HTP-1500 LOCALIZED HEAT THERAPY PUMP

K970197 · Adroit Medical Systems, Inc. · ILO · Sep 10, 1997 · Physical Medicine

Device Facts

• Record ID: K970197
• Device Name: HTP-1500 LOCALIZED HEAT THERAPY PUMP
• Applicant: Adroit Medical Systems, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Device Story

HTP-1500 is an electronically controlled water heater/pump for localized heat therapy. System includes water reservoir, electric resistance heater, heat exchanger, pump, and tubing connecting to an external pad. Operator uses membrane keypad to select temperature; digital display shows set point and actual water temperature. Microprocessor-based controller regulates heater to maintain desired temperature. Used in clinical settings to provide heat therapy for orthopedic conditions and trauma. Benefits include controlled, consistent heat delivery to affected areas to alleviate pain and muscle spasms.

Clinical Evidence

No clinical data. Substantial equivalence is based on intended use and device characteristics/specifications.

Technological Characteristics

Polypropylene housing; 115V/60Hz power; 200W electric resistance heater; digital solid-state microprocessor-based control system; 1.5L reservoir; 10-14 GPH flow rate. Safety features include software-based primary limit thermostat (109°F) and hardware-based secondary limit thermostat (115°F +/- 5°F).

Indications for Use

Indicated for patients requiring heat therapy for orthopedic conditions (lower back pain, strains, acute injuries, chronic pain, muscle spasm, tendonitis, arthritis) or skin trauma/medical issues (bruises, contusions, abscesses, boils, burns, infection, phlebitis, I.V. infiltration, neuritis).

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

• MICRO-TEMP model SMS-1000
• MICRO-TEMP model SMS-2000

Submission Summary (Full Text)

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SEP 10 1997
510(k) Summary

a(1) Submitted by: Adroit Medical Systems, Inc.
1146 Carding Machine Rd.
Loudon, TN 37774
423-458-8600
*K970197*

Contact Person: Richard L. Studer
423-458-8600

Prepared on: January 17, 1997

a(2) Proprietary Name: HTP-1500 Localized Heat Therapy Pump
Common Name: Heat Therapy Pump
Classification Name: Water Circulating Hot or Cold Pack

a(3) Adroit Medical Systems, Inc. believes that the HTP-1500 Localized Heat Therapy Pump is substantially equivalent to the MICRO-TEMP models SMS-1000 and SMS-2000 Localized Heat Therapy Pumps which are currently distributed by Seabrook Medical Systems, Inc.

a(4) The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled electric water heater containing a water reservoir, an electric resistance heater, a heat exchanger, an integral electric pump and associated tubing, hoses and fittings that allow it to be connected to a separate external pad. In use, the pump circulates water from the reservoir through the heat exchanger, associated tubing, hoses and fittings into and through the external pad. The operator, using a membrane switch keypad, selects the desired water temperature as observed and confirmed on a digital display. The electronic controller selectively turns on and off the electric resistance heater to heat the heat exchanger, thereby heating the water to the desired temperature. The actual water temperature is monitored and displayed on the digital display.

Included in this section is a three dimensional drawing of the HTP-1500 Localized Heat Therapy Pump showing the control panel, water reservoir fill cap, folding handle, water level viewing window, power switch, hose for connection to the pad, and the location of the power cord; and a schematic representation of an HTP-1500 connected to a pad.

510(k) Summary page # 1 of 5

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510(k) Summary page # 2 of 5

a(5) The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.

Localized heat therapy is of particular benefit in, but not limited to, orthopedic conditions such as lower back pain, strains, acute injuries, chronic pain, muscle spasm, tendonitis, and arthritis. Heat therapy is also sometimes prescribed for skin trauma (bruises, contusions, abscesses, boils, burns) and other medical problems like infection, phlebitis, I.V. infiltration, and neuritis.

a(6) The HTP-1500 Localized Heat Therapy Pump and the SMS-1000 and SMS-2000 MICRO-TEMP heat therapy pumps have substantially equivalent technological characteristics in that each use electrical resistance heaters to heat water, a solid state controller to control the temperature of the water, and an electric pump to circulate the water through a pad. This fact is further supported by the “SPECIFICATION COMPARISON” table included with this section.

b This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data.

