(217 days)
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is described as a protective barrier to reduce exposure to microorganisms, body fluids, and particulate aerosols, rather than treating a disease or condition.
No.
This device, a face mask, is described as a protective barrier to prevent the transfer of microorganisms, body fluids, and particulate aerosols. It is not used for diagnosing medical conditions, but rather for protection.
No
The device description clearly outlines a physical, manufactured product composed of various materials (polypropylene, polyester, iron wire, aluminum). It undergoes non-clinical performance testing related to physical properties and filtration, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "face mask" intended to be worn on the nose and mouth as a "protective barrier to provide respiratory protection." It filters air and prevents the transfer of microorganisms, body fluids, and particulate aerosols.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
- Performance Metrics: The performance metrics listed (filtration efficiency, differential pressure, resistance to synthetic blood, material composition tests) are related to the physical barrier and safety properties of the mask, not to the analysis of biological samples.
The device is a personal protective equipment (PPE) designed to protect the wearer and others from the spread of respiratory droplets and particles.
N/A
Intended Use / Indications for Use
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.
Product codes
OXZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nose and mouth
Indicated Patient Age Range
4-12 years of age
Intended User / Care Setting
healthcare settings with appropriate adult supervision.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing and Biocompatibility testing demonstrating compliance with ASTM F2100, ASTM F2299M -03 (2017), ASTM F2101-14, Mil - M369454C, Section 4.4.1.2 & EN 14683, Annx. B, ASTM F1862M-17, ISO 10993-5, ISO 10993-10, CPSC-CH-E1002-08.3 16 CFR 1303, CPSC-CH-E1001-08.3, CPSC-CH-C1001-09.3 16 CFR part 1307, 16 CFR 1500.48, 49, 51-53 ISO 17025, and 16 CFR 1500.44. Anthropometry Study on children aged 4-12 years old, ranging 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particulate filtration efficiency (PFE) at 0.1 micron, %: 98.68 - 99.21%
Bacterial filtration efficiency (BFE), %: 99.43 - 99.5%
Differential pressure (dP): 2.89 - 3.12
Total Lead (Pb) content in non-metal Children's Products: (≤20 ppm) Meet acceptance criteria
Total Lead (Pb) content in metal Children's Products: (≤40 ppm) Meet acceptance criteria
Analysis of Phthalates (DBP, DEHP, DINP, BBP, DNOP and DIDP): (≤50 ppm) Meet acceptance criteria
Flammability: Class 1
Predicate Device(s)
Prestige Ameritech Pediatric Child's Face Mask (K160100)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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 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 | ||
| 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.
1 of 4
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
4
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.
| Component
Comparison | Prestige Ameritech Pediatric/Child's Face
Mask (Predicate) | Medicom Pediatric/Child's Face Mask
Subject device |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Prestige Ameritech Ltd. | AMD Medicom Inc. |
| 510k Number | K160100 | K190308 |
| Intended Use | The Prestige Ameritech Pediatric/Child Face
Mask is intended to be worn by patient/child. The
Pediatric/Child Facemask is a single use,
disposable device, provided non-sterile. The
Pediatric/Child Facemask is intended to be worn
by the patient (ages 4-12) to cover the nose and
mouth to provide a barrier for the respiratory tract
for microorganisms and particulate materials. The
mask is specifically for use with patients whose
age or illness may prevent them from taking
necessary precautions in situations where transfer
of microorganisms, body fluids, and particulates
can occur. | The Medicom Pediatric/Child's Face
Mask is 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. |
| Mask
Construction &
Technological
Features | The Prestige Ameritech Pediatric/Child's Face
Mask is manufactured using ultrasonic bonding,
composed of 3 layers of materials and pleated to
form the mask. | Medicom Pediatric/Child's Face Mask is
a manufactured pleated three-layer mask
construction utilizing ultrasonic bonding.
The patterned (ink printed) outer layer is |
5
| The inner layer is composed of nonwoven, the
middle layer is meltblown polypropylene filter
material, and the outer layer is cellulose.
Decorative patterns are printed with colored inks.
Masks are help in place on wearer with knitted
polyester/spandex elastic earloop and contain a
malleable aluminum nosepiece strip. The
Pediatric/Child's Face Mask is appropriately
sized to the smaller faces of children across
diverse population. The Pediatric/Child Face
Mask is a single use, disposable device, provided
non-sterile with no shelf-life. Storage conditions
will not affect device safety or effectiveness. All
of the materials used in this device are typical
materials commonly used in the construction of
Surgical Masks and are being used in current
legally marketed devices. This product is not
made with natural rubber latex. | 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 and
function is not affected by storage
conditions with no shelf life. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| | Non-Clinical Performance Testing | Prestige Ameritech | Medicom Pediatric/Child's
Face Mask |
|-----------------------------------------------------------|----------------------------------------------------------------|--------------------|------------------------------------------------------------------------|
| ASTM F2100 | | | Subject device (range of
performance based on
design variations) |
| Standard | Title | Predicate | |
| 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 | | | |
| Standard | Title | Predicate | Subject device |
| 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 | | Predicate | Subject device |
| Standard | Title | | |
6
| 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 | | | |
| Predicate | Subject device | | |
| Based on an anthropometric study sample that is
representative of the current US population in both
gender and racial distribution, the Prestige
Ameritech Pediatric/Child's Face Mask will provide
adequate coverage to children between the ages of 4-
12 years old, of weight between 24-153 pounds and
of height between 3'3" and 5'4". | The Medicom Pediatric/Child's Face Mask was evaluated
based on anthropometry study on children aged 4-12 years
old. 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 adequate
coverage to children 4-12 years old based on proper adult
supervision and assurance that mask fits correctly on the
child's face (by sitting on the bridge of the nose and it is
secured under chin, by not impeding vision by covering the
eyes, not pulling at the ears and ensuring child is breathing
normally 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.