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 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, 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.

AI/ML Overview

The provided text describes the T-Pump Localized Temperature Therapy Pump (K073675) and its regulatory submission, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) summary and approval letter from the FDA. Its primary purpose is to demonstrate "substantial equivalence" to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.

The information sought in your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set size and ground truth establishment) is typically found in design validation reports or clinical study reports, which are part of the detailed submission to the FDA but are not usually included in the publicly available 510(k) summary.

Therefore, I cannot provide the requested table and details based solely on the provided text.

Here's a breakdown of why the information is not present and what is mentioned:

Acceptance Criteria & Reported Performance: Not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish equivalence.
Sample Size (Test Set) & Data Provenance: Not mentioned for any specific performance test.
Number of Experts, Qualifications, Adjudication Method: Not applicable as no specific test set or ground truth establishment process is described beyond the general device description.
MRMC Comparative Effectiveness Study: Not mentioned. The 510(k) pathway for this device typically relies on demonstrating equivalence rather than conducting a full comparative effectiveness study with human readers/users.
Standalone Performance Study: Not mentioned in terms of quantitative performance metrics, sensitivity, specificity, accuracy, etc. The document describes the device's technical specifications and intended function.
Type of Ground Truth: Not mentioned.
Sample Size (Training Set): Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires training data in the same way.
How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in relation to product performance and characteristics:

Temperature Range: "From 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point)."
Physical Dimensions: "11.5 x 8 x 8 inches."
Weight: "Under 10 pounds with the unit filled with water."
Reservoir Capacity: "Maximum capacity of 2750ml."
Leakage Current: "100 microamperes maximum."
Flow Rate: "9 gph (34 lph) minimum, with the water circulating pad attached."

These are specifications, not "acceptance criteria" against which a clinical or performance study's results are measured and reported for the purpose of demonstrating efficacy or safety in the way an AI algorithm's performance would be.

Summary

{0}------------------------------------------------

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)
1. Adroit Medical Systems, Inc. HTP-1500 Localized Heat Therapy Pump (K970197)

DEVICE DESCRIPTION

{1}------------------------------------------------

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

INTENDED USE

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

{2}------------------------------------------------

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

. . . . . . . . . .

September 19. 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199

{3}------------------------------------------------

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

{4}------------------------------------------------

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

T-Pump Localized Temperature Therapy Pump

Indications For Use:

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

Page 1 of

Regulation Number and Section

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