(262 days)
K113340 Kimberly-Clark Pediatric/Child face mask(s)
Not Found
No
The description details a physical face mask with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a face mask intended to provide a barrier for microorganisms and particulate materials, not to treat or cure a medical condition.
No
The device, a pediatric/child face mask, is intended to provide a barrier for the respiratory tract against microorganisms and particulate materials. It does not analyze or interpret any biological, chemical, or physical parameters to determine a medical condition or disease. Therefore, it is not a diagnostic device.
No
The device description clearly outlines physical components like nonwoven material, meltblown polypropylene, cellulose, elastic earloops, and an aluminum nosepiece, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a physical barrier for the respiratory tract against microorganisms and particulate materials by covering the nose and mouth. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The device is a physical mask made of layers of material. It does not contain reagents, instruments, or software designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring specific substances or markers in a sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the 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 where transfer of microorganisms, body fluids, and particulates can occur.
Product codes (comma separated list FDA assigned to the subject device)
OXZ
Device Description
The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. 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 held 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 a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and Mouth / respiratory tract
Indicated Patient Age Range
The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12)
Intended User / Care Setting
Not Found
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)
Summary of Testing:
This device performs at the same fluid resistant level, equivalent particulate filtration efficiency, marginally lower bacterial filtration efficiency, a better differential pressure, and the same flammability class as the predicate device. The intended use is the same and that the subject Prestige Ameritech Device does not seek shelf life claim or provide storage conditions. These differences are not critical to the intended use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particulate Filtration Efficiency at 0.1 microns, ASTM F2299: 98%
Bacterial Filtration, ASTM F2101: 96.32%
Differential Pressure, Mil M36954C: 1.74
Flammability Class, 16 CFR Part 1610: Class I
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113340 Kimberly-Clark Pediatric/Child face mask(s)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Public Health Service
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
October 7, 2016
Rodney Gregory RA/QA Manager Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills. TX 76180 United States
Re: K160100
Trade/Device Name: Prestige Ameritech Pediatric/Child's Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: OXZ Dated: August 30, 2016 Received: September 9, 2016
Dear Mr. Gregory,
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michae D/Ryan -S
for Tina Kiang, Ph.D Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160100
Device Name
Prestige Ameritech Pediatric/Child Face Mask
Indications for Use (Describe)
The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/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 where transfer of microorganisms, body fluids, and particulates can occur.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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PRESTIGE AMERITECH
510(k) Summary
| Date Summary was Prepared: | January 7, 2016 |
|---|---|
| 510(k) Submitter: | Rodney Gregory |
| RA/QA Manager | |
| North Richland Hills, TX 76180 | |
| Phone: 817-427-2700 | |
| Fax: 817-886-2733 | |
| rodney@prestigeam.com | |
| Device Trade Name: | Prestige Ameritech Pediatric/Child's Face Mask |
| Device Common Name: | Mask, Surgical |
| Device Product Codes and Classification Names: | OXZ, Class II |
| Mask, Surgical (21 CFR 878.4040) | |
| Predicate Devices: | K113340 Kimberly-Clark Pediatric/Child face mask(s) |
| Device Description: | The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. 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 held 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 a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of 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. |
| Intended Use: | The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the 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 P008 |
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| | 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. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | This is a surface-contacting, less than 24 hour duration device. The
components that come into direct contact with the user are the
inner material and earloops. The earloop and the manufacturing
methods by which it is processed are identical to the predicate. The
inner material has had MEM Elution, Repeated Patch Dermal
Sensitization, and ISO Primary Skin Irritation, while the earloop
material had MEM Elution and ISO Primary Skin Irritation
biocompatibility tests performed. |
| Sterilization
And Shelf Life: | The device is not proved sterile, has no proposed shelf
