(786 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Soteria Bed Barrier, a Class I medical device. The document details the device's characteristics, indications for use, and a comparison to a predicate device. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate, not to prove improved human performance or algorithm-only performance. Therefore, many of the typical acceptance criteria for AI/ML-based diagnostic devices, such as MRMC studies, expert consensus ground truth, or training set details, are not applicable here.
This document focuses on the physical and material performance of a barrier product, not on a diagnostic or assistive AI system.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable given the device type:
Device: Soteria Bed Barrier
Device Type: Mattress Cover for Medical Purposes (Class I)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 42; Water Resistance: Impact Penetration Test (per ASTM F2407) | Measure the resistance of fabric to the penetration of water by impact | The average blotter weight gain for all test specimens must be less than or equal to 1 gram. | Pass |
| AATCC 127; Water Resistance: Hydrostatic Pressure Test (per ASTM F2407) | Measure the resistance of fabric to the penetration of water under hydrostatic pressure | The average hydrostatic pressure for all test specimens must be greater than or equal to 50 cm of water pressure (0.71 psi). Hydrostatic pressure is recorded when water penetrates the specimen in 3 different locations. | Pass |
| ASTM D5034; Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (per ASTM F2407) | Measure the breaking strength and elongation of fabric | The average tensile strength in each direction must be greater than or equal to 7lbf. Tensile strength is the peak force recorded when the fabric separates. | Pass |
| ASTM D5587; Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure (per ASTM F2407) | Measure the tearing strength of textile fabric | The average tear strength in each direction must be greater than or equal to 2.3 lbf. Tear strength is the average of the five highest peak forces recorded after a total tear of 3 inches or complete tear. | Pass |
| ASTM D751; Standard Test Method for Coated Fabrics: Seam Strength (per ASTM F2407) | Measure the seam strength of coated fabric | The average seam strength in each direction and combination of directions must be greater than or equal to 7 lbf. Seam strength is the peak force recorded when the seam or fabric separates. | Pass |
| 16 CFR Part 1610; Standard for the Flammability of Clothing Textiles (per ASTM F2407) | Measure the flammability of textiles | Class 1 (normal flammability). Class 1 rating is assigned when the average burn time is greater than or equal to 3.5 seconds. Burn time is the time recorded when 5" of fabric burns. | Pass |
| Cleaning Validation | Validate efficacy of the cleaning process by analyzing the test sample for residual protein and hemoglobin after soiling | The residual protein for each test replicate must be <6.4 µg/cm². The residual hemoglobin for each test replicate must be <2.2 µg/cm². | Pass |
| Laundering Validation | Measurement of the viable microbes and bacteria after laundering | >99.9999% reduction by wash-off of a mixed suspension containing Escherichia coli ATCC 11229, Pseudomonas aeruginosa ATCC 15442, Methicillin Resistant Staphylococcus aureus (MRSA) ATCC 33592, and Klebsiella pneumoniae ATCC 10031. >99.9999% reduction by wash-off of Mycobacterium terrae ATCC 15755. >99.9999% reduction by wash-off of Clostridium difficile spores ATCC 43598. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of fabric samples or cleaning cycles) for each test. Instead, it refers to "all test specimens" or "each test replicate," implying that multiple samples were used as per standard testing protocols for these types of materials.
- Data Provenance: Not applicable in the context of patient data. The "test set" here refers to physical samples of the Soteria Bed Barrier material. The testing appears to be laboratory-based performance testing conducted by the manufacturer. No country of origin for "data" (in the sense of patient data) is relevant here. The studies were prospective in the sense that the manufacturer conducted these specific tests on their device samples to demonstrate compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is a physical device, not a diagnostic or AI algorithm requiring expert interpretation of medical images or data. The "ground truth" is established by adherence to recognized engineering and material testing standards (e.g., AATCC, ASTM, 16 CFR).
4. Adjudication Method for the Test Set
- Not Applicable. As this is material and performance testing against objective, standardized criteria, no human adjudication (e.g., 2+1, 3+1) is relevant. The results are quantitative measurements against predefined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Was it done? No. This type of study (MRMC) is relevant for diagnostic devices, particularly those involving human readers of medical images, often with AI assistance. The Soteria Bed Barrier is a physical barrier, so an MRMC study is not applicable.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Was it done? No. This concept applies to AI algorithms. The device is a physical product. Its "performance" is inherently "standalone" in that it performs its function (barrier protection, cleanability) without human intervention in the function itself, but this is distinct from an AI algorithm's standalone performance.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective, quantitative measurements against recognized industry standards and regulatory requirements. For example:
- Water resistance (AATCC 42, AATCC 127) measured in grams of weight gain or cm of water pressure.
- Strength (ASTM D5034, D5587, D751) measured in pounds-force (lbf).
- Flammability (16 CFR Part 1610) measured in burn time.
- Cleaning validation measured in µg/cm² of residual protein/hemoglobin.
- Laundering validation measured in % reduction of specific microbial strains.
- This is not "expert consensus," "pathology," or "outcomes data" in the medical sense, but rather compliance with engineering and material science metrics.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/Machine Learning device that requires a "training set." The device itself is manufactured; it does not "learn."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
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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
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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
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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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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TRINITY O GUARDION
K201876 - 510(k) Summary
Submitter's Information I.
| Company Name: | Trinity Guardion |
|---|---|
| Address: | 4 S Park Ave Ste 204Batesville, 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.
