Soteria Bed Barrier

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September 1, 2022 Trinity Guardion Bruce Rippe Chief Executive Officer 4 S Park Ave Ste 204 Batesville, Indiana 47006 Re: K201876 Trade/Device Name: Soteria Bed Barrier Regulation Number: 21 CFR 880.6190 Regulation Name: Mattress Cover For Medical Purpose Regulatory Class: Class I Product Code: QTV Dated: April 15, 2022 Received: April 21, 2022 Dear Bruce Rippe: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201876 Device Name Soteria Bed Barrier ### Indications for Use (Describe) The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use. The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # TRINITY O GUARDION ## K201876 - 510(k) Summary #### Submitter's Information I. | Company Name: | Trinity Guardion | |-----------------|----------------------------------------------| | Address: | 4 S Park Ave Ste 204<br>Batesville, IN 47006 | | Phone Number: | 812-932-2600 | | Contact Person: | Bruce Rippe | | Phone Number: | 812-932-2600 | | Email Address: | brippe@trinityguardion.com | | Date Prepared: | August 31, 2022 | #### II. Device | Tradename: | Soteria Bed Barrier | |----------------------|------------------------------------------------| | Common Name: | Mattress and Bed Deck Cover (Medical Purposes) | | Classification Name: | Mattress cover for medical purposes | | Classification: | Class 1 (21 CFR 880.6190) | | Product Code: | QTV | #### III. Predicate Device Predicate Device: Chase Mfg. Co Mattress Cover, K780033 Reference Devices: Welmed Surgical Drape, K070432, DAS Medical, DAS Medical Equipment Drapes, K121436 #### IV. Device Description The Soteria Bed Barrier is a mattress cover that fits securely over a healthcare mattress and bed deck and attaches to the bed frame. The device is available in multiple configurations to fit specific mattresses and beds, attaching with hooks or clips on each side and the head and foot section of the mattress fit inside a pocket allowing fitted sheets to work over the mattress. Color coding of the label used by the laundry and edge ribbon correspond to compatible beds and mattresses, each barrier model has a different ribbon color. The Soteria Bed Barrier helps to reduce contamination of the underlying surfaces by preventing the penetration of fluids. The Soteria Bed Barrier is a nonsterile reusable device that is laundered in accordance with the validated procedure to remove microbes and spores between each patient use. The Soteria Bed Barrier is removed from the mattress/bed deck for laundering upon soiling or between patient uses. After laundering and inspection, the product is then folded and wrapped with appropriate labels to be used again. {4}------------------------------------------------ # TRINITY O GUARDION #### V. Indications for Use / Intended Use The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use. The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. #### VI. Substantial Equivalence Discussion The Soteria Bed Barrier and its predicate have been evaluated to determine substantial equivalence. | | Soteria Bed Barrier<br>(Subject Device) | Mattress Cover<br>(Predicate Device)<br>K780033 | Determination | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Soteria Bed Barrier | Mattress Cover | N/A | | 510(k) Holder | Trinity Guardion | Chase Mfg. Co. | N/A | | Principle of operation | The Soteria Bed Barrier is placed over the<br>medical equipment (mattress and bed<br>deck) in the clinical setting. The device<br>prevents fluids and contaminants from<br>reaching the surfaces below in order to<br>prevent contamination of the underlying<br>surfaces. | A mattress cover for medical<br>purposes. Intended for medical<br>purposes and used to protect a<br>mattress. | Same | | Components | Barrier with hooks, clips, and elastic to aid<br>in positioning and securing the product to<br>the equipment | Mattress cover with elastic to<br>aid in positioning and securing<br>the product to the mattress. | Same | | Design | Various designs and sizes to fit specific<br>mattresses and beds | Various designs and sizes to fit<br>specific mattresses | Same | | Materials | knit polyester fabric with a polyurethane<br>coating | Unknown | Equivalent -materials used<br>are sufficient for their<br>intended purposes | | Resistance of<br>Penetration to<br>Liquid | AATCC Test Method 42, AATCC Test<br>Method 127 | Unknown | Same - Resistance of<br>Penetration to Liquid was<br>performed in accordance with<br>the same standard utilized as<br>the reference device. | | Tensile Testing | ASTM - D5034 | Unknown | Same – Tensile testing was<br>performed in accordance with<br>the same standard utilized as<br>the reference device. | | Flammability | 16 CFR Part 10, Class I | Unknown | Same – Flammability testing<br>was performed in the same<br>manner as the reference<br>device. | Table 1: Overview of technological characteristics {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Trinity Guardian. The word "TRINITY" is in gray, and the word "GUARDIAN" is in green. There is a green circle between the