DermaTherapy Bed Linens

K152884 · Precision Fabrics Group, Inc. · FMW · Jun 20, 2016 · General Hospital

Device Facts

• Record ID: K152884
• Device Name: DermaTherapy Bed Linens
• Applicant: Precision Fabrics Group, Inc.
• Product Code: FMW · General Hospital
• Decision Date: Jun 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6190
• Device Class: Class 1
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K152884 · Jun 20, 2016	DermaTherapy Bed Linens	Precision Fabrics Group, Inc.	Hospital clinical records; Facility-acquired pressure ulcer incidence data	The studies were used to demonstrate the performance of the DermaTherapy Bed Linens in reducing the incidence of facility-acquired pressure ulcers in various acute care hospital units compared to standard bedding controls.	Pressure ulcers; Acute care; Facility-acquired incidence; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Acute Care Clinical Studies (Studies 1-3); Retrospective/Observational clinical evaluation; Study Period: Since 2008	Patients 18 years of age and older in acute care settings (medical renal, urology, surgical ICU, non-surgical ICU, and telemetry units); Sample Size: 2,009 total subjects; Number of Sites: Multiple healthcare sites	Standard hospital bedding (Control group)	Incidence of facility-acquired pressure ulcers

Indications for Use

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.

Device Story

DermaTherapy Bed Linens (pillow cases, flat sheets, fitted sheets, underpads) function as passive medical textiles to mitigate pressure ulcer risk. Fabric utilizes 100% continuous-filament polyester yarns with non-round cross-sections to create micro-channels for moisture wicking and rapid drying. Smooth surface minimizes skin irritation/abrasion. Static-dissipative polyester yarn (0.8% weight) added to reduce static during institutional laundering. Antimicrobial agent (quaternary ammonium compound) applied to fabric. Used in hospital settings; operated by clinical staff. Device provides physical barrier between patient skin and bed support surface; reduces moisture, friction, and shear. Clinical benefit: reduction in incidence of facility-acquired pressure ulcers.

Clinical Evidence

Three prospective clinical studies (n=2,009) conducted in acute care settings (renal, surgical ICU, telemetry/urology). Primary endpoint: incidence of facility-acquired pressure ulcers. Results showed consistent reduction in pressure ulcer incidence in DermaTherapy group vs. control: Study 1 (4.6% vs 12.3%, p=.01), Study 2 (0.0% vs 7.5%, p=.01), Study 3 (3.1% vs 11.5%, p<.001). No product-related adverse events reported.

Technological Characteristics

Textile-based mattress cover. Materials: nylon, polyester, static-dissipative polyester (0.8%), antimicrobial quaternary ammonium compound (3-Trimethoxy silyl propyl dimethyl octadecyl ammonium chloride). Construction: plain-weave, continuous-filament yarns with micro-channels. Standards: ASTM-D-3776 (weight), ASTM-D-3775 (ends/picks), ASTM-D-5034 (tensile), ASTM-D-2261 (tear), ASTM-D-4032 (circular bend), ASTM-E-1294 (pore size), ASTM-D-2654 (moisture). Biocompatibility per ISO 10993. Non-sterile.

Indications for Use

Indicated for patients 18+ in hospital settings susceptible to pressure ulcers. Helps reduce likelihood of pressure ulcers by minimizing moisture, friction, and shear on skin.

Regulatory Classification

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.

Predicate Devices

• Institutional Bedding made with DermaTherapy Fabrics (K061242)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2016

Precision Fabrics Group, Inc. % Mr. Jonathan Kahan Partner Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004

Re: K152884

Trade/Device Name: DermaTherapy Bed Linens Regulation Number: 21 CFR 880.6190 Regulation Name: Mattress Cover for Medical Purposes Regulatory Class: I Product Code: FMW Dated: May 20, 2016 Received: May 20, 2016

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K152884

Device Name

DermaTherapy Bed Linens

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) SUMMARY K152884

### Precision Fabrics Group's DermaTherapy Bed Linens

#### Submitter Information:

| Applicant: | Precision Fabrics Group, Inc.<br>301 North Elm Street, Suite 600<br>Greensboro, NC 27401 |
|-----------------|------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Terry Montgomery, PhD, Vice President |
| Date Prepared: | June 15, 2016 |

#### Subject Device:

| Device Name: | DermaTherapy Bed Linens |
|----------------------|-------------------------------------|
| Common Name: | Bed linens |
| Classification Name: | Mattress Cover for Medical Purposes |
| Regulation: | Class I, 21 C.F.R. § 880.6190 |
| Product Code: | FMW |
| Predicate Devices: | |

Primary Predicate: Precision Fabrics Group's Institutional Bedding made with DermaTherapy Fabrics (K061242)

#### Indications for Use:

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.

