(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) | < 5.0 mmH2O/cm² | < 3.7 mmH2O/cm² (EN 14683) |
| Fluid Resistance (Synthetic Blood) | ≥ 80 mmHg | > 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.
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November 22, 2022
PRIMED Medical Products Inc. Mitra Fard Regulatory Affairs Specialist 200, 2003-91 St. SW Edmonton, AB T6X 0W8 Canada
Re: K213427
Trade/Device Name: PRIMED Pediatric Facemask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OXZ Dated: October 26, 2022 Received: October 27, 2022
Dear Ms. Fard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213427
Device Name PRIMED Pediatric Facemask
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Summary Date: | November 21, 2022 |
|---|---|
| Manufacturer Information: | PRIMED Medical Products Inc. |
| Address: | 200, 2003-91 St. SW, Edmonton, AB,Canada, T6X 0W8 |
| Phone NumberFax NumberEmailContact person: | +1.877.877.4633+1.780.497.7670mitra.fard@primed.caMitra Fard |
| Common name of the device | Pediatric Facemask |
| Trade or Proprietary Name: | PRIMED Pediatric Facemask |
| Classification name for the device | Surgical Apparel |
| Classification regulation:Class: | 878.40402 |
| Product Code: | OXZ (Pediatric/Child Facemask) |
| Predicate device(s) | Dukal level 1 Pediatric face mask 510(k)#: K210321Kimberly-Clark Child's Facemask 510(k)#: K113340 |
| Device Description | The PRIMED level 1 Pediatric Facemask is a single use, disposabledevice intended to be used by patient/child 4 to 12 years old inhealthcare setting under an adult supervision to prevent thetransmission of microorganism. |
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Product Description:
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.
Available Models
PG4-1680 Pediatric Mask, ASTM Level 1, Earloop, Dinosaur pattern,
Indication for Use:
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.
| Elements ofcomparison | Proposed PRIMED Pediatric mask | Primary Predicate | Secondary Predicate | Comparison |
|---|---|---|---|---|
| Manufacturer | PRIMED Medical Products Inc. | Kimberly-Clark | Dukal | |
| 510(k) Number | K213427 | K113340 | K210321 | |
| Product Code: | OXZ | OXZ | OXZ | Similar |
| Regulationnumber | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Similar |
| Indication foruse | The PRIMED level 1 PediatricFacemask is a single use,disposable device that is intendedto be used by patient/child 4 to 12years old in healthcare settingunder an adult supervision toprovide a barrier for therespiratory tract frommicroorganisms, body fluids andparticulate material. | The Kimberly-Clark Pediatric/ ChildFacemask is intended to be worn bythe patient/child (recommendedages 4-12) to provide protection forthe respiratory tract. It is a single use,disposable device that is providednon-sterile. This Face Mask isrecommended for use in a healthcareselling with appropriate adultsupervision | The Dukal Level 1 Pediatric Face Masksare intended to be worn by thepatient/child to cover the nose andmouth to provide a barrier for therespiratory tract from microorganisms,body fluids, and particulate material.Recommended ages are 4-12. The facemask is specifically for use with patientswhose age or illness may prevent themfrom taking necessary precautions insituations where transfer ofmicroorganisms, body fluids, andparticulates can occur. The face masksare recommended for use in a healthcaresetting with appropriate adultsupervision. The Dukal Level 1 Pediatric | Similar |
| Elements ofcomparison | Proposed PRIMED Pediatric mask | Primary Predicate | Secondary Predicate | Comparison |
| Face Masks are single use, disposabledevices that are provided non-sterile. | ||||
| Material | Non- woven | Non-woven | Non-woven | Similar |
| BacterialFiltration(ASTM F2101) | >99% | 99.6% | >99% | Similar |
| ParticulateFiltration(ASTM F2299) | >99% | 98.5% | >99% | Similar |
| DifferentialPressure (MILM 3654C) | <3.7 mmH2O/cm² | 2.6 mmH2O/cm² | <3.1 mmH2O/cm² | Similar |
| FluidResistance(ASTM F1862) | > 80mmHg | Not applicable | > 80mmHg | Similar |
| Flammability(16 CFR 1610) | Class I | Class I | Class I | Similar |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Similar |
| Irritation | Not an irritant | Not an irritant | Not an irritant | Similar |
| Sensitization | Not a sensitizer | Not a sensitizer | Not a sensitizer | Similar |
| Migration ofcertainElements)EN71-3 | Pass | Pass | Tested under EN 71.3 | Similar |
| Total leadcontent | Tested under CPSC-CH-E1002-08.3 | Not Available | Tested under CPSC-CHE1002-08.3 &CPSC-CH-E1001-08.3 | Similar |
| PhthalateAnalysis | Tested under CPSC-CH-C1001-09.3 | Not Available | Tested under CPSC-CHC1001-09.4 | Similar |
| Sharp edgehazard | Meet the requirements of 16 CFR1500.48 and 16 CFR 1500.49 whenafter simulating use and abuse oftoys as per 16CFR 1500.53 | Not Available | ested under ASTM F963-17 (sec. 4.6, 4.7,and 4.9), 16 CFR Part 1500, 16 CFR Part1501 | Similar |
