(100 days)
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
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The Welmed, Inc. Surgical Gowns were evaluated for their performance based on a range of established standards and testing methods. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (IMC Surgical Gowns, K052550) through similarities in intended use, materials, design, and testing methodology.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the chosen standard test methods and the expectation that the Welmed Surgical Gowns perform comparably to, or in accordance with, these recognized standards for surgical gowns. The document reports that data was "Generated" in accordance with these standards, implying that the device demonstrated performance meeting the criteria outlined in each standard for its respective characteristic.
| Acceptance Criteria (Standard/Guidance Document) | Reported Device Performance (Data Generated) |
|---|---|
| AATCC Test Method 127-1998 Water Resistance: Hydrostatic Pressure Test | Hydrostatic Pressure - Water Resistance |
| AATCC Test Method 42-2000 Water Resistance: Impact Penetration Test | Impact Penetration - Water Resistance |
| ASTM - D5034-95(2001) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | Tensile Strength |
| ASTM - D5734-95(2001) Standard Test Method for Tearing Strength of Nonwoven Fabrics by Falling-Pendulum (Elmendorf) Apparatus | Elmendorf Tear |
| ISO 9073-10:2003 - Textiles - Test methods for nonwovens -- Part 10: Lint and other particles generation in the dry state | Gelbo Flex - Lint |
| CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability of Clothing Textiles | Flammability |
| AAMI / ANSI / ISO 10993-1:2003(E). Biological evaluation of medical devices -- Part 1: Evaluation and testing | Biocompatibility Testing Evaluation |
| AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity | Cytotoxicity |
| AAMI / ANSI / ISO 10993-10:2002(E), Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization | Skin Irritation, intra-cutaneous reactivity & sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the performance tests. It only lists the test methods used to generate data. There is no information regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of these tests (material properties), they are typically conducted on new material samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the evaluation of surgical gowns based on physical and biological performance standards. The "ground truth" for these tests is established by the well-defined methodologies and criteria within the internationally recognized standards themselves, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements of material properties and biological responses, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for the evaluation of surgical gowns. MRMC studies are typically used to assess the effectiveness of diagnostic or screening devices where human interpretation plays a significant role.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is not applicable as the device is a physical surgical gown, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on established scientific and engineering standards and their predefined pass/fail criteria. For example:
- Physical Properties: The tensile strength, tear strength, hydrostatic pressure, and impact penetration are measured against the requirements specified in the respective ASTM and AATCC standards for surgical gowns to provide a barrier.
- Flammability: Assessed against CPSC CS-191-53.
- Lint Generation: Assessed against ISO 9073-10.
- Biocompatibility: Evaluated based on the criteria set forth in the ISO 10993 series, which define acceptable levels of cytotoxicity, irritation, and sensitization.
8. The Sample Size for the Training Set
There is no "training set" in the context of this submission. The device is a physical product, and its performance is evaluated directly through standardized laboratory testing, not through machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.