(162 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a hot/cold therapy pad, with no mention of AI or ML technology.
Yes
The device is described as a "hot/cold therapy pad" and its intended use is for "hot or cold therapy" when a physician determines it is necessary, indicating a therapeutic purpose.
No
Explanation: The device is described as a therapy pad used for hot or cold therapy, not for diagnosing medical conditions. Its function is to provide temperature-controlled surfaces for treatment, not to identify or monitor diseases.
No
The device description clearly outlines physical components like pads, films, cloth, tubes, clamps, and connectors, indicating it is a hardware device for thermal therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hot or cold therapy," which is a physical treatment applied to the body.
- Device Description: The device is a pad that circulates hot or cold water for thermal therapy. This is a physical therapy device.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed for direct application to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Sterile Soft-Temp hot/cold therapy pads are intended for use in those situations where a physician determines that hot or cold therapy is necessary.
Product codes
Not Found
Device Description
Sterile Soft-Temp hot/cold therapy pads are flat flexible pads with interconnecting passages for the circulation of hot or cold water. They are available in various sizes and shapes. The main portion of the pads consists of two inner layers of polyurethane film sandwiched between two outer layers of nonwoven cloth. These materials are held together by a pattern of welds created in a heat press. This pattern of welds produces the interconnecting passages that allow the hot or cold water to circulate from the input to the output.
Two small diameter thermoplastic tubes are attached to the input and output areas of the pads, and fitted with plastic clamps for flow control and connectors. These connectors are used to attach the pads to longer tubes and adapters allowing connection to a source of hot or cold water. Thus a soft hot or cold flexible surface is available for thermal therapy.
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
To determine that the gamma radiation process does not affect the performance of the finished devices, burst strength, leak, and flow tests were conducted on pads that were subjected to the gamma sterilization process and on pads that were not subjected to the gamma sterilization process. These tests showed that there was no substantial performance difference between sterile pads and non-sterile pads.
No clinical tests were conducted.
Key Metrics
burst strength, leak, and flow tests were conducted
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary : K962983
- Submitted by: Adroit Medical Systems, Inc. a(1) 1146 Carding Machine Rd. Loudon, TN 37774 423-458-8600
Richard L. Studer Contact Person: 606-578-9927
July 27, 1996 Prepared on:
| a(2) Proprietary Name: | Sterile Soft-Temp |
|---|---|
| Common Name: | Hot/Cold Therapy Pads |
| Classification Name: | Water Circulating Hot or Cold Pack |
- Adroit Medical Systems, Inc. believes that the Sterile Soft-Temp hot/cold a(3) therapy pads are substantially equivalent to the Soft-Temp hot/cold therapy pads presently distributed by Adroit as non-sterile products. These nonsterile products were the subject of a 510(k) which was approved in 1992.
- Sterile Soft-Temp hot/cold therapy pads are flat flexible pads with a(4) interconnecting passages for the circulation of hot or cold water. They are available in various sizes and shapes. The main portion of the pads consists of two inner layers of polyurethane film sandwiched between two outer layers of nonwoven cloth. These materials are held together by a pattern of welds created in a heat press. This pattern of welds produces the interconnecting passages that allow the hot or cold water to circulate from the input to the output.
Two small diameter thermoplastic tubes are attached to the input and output areas of the pads, and fitted with plastic clamps for flow control and connectors. These connectors are used to attach the pads to longer tubes and adapters allowing connection to a source of hot or cold water. Thus a soft hot or cold flexible surface is available for thermal therapy.
Refer to the specification data sheet included with this 510(k) summary for material, dimensional and performance specifications.
1
- Sterile Soft-Temp hot/cold therapy pads are intended for use in those a(5) situations where a physician determines that hot or cold therapy is necessary.
- The technological characteristics of Sterile Soft-Temp hot/cold therapy pads a(6) are identical to the technological characteristics of Soft-Temp hot/cold therapy pads presently distributed by Adroit. The only difference in the two product lines is that the Sterile Soft-Temp hot/cold therapy pads are sterilized and Soft-Temp hot/cold therapy pads are not.
- b(1) To determine that the gamma radiation process does not affect the performance of the finished devices, burst strength, leak, and flow tests were conducted on pads that were subjected to the gamma sterilization process and on pads that were not subjected to the gamma sterilization process. These tests showed that there was no substantial performance difference between sterile pads and non-sterile pads.
- No clinical tests were conducted. b(2)
- b(3) The fact that the design, construction, materials, and performance of Sterile Soft-Temp hot/cold therapy pads are the same as that of Soft-Temp hot/cold therapy pads leads to the conclusion that they are equally safe and effective.
2
Specifications Data Sheet 07/16/96
Image /page/2/Picture/1 description: The image shows the text "Soft-Temp." in a stylized, cursive font. The words are connected by a hyphen. There is a registered trademark symbol to the right of the word "Temp."
Sterile Heat / Cold-Therapy Pads
Image /page/2/Figure/3 description: The image shows five different medical pads with their names and descriptions. The first pad is labeled "ST-024S Large Pad, Sterile", and it is a large rectangular pad. The second pad is labeled "ST-020S Medium Pad, Sterile", and it is a medium rectangular pad. The third pad is labeled "ST-017S Small Pad, Sterile", and it is a small rectangular pad. The fourth pad is labeled "ST-012S Kneepad, Sterile", and it is a u-shaped pad. The fifth pad is labeled "ST-003S Neck Collar, Sterile", and it is a long, narrow pad with a curved end.
Materials of Construction
Soft-Temp blankets and pads are made from 1 a top layer of 1.3 oz nonwoven cloth (25% polyester / 75% cellulose blend); ② two inner layers of 3.5 mil thick polyurethane film (95 A durometer); 3 a bottom layer of 45 gram nonwoven cloth (70% rayon / 30% polypropylene blend); and ® two 5/16" ID polyurethane tubes (63A durometer). Hose-sets, not shown, are made of vinyl.
Quality Assurance
All blankets and pads are 100% leak tested at 11psi-air.
Sterilization Method
Gamma Radiation.
| Item No. | width | length | dry
weight | flow
rate | max/min
temp. °F | patient
weight |
|----------|-------|--------|---------------|--------------|---------------------|-------------------|
| ST-024S | 18" | 24" | 5 oz | 23 gph | 38/107° | 300 lb |
| ST-020S | 14" | 20" | 4 oz | 23 gph | 38/107° | 300 lb |
| ST-017S | 12" | 17" | 3 oz | 23 gph | 38/107° | 300 lb |
| ST-012S | 13" | 12" | 2 oz | 23 gph | 38/107 | 300 lb |
| ST-003S | 4.75" | 19" | 2 oz | 23 gph | 38/107° | 300 lb |
Image /page/2/Picture/11 description: The image shows a diagram with four numbered parts. The parts are labeled 1, 2, 3, and 4. The diagram appears to show layers of a material, possibly paper or fabric.
Image /page/2/Picture/12 description: The image shows a black and white abstract design. The design features a repeating pattern of interconnected shapes that resemble stylized mountains or peaks. The shapes are arranged in a horizontal row, creating a continuous, jagged line. The overall impression is geometric and somewhat symmetrical.