T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

K073675 · Gaymar Industries, Inc. · ILO · May 8, 2008 · Physical Medicine

Device Facts

• Record ID: K073675
• Device Name: T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
• Applicant: Gaymar Industries, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: May 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable. Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.

Device Story

T-Pump is an electronically controlled water heater/circulator for localized temperature therapy. Device uses heating element to warm water to user-selected set points via digital interface; cooling achieved by adding ice water to reservoir. Dual microprocessor circuit and thermostat manage temperature range (50°F to 107°F) and prevent overheating. Water circulates through a connector hose to a patient-applied pad. Used in clinical settings; operated by healthcare providers. Provides controlled thermal therapy to treat orthopedic injuries, chronic pain, skin trauma, and inflammatory conditions. Benefits include localized symptom relief and management of specific medical conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Water circulating pump; ABS plastic and polycarbonate housing; 11.5 x 8 x 8 inches; <10 lbs; 2750ml reservoir capacity. Heating element; dual microprocessor control circuit; thermostat; digital display. Flow rate 9 gph minimum. Leakage current 100 microamperes max. Temperature range 50°F-107°F.

Indications for Use

Indicated for patients requiring localized temperature therapy for orthopedic conditions (acute injuries, chronic pain, back pain, spasms, strains), skin trauma (abscesses, boils, bruises, burns, contusions), or medical conditions (arthritis, neuritis, phlebitis, tendonitis, I.V. infiltration) and associated symptoms like infection or localized pain.

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

• Gaymar Industries, Inc. T-Pump Temperature Therapy Pump (K760804)
• Adroit Medical Systems, Inc. HTP-1500 Localized Heat Therapy Pump (K970197)

Submission Summary (Full Text)

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Ko73675

MAY - 8 2006

# 510(k) SUMMARY

### DATE PREPARED

December 27, 2007

### INTRODUCTION

According to the requirements of 21 CFR 807.92, the following provides sufficient detail to understand the basis for a determination of substantial equivalence.

### CONTACT INFORMATION

Submitter: Gaymar Industries, Inc. 10 Centre Drive Orchard Park, NY 14127 716.662.8636 Contact Person: Greg Pepe Application Correspondent: Hodgson Russ LLP 140 Pearl Street, Suite 100 Buffalo, NY 14202 716.848.1554 Contact Person: Bethany Gilbert, Esq.

#### DEVICE NAME

| Proprietary Name: | T-Pump Localized Temperature Therapy Pump |
|----------------------|-------------------------------------------|
| Catalog Numbers: | TP650, TP650C, TP700, TP700C |
| Common Name: | Temperature Therapy Pump |
| Classification Name: | Pack, Hot or Cold Pack, Water Circulating |

### PREDICATE DEVICE

Gaymar Industries, Inc. ('Gaymar'') claims substantial equivalence to:

- 1. Gaymar Industries, Inc. T-Pump Temperature Therapy Pump (K760804)
- 2. Adroit Medical Systems, Inc. HTP-1500 Localized Heat Therapy Pump (K970197)

### DEVICE DESCRIPTION

The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points,

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which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point).

The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy.

The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate.

The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.

### INTENDED USE

The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.

Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.

### SUBSTANTIAL EQUIVALENCE

Substantial equivalence is based on two predicate devices.

First, the T-Pump Localized Temperature Therapy Pump is substantially equivalent to the predicate T-Pump Temperature Therapy Pump. Both devices supply warm or cold water to a water-circulating pad for the application of localized heat or cold therapy. None of the device modifications pose risk to safety or effectiveness different from those posed by the predicate T-Pump Temperature Therapy Pump.

Second, the T-Pump Localized Temperature Therapy Pump is substantially equivalent to the predicate Adroit HTP 1500 Localized Heat Therapy Pump. Both devices use a digital interface and software to control the temperature of the circulating water. None of the device

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modifications pose a risk to safety or effectiveness different from those posed by the predicate Adroit HTP 1500 Localized Heat Therapy Pump.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gaymar Industries, Inc. % Hodgson Russ LLP Ms. Bethany Gilbert Associate Attorney 140 Pearl St., Suite 100 Buffalo, New York 14202

MAY -8 2008

K073675 Re:

> Trade Name: T-Pump Localized Temperature Therapy Pump Regulation Number: 21 CFR 890.5720 Regulation Name: Water Circulating Hot, Cold Pack Regulatory Class: Class II Product Code: ILO Dated: March 21, 2008 Received: March 24, 2008

Dear Ms. Gilbert:

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

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### Page 2 - Ms. Bethany Gilbert

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. 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Millman

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

T-Pump Localized Temperature Therapy Pump

Indications For Use:

The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.

Localized temperature therapy is of particular benefit in treating the following: orthonedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration; and symptoms such as infection and localized pain.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Neil RP Oyler for MMM

| Sign-Off | |
|--------------------------------------------------------|---------|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Division of General, Restorative, | |
| Neurological Devices | |
| (k) Number | K073675 |

001978/00406 GBDOCS 910698v2

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