| Maskconstructionandtechnologicalfeatures | PRIMED Pediatric Child mask isgenerally composed of a filterlayer that is ultrasonically bondedbetween layers of nonwovenfabric. This mask is appropriatelysized to the smaller faces ofchildren between ages of 4 to 12years old. The PRIMED single use,non-sterile Pediatric/ChildFacemask meet requirements oflevel 1 masks as per ASTM F2100.All of materials used in this deviceare typical materials commonlyused in the construction of legallymarketed surgical masks with asafe history of use. The masks are | The Kimberly-Clark Pediatric/ChildFacemask is a three layer mask,constructed of nonwoven polyesterblends and polypropylene materials.Bindings are nonwoven polyesterand earloops are knittedpolyester/lycra. A malleablenosepiece is placed within thebindings for comfort andindividualized fit around thewearer's nose. The Pediatric/ChildFacemask is appropriately sized tothe smaller faces of children across adiverse population. ThePediatric/Child Facemask is a singleuse, disposable device, providednon-sterile. | The Dukal Level 1 Pediatric Face Mask ismanufactured using ultrasonic hotsealing, composed of three layers ofmaterials and pleated to form the mask.The inner layer is composed ofPolypropylene (Spunbond), the middlelayer is Polypropylene (Meltblown) filtermaterial, and the outer layer ispolypropylene (Spunbond). Decorativepatterns are printed with colored inks.Masks are held in place on wearer withpolyester/spandex elastic earloop andcontain a malleable aluminum wire nosepiece. The Pediatric/Child's Face Mask isappropriately sized to the smaller facesof children across a diverse population.All of the materials used in this device | Similar |
| Elementsofcomparison | Proposed PRIMED Pediatric mask | Primary Predicate | Secondary Predicate | Comparison |
| not made with natural rubberlatex. | are typical materials commonly used inthe construction of Surgical Masks andare being used in current legallymarketed devices. This product is notmade with natural rubber latex. | |||
| Anthropometry | Based on an anthropometric studysample that is representative ofthe US population in both genderand racial distribution, the DukalLevel 1 Pediatric Face Mask willprovide adequate coverage tochildren 4 to 12 years old with facewidth of 8.5 to 12.8 cm and lowerface length of 8.5 to 11.4 cm | Not available | Based on an anthropometric studysample that is representative of the USpopulation in both gender and racialdistribution, the Dukal Level 1 PediatricFace Mask will provide adequatecoverage to children between the agesof 4-12 years old of weight between 25-176 pounds, and of height between3′00″ — 5′08″". | Similar |
Summary of the Technological Characteristics of PRIMED Pediatric Facemask and the predicate
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510(k) Summary
Summary of Testing:
PRIMED pediatric masks are tested to below listed standards:
| Standard | Result | |
|---|---|---|
| ASTM F2100:2020 | Standard Specification for Performance of MaterialsUsed in Medical Face Masks | Meet and exceed requirementof Level 1 procedure mask |
| ASTM F2101: 2019 | Standard Test Method for Evaluating the BacterialFiltration Efficiency (BFE) of Medical Face MaskMaterials, Using a Biological Aerosol of Staphylococcusaureus | >99 % |
| ASTM F2299:2003 | Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres | >99% |
| ASTM F1862: 2017 | Standard Test Method for Resistance of Medical FaceMasks to Penetration by Synthetic Blood | >80 mmHg |
| EN 14683:2019 | Medical Face Masks—Requirements and Test Methods:Determine breathing resistance or differential pressureas directed in EN 14683:2019, Annex C. | < 3.7 mmH2O/cm² |
| 16 CFR part 1610 | Standard for the Flammability of Clothing Textiles | Class 1 |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Testsfor in vitro cytotoxicity | Pass |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Testsfor irritation and skin sensitization | Pass |
| EN 71-3: 2013 | Migration of certain elements | pass |
| CPSC 16 CFR 1500.48 | Technical requirements for determining a sharp point intoys and other articles for use by children under 8 yearsold after simulating use and abuse of device as per CPSC16 CFR 1500.53 | pass |
| CPSC 16 CFR 15003.49 | Technical requirements for determining a sharp metal orglass edge in toys and other articles for use by children | Pass |
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PRIMED Pediatric Facemask
510(k) Summary
| Standard | Result | |
|---|---|---|
| under 8 years old, after simulating use and abuse ofdevice as per CPSC 16 CFR 1500.53 | ||
| CPSC-CH-E1002-08.3 | Standard operation procedure for determining totalLead in non-metal children product | Pass |
| CPSC-CH-C1001-09.3 | Analysis of Phthalate | Pass |
Conclusion:
Based on the test results and comparison of PRIMED Pediatric Facemasks with the predicate devices, it can be concluded that PRIMED Pediatric mask is substantially equivalent and as effective as the predicate devices.
§ 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.