ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY

K964799 · Ormed GmbH · ILO · Aug 29, 1997 · Physical Medicine

Device Facts

• Record ID: K964799
• Device Name: ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
• Applicant: Ormed GmbH
• Product Code: ILO · Physical Medicine
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.

Device Story

Portable thermal therapy unit; provides localized hot or cold therapy via water-circulating cuffs. Input: electrical power (110-230 VAC); water/alcohol mixture fluid. Operation: electric pump circulates temperature-controlled fluid through insulated tubing to patient-contact pads/cuffs. Temperature controlled via manual rheostat; monitored via LCD display. High-temperature alarm sounds if temperature exceeds +50°C; no automatic shut-off. Used in clinical or home settings; operated by patient or clinician. Output: thermal energy applied to body surfaces (ankle, foot, wrist, hand, back, shoulder, hip, neck, knee). Benefits: reduction of pain and swelling for post-traumatic/post-surgical conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design comparison, and adherence to established performance standards for water circulating hot/cold packs.

Technological Characteristics

Portable unit with electric pump, heat exchanger, and insulated tubing. Materials: plastic reservoir, tubing, and cuffs. Energy: 110-230 VAC. Temperature range: +4°C to +50°C. Control: manual rheostat. Display: LCD. Safety: grounded, fused, overload protected, auditory high-temp alarm. Sterilization: none (surface disinfection only).

Indications for Use

Indicated for treatment of pain and swelling of acute periarticular processes, pain and swelling following mobilization of shoulder stiffness under anesthesia, pain and swelling postoperatively for bones, joints and soft tissue, and pain and swelling caused by musculoskeletal contusions and athletic injury.

Regulatory Classification

Identification

A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

Predicate Devices

• TTU-100 by Danninger Medical Technology, Inc.
• Hot/Ice® HE500/A by ThermoTemp, Inc.

Submission Summary (Full Text)

{0}

AUG 29 1997

K964799

ATTACHMENT III

REVISED
SUMMARY OF SAFETY AND
EFFECTIVENESS INFORMATION

{1}

14964799

Section 510(k) Premarket Notification
Summary of Safety and Effectiveness Information

For the ORMED, GMBH - ARTROTHERM™
CRYOTHERAPY AND THERMOTHERAPY UNIT

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Trade Name: ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY

Common Name: Water Circulating Hot or Cold Pack

Classification Name: Water Circulating Hot or Cold Pack

3. Establishment Name & Registration Number:

Name: ORMED, GMBH

Number: 2247872

4. Classification:

§ 890.5720 Water circulating hot or cold pack. (a) Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces. (b) Classification. Class II (performance standards).

Product Code: 89ILO

Device Class: Class II

Classification Panel: Physical Medicine

5. Contact Person:

Mrs. Margit Bayha
ORMED, GMBH
Merzhauser Strasse 112
D-79100 Freiberg I. B.
Germany
011 49 7 61/45 84 471 (voice)
011 49 7 61/45 84 450 (fax)

6. Special Controls:

Special controls have not been established for this device.

{2}

# 7. Device Description:

Intended Use: Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.

Indications for Use: 1) Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

Background: The ARTROHERM™ CRYOTHERAPY AND THERMOTHERAPY like the referenced equivalent devices, is a typical thermal therapy device. As a group, thermal therapy devices are capable of producing both heating and cooling effects depending on the therapy mode selected. Thus, it is possible to administer hot or cold therapy or hot & cold therapy in alternating fashion without removal and reapplication of different pieces of equipment.

Typical thermal therapy units consist of a compact heating and chilling unit equipped with a liquid circulating electric pump. The pump circulates a liquid (usually water or a water/alcohol mixture) around the heating/cooling elements or heat exchanger of the thermal therapy device. The heated or cooled liquid is then circulated to the treatment site via insulated tubing to a patient contact pad or cuff. Placement straps or wraps are used to hold the cuff/pad in place during treatment. Frequently, standard elastic wraps (Ace-type bandages) are used to hold the cuff/pad in place.

Following the fashion of available devices, the ARTROHERM™ CRYOTHERAPY AND THERMOTHERAPY unit also utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROHERM™ are shaped to better contour to different body surfaces.

Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps.

Basic Operation: For the first set-up, the cap of the fluid reservoir is removed and a 4:1 solution of water and alcohol is poured into the unit. A premixed alcohol/water solution is available for use with the unit. With the pump running and the connecting tubing and cuff attached, the alcohol/water solution is poured in until the reservoir no longer pumps dry. When the air bubbles have been purged from the system, the reservoir will be about 3/4 full. Replace the fluid reservoir cap tightly, the unit is now ready for service. The cuff and tubing are equipped with sealing connectors and will remain filled after the initial set-up application. A few drops of fluid may escape when the cuff/tubing are disconnected, this is normal. Additional fluid is added to the reservoir whenever a new empty cuff is attached to the system for the first time.

The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps.

Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. The heating cycle is generally less affected by environmental conditions.

{3}

A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C. There is no automatic high temp system shut off, the device is to be shut off and removed by the patient or operator when the high temperature alarm sounds.

