(332 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a facemask, with no mention of AI or ML.
No.
This device is a facemask intended to protect the respiratory tract, not to treat a pre-existing condition or illness.
No
The device is a facemask intended to provide protection for the respiratory tract, not to diagnose any condition.
No
The device description clearly states it is a physical facemask constructed of nonwoven materials, bindings, earloops, and a nosepiece. It is a tangible, disposable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by a patient/child to provide protection for the respiratory tract. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction and materials of a facemask. It does not mention any components or mechanisms for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and protective capabilities of the mask (filtration efficiency, flammability, biocompatibility, etc.). They do not involve any diagnostic testing or analysis of biological markers.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This facemask does not fit that definition.
N/A
Intended Use / Indications for Use
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) 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.
Product codes
OXZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
respiratory tract
Indicated Patient Age Range
5-12
Intended User / Care Setting
healthcare setting 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
Consumer evaluation of potential mechanical and physical hazards (e.g., choking, strangulation, tissue tear/injury) as well as the following tests were conducted on the Pediatric/ Child Facemask:
| Standard | Title |
|---|---|
| Mil-M369454C | Military Specifications: 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 inMedical Masks to Penetration of Particulates Using Latex Spheres |
| ISO 10993 | Standards for evaluating the biocompatibility of a medical device |
| EN 71-3 | Safety of Toys- Part 3: Migration of Certain Elements |
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All testing conducted on the Pediatric/Child Face Mask met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K103150
SEP 2 3 2011
510(k) Summary
| Date of Submission of Pre-IDE information: | October 8, 2010 |
|---|---|
| Sponsor: | Kimberly-Clark |
| Address: | 1400 Holcomb Bridge Rd, Roswell, GA30076 |
| Contact: | Ann Waterhouse, RAC |
| Telephone: | (678) 352-6719 |
| Facsimile: | (920) 225-3108 |
Name of Device: Kimberly-Clark Pediatric/ Child Facemask Common Name/Classification Name: Mask, Surgical Classification: Class II Product Code: OXZ Regulation Number: 878.4040 Panel: General & Plastic Surgery
Indication for Use Statement:
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) 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.
Device Description:
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.
1
510(k) Summary, continued
Consumer evaluation of potential mechanical and physical hazards (e.g., choking, strangulation, tissue tear/injury) as well as the following tests were conducted on the Pediatric/ Child Facemask:
| Standard | Title |
|---|---|
| Mil-M369454C | Military Specifications: 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 | |
| ISO 10993 | Standards for evaluating the biocompatibility of a medical device |
| EN 71-3 | Safety of Toys- Part 3: Migration of Certain Elements |
All testing conducted on the Pediatric/Child Face Mask met acceptance criteria.
Predicate Devices:
| K061716 | Prestige Ameritech Face Mask |
|---|---|
| K082258 | CrossTex® Surgical Masks |
| K060776 | Hong Ya Surgical Face Mask |
The Kimberly-Clark Pediatric/ Child Facemask is comparable to the predicate devices cited in terms of materials of composition and performance.
The indications for use are slightly different from predicate devices due to the pediatric population for which this mask is intended to be worn, the differences are not critical to the intended use of the device, and do not affect the safety and effectiveness of the device when used as labeled.
Conclusions:
The Kimberly-Clark Pediatric/ Child Facemask have the same or similar intended use and technological characteristics as the predicate devices. Bench testing demonstrates the safety and efficacy of the Pediatric/ Child Facemask to standards cited. The Kimberly-Clark Pediatric/ Child Facemask does not raise any new questions concerning safety and effectiveness. The Kimberly-Clark Pediatric/ Child Facemask is substantially equivalent to referenced predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem with three stylized human figures, representing health and well-being. The figures are connected and appear to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ann Waterhouse Associate Director, Regulatory Affairs Kimberly-Clark 1400 Holcomb Bridge Road. Suite 1154. Bldg 300 Roswell, Georgia 30076
SEP 23 2011
Re: K103150
Trade/Device Name: Kimberly-Clark Pediatric/Child Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: OXZ Dated: September 12, 2011 Received: September 13, 2011
Dear Ms. Waterhouse:
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.
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Nitt
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103150
Device Name:
Kimberly-Clark Pediatric/Child Face Mask
Indications For Use:
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) 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.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINEcontinue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clavins-Williams
Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antrol, Dental Devices
510(k) Number: K103150