(262 days)
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.
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.
The provided text describes the acceptance criteria and performance of the Prestige Ameritech Pediatric/Child's Face Mask, comparing it to a predicate device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Prestige Ameritech Pediatric/Child's Face Mask) |
|---|---|---|
| Particulate Filtration Efficiency at 0.1 microns, ASTM F2299 | 98.5% | 98% |
| Bacterial Filtration Efficiency (BFE), 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 (MEM Elution, Repeated Patch Dermal Sensitization, ISO Primary Skin Irritation) | Tested under ISO 10993 Standard | Tested under ISO 10993 Standard |
| Anthropometry (adequate coverage for ages 4-12, 24-153 lbs, 3'3"-5'4") | Achieved by predicate | Achieved |
| Total Lead Content Analysis, CPSC-CH-E1002-08 | Met standard | Met acceptance criteria |
| Phthalate Analysis (DEHP, DBP, BBP, DINP, DIDP, DnOP, and DnHP), CPSC-CH-C1001-09.3 | Met standard | Met acceptance criteria |
| Migration of certain 19 elements, EN 71-3 | Met standard | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test performed on the Prestige Ameritech Pediatric/Child's Face Mask. It mentions that the anthropometric study sample for determining fit was "representative of the current US population in both gender and racial distribution," implying a prospective study, but exact numbers are not given. The origin of the data is not specified beyond being generated for a U.S. FDA 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document pertains to the performance testing of a physical medical device (a face mask) against established industry standards. There is no mention of "experts" in the context of establishing ground truth for a test set, as the evaluation relies on standardized laboratory testing methods rather than expert interpretation of data like in an AI/imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation is based on objective laboratory test results against predefined standards, not on human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a review of a physical medical device (face mask) and does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a review of a physical medical device (face mask) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the results of standardized laboratory tests conducted according to recognized national and international standards (e.g., ASTM F2101, Mil M36954C, ISO 10993, CPSC, EN 71-3). These standards define the methodology and expected outcomes for measuring properties like filtration efficiency, breathability, flammability, and biocompatibility. For anthropometry, it's based on measurements against a "representative" population sample.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.
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Public Health Service
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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 GregoryRA/QA ManagerNorth Richland Hills, TX 76180Phone: 817-427-2700Fax: 817-886-2733rodney@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 IIMask, 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. Themask is specifically for use with patients whose age or illness mayprevent them from taking necessary precautions in situations wheretransfer of microorganisms, body fluids, and particulates canoccur. | |
|---|---|
| Biocompatibility: | This is a surface-contacting, less than 24 hour duration device. Thecomponents that come into direct contact with the user are theinner material and earloops. The earloop and the manufacturingmethods by which it is processed are identical to the predicate. Theinner material has had MEM Elution, Repeated Patch DermalSensitization, and ISO Primary Skin Irritation, while the earloopmaterial had MEM Elution and ISO Primary Skin Irritationbiocompatibility tests performed. |
| SterilizationAnd Shelf Life: | The device is not proved sterile, has no proposed shelflife/expiration date, and is not a reprocessed single use device. Thedevice is manufactured from non-woven materials that are notimpacted by storage conditions or aging and thus does not have ashelf life. |
| Anthropometry: | Based on an anthropometric study sample that is representative ofthe current US population in both gender and racial distribution,the Prestige Ameritech Child's/Pediatric face mask will provideadequate coverage to children between the ages of 4-12 years old,of weight between 24-153 pounds, and of height between 3'3" and5'4". |
Comparison to Predicate Device
| Characteristic | K113340 (Predicate) | PRESTIGE AMERITECH DEVICE |
|---|---|---|
| Particulate FiltrationEfficiency at 0.1 microns,ASTM F2299 | 98.5% | 98% |
| Bacterial Filtration, ASTMF2101 | 99.6% | 96.32% |
| Differential Pressure, MilM36954C | 2.6 | 1.74 |
| Flammability Class, 16 CFRPart 1610 | Class I | Class I |
| Biocompatibility | Tested under ISO 10993Standard | Tested under ISO 10993Standard |
| Intended Use | The Kimberly-ClarkPediatric/Child Facemask,is intended to be worn bythe patient/child | The Prestige AmeritechPediatric/Child Face Maskis intended to be worn bythe patient/child |
| (recommended ages 4-12)to provide protection forthe respiratory tract. It is asingle use, disposabledevice that is provided non-sterile. This Face Mask isrecommended for use in ahealthcare setting withappropriate adultsupervision. | (recommended ages 4-12)to provide protection forthe respiratory tract. ThePediatric/Child's FaceMask is a single use,disposable device, providednon-sterile with no shelf-life. Storage conditions willnot affect device safety ofeffectiveness. This FaceMask is recommended foruse in a healthcare settingwith appropriate adultsupervision. | |
| Intended Use Sites | Healthcare setting | Healthcare setting |
| Product Code, Device Class,and Regulation | OXZ, Class IIMask, surgical (21 CFR878.4040) | OXZ, Class IIMask, Surgical (21 CFR878.4040) |
| Mask Construction andTechnological Features | The Kimberly-ClarkPediatric/Child Facemaskis a three layer mask,constructed of nonwovenpolyester blends andpolypropylene materials.Bindings are nonwovenpolyester and earloops areknitted polyester/lycra. Amalleable nosepiece isplaced within the bindingsfor comfort andindividualized fit aroundthe wearer's nose. ThePediatric/Child Facemaskis appropriately sized to thesmaller faces of childrenacross a diverse population.The Pediatric/ChildFacemask is a single use,disposable device, providednon-sterile. | The Prestige AmeritechPediatric/Childs Face Maskis manufactured usingultrasonic bonding,composed of three layers ofmaterials and pleated toform the mask. The innerlayer is composed ofnonwoven, the middle layeris meltblownpolypropylene filtermaterial, and the outerlayer is cellulose.Decorative patterns areprinted with colored inks.Masks are held in place onwearer with knittedpolyester/spandex elasticearloop and contain amalleable aluminumnosepiece strip. ThePediatric/Child's FaceMask is appropriately sizedto the smaller faces ofchildren across a diversepopulation. ThePediatric/Child's FaceMask is a single use,disposable device, providednon-sterile with no shelf-life. Storage conditions willnot 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 thebiocompatibility of a medical device |
| EN 71-3 | Safety of Toys - Migration of certain 19elements |
All results of testing met acceptance criteria.
§ 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.