## 8. Substantially Equivalent Device(s):

The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY is substantially equivalent to the following devices:

1. TTU-100 by Danninger Medical Technology, Inc.
2. Hot/Ice® HE500/A by ThermoTemp, Inc.

## 9. Comparison to Predicate Device(s):

Two currently available thermal therapy devices have been selected for comparison with the ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY. The first is the TTU-100 Thermal Therapy Unit from Danninger Medical Technology, Inc. The second device is called the Hot/Ice® HE500/A made by ThermoTemp, Inc.

Minimum and maximum operation temperatures are 35° and 116° F. for the TTU-100 and 40° to 105° F. for the Hot/Ice unit. These temperature ranges compare equivalently to the ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit temperature range of 43° to 122° F. The intended use of all three units are the same. All devices provide localized heating or cooling therapy to selected body surfaces. Hot or cold therapy is useful in treating various traumatic or surgical conditions related to orthopaedics, sports medicine, rheumatology, general surgery, plastic surgery, reconstructive surgery, chirosurgery, foot surgery and selected neurology conditions.

Water temperature control is accomplished by rheostat in the ARTROTHERM™ device and by digital controls in both of the comparison devices. This slight difference in temperature control mechanism is unimportant because either control is adequate. Water temp display is digital for all three devices utilizing either LCD or LED display characters.

All three units function on standard electrical outlet current of 120 VAC 60 Hz, though both the ARTROTHERM™ and the Hot/Ice® HE500/A units will operate on 220-230 VAC 50/60 Hz current as well. All three units meet UL-544 requirements for electrical safety. All three units are grounded, safety fused and overload protected. The ground leakage current value for the ARTROTHERM™ and the comparison units is less than 55 micro-amps.

The weight of all three units is essentially the same, being 21, 23 and 22 pounds respectively.

The circulating heat transfer fluid for the units is equivalent. A water alcohol mixture is used in the ARTROTHERM™ (80%-20%) and the Hot/Ice® HE500/A (70%-30%) units while only distilled water is used in the TTU-100 Thermal Therapy unit. The TTU-100 Thermal Therapy unit uses a water alcohol mixture for cleaning and maintenance.

## 10. Packaging:

Standard, paper fiber industry typical bulk shipper packaging is utilized. The packaging selected for use is sufficient to identify, protect and transport the device safely.

{4}

11. Sterilization/Re-sterilization:

The device may not be sterilized or re-sterilized. Surface disinfecting is possible using commercially available non-solvent based disinfectant products. Cleaning and sanitizing instructions are supplied with each ARTROTHERM™ unit.

12. Conclusion:

Based on the materials, intended uses, design, and effectiveness, the ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit is equivalent to the referenced legally marketed comparison water circulating cold packs. The feature comparison chart below graphically demonstrates this equivalence.

13. Comparison Table:

| FEATURE | ARTROTHERM™ | TTU-100 | Hot/Ice® | SE? |
| --- | --- | --- | --- | --- |
| Intended Use: | Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions. | Same | Same | Yes |
| Cuff: | 5 styles/sizes | 3 styles/sizes | 5 styles/sizes | Yes |
| Water Temp Control: | Rheostat | Digital | Digital | Yes |
| Water Temp Indicator: | LCD | LCD | LED | Yes |
| Temperature Range(s): | 43°F to 122°F, user selectable | 35°F -116°F user selectable in 1° increments | 40°F -105°F user selectable in 1° increments | Yes |
| Electrical Requirements: | 110 -120 VAC 50/60 Hz 220-230 VAC 50 Hz | 120 VAC 60 Hz | 115 VAC 50/60 Hz 230 VAC 50/60 Hz | Yes |
| Ground Leakage Current Value: | <55 micro-amps | <55 micro-amps | <55 micro-amps | Yes |
| Weight: | 22 lb. | 23 lb. | 21 lb. | Yes |
| Recirculating Fluid: | Water/alcohol, 80%/20% mixture | Distilled water, water/alcohol mix for cleaning and maintenance only | Water/alcohol mix 70%/30% | Yes |
| Performance Standards: | UL/ETL compliant | UL/ETL compliant | UL/ETL compliant | Yes |
| Disposable cuff covers: | Yes | Yes | Yes | |
| Safety: | Grounded, fused & overload protected Auditory alarm - water for temp above 122°F | Automatic shutoff above 116°F or below 35°F water outlet temperature, Low water level or unit tilt greater than 45° | Low fluid, no- fluid flow, high/low temperature extreme and blocked air flow indicator lights | Yes |
| Manufacturer: | Medireha | Danninger | ThermoTemp, Inc. | Yes |

{5}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. David W. Schlerf
Buckman Company, Inc.
Representing Ormed, GmbH
1000 Burnett Avenue, Suite 450
Concord, California 94520

Re: K964354
Artrocool®-S Water Circulating Cold Pack
K964799
Artrotherm™ Cryotherapy and Thermotherapy
Regulatory Class: II
Product Code: ILO
Dated: July 27, 1997
Received: July 29, 1997

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

{6}

Page 2 - Mr. David W. Schlerf

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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosures

{7}

Page 1 of 1

510(k) Number (if known): ___________________________

Device Name: ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY

## Indications For Use:

1. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☐
OR
Over-The-Counter Use ☑
(Per 21 CFR 801.109)
(Optional format 1-2-96)

Ormed/hot.doc