(397 days)
The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.
The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism.
PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.
The provided text describes the regulatory clearance (510(k)) for the PRIMED Pediatric Facemask, classifying it as a Class II medical device (Surgical Apparel, product code OXZ). The document details the device's indications for use and presents a comparison to predicate devices, along with performance data demonstrating compliance with relevant standards.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the PRIMED Pediatric Facemask are based on meeting or exceeding the performance requirements for a Level 1 procedure mask as per ASTM F2100. The table below summarizes these criteria and the reported performance of the device.
| Test / Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (PRIMED Pediatric Facemask) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% | > 99% (ASTM F2101) |
| Particulate Filtration Efficiency (PFE) | ≥ 95% | > 99% (ASTM F2299) |
| Differential Pressure (Breathability) | 80 mmHg (ASTM F1862) | |
| Flammability | Class 1 | Class 1 (16 CFR part 1610) |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass |
| Irritation & Sensitization (ISO 10993-10) | Non-irritant, Non-sensitizer | Pass |
| Migration of certain elements (EN 71-3) | Pass | Pass |
| Total Lead Content (CPSC-CH-E1002-08.3) | Pass | Pass |
| Phthalate Analysis (CPSC-CH-C1001-09.3) | Pass | Pass |
| Sharp edge/point hazard (16 CFR 1500.48/49) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each individual test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the performance results.
The data provenance is implied to be from laboratory testing performed by the manufacturer or accredited testing facilities, as evidenced by the reference to specific ASTM, EN, ISO, and CPSC standards. The document does not specify the country of origin of the testing data, nor does it indicate if the data is retrospective or prospective in the context of clinical trials. These are performance tests on the device itself, not clinical data from human subjects.
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 this document. The "ground truth" for the performance tests of a medical facemask (like BFE, PFE, fluid resistance) is established by the validated and standardized test methods themselves (e.g., ASTM F2101 for BFE). These are objective measurements in a laboratory setting, not subjective assessments by human experts.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are objective laboratory measurements, not subjective assessments requiring adjudication.
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:
This information is not applicable. The device is a pediatric facemask, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical product (facemask), not an algorithm or AI system.
7. The type of ground truth used:
The "ground truth" for the device's performance is based on objective measurements obtained through standardized laboratory tests according to recognized international and national standards (ASTM, EN, ISO, CPSC). This is an objective, quantitative ground truth for the physical and functional properties of the mask materials and construction.
8. The sample size for the training set:
This information is not applicable. As a physical medical device (facemask), there is no 'training set' in the context of machine learning. The design and manufacturing processes are refined through engineering principles and testing to meet specifications, not through machine learning training.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 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.