conciseness, (10), (15), (20) and (30) refer to the ST-100, ST-150, ST-200 and ST-300 respectively. "Same" plus one or more of these labels in a Predicate column means "same as in the indicated ST Series™ device(s)," while without a label it means "same for all." See also notes 1-3 at the bottom of the table.

| Unit Characteristic | Proposed Device | Predicate #1 | Predicate #2 |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Device name and model | MedRelief® ST Series<br>(ST-100, ST-150, ST-200 and ST-300) | MedRelief® SE-50<br>(in SE Series). | BioniCare®<br>Stimulator, Model<br>BIO-1000™ |
| Manufacturer | Healthonics, Inc.<br>903 Main Street South<br>New Ellenton, SC 29803 | Same. | BioniCare Medical<br>Technologies, Inc.<br>47 R. Loveton Circle<br>Sparks, MD 21152 |
| 510(k) number | To be assigned | K030998 | K030332, K983228 |
| Procode | GZJ, NYN | GZJ | NYN |
| Intended Use<br>(indications; abbreviated,<br>see full list above.) | 1. Chronic intractable pain.<br>2. Post-surgical/post-traumatic acute<br>pain.<br>3. Pain/symptoms from osteoarthritis<br>of the knee.<br>4. Pain/stiffness from rheumatoid<br>arthritis of the hand. | Same as #1 and #2<br>for proposed device. | Same as #3 and #4<br>for proposed device |
| Number of output<br>modes | One: subthreshold<br>TENS. | Same. | Same. |
| Number of output<br>channels. | One (10, 15), two (20), or four (30). | One. | Version A: one.<br>Version B: two. |
| Pulse shape | Rectangular to exponential,<br>depending on pulse length and<br>charge balancing time chosen. | Same. | One phase<br>exponential, other<br>phase rectangular. |
| Mono- or biphasic | Biphasic | Biphasic | Biphasic (note 1) |
| Maximum instantaneous<br>current | 8.62 mA | Same | 24 mA |
| Maximum time averaged<br>current | 2.27 mA (2.71 mA, note 2) | Same | 2 mA |
| Maximum phase charge | 12.4 µC at 100 Hz;<br>1.87 µC at 700 Hz (note 2) | 1.87 µC at 700 Hz<br>(note 2) | 20 µC at 100 Hz |
| Maximum current density<br>at electrode | 0.41 mA/sq.cm. (note 2) | Same | 0.14 mA/sq.cm.<br>(note 3) |
| Maximum power density<br>at electrode | 0.133 mW/sq.cm. (note 2) | Same | 0.83 mW/sq.cm.<br>(note 3) |
| Regulated current or<br>regulated voltage? | Regulated current. | Same. | Regulated voltage. |
| Software/ firmware/<br>/microprocessor control? | No | No | No in Version A; yes<br>in Version B. |
| Housing materials and<br>construction. | Flame-retardant ABS plastic. | Same. | Flame-retardant<br>Cycolac plastic |
| Accessories:<br>1. Electrodes. | Pregelled reusable electrode,<br>25 cm² gel area, with "pigtail" wire<br>connection. For 100 Hz use (15, 20,<br>30), same but with 175 cm² gel area. | Pregelled reusable<br>electrode, 25 cm² gel<br>area, with "pigtail"<br>wire connection. | BioniCare special<br>design, metal mesh,<br>170-176 cm² gel-<br>coated area. |
| 2. Conductive<br>medium (gel) | None | None | Spectra 360 |

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### Applicant: Healthonics, Inc.

x 4:4

| 3. Electrode lead<br>wires. | 2 mm pin joined to 2mm socket by<br>flexible wire | Same. | Semicustom wires,<br>snap connectors |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------|-----------------------------------------|
| 4. Batteries. | 9V lithium batteries: miniature<br>semicustom (10, 15, 20) ; standard<br>rectangular (30). | Same (10, 15, 20) | Self-contained<br>rechargeable battery. |
| 5. Battery charger,<br>if used. | None. | None. | Plug-in wall<br>transformer type |
| Note 1. BioniCare claims monophasic pulses, but Healthonics scope measurements show the second phase is not<br>completely suppressed so the BioniCare pulses are actually biphasic.<br>Note 2: Taken under conservative worst-case conditions including any single-component failure. | | | |

:

:

:

Note 3. Healthonics measured from predicate device or calculated from information in predicate's 510(k).

.

.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 3 2006

Healthonics, Inc. % Mr. James W. Kronberg Chief Engineer 903 Main Street South New Ellenton, South Carolina 29809

Re: K060669

Trade Name: MedRelief ST ("Sub-Threshold") Series consisting of model numbers ST-100. ST-150, ST-200, and ST-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: September 13, 2006 Received: September 14, 2006

Dear Mr. Kronberg:

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 Pegister.

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 not mour 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 100-1050.

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Page 2 - Mr. James W. Kronberg

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 [phone]. 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkonian

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) number (if known): ___K060669

Device Name: MedRelief ST ("Sub-Threshold") Series, consisting of model numbers ST-100, ST-150, ST-200 and ST-300.

Indications for Use.

For Prescription Use Model SE-100:

- Relief of chronic intractable pain. .
- Adjunctive treatment of post-surgical or post-traumatic acute pain. .

For Prescription Use Models ST-150, ST-200 and ST-300:

- Relief of chronic intractable pain. .
- Adjunctive treatment of post-surgical or post-traumatic acute pain. .
- Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
- Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .

| Prescription Use<br>(21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart D) |
|--------------------------------------------|--------|------------------------------------------------|
|--------------------------------------------|--------|------------------------------------------------|

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | L060669 |
|---------------|---------|
|---------------|---------|