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### Device Description

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.

# Substantial Equivalence

The DermaTherapy Bed Linens are substantially equivalent to the primary predicate device, Institutional Bedding made with DermaTherapy Fabrics (K061242). Both devices have intended use as mattress covers that protect the skin, and similar technological characteristics. The new indications for use do not raise new questions of safety and effectiveness. The additional static-dissipative yarn does not affect the intended use or the device performance. Furthermore, bench testing demonstrated that the device met performance specifications, which support the new indications for use. Thus, the subject device is substantially equivalent to the primary predicate devices.

A summary of substantial equivalence between the subject, primary predicate, and reference devices are provided in Table 1 below.

| | Subject Device:<br>DermaTherapy Bed Linens | Primary Predicate Device:<br>Institutional Bedding made with DermaTherapy<br>fabrics (K061242) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Bed linens made with DermaTherapy® fabrics are<br>intended for use by patients 18 years of age and<br>older in hospital settings who are susceptible to<br>pressure ulcers. The DermaTherapy Bed Linens help<br>to reduce the likelihood of patients developing<br>pressure ulcers by reducing moisture, friction and<br>shear on the patient's skin. | Institutional Bedding (bed sheets and pillow cases)<br>made with DermaTherapy fabrics is intended for use<br>by patients in a hospital, healthcare or home setting<br>who are susceptible to or may have mild atopic<br>dermatitis. |
| User Population | Patients in hospital settings | Patients in hospital and long-term care settings |

### Table 1: Substantial Equivalence Comparison

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| | Subject Device:<br>DermaTherapy Bed Linens | Primary Predicate Device:<br>Institutional Bedding made with DermaTherapy<br>fabrics (K061242) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Mattress Cover for Medical Purposes<br>Class I<br>21 CFR 880.6190<br>Product Code FMW | Mattress Cover for Medical Purposes<br>Class I<br>21 CFR 880.6190<br>Product Code FMW |
| Technological<br>Characteristics | DermaTherapy fabrics made of nylon, polyester, and<br>static-dissipating yarn with antimicrobial treatment | DermaTherapy fabrics made of nylon and polyester<br>yarn with antimicrobial treatment |
| Features | Bed linens designed to reduce moisture, friction and<br>shear on the patient's skin.<br>Fabric is undyed in natural white color. | Bed linens designed to reduce moisture, friction and<br>shear on the patient's skin.<br>Fabric is undyed in natural white color. |
| Components | Pillow cases, top flat sheets, bottom fitted sheets,<br>and underpads<br>Antimicrobial agent: quaternary ammonium<br>compound (3-Trimethoxy silyl propyl dimethyl<br>octadecyl ammonium chloride), is applied to the<br>DermaTherapy fabric | Pillow cases, top flat sheets, and bottom fitted sheets<br>Antimicrobial agent: quaternary ammonium<br>compound (3-Trimethoxy silyl propyl dimethyl<br>octadecyl ammonium chloride), is applied to the<br>DermaTherapy fabric |
| Dimensions | Pillow Case at 21" width x 32" length (Standard).<br>Top Flat Sheet at 70" width x 108" length (XL Twin).<br>Bottom Fitted Sheet at 39" width x 81" length x 15"<br>height (XL Twin).<br>Underpad at 32″ width x 30″ length. | Pillow Case at 21" width x 32" length (Standard).<br>Top Flat Sheet at 70" width x 108" length (XL Twin).<br>Bottom Fitted Sheet at 39" width x 81" length x 15"<br>height (XL Twin). |
| Biocompatibility | Cytotoxicity, sensitization, and irritation testing | Cytotoxicity, sensitization, and irritation testing |
| Sterilization | Not sterile | Not sterile |

