(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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
September 17, 2019
AMD Medicom, Inc. Nektaria Markoglou Director, Product Innovation and Development 2555 Chemin de l'Aviation, Pointe-Claire Montreal, H9P 2Z2 Ca
Re: K190308
Trade/Device Name: Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OXZ Dated: February 7, 2019 Received: February 15, 2019
Dear Nektaria Markoglou:
We have reviewed vour 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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 mediation-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,
Clarence W. Murray lii III -S
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190308
Device Name
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) and Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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AMD Medicom®
510(k) Summary K190308
| 510(k) Submitter: | AMD Medicom Inc. | |
|---|---|---|
| Address: | 2555 Chemin de l'Aviation,Pointe-Claire, Québec, H9P 2Z2, Canada | |
| Contact person: | Dr. Nektaria Markoglou,Director, Product Innovation and Development | |
| Date Prepared: | September 16, 2019 | |
| Trade Name: | Medicom SafeMask Sofskin Pediatric Procedure Earloop FaceMasks (ASTM Level 1), Medicom SafeMask Sofskin PediatricProcedure Earloop Face Masks, Medicom SafeMask PremierPediatric Procedure Earloop Face Masks (ASTM Level 1) andMedicom SafeMask Premier Pediatric Procedure Earloop FaceMasks | |
| Regulation Number: | 21CFR878.4040 | |
| Regulation Name: | Mask, Surgical | |
| Device Class: | Class II | |
| Device Product Code: | OXZ | |
| Device Classification Name:Mask, Surgical | ||
| Predicate Device: | Prestige Ameritech Pediatric Child's Face Mask (K160100) |
Device Description
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.
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AMD Medicom Inc. | www.medicom.com
n de l'Aviation, Pointe-Claire, Montréal, Québec H9P 2Z2 Canada | Tel: (514) 636-6262 | 1 (800) 308-6589 | Fax: (514) 636-6266 address | 6054 Shook Road, Suite 200, Lockbourne, Ohio, 43137
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Indication for Use
Prestige Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) and Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks 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.
Predicate Device
- Ameritech Pediatric Child's Face Mask (K160100)
Comparison of the Technological Characteristics with the Predicate
The table below compares the construction, technology, design, claims and intended use of Medicom Pediatric/ Child's Face Mask and the predicate device.
| ComponentComparison | Prestige Ameritech Pediatric/Child's FaceMask (Predicate) | Medicom Pediatric/Child's Face MaskSubject device |
|---|---|---|
| Manufacturer | Prestige Ameritech Ltd. | AMD Medicom Inc. |
| 510k Number | K160100 | K190308 |
| Intended Use | The Prestige Ameritech Pediatric/Child FaceMask is intended to be worn by patient/child. ThePediatric/Child Facemask is a single use,disposable device, provided non-sterile. ThePediatric/Child Facemask is intended to be wornby the patient (ages 4-12) to cover the nose andmouth to provide a barrier for the respiratory tractfor microorganisms and particulate materials. Themask is specifically for use with patients whoseage or illness may prevent them from takingnecessary precautions in situations where transferof microorganisms, body fluids, and particulatescan occur. | The Medicom Pediatric/Child's FaceMask is intended to be worn by thepatient/child (recommended 4-12 yearsof age). The face mask is to be placed onnose and mouth as a protective barrier toprovide respiratory protection inprocedures or situations where there is arisk of microorganism, body fluid andparticulate aerosol transfer. It is a singleuse, non-sterile disposable device that isrecommended for use in healthcaresettings with appropriate adultsupervision. |
| MaskConstruction &TechnologicalFeatures | The Prestige Ameritech Pediatric/Child's FaceMask is manufactured using ultrasonic bonding,composed of 3 layers of materials and pleated toform the mask. | Medicom Pediatric/Child's Face Mask isa manufactured pleated three-layer maskconstruction utilizing ultrasonic bonding.The patterned (ink printed) outer layer is |
