(162 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Burst Strength Test | No substantial performance difference between sterile and non-sterile pads. |
| Leak Test | No substantial performance difference between sterile and non-sterile pads. |
| Flow Test | No substantial performance difference between sterile and non-sterile pads. |
| 100% Leak Tested (QA) | All blankets and pads are 100% leak tested at 11 psi-air. |
Notes on Acceptance Criteria: The document primarily focuses on demonstrating that the sterilization process does not negatively impact the device's performance compared to its non-sterile equivalent. The specific quantitative acceptance criteria for burst strength, leak, and flow are not provided, only that there was "no substantial performance difference," which implies that the sterile pads met the same performance standards as the non-sterile ones. The "100% leak tested at 11psi-air" is a quality assurance parameter mentioned in the specifications data sheet, indicating a manufacturing quality control step that all units must pass.
Study Details
Based on the provided text, the study conducted was a non-clinical bench top study comparing the performance of sterile and non-sterile versions of the device.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "pads that were subjected to the gamma sterilization process and on pads that were not subjected to the gamma sterilization process," implying a comparison group. However, the exact number of pads tested is not provided.
- Data Provenance: Not explicitly stated, but it would be considered internal company testing since it was conducted by Adroit Medical Systems, Inc. The nature of the tests (burst strength, leak, flow) suggests these are bench-top engineering tests, not clinical data from patients. Therefore, country of origin related to patient data is not applicable. The study is prospective in the sense that the sterile pads were deliberately subjected to gamma radiation for the purpose of this comparison.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a physical performance study (burst strength, leak, flow) on the device itself, not a study requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" would be objective measurements of physical properties.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. This study involved objective physical measurements.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC comparative effectiveness study involving human readers or AI. It was a physical performance study of a medical device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a hot/cold therapy pad, not an algorithm or AI system.
-
The type of ground truth used:
- The "ground truth" for this study was objective physical measurements of device performance characteristics (burst strength, leak integrity, and flow rate). The performance of the non-sterile pads served as the baseline or existing "truth" against which the sterile pads were compared.
-
The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
{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 | dryweight | flowrate | max/mintemp. °F | patientweight |
|---|---|---|---|---|---|---|
| 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.
§ 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.