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HTP-1500

SHOWN WITH HOSE AND POWER CORD

IN STORAGE POSITION


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Pad

HTP-1500

HTP-1500 Hookup To Pad
Note: Bi-directional Water Flow

510(k) Summary page # 4 of 5

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SPECIFICATION COMPARISON

| | Adroit HTP-1500 | Seabrook SMS-2000 | Seabrook SMS-1000 |
| --- | --- | --- | --- |
| Physical | | | |
| Size | 7" Diameter, 8.5" High | 8.5" Wide, 6.0625" Deep, 5.75" High | 8.5" Wide, 6.0625" Deep, 5.75" High |
| Weight (empty) | 7 Pounds | 5.25 Pounds | 4.7 Pounds |
| Connector Fitting Type | Quick-Connect | Quick-Connect | Quick-Connect |
| Housing Material | Polypropylene | G.E. Noryl Plastic | G.E. Noryl Plastic |
| Housing Color | Off White | Off White | Off White |
| Electrical System | | | |
| Voltage | 115 Volt, 60 Hz. | 115 Volt, 60 Hz. | 115 Volt, 60 Hz. |
| Current | 2.2 Amp. | 1.75 Amp. | 1.75 Amp. |
| Fuse | 3 Amp., Type 3AG | 3 Amp., Type 3AG | 3 Amp., Type 3AG |
| Power Cord | 3 Conductor, 18 AWG, 10 Feet Long, Hospital Grade Plug | 3 Conductor, 18 AWG, 10 Feet Long, Hospital Grade Plug | 3 Conductor, 18 AWG, 10 Feet Long, Hospital Grade Plug |
| Leakage Current | Less Than 50 Microamp | Less Than 50 Microamp | Less Than 50 Microamp |
| Heating System | | | |
| Temperature Range | 75 °F to 107 °F | 78 °F to 107 °F | 86 °F to 107 °F |
| Heating Element | 200 Watts | 150 Watts | 150 Watts |
| Control System | | | |
| Type | Digital, Solid State (Microprocessor based) | Digital, Solid State (Microprocessor based) | Analog, Solid State |
| Accuracy | +/- 1 °F (95 °F to 107 °F) | +/- 1 °F (Range ??) | +/- 1 °F (Range ??) |
| Self-Calibrating | No | Yes | Yes |
| Set Point Read Out | Digital Display | Digital Display | Analog Dial |
| Water Temperature Readout | Digital Display | Digital Display | None |
| Water Temperature Display Range | 32 °F to 122 °F | 31 °F to 121 °F | None |
| Safety Range | | | |
| Primary Limit Thermostat | Software Set at 109 °F | Hardware set at 113 °F +/- 3 °F | Hardware set at 113 °F +/- 3 °F |
| Secondary Limit Thermostat | Hardware set at 115 °F +/- 5 °F | Hardware set at 117 °F +/- 5 °F | Hardware set at 117 °F +/- 5 °F |
| Warning Lights | Flashing Display for Over Temperature | Light for Low Water and Over Temperature | Light for Low Water and Over Temperature |
| Audible Alarms | Over Temperature | Low Water and Over Temperature | None |
| Circulating System | | | |
| Reservoir Capacity | 1.5 Liter (50.72) | 0.89 Liter (30 Ounces) | 0.89 Liter (30 Ounces) |
| Reservoir Fluid | Distilled Water | Distilled Water | Distilled Water |
| Fill Cap | Vented | Vented | Vented |
| Flow Rate Through Pad | 10 to 14 GPH Average | 10 to 14 GPH Average | 10 to 14 GPH Average |

510(k) Summary page # 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard

Rockville MD 20850

SEP 10 1997

Mr. Richard L. Studer
*Adroit Medical Systems, Inc.*
P.O. Box 277
Loudon, Tennessee 37774

Re: K970197
HTP-1500 Localized Heat Therapy Pump
Regulatory Class: II
Product Code: ILO
Dated: July 15, 1997
Received: July 16, 1997

Dear Mr. Studer:

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 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 (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 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 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.

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Page 2 - Mr. Richard L. Studer

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 [phone]. Additionally, for questions on the promotion and advertising of your device, 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,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ___________________________

Device Name: HTP-1500 Localized Heat Therapy Pump

Indications For Use:

The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.

**CAUTION:** Federal law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)


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