STERILE SOFT-TEMP

K962983 · Adroit Medical Systems, Inc. · ILO · Jan 10, 1997 · Physical Medicine

Device Facts

• Record ID: K962983
• Device Name: STERILE SOFT-TEMP
• Applicant: Adroit Medical Systems, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sterile Soft-Temp pads are flat, flexible thermal therapy devices consisting of two inner polyurethane film layers sandwiched between two outer nonwoven cloth layers, heat-welded to create internal channels. Thermoplastic tubes with connectors and flow-control clamps attach to the pads to circulate hot or cold water from an external source. Used in clinical settings, the pads provide a flexible surface for thermal therapy. The device is operated by healthcare personnel to deliver localized heat or cold to a patient. The output is the thermal transfer to the patient's skin, which aids in therapeutic management as prescribed by a physician.

Clinical Evidence

No clinical tests were conducted. Bench testing (burst strength, leak, and flow tests) compared sterile and non-sterile pads to ensure the gamma radiation process did not impact performance.

Technological Characteristics

Materials: Top layer 1.3 oz nonwoven cloth (25% polyester/75% cellulose); two inner layers 3.5 mil polyurethane film (95A durometer); bottom layer 45g nonwoven cloth (70% rayon/30% polypropylene); 5/16" ID polyurethane tubes (63A durometer). Form factor: Flat, flexible pads in various sizes/shapes. Energy source: External water circulation. Sterilization: Gamma radiation. Quality assurance: 100% leak tested at 11 psi air.

Indications for Use

Indicated for patients requiring hot or cold thermal therapy as determined by a physician.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Soft-Temp hot/cold therapy pads (K92 approved)

Submission Summary (Full Text)

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JAN 10 1997

510(k) Summary : K962983

a(1) Submitted by: Adroit Medical Systems, Inc.
1146 Carding Machine Rd.
Loudon, TN 37774
423-458-8600

Contact Person: Richard L. Studer
606-578-9927

Prepared on: July 27, 1996

a(2) Proprietary Name: Sterile Soft-Temp
Common Name: Hot/Cold Therapy Pads
Classification Name: Water Circulating Hot or Cold Pack

a(3) Adroit Medical Systems, Inc. believes that the Sterile Soft-Temp hot/cold therapy pads are substantially equivalent to the Soft-Temp hot/cold therapy pads presently distributed by Adroit as non-sterile products. These non-sterile products were the subject of a 510(k) which was approved in 1992.

a(4) 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.

Refer to the specification data sheet included with this 510(k) summary for material, dimensional and performance specifications.

510(k) Summary page # 1 of 3

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a(5) 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.

a(6) The technological characteristics of Sterile Soft-Temp hot/cold therapy pads 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.

b(2) No clinical tests were conducted.

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.

510(k) Summary page # 2 of 3

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Specifications Data Sheet 07/16/96

# Soft-Temp®

Sterile Heat / Cold-Therapy Pads

ST-024S Large Pad, Sterile

ST-020S Medium Pad, Sterile

ST-017S Small Pad, Sterile

ST-012S Kneepad, Sterile

ST-003S Neck Collar, Sterile

## 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 (95A durometer); ③ a bottom layer of 45 gram nonwoven cloth (70% rayon / 30% polypropylene blend); and ④ 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 |

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Adroit Medical Systems, Inc. [phone]