(38 days)
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No
The description focuses on a water-based thermal therapy system with standard components and control mechanisms, with no mention of AI or ML.
Yes
The intended use states it applies localized cold or heat therapy, which is a therapeutic intervention.
No
The device is described as a thermal therapy system intended to apply localized cold or heat therapy to body surfaces to lower or raise surface skin temperature. Its function is therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components including a water delivery system, insulated hoses, thermal pad, water pump, fan, water reservoir, thermal exchangers, electronic control module, display, and keypad. This is clearly a hardware-based medical device.
Based on the provided information, the EBI Thermal Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to apply localized cold or heat therapy to body surfaces. This is a therapeutic application, not a diagnostic one.
- Device Description: The device components and operation (water delivery, thermal pads, etc.) are consistent with a physical therapy or therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The EBI Thermal Therapy System's function is purely therapeutic.
N/A
Intended Use / Indications for Use
The EBI Thermal Therapy System is intended to apply localized cold or heat therapy to body surfaces. The EBI Thermal Therapy System is designed to lower or raise the surface skin temperature by delivering water at a controlled temperature to the target site via a thermal pad. The system is designed for repeated uses in the hospital or home. The thermal pad is designed for single patient use. (Water Circulating Hot or Cold Pack Devices have been recommended by the Physical Medicine Panel for classification into Class II under 21 CFR 890.5720).
Product codes
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Device Description
The EBI Thermal Therapy System consists of a water delivery system, insulated hoses and a thermal pad. The water delivery system includes the following components: case, water pump, fan, water reservoir, thermal exchangers, electronic control module, display, and keypad. The EBI Thermal Therapy System operates on standard house current. A variety of pads, in different shapes and sizes, are available to accommodate different anatomical sites. Both sterile and nonsterile pads are available for use with the EBI Thermal Therapy System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body surfaces, different anatomical sites
Indicated Patient Age Range
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Intended User / Care Setting
hospital or home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing was performed on the EBI Thermal Therapy System and the Danninger Thermal-Max Thermal Therapy Unit. The performance testing demonstrates that the systems have equivalent performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image shows the logo for EBI Electro Biology. The letters "EBI" are in a bold, sans-serif font, and the words "Electro Biology" are in a serif font. There is a line above the word "Electro". The logo is black and white.
Image /page/0/Picture/1 description: The image shows the number 21 in bold black font. The number is slightly blurred, but the digits are still easily recognizable. The background is plain white, which makes the number stand out. The image is simple and straightforward, with the focus solely on the number 21.
Inhancing Bone Healing through Applied Science
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE EBI THERMAL THERAPY SYSTEM
Date Prepared: August 19, 1996
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The EBI Thermal Therapy System is intended to apply localized cold or heat therapy to body surfaces. The EBI Thermal Therapy System is designed to lower or raise the surface skin temperature by delivering water at a controlled temperature to the target site via a thermal pad. The system is designed for repeated uses in the hospital or home. The thermal pad is designed for single patient use. (Water Circulating Hot or Cold Pack Devices have been recommended by the Physical Medicine Panel for classification into Class II under 21 CFR 890.5720).
The EBI Thermal Therapy System consists of a water delivery system, insulated hoses and a thermal pad. The water delivery system includes the following components: case, water pump, fan, water reservoir, thermal exchangers, electronic control module, display, and keypad. The EBI Thermal Therapy System operates on standard house current. A variety of pads, in different shapes and sizes, are available to accommodate different anatomical sites. Both sterile and nonsterile pads are available for use with the EBI Thermal Therapy System. The EBI Thermal Therapy System is substantially equivalent to the Danninger Thermal-Max Thermal Therapy Unit and the InCare Hot/Ice System.
Comparative testing was performed on the EBI Thermal Therapy System and the Danninger Thermal-Max Thermal Therapy Unit. The performance testing demonstrates that the systems have equivalent performance characteristics.
In conclusion, the performance testing as well as the comparison of the systems' intended uses, designs and components demonstrate that the EBI Thermal Therapy System is substantially equivalent to the Danninger Thermal Thermal Therapy Unit and the InCare Hot/Ice System 3.
Contact Person: Sharon A. Starowicz, Director, Regulatory Affairs Electro-Biology, Inc. (201) 331-3904
Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977 42 FR 42520 (Docket No 76N-0355)]