### Performance Data

Extensive bench testing has been performed to various standards, both industry- and company-specific, to ensure that the device meets the device performance specifications at the beginning and at the end of its use life. A summary of the testing conducted is provided in Table 2 below:

### Table 2: Performance Characteristics and Test Methodology

| Performance Characteristics | Test Method / Standard |
|-----------------------------|------------------------|
| Weave Pattern | Visual |
| Weight | ASTM-D-3776 |
| Ends | ASTM-D-3775 |
| Picks | ASTM-D-3775 |
| Grab Tensile - Warp & Fill | ASTM-D-5034 |
| Tongue Tear - Warp & Fill | ASTM-D-2261 |
| Circular Bend | ASTM-D-4032 |
| Pore Size | ASTM-E-1294 |
| Moisture Regain | ASTM-D-2654 |

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| Performance Characteristics | Test Method / Standard |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Geometric Roughness | The surface contour (geometric roughness) is determined using the Kawabata KES-FB4<br>Surface Tester. Measurements are made using a standard specimen size of 20 x 20 cm in<br>three replications. Using a calibrated surface probe, geometric roughness is measured in<br>microns. Higher values correspond to a geometrically rougher surface. |
| Fabric Wicking Rate - Warp & Fill | A determination of the rate at which a fabric wicks water, measured as the distance water<br>travels in five minutes. A 1" x 6" sample is marked and lowered into deionized water. The<br>wicking rate is calculated by determining the distance, measured in millimeters, water<br>rises along the sample fabric in a 5-minute period. |
| % Dry after 0 - 60 minutes | A determination of % moisture loss of a fabric until dryness, measured in 15-minute<br>intervals up to 60 minutes, whichever comes first. An 8"x10" fabric sample is tested at<br>intervals. The rate is calculated based upon the time it takes for the sample to return to its<br>original dry weight. |
| Coefficient of Friction | The surface properties of friction (resistance/drag) are determined using the Kawabata<br>KES-FB4 Surface Tester. Measurements are made using a standard specimen size of 20 x<br>20 cm in three replications. Using a calibrated friction probe, coefficient of friction (COF)<br>values of 0 to 1 are determined, with the higher COF value corresponding to higher<br>friction. |

Cytotoxicity, intracutaneous reactivity, and skin sensitization testing were conducted according to ISO 10993 consensus standards to evaluate the biocompatibility of the device at various points of its use life.

PFG conducted a leachability study to quantify and to analyze the antimicrobial agent leaching from the subject device and the predicate device. Test results demonstrated that the subject device exhibited substantially equivalent amount of antimicrobial agent leaching from the device. In addition, a risk assessment of the antimicrobial agent completely leaching from the product demonstrated that there is no safety risk to the patient.

# Clinical Data

To further demonstrate the substantial equivalence and performance of the device in reducing the likelihood of patients developing pressure ulcers, the company has conducted three studies since 2008 that included a total of 2,009 study subjects. A summary of the studies is provided in Table 3 below. Study subjects included patients 18 years of age and older in acute care setting at multiple healthcare sites including medical renal, urology, surgical intensive care, non-surgical intensive care, and telemetry units. Comparison of data between the study and control groups showed a consistent reduction in the incidence of facility-acquired pressure ulcers in a wide range of clinical settings and patient populations. No product-related adverse events or complications were reported over the entire study period.

| Study | Clinical Trials | Total Patients | Control | DermaTherapy | P |
|-------|--------------------------------------|----------------|---------|--------------|-------|
| 1. | Acute Care:<br>Medical Renal Unit | 307 | 12.3% | 4.6% | .01 |
| 2. | Acute Care:<br>Surgical ICU | 275 | 7.5% | 0.0% | .01 |
| 3. | Acute Care:<br>Telemetry/Urology/ICU | 1,427 | 11.5% | 3.1% | <.001 |

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# Conclusions

Precision Fabrics Group believes that DermaTherapy Bed Linens are substantially equivalent to the primary predicate device Institutional Bedding made with DermaTherapy fabrics (K061242). Both devices have the same intended use and similar indications for use. The only difference to the predicate device is the addition of static-dissipative polyester yarn. Bench testing has demonstrated substantially equivalent device performance and supports the expanded indications for use to reduce the formation of pressure ulcers. Therefore, the subject device is substantially equivalent to the primary predicate device.