(786 days)
No
The device is a physical barrier (mattress cover) and the description focuses on its material properties and physical attachment, with no mention of AI or ML.
No.
The device is a mattress cover intended to prevent soiling and contamination of bed decks and mattresses, not to provide therapeutic benefits to the patient.
No
The device is a mattress cover designed to prevent soiling and contamination, not to detect or monitor health conditions or diagnose diseases.
No
The device description clearly states it is a "mattress cover" and describes physical components like hooks, clips, and pockets. The performance studies also focus on physical properties of the textile material.
Based on the provided information, the Soteria Bed Barrier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a physical barrier to prevent soiling of bed decks and mattresses and reduce contamination. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a physical cover for a bed and mattress, designed to prevent fluid penetration. It's a reusable, laundered textile product.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties like water resistance, strength, flammability, and cleaning/laundering validation. These are relevant to a physical barrier, not a diagnostic test.
- Predicate and Reference Devices: The predicate and reference devices are also physical barriers (mattress covers and surgical drapes), further supporting its classification as a non-IVD device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Soteria Bed Barrier does not perform any such function.
N/A
Intended Use / Indications for 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.
Product codes
QTV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Table 2: Soteria Bed Barrier Performance Testing.
AATCC 42; Water Resistance: Impact Penetration Test (per ASTM F2407)1: Purpose - Measure the resistance of fabric to the penetration of water by impact. Acceptance Criteria - The average blotter weight gain for all test specimens must be less than or equal to 1 gram. Result - Pass.
AATCC 127; Water Resistance: Hydrostatic Pressure Test (per ASTM F2407)1: Purpose - Measure the resistance of fabric to the penetration of water under hydrostatic pressure. Acceptance Criteria - 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. Result - Pass.
ASTM D5034; Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (per ASTM F2407)1: Purpose - Measure the breaking strength and elongation of fabric. Acceptance Criteria - 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. Result - Pass.
ASTM D5587; Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure (per ASTM F2407)¹: Purpose - Measure the tearing strength of textile fabric. Acceptance Criteria - 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. Result - Pass.
ASTM D751; Standard Test Method for Coated Fabrics: Seam Strength (per ASTM F2407): Purpose - Measure the seam strength of coated fabric. Acceptance Criteria - 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. Result - Pass.
16 CFR Part 1610; Standard for the Flammability of Clothing Textiles (per ASTM F2407): Purpose - Measure the flammability of textiles. Acceptance Criteria - 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. Result - Pass.
Cleaning Validation: Purpose - Validate efficacy of the cleaning process by analyzing the test sample for residual protein and hemoglobin after soiling. Acceptance Criteria - The residual protein for each test replicate must be 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. Result - Pass.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
TRINITY O GUARDION
K201876 - 510(k) Summary
Submitter's Information I.
| Company Name: | Trinity Guardion |
|---|---|
| Address: | 4 S Park Ave Ste 204 |
| 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
(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 the
medical equipment (mattress and bed
deck) in the clinical setting. The device
prevents fluids and contaminants from
reaching the surfaces below in order to
prevent contamination of the underlying
surfaces. | A mattress cover for medical
purposes. Intended for medical
purposes and used to protect a
mattress. | Same |
| Components | Barrier with hooks, clips, and elastic to aid
in positioning and securing the product to
the equipment | Mattress cover with elastic to
aid in positioning and securing
the product to the mattress. | Same |
| Design | Various designs and sizes to fit specific
mattresses and beds | Various designs and sizes to fit
specific mattresses | Same |
| Materials | knit polyester fabric with a polyurethane
coating | Unknown | Equivalent -materials used
are sufficient for their
intended purposes |
| Resistance of
Penetration to
Liquid | AATCC Test Method 42, AATCC Test
Method 127 | Unknown | Same - Resistance of
Penetration to Liquid was
performed in accordance with
the same standard utilized as
the reference device. |
| Tensile Testing | ASTM - D5034 | Unknown | Same – Tensile testing was
performed in accordance with
the same standard utilized as
the reference device. |
| Flammability | 16 CFR Part 10, Class I | Unknown | Same – Flammability testing
was performed in the same
manner as the reference
device. |
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 was
evaluated per the Biological
Risk Assessment and found
to be suitable for its intended
use. |
| Seam Strength | ASTM D751; Standard Test Method for
Coated Fabrics: Seam Strength (per
ASTM F2407) | Unknown | NA |
| Tear Strength | ASTM D5587; Standard Test Method for
Tearing Strength of Fabrics by Trapezoid
Procedure (per ASTM F2407) | Unknown | Equivalent - The subject and
reference devices utilized
differing standards for tear
strength, however each met
the criteria for success
established in the applicable
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: | |||
| Impact Penetration Test (per | |||
| ASTM F2407)1 | 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)1 | 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)1 | 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 |
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 Test
Method for Tearing Strength of
Fabrics by Trapezoid
Procedure (per ASTM F2407)¹ | 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 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 |
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.