Who is the manufacturer of Prestige Ameritech Pediatric/Child’s Face mask?

Prestige Ameritech filed the 510(k) submission for Prestige Ameritech Pediatric/Child’s Face mask (K160100).

What is the FDA product code for Prestige Ameritech Pediatric/Child’s Face mask?

OXZ. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Prestige Ameritech Pediatric/Child’s Face mask?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Prestige Ameritech Pediatric/Child’s Face mask?

Kimberly-Clark Pediatric/Child face mask(s) (K113340).

Who can help prepare an FDA 510(k) submission like Prestige Ameritech Pediatric/Child’s Face mask?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Prestige Ameritech Pediatric/Child’s Face mask

K160100 · Prestige Ameritech · OXZ · Oct 7, 2016 · General, Plastic Surgery

Device Facts

Record ID	K160100
Device Name	Prestige Ameritech Pediatric/Child’s Face mask
Applicant	Prestige Ameritech
Product Code	OXZ · General, Plastic Surgery
Decision Date	Oct 7, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Single-use, non-sterile disposable face mask; designed for pediatric patients (ages 4-12). Construction: three-layer design; inner nonwoven layer; middle meltblown polypropylene filter; outer cellulose layer; ultrasonic bonding; pleated form factor. Features: knitted polyester/spandex elastic earloops; malleable aluminum nosepiece; decorative printed inks. Used in healthcare settings; worn by patient under adult supervision. Provides physical barrier against microorganisms, body fluids, and particulates. Benefits: reduces risk of cross-contamination for children unable to maintain standard precautions due to age or illness. No shelf-life; storage conditions do not affect safety/effectiveness.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2299 (particulate filtration 98%), ASTM F2101 (bacterial filtration 96.32%), Mil M36954C (differential pressure 1.74), and 16 CFR 1610 (flammability Class I). Biocompatibility testing performed per ISO 10993 (MEM Elution, sensitization, skin irritation). Chemical safety testing included lead content (CPSC-CH-E1002-08), phthalates (CPSC-CH-C1001-09.3), and migration of elements (EN 71-3).

Technological Characteristics

Three-layer construction: nonwoven inner, meltblown polypropylene middle, cellulose outer. Ultrasonic bonding. Malleable aluminum nosepiece. Knitted polyester/spandex earloops. Dimensions sized for pediatric anthropometry (ages 4-12). Non-sterile. Standards: ASTM F2299, ASTM F2101-07, 16 CFR 1610, ISO 10993, EN 71-3.

Indications for Use

Indicated for pediatric patients (ages 4-12) to cover nose and mouth as a barrier against microorganisms, body fluids, and particulates. Intended for use in healthcare settings with adult supervision, particularly for patients whose age or illness prevents them from taking necessary precautions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Kimberly-Clark Pediatric/Child face mask(s) (K113340)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 | {5}------------------------------------------------ | | 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. | | {6}------------------------------------------------ {7}------------------------------------------------ #### 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 {8}------------------------------------------------ | 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.

Prestige Ameritech Pediatric/Child’s Face mask

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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Prestige Ameritech Pediatric/Child’s Face mask

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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