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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(Subject Device) | Mattress Cover(Predicate Device)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 themedical equipment (mattress and beddeck) in the clinical setting. The deviceprevents fluids and contaminants fromreaching the surfaces below in order toprevent contamination of the underlyingsurfaces. | A mattress cover for medicalpurposes. Intended for medicalpurposes and used to protect amattress. | Same |
| Components | Barrier with hooks, clips, and elastic to aidin positioning and securing the product tothe equipment | Mattress cover with elastic toaid in positioning and securingthe product to the mattress. | Same |
| Design | Various designs and sizes to fit specificmattresses and beds | Various designs and sizes to fitspecific mattresses | Same |
| Materials | knit polyester fabric with a polyurethanecoating | Unknown | Equivalent -materials usedare sufficient for theirintended purposes |
| Resistance ofPenetration toLiquid | AATCC Test Method 42, AATCC TestMethod 127 | Unknown | Same - Resistance ofPenetration to Liquid wasperformed in accordance withthe same standard utilized asthe reference device. |
| Tensile Testing | ASTM - D5034 | Unknown | Same – Tensile testing wasperformed in accordance withthe same standard utilized asthe reference device. |
| Flammability | 16 CFR Part 10, Class I | Unknown | Same – Flammability testingwas performed in the samemanner as the referencedevice. |
Table 1: Overview of technological characteristics
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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(Subject Device) | Mattress Cover(Predicate Device)K780033 | Determination | |
|---|---|---|---|
| Biocompatibility | Biocompatible per ISO 10993-1 | Unknown | Same – Biocompatibility wasevaluated per the BiologicalRisk Assessment and foundto be suitable for its intendeduse. |
| Seam Strength | ASTM D751; Standard Test Method forCoated Fabrics: Seam Strength (perASTM F2407) | Unknown | NA |
| Tear Strength | ASTM D5587; Standard Test Method forTearing Strength of Fabrics by TrapezoidProcedure (per ASTM F2407) | Unknown | Equivalent - The subject andreference devices utilizeddiffering standards for tearstrength, however each metthe criteria for successestablished in the applicablestandard. |
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:Impact Penetration Test (perASTM F2407)1 | Measure the resistance offabric to the penetration ofwater by impact | The average blotter weight gain for all testspecimens must be less than or equal to 1gram. | Pass |
| AATCC 127; WaterResistance: HydrostaticPressure Test (per ASTMF2407)1 | Measure the resistance offabric to the penetration ofwater under hydrostaticpressure | The average hydrostatic pressure for all testspecimens must be greater than or equal to50 cm of water pressure (0.71 psi).Hydrostatic pressure is recorded when waterpenetrates the specimen in 3 differentlocations. | Pass |
| ASTM D5034; Standard TestMethod for Breaking Strengthand Elongation of TextileFabrics (per ASTM F2407)1 | Measure the breakingstrength and elongation offabric | The average tensile strength in eachdirection must be greater than or equal to7lbf. Tensile strength is the peak forcerecorded when the fabric separates. | Pass |
1 Test method utilized by Welmed Surgical Drape (Reference Device) K070432.
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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 TestMethod for Tearing Strength ofFabrics by TrapezoidProcedure (per ASTM F2407)¹ | Measure the tearingstrength of textile fabric | The average tear strength in each directionmust be greater than or equal to 2.3 lbf. Tearstrength is the average of the five highestpeak forces recorded after a total tear of 3inches or complete tear. | Pass |
|---|---|---|---|
| ASTM D751; Standard TestMethod for Coated Fabrics:Seam Strength (per ASTMF2407) | Measure the seam strengthof coated fabric | The average seam strength in each directionand combination of directions must begreater than or equal to 7 lbf. Seam strengthis the peak force recorded when the seam orfabric separates. | Pass |
| 16 CFR Part 1610; Standard forthe Flammability of ClothingTextiles (per ASTM F2407) | Measure the flammabilityof textiles | Class 1 (normal flammability). Class 1rating is assigned when the average burntime is greater than or equal to 3.5 seconds.Burn time is the time recorded when 5" offabric burns. | Pass |
| Cleaning Validation | Validate efficacy of thecleaning process byanalyzing the test samplefor residual protein andhemoglobin after soiling | The residual protein for each test replicatemust be <6.4 µg/cm²The residual hemoglobin for each testreplicate must be <2.2 µg/cm² | Pass |
| Laundering Validation | Measurement of the viablemicrobes and bacteria afterlaundering | >99.9999% reduction by wash-offof a mixed suspension containingEscherichia coli ATCC 11229Pseudomonas aeruginosa ATCC15442, Methicillin ResistantStaphylococcus aureus (MRSA)ATCC 33592, and Klebsiellapneumoniae ATCC 10031 >99.9999% reduction by wash-offof Mycobacterium terrae ATCC15755, >99.9999% reduction by wash-offof Clostridium difficile sporesATCC 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.
§ 880.6190 Mattress cover for medical purposes.
Link to an amendment published at 90 FR 55988, Dec. 4, 2025. (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.