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| The inner layer is composed of nonwoven, themiddle layer is meltblown polypropylene filtermaterial, and the outer layer is cellulose.Decorative patterns are printed with colored inks.Masks are help in place on wearer with knittedpolyester/spandex elastic earloop and contain amalleable aluminum nosepiece strip. ThePediatric/Child's Face Mask is appropriatelysized to the smaller faces of children acrossdiverse population. The Pediatric/Child FaceMask is a single use, disposable device, providednon-sterile with no shelf-life. Storage conditionswill not affect device safety or effectiveness. Allof the materials used in this device are typicalmaterials commonly used in the construction ofSurgical Masks and are being used in currentlegally marketed devices. This product is notmade with natural rubber latex. | composed of spunbound polypropylene(SBPP) material. The filter media iscomposed of meltblown polypropylene(MBPP). The inner is either tissue/cellulose or a spunbound polypropylene(SBPP) layer. Bindings are composed ofnonwoven polyester and earloops aremade of flat elastic knitted polyesterband. A malleable polypropylenenosepiece (made of plastic covered ironwire or 100% aluminum piece) is placedwithin the bindings for comfort andindividualized fit around the wearer'snose. Medicom Pediatric/Child's FaceMask is a non-sterile single usedisposable device. The device safety andfunction is not affected by storageconditions with no shelf life. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Non-Clinical Performance Testing | Prestige Ameritech | Medicom Pediatric/Child'sFace Mask | |
|---|---|---|---|
| ASTM F2100 | Subject device (range ofperformance based ondesign variations) | ||
| Standard | Title | Predicate | |
| ASTM F2299M -03(2017) | Particulate filtrationefficiency (PFE) at 0.1micron, % | 98% | 98.68 - 99.21% |
| ASTM F2101-14 | Bacterial filtrationefficiency (BFE), % | 96.32% | 99.43 - 99.5% |
| Mil - M369454C,Section 4.4.1.2 & EN14683, Annx. B | Differential pressure(dP) | 1.74 | 2.89 - 3.12 |
| ASTM F1862M-17 | Resistance topenetration bySynthetic Blood | N/A | N/A to@ 80 mm Hg (Level 1) |
| Biocompatibility | |||
| Standard | Title | Predicate | Subject device |
| ISO 10993-5 | Cytotoxicity by MEMelution | 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 | Predicate | Subject device | |
| Standard | Title |
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| CPSC-CH-E1002-08.316 CFR 1303 | Total Lead (Pb) contentin non-metal Children'sProducts | Meet acceptance criteria | (≤20 ppm)Meet acceptance criteria |
|---|---|---|---|
| CPSC-CH-E1001-08.3 | Total Lead (Pb) contentin metal Children'sProducts | Meet acceptance criteria | (≤40 ppm)Meet acceptance criteria |
| CPSC-CH-C1001-09.316 CFR part 1307 | Analysis of Phthalates(DBP, DEHP, DINP,BBP, DNOPand DIDP) | Meet acceptance criteria | (≤50 ppm)Meet acceptance criteria |
| 16 CFR 1500.48, 49, 51-53ISO 17025 | Mechanical Hazards:sharp points, sharpedges and small partssubstances | N/A | Meet acceptance criteria |
| 16 CFR 1500.44 | Flammability | Class 1 | Class 1 |
| Anthropometry Study | |||
| Predicate | Subject device | ||
| Based on an anthropometric study sample that isrepresentative of the current US population in bothgender and racial distribution, the PrestigeAmeritech Pediatric/Child's Face Mask will provideadequate coverage to children between the ages of 4-12 years old, of weight between 24-153 pounds andof height between 3'3" and 5'4". | The Medicom Pediatric/Child's Face Mask was evaluatedbased on anthropometry study on children aged 4-12 yearsold. The participants ranged from 84.8 cm (33.4 inches) –170.2 cm (67 inches) in height and 16.3 kg (35.94 pounds) –76.7 kg (169.1 pounds) in weight.Medicom Pediatric/Child's Face Mask provides adequatecoverage to children 4-12 years old based on proper adultsupervision and assurance that mask fits correctly on thechild's face (by sitting on the bridge of the nose and it issecured under chin, by not impeding vision by covering theeyes, not pulling at the ears and ensuring child is breathingnormally while wearing the masks. | ||
| Predicate | Subject device |
Abbreviation: N/A: Not Applicable
Conclusion:
The conclusion drawn from the non-clinical tests performed (discussed above) demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.