life/expiration date, and is not a reprocessed single use device. The
device is manufactured from non-woven materials that are not
impacted by storage conditions or aging and thus does not have a
shelf life. |
| Anthropometry: | Based on an anthropometric study sample that is representative of
the current US population in both gender and racial distribution,
the Prestige Ameritech Child's/Pediatric 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". |
Comparison to Predicate Device
| Characteristic | K113340 (Predicate) | PRESTIGE AMERITECH DEVICE |
|---|---|---|
| Particulate Filtration | ||
| Efficiency at 0.1 microns, | ||
| ASTM F2299 | 98.5% | 98% |
| Bacterial Filtration, ASTM | ||
| F2101 | 99.6% | 96.32% |
| Differential Pressure, Mil | ||
| M36954C | 2.6 | 1.74 |
| Flammability Class, 16 CFR | ||
| Part 1610 | Class I | Class I |
| Biocompatibility | Tested under ISO 10993 | |
| Standard | Tested under ISO 10993 | |
| Standard | ||
| Intended Use | The Kimberly-Clark | |
| Pediatric/Child Facemask, | ||
| is intended to be worn by | ||
| the patient/child | The Prestige Ameritech | |
| Pediatric/Child Face Mask | ||
| is intended to be worn by | ||
| the patient/child | ||
| (recommended ages 4-12) | ||
| to provide protection for | ||
| the respiratory tract. It is a | ||
| single use, disposable | ||
| device that is provided non- | ||
| sterile. This Face Mask is | ||
| recommended for use in a | ||
| healthcare setting with | ||
| appropriate adult | ||
| supervision. | (recommended ages 4-12) | |
| to provide protection for | ||
| the respiratory tract. The | ||
| Pediatric/Child's Face | ||
| Mask is a single use, | ||
| disposable device, provided | ||
| non-sterile with no shelf- | ||
| life. Storage conditions will | ||
| not affect device safety of | ||
| effectiveness. This Face | ||
| Mask is recommended for | ||
| use in a healthcare setting | ||
| with appropriate adult | ||
| supervision. | ||
| Intended Use Sites | Healthcare setting | Healthcare setting |
| Product Code, Device Class, | ||
| and Regulation | OXZ, Class II | |
| Mask, surgical (21 CFR | ||
| 878.4040) | OXZ, Class II | |
| Mask, Surgical (21 CFR | ||
| 878.4040) | ||
| Mask Construction and | ||
| Technological Features | The Kimberly-Clark | |
| Pediatric/Child Facemask | ||
| is a three layer mask, | ||
| constructed of nonwoven | ||
| polyester blends and | ||
| polypropylene materials. | ||
| Bindings are nonwoven | ||
| polyester and earloops are | ||
| knitted polyester/lycra. A | ||
| malleable nosepiece is | ||
| placed within the bindings | ||
| for comfort and | ||
| individualized fit around | ||
| the wearer's nose. The | ||
| Pediatric/Child Facemask | ||
| is appropriately sized to the | ||
| smaller faces of children | ||
| across a diverse population. | ||
| The Pediatric/Child | ||
| Facemask is a single use, | ||
| disposable device, provided | ||
| non-sterile. | The Prestige Ameritech | |
| Pediatric/Childs Face Mask | ||
| is manufactured using | ||
| ultrasonic bonding, | ||
| composed of three layers of | ||
| materials and pleated to | ||
| form the mask. 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 held 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 a diverse | ||
| population. The | ||
| Pediatric/Child's 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. |
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Summary:
Summary of Testing:
This device performs at the same fluid resistant level, equivalent particulate filtration efficiency, marginally lower bacterial filtration efficiency, a better differential pressure, and the same flammability class as the predicate device. The intended use is the same and that the subject Prestige Ameritech Device does not seek shelf life claim or provide storage conditions. These differences are not critical to the intended use of the device.
The mask construction is similar but has the following differences: the predicate device claims lycra in their earloops which is the same material as the Prestige Ameritech device's spandex in their ear loops; the Prestige Ameritech device has a cellulose outer facing instead of a polyester or polypropylene material. The Prestige Ameritech device also states the use of flexo-printed inks and that the device is not made with natural rubber latex.
Technological Characteristics and Substantial Equivalence: The Prestige Ameritech Pediatric/Child face mask has the same intended use and principles of operation as the predicate device. Based on the intended use, technological characteristics, and performance data, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device.
| Standard | Title |
|---|---|
| Mil – M369454C | Military Specification: Surgical Mask, disposable 1992 |
| ASTM F2101-07 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus |
| PSC CS-191-53 | Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles |
| ASTM F2299 | Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres |
The Prestige Ameritech Pediatric/Child face mask has been tested
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| CPSC-CH-E1002-08 | Total Lead Content Analysis |
|---|---|
| CPSC-CH-C1001- | |
| 09.3 | Phthalate Analysis DEHP, DBP, BBP, |
| DINP, DIDP, DnOP, and DnHP | |
| ISO 10993 | Standards for evaluating the |
| biocompatibility of a medical device | |
| EN 71-3 | Safety of Toys - Migration of certain 19 |
| elements |
All results of testing met acceptance criteria.