two words with a gray sphere in the center. | | Soteria Bed Barrier<br>(Subject Device) | Mattress Cover<br>(Predicate Device)<br>K780033 | Determination | |------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Biocompatible per ISO 10993-1 | Unknown | Same – Biocompatibility was<br>evaluated per the Biological<br>Risk Assessment and found<br>to be suitable for its intended<br>use. | | Seam Strength | ASTM D751; Standard Test Method for<br>Coated Fabrics: Seam Strength (per<br>ASTM F2407) | Unknown | NA | | Tear Strength | ASTM D5587; Standard Test Method for<br>Tearing Strength of Fabrics by Trapezoid<br>Procedure (per ASTM F2407) | Unknown | Equivalent - The subject and<br>reference devices utilized<br>differing standards for tear<br>strength, however each met<br>the criteria for success<br>established in the applicable<br>standard. | #### VII. Performance Testing Performance Testing was conducted to evaluate the technological and performance characteristics. Test methods were utilized in the same manner as the reference devices, the DAS Medical Equipment Cover (K121436), and Welmed Surgical Drape (K070432). Pre-determined performance specifications were tested and verification and validation activities were conducted to demonstrate that the Soteria Bed Barrier meets the defined criteria. Testing on the subject device is described in Table 2. ### Table 2: Soteria Bed Barrier Performance Testing. | Test method | Purpose | Acceptance Criteria | Result | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | AATCC 42; Water Resistance:<br>Impact Penetration Test (per<br>ASTM F2407)1 | Measure the resistance of<br>fabric to the penetration of<br>water by impact | The average blotter weight gain for all test<br>specimens must be less than or equal to 1<br>gram. | Pass | | AATCC 127; Water<br>Resistance: Hydrostatic<br>Pressure Test (per ASTM<br>F2407)1 | Measure the resistance of<br>fabric to the penetration of<br>water under hydrostatic<br>pressure | The average hydrostatic pressure for all test<br>specimens must be greater than or equal to<br>50 cm of water pressure (0.71 psi).<br>Hydrostatic pressure is recorded when water<br>penetrates the specimen in 3 different<br>locations. | Pass | | ASTM D5034; Standard Test<br>Method for Breaking Strength<br>and Elongation of Textile<br>Fabrics (per ASTM F2407)1 | Measure the breaking<br>strength and elongation of<br>fabric | The average tensile strength in each<br>direction must be greater than or equal to<br>7lbf. Tensile strength is the peak force<br>recorded when the fabric separates. | Pass | ¹ Test method utilized by Welmed Surgical Drape (Reference Device) K070432. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Trinity Guardion. The word "TRINITY" is in gray, block letters. To the right of the word is a green circle with a gray sphere in the center, and the word "GUARDION" is in green, block letters. | ASTM D5587; Standard Test<br>Method for Tearing Strength of<br>Fabrics by Trapezoid<br>Procedure (per ASTM F2407)¹ | Measure the tearing<br>strength of textile fabric | The average tear strength in each direction<br>must be greater than or equal to 2.3 lbf. Tear<br>strength is the average of the five highest<br>peak forces recorded after a total tear of 3<br>inches or complete tear. | Pass | |--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | ASTM D751; Standard Test<br>Method for Coated Fabrics:<br>Seam Strength (per ASTM<br>F2407) | Measure the seam strength<br>of coated fabric | The average seam strength in each direction<br>and combination of directions must be<br>greater than or equal to 7 lbf. Seam strength<br>is the peak force recorded when the seam or<br>fabric separates. | Pass | | 16 CFR Part 1610; Standard for<br>the Flammability of Clothing<br>Textiles (per ASTM F2407) | Measure the flammability<br>of textiles | Class 1 (normal flammability). Class 1<br>rating is assigned when the average burn<br>time is greater than or equal to 3.5 seconds.<br>Burn time is the time recorded when 5" of<br>fabric burns. | Pass | | Cleaning Validation | Validate efficacy of the<br>cleaning process by<br>analyzing the test sample<br>for residual protein and<br>hemoglobin after soiling | The residual protein for each test replicate<br>must be <6.4 µg/cm²<br>The residual hemoglobin for each test<br>replicate must be <2.2 µg/cm² | Pass | | Laundering Validation | Measurement of the viable<br>microbes and bacteria after<br>laundering | >99.9999% reduction by wash-off<br>of a mixed suspension containing<br><i>Escherichia coli</i> ATCC 11229<br><i>Pseudomonas aeruginosa</i> ATCC<br>15442, Methicillin Resistant<br><i>Staphylococcus aureus</i> (MRSA)<br>ATCC 33592, and <i>Klebsiella<br/>pneumoniae</i> ATCC 10031 >99.9999% reduction by wash-off<br>of <i>Mycobacterium terrae</i> ATCC<br>15755, >99.9999% reduction by wash-off<br>of <i>Clostridium difficile</i> spores<br>ATCC 43598 | Pass | #### VIII. Conclusions The conclusion drawn from the risk-benefit assessment and from nonclinical tests demonstrates that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.