(264 days)
Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient's skin.
DermaTherapy uses a silk-like fabric to minimize moisture, friction, and shear between the skin and the bedsupport surface. Continuous-filament yarns woven into the silk-like synthetic DermaTherapy fabric provide a smooth surface, free of broken or discontinuous fibers. This enhanced smoothness helps minimize the potential for irritation and abrasion of sensitive skin.
DermaTherapy Bed Linens consists of pillow cases, top flat sheets, and underpads. The subject devices are made from DermaTherapy fabrics which are plain-weave constructions of 100% continuous-filament yarns. The polyester yarns have a non-round fiber cross-section to create micro-channels to facilitate moisture wicking and rapid drying. The yarns used in DermaTherapy fabrics are commercially available products, typically used in apparel.
The only technological difference in the fabric construction between the subject device and the predicate device is the addition of a secondary static-dissipative polyester yarn at 0.8% of the total fabric weight. The static-dissipative yarn is incorporated to reduce the potential for static electricity that may occur during institutional laundering processes. The company has made no other modifications to the fabric or the manufacturing process of turning the fabric into the final product.
This document describes data for a medical device called "DermaTherapy Bed Linens," which are intended to reduce the likelihood of pressure ulcers in hospital patients. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it lists the "Performance Characteristics" and the "Test Method / Standard" used to evaluate the device. The conclusion states that "bench testing demonstrated that the device met performance specifications" and "demonstrated substantially equivalent device performance." It also includes clinical study results showing a reduction in pressure ulcer incidence.
Given the information, the table below will combine the performance characteristics (which can be inferred as criteria for evaluation) and the clinical performance results.
| Performance Characteristic | Test Method / Standard (Acceptance Criteria are implied by meeting these standards) | Reported Device Performance |
|---|---|---|
| Weave Pattern | Visual | Not explicitly stated, implied to meet visual standards. |
| Weight | ASTM-D-3776 | Not explicitly stated, implied to meet standards. |
| Ends | ASTM-D-3775 | Not explicitly stated, implied to meet standards. |
| Picks | ASTM-D-3775 | Not explicitly stated, implied to meet standards. |
| Grab Tensile - Warp & Fill | ASTM-D-5034 | Not explicitly stated, implied to meet standards. |
| Tongue Tear - Warp & Fill | ASTM-D-2261 | Not explicitly stated, implied to meet standards. |
| Circular Bend | ASTM-D-4032 | Not explicitly stated, implied to meet standards. |
| Pore Size | ASTM-E-1294 | Not explicitly stated, implied to meet standards. |
| Moisture Regain | ASTM-D-2654 | Not explicitly stated, implied to meet standards. |
| Geometric Roughness | Kawabata KES-FB4 Surface Tester (measured in microns) | Not explicitly stated, implied to meet intended smoothness. |
| Fabric Wicking Rate | Distance water travels in five minutes (measured in millimeters) | Not explicitly stated, implied to meet intended wicking rate. |
| % Dry after 0-60 minutes | % moisture loss of fabric until dryness (measured in 15-minute intervals) | Not explicitly stated, implied to meet intended rapid drying. |
| Coefficient of Friction | Kawabata KES-FB4 Surface Tester (values of 0 to 1) | Not explicitly stated, implied to meet intended low friction. |
| Biocompatibility | ISO 10993 consensus standards (Cytotoxicity, sensitization, and irritation testing) | Test results demonstrated biocompatibility. |
| Antimicrobial Agent Leaching | PFG conducted leachability study | Test results demonstrated substantially equivalent amount of antimicrobial agent leaching, with no safety risk to the patient. |
| Reduction in Pressure Ulcers (Clinical) | Clinical studies comparing control vs. DermaTherapy | Study 1: Control: 12.3%, DermaTherapy: 4.6% (P = .01) |
| Study 2: Control: 7.5%, DermaTherapy: 0.0% (P = .01) | ||
| Study 3: Control: 11.5%, DermaTherapy: 3.1% (P |
§ 880.6190 Mattress cover for medical purposes.
(a)
Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.