(217 days)
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.
Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.
The provided text describes the acceptance criteria and performance data for AMD Medicom's pediatric procedure earloop face masks.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Standard | Title | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device - Range) |
|---|---|---|---|---|
| Performance Testing | ASTM F2299M -03 (2017) | Particulate filtration efficiency (PFE) at 0.1 micron, % | 98% | 98.68 - 99.21% |
| ASTM F2101-14 | Bacterial filtration efficiency (BFE), % | 96.32% | 99.43 - 99.5% | |
| Mil - M369454C, Section 4.4.1.2 & EN 14683, Annx. B | Differential pressure (dP) | 1.74 | 2.89 - 3.12 | |
| ASTM F1862M-17 | Resistance to penetration by Synthetic Blood | N/A | N/A to @ 80 mm Hg (Level 1) | |
| Biocompatibility | ISO 10993-5 | Cytotoxicity by MEM elution | Criteria met | Criteria met |
| ISO 10993-10 | Primary Skin irritation | Criteria met | Criteria met | |
| ISO 10993-10 | Dermal Sensitization | Criteria met | Criteria met | |
| Product Safety Tests | CPSC-CH-E1002-08.3 16 CFR 1303 | Total Lead (Pb) content in non-metal Children's Products | Meet acceptance criteria | ≤20 ppm (Meet acceptance criteria) |
| CPSC-CH-E1001-08.3 | Total Lead (Pb) content in metal Children's Products | Meet acceptance criteria | ≤40 ppm (Meet acceptance criteria) | |
| CPSC-CH-C1001-09.3 16 CFR part 1307 | Analysis of Phthalates (DBP, DEHP, DINP, BBP, DNOP and DIDP) | Meet acceptance criteria | ≤50 ppm (Meet acceptance criteria) | |
| 16 CFR 1500.48, 49, 51-53 ISO 17025 | Mechanical Hazards: sharp points, sharp edges and small parts substances | N/A | Meet acceptance criteria | |
| 16 CFR 1500.44 | Flammability | Class 1 | Class 1 | |
| Anthropometry Study | Not explicitly a standard | Face mask fit and coverage for children aged 4-12 years, weighing 24-153 pounds and 3'3" and 5'4" tall. (Based on predicate device's study) | Adequate coverage | Adequate coverage for children 4-12 years old (based on specific height/weight range and proper adult supervision for fit) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (PFE, BFE, differential pressure, blood penetration). It only provides the performance range for a "range of performance based on design variations" for the subject device.
For the anthropometry study, the subject device's evaluation involved participants aged 4-12 years old, ranging from 84.8 cm (33.4 inches) to 170.2 cm (67 inches) in height and 16.3 kg (35.94 pounds) to 76.7 kg (169.1 pounds) in weight. The sample size for this study is not explicitly stated, but it refers to a study on children based on the given age, height, and weight ranges.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided. However, the manufacturer is in Canada, and the predicate device's anthropometric study refers to the "current US population."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are laboratory-based and do not involve expert interpretation or ground truth establishment in the context of medical image analysis or similar fields.
4. Adjudication method for the test set
This information is not applicable as the tests are laboratory measurements of physical and biological properties.
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 medical face mask, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical face mask, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests (PFE, BFE, differential pressure, etc.) is established by the specifications defined in the referenced ASTM, Mil, and EN standards. These standards dictate the methodology and expected outcomes for measuring the specific properties of the face masks. For biocompatibility and product safety tests, the "ground truth" is defined by meeting the specified criteria (e.g., "Criteria met," "≤20 ppm," "Class 1") according to the referenced ISO and CPSC standards.
8. The sample size for the training set
This information is not applicable. The device is a physical product (face mask), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason 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.