(332 days)
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Kimberly-Clark Pediatric/Child Facemask:
This document describes a medical device, specifically a surgical mask, and its submission for FDA clearance. The "studies" referred to are bench tests and consumer evaluations, not clinical trials in the sense of comparing diagnostic accuracy or treatment outcomes. Therefore, many standard questions related to a typical AI/diagnostic device study (like MRMC, expert consensus for ground truth, training set size, etc.) are not applicable here.
Acceptance Criteria and Reported Device Performance
| Standard | Title | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mil-M369454C | Military Specifications: Surgical Mask, disposable 1992 | Device meets the performance requirements specified in this military standard for surgical masks. | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| ASTM F2101-07 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus | Device meets the BFE threshold defined by the standard for its intended classification (e.g., specific percentage of bacterial filtration). | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| PSC CS-191- 53 | Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles | Material must meet flammability requirements for clothing textiles (e.g., specific burn rate or no ignition). | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| ASTM F2299 | Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres | Device meets the particulate filtration efficiency (PFE) threshold defined by the standard (ee.g., specific percentage of particulate filtration). | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| ISO 10993 | Standards for evaluating the biocompatibility of a medical device | Device materials must demonstrate biocompatibility (e.g., non-cytotoxic, non-irritating, non-sensitizing). | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| EN 71-3 | Safety of Toys- Part 3: Migration of Certain Elements | Device materials must comply with limits for the migration of certain elements (e.g., heavy metals), ensuring safety for incidental contact/ingestion by children. | "All testing conducted on the Pediatric/Child Face Mask met acceptance criteria." |
| N/A | Potential mechanical and physical hazards (e.g., choking, strangulation, tissue tear/injury) | Device design and materials minimize these hazards for the pediatric population. | "Consumer evaluation of potential mechanical and physical hazards...were conducted on the Pediatric/Child Facemask" and "All testing conducted...met acceptance criteria." (Implied successful mitigation). |
Study Information (as applicable to a medical device bench test submission):
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for each specific test. For bench testing of materials, this would typically involve a certain number of material samples or manufactured devices.
- Data Provenance: The tests are described as conducted by Kimberly-Clark, implying internal testing or contracted lab testing. The country of origin of the data (i.e., where the labs were located) is not specified. The tests are general standards, not tied to a specific population's data. These are bench tests, not data derived from retrospective or prospective patient studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For bench testing of a physical product like a mask, "ground truth" is established by the standardized test methods themselves and the precise measurement of physical properties. Experts are involved in conducting and interpreting these tests, but it's not a consensus interpretation of clinical data.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where consensus is needed to establish ground truth (e.g., image reading). This is a physical product undergoing standardized performance tests.
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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:
- Not Applicable. This is not an AI-powered diagnostic or interpretive device. It is a physical product (face mask) undergoing performance testing.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
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The type of ground truth used:
- Performance against established industry and regulatory standards. The "ground truth" here is determined by whether the device's measured performance (e.g., BFE, PFE, flammability, biocompatibility) meets the numerical thresholds or qualitative criteria set forth in the referenced standards (Mil-M369454C, ASTM F2101-07, PSC CS-191- 53, ASTM F2299, ISO 10993, EN 71-3) and by the "consumer evaluation of potential mechanical and physical hazards."
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of this type of medical device submission. The device design and materials are developed, and then the finished product is tested against standards.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.