(38 days)
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.
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 provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the way described in the prompt. Instead, it is a 510(k) summary for the EBI Thermal Therapy System, focusing on its substantial equivalence to predicate devices.
The summary outlines:
- Intended Use: To apply localized cold or heat therapy to body surfaces.
- Device Description: Consists of a water delivery system, insulated hoses, and a thermal pad.
- Predicate Devices: Danninger Thermal-Max Thermal Therapy Unit and the InCare Hot/Ice System.
- Evidence of Substantial Equivalence: Comparative testing was performed between the EBI Thermal Therapy System and the Danninger Thermal-Max Thermal Therapy Unit, which "demonstrates that the systems have equivalent performance characteristics."
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth, as this information is not present in the provided document. The document describes a comparison to demonstrate substantial equivalence to an already legally marketed device, rather than a study against a pre-defined set of acceptance criteria for a novel performance claim.
{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)]
§ 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.