(515 days)
These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective . They are not intended for use in the operating room.
SafeCare® Open Back Protective Gowns (Models: 46969-097X, 46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare® Open Back (Model: 4550-25X) Protective Gowns are open back gowns made from extruded plastic film.
The SafeCare® and ValueCare® Open Back Protective gowns provide barrier protection to the wearer from body fluids and particulate materials and have passed barrier testing according to ANSI/AAMI PB70:2012 Level 3 protection or equivalent.
The significant design points of the gowns are:
- Made from extruded plastic film to provide an effective barrier meeting the requirements for penetration testing as per ANSI/AAMI PB70: 2012 Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods.
- Backless to provide comfort
- Thumb loops at the wrist which help to hold gown sleeves down
- Back has perforations so the gowns can be removed without taking over the head in case they are contaminated
The provided text describes information about the substantial equivalence of SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns to a predicate device, the Poly-Med Disposable Personal Protective Gown Apron. The information focuses on design, materials, indications for use, labeling, and various performance tests to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for each test in a numerical or pass/fail threshold. Instead, it states that the device "meets" certain levels or is "non-irritating," "non-sensitizing," etc. The table below synthesizes the test results for the subject devices (SafeCare® and ValueCare® Open Back Protective Gowns) against relevant standards, effectively serving as the reported device performance. The "Acceptance Criteria" column reflects the standard or outcome deemed acceptable.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (SafeCare® & ValueCare® Open Back Protective Gowns) |
|---|---|
| Dermal Irritation Test: ISO 10993-10:2010 Skin Irritation | The subject device is non-irritating. |
| Dermal Sensitization Test: ISO 10993-10:2010 Skin Sensitization | The subject device is non-sensitizing. |
| Cytotoxicity Test: ISO 10993-5:2009 In Vitro Cytotoxicity | The device extract did not show potential toxicity to L-929 cells. |
| Flammability Test: 16 CFR Part 1610 (Class 1 "normal flammability") | Meets Class 1 "normal flammability" in accordance with 16 CFR Part 1610. |
| Fluid Penetration Test: ANSI/AAMI PB70:2012 Level 3 (AATCC 127:2014 Hydrostatic Pressure Test & AATCC 42:2013 Impact Penetration Test) | Successfully tested and meets the Level 3 requirements of the ANSI/AAMI PB70:2012 liquid barrier classifications. |
| Sterility | Provided non-sterile. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for any of the tests (e.g., dermal irritation, sensitization, cytotoxicity, flammability, fluid penetration).
Regarding data provenance, the studies were conducted to support the 510(k) submission for BAM Corporation Limited, Hong Kong, China. The text does not explicitly state whether the studies were retrospective or prospective, but clinical trials are not mentioned, suggesting these are likely laboratory-based performance tests performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The tests conducted are laboratory-based performance tests (e.g., biocompatibility and barrier testing) against established standards and test methods. They do not involve expert interpretation or ground truth establishment in the way clinical studies or diagnostic imaging studies would.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. As this submission describes laboratory performance tests, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This submission is for protective gowns and involves laboratory performance testing, not an AI-assisted diagnostic or interpretive device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a protective gown, not an algorithm or software. The performance tests are for the physical properties of the gown.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the performance tests described, the "ground truth" is established by adherence to recognized international and national standards and test methods. For example:
- Biocompatibility (Dermal Irritation, Sensitization, Cytotoxicity): Ground truth is determined by the criteria and pass/fail results defined within ISO 10993-10:2010 and ISO 10993-5:2009.
- Flammability: Ground truth is defined by the success criteria outlined in 16 CFR Part 1610 (meeting Class 1).
- Fluid Penetration: Ground truth is the successful adherence to the Level 3 requirements of ANSI/AAMI PB70:2012, as measured by AATCC 127:2014 and AATCC 42:2013.
8. The Sample Size for the Training Set
This question is not applicable. Training sets are used for machine learning algorithms. The device described, protective gowns, does not involve such algorithms. The tests performed are physical and biological property assessments of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.