(232 days)
Not Found
Not Found
No
The description details a simple electronically controlled water heater with a pump and temperature control based on operator input and a digital display. There is no mention of AI, ML, or any complex algorithms that would suggest their use.
Yes.
The device's intended use is for heat therapy, and it is designed to provide this therapy to patients as determined by a physician.
No
The device, HTP-1500 Localized Heat Therapy Pump, is described as a heat therapy pump used to apply heat to a patient, which is a therapeutic function, not a diagnostic one. Its intended use is "where a physician determines that heat therapy is necessary or desirable," meaning it treats a condition, rather than identifying or analyzing one.
No
The device description explicitly details hardware components such as a water reservoir, electric resistance heater, heat exchanger, pump, tubing, hoses, and fittings.
Based on the provided information, the HTP-1500 Localized Heat Therapy Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "localized heat therapy," which is a physical treatment applied to the body. IVD devices are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose diseases or conditions.
- Device Description: The description details a system for heating and circulating water through an external pad applied to the body. This is consistent with a physical therapy device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes related to in vitro testing.
Therefore, the HTP-1500 Localized Heat Therapy Pump falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
SEP 1 0 1997
510(k) Summary
| a(1) | Submitted by: | Adroit Medical Systems, Inc.
1146 Carding Machine Rd.
Loudon, TN 37774
423-458-8600 |
|------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | Contact Person: | Richard L. Studer
423-458-8600 |
| | Prepared on: | January 17, 1997 |
| a(2) | Proprietary Name:
Common Name:
Classification Name: | HTP-1500 Localized Heat Therapy Pump
Heat Therapy Pump
Water Circulating Hot or Cold Pack |
- Adroit Medical Systems, Inc. believes that the HTP-1500 Localized Heat a(3) 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.
- The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled a(4) 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
1
-
The HTP-1500 Localized Heat Therapy Pump is intended for use in those a(5) 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.
2
Image /page/2/Picture/1 description: This image shows a product called HTP-1500, which is shown with a hose and power cord in the storage position. The image labels the water reservoir fill cap, folding handle, control panel, water level viewing window, hose for connection to pad, power switch, and power cord. The control panel displays "HTP-1500 Heat Therapy Pump" and a water temperature of 107 degrees Fahrenheit.
3
Image /page/3/Picture/0 description: The image shows a diagram of a device with a rectangular panel on the left and a cylindrical component on the right. Two tubes connect the panel to the cylindrical component, with arrows indicating the direction of flow. The cylindrical component has a label that reads "HTP-1500" and some symbols.
Pad
f
HTP-1500
HTP-1500 Hookup To Pad Note: Bi-directional Water Flow
510(k) Summary page # 4 of 5
4
SPECIFICATION COMPARISON
r
r
ﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴ
: ***************************************************************************************************************************************************************************
| 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 3 AG | 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 | Digital Display | Digital Display | None |
| Readout | |||
| 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 | Hardware set at 115 °F +/- | Hardware set at 117 °F +/- | Hardware set at 117 °F +/- |
| Thermostat | 5 °F | 5 °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 |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1997
Mr. Richard L. Studer ·Adroit Medical Systems, Inc. P.O. Box 277 Loudon, Tennessee 37774
K970197 Re: HTP-1500 Localized Heat Therapy Pump Requlatory 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 In addition, FDA may publish further announcements action. 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.
6
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
7
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)
tocoefo
Prescription Use X (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)