(149 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The document describes a surgical mask intended to protect individuals from the transfer of microorganisms, not to treat a condition.
No.
The device is a surgical mask intended to protect against the transfer of microorganisms and particulates, not to diagnose a medical condition.
No
The device description clearly outlines the physical components and materials of a surgical mask, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both patients and healthcare workers against the transfer of microorganisms, blood and body fluids, and airborne particulates. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask, focusing on materials and how they are assembled. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
- Performance Studies and Metrics: The performance studies and metrics listed (ASTM standards for barrier properties, filtration efficiency, breathability, flammability) are all related to the physical protective function of the mask, not diagnostic accuracy.
In summary, the Cardinal Health Secure-Gard® surgical and procedure mask is a personal protective equipment (PPE) device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel and other general healthcare workers
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)
The Cardinal Health Secure-Gard® surgical and procedure masks have been tested according to ASTM 2100-11 and standards which comprise ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks. All results of testing met ASTM F2100-11 Level 3 acceptance criteria. ASTM F2100-11 Level 3 was performed at an AQL of 4% (32 samples tested, accept on 3 failures and reject on 4 failures). Testing included ASTM F1862 Synthetic Blood (Pass), ASTM F2101 BFE (99.4 - 99.7%), ASTM F2299 PFE at 0.1 micron (98.6 - 99.1%), Mil-M-36954C Delta P (3.1- 3.5 mmH₂0/cm²), and CPSC 1610 Flammability (Class 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ASTM F2101 BFE: ≥ 98% (Current device test results: 99.4 - 99.7%)
ASTM F2299 PFE at 0.1 micron: ≥ 98% (Current device test results: 98.6 - 99.1%)
Mil-M-36954C Delta P:
§ 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
JUN 2 0 2014
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a simple, sans-serif font.
1500 Waukegan Road
Waukegan, IL 60085
510(k) SUMMARY Secure-Gard® Surgical and Procedure Masks
Manufacturer:
Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085
1500 Waukegan Road Waukegan, IL 60085
Lavenia Ford
(847) 887-3323
(847) 887-2461
Surgical Mask
FXX
Regulatory Affairs Contact:
Telephone Number:
Fax Number:
Date summary Prepared: May 21, 2014
Trade Name:
Secure-Gard® Surgical Mask
Secure-Gard® Procedure Mask
Regulation Number/Device Class: Class II per 21 CFR § 878.4040
Regulation Name: Surgical Apparel
Common Name:
Procedure Mask
Product Code:
Predicate Device:
K111402 -Kimberly-Clark, KC300 Face Mask(s)
1
Description
The Cardinal Health Secure-Gard® surgical and procedure masks are identified by Regulation 21 CFR 878.4040 with product code FXX.
The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile
Indications for Use
Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
This submission covers 7 catalog numbers of Secure-Gard® surgical and procedure masks models, see Table 1 below. Each model is the same four-laver mask constructed of 1 laver of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media), 1 layer of nonwoven polyester/polyethylene blends (media), and 1 layer polyolefin spunbond material (outer facing) and has been tested according to ASTM 2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks.
| Catalog # | Trade Name | Design Features | Color |
|---|---|---|---|
| AT74535 | Secure-Gard® surgical mask | Anti-fog foam strip | |
| and ties | Teal and Purple | ||
| AT74635 | Secure-Gard® surgical mask | Anti-fog foam strip, | |
| eye shield, and ties | Teal and Purple | ||
| AT74635-1 | Secure-Gard® surgical mask | Anti-fog foam strip, | |
| anti-glare eye shield, | |||
| and ties | Teal and Purple | ||
| AT744235 | Secure-Gard® surgical mask | Light weight anti-fog | |
| strip and ties | Teal and Purple | ||
| AT744335 | Secure-Gard® surgical mask | Light weight anti-fog | |
| strip with eye shield | |||
| and ties | Teal and Purple | ||
| AT74531 | Secure-Gard® procedure mask | Earloops | Teal and Purple |
| AT74631 | Secure-Gard® procedure mask | Eye shield and | |
| earloops | Teal and Purple |
Table 1: Product Description and Catalog Number
2
Device and Predicate Device Technical Characteristics
The Cardinal Health Secure-Gard® surgical and procedure face masks are substantially equivalent to the predicate device Kimberly-Clark KC300 of K111402 in intended use and principles of operation see Table 3 below. The Cardinal Health Secure-Gard® surgical and procedure masks and predicate masks meet ASTM F2100-11 as shown below in Table 11.
| Element of Comparison | Kimberly-Clark (KC300) | Cardinal Health Secure-Gard® Surgical and Procedure Masks |
|---|---|---|
| Intended Use | The Kimberly Clark KC300 Face Mask(s) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Kimberly Clark KC300 face mask(s) is a single use, disposable device(s), provided non-sterile. | Secure-Gard Surgical Mask |
| Cardinal Health Secure-Gard® surgical masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical masks are single use, disposable devices provided non-sterile |
Secure-Gard Procedure Mask
Cardinal Health Secure-Gard® procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® procedure masks are single use, disposable devices provided non-sterile |
| Material Composition | 4 layer mask made from nonwoven polyester blends and polypropylene materials | Secure-Gard Surgical Mask
4 layer mask made from 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media), 1 layer of nonwoven polyester/polyethylene blends (media), and 1 layer polyolefin spunbond material (outer facing)
Secure-Gard Procedure Mask
4 layer mask made from 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polyolefin melt blown (media) 1 |
| Table 3: Comparison of Predicate device and Cardinal Health Secure-Gard® Surgical and | ||||
|---|---|---|---|---|
| Procedure masks |
3
| | | layer of nonwoven
polyester/polyethylene blends
(media), and 1 layer polyolefin
spunbond material (outer facing) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specifications and Dimensions | KC300 Surgical Mask
7.0"x3.7" | Secure-Gard Surgical Mask
AT74535 - 7"x4" |
| | KC300 Procedure Mask
6.9"x3.8" | AT74635 - 7 ¼"x4 1/8"
AT74635-1 - 7 ¼"x4 1/8"
AT744235 - 7"x4"
AT744335 - 7"x4" |
| | | Secure-Gard Procedure Mask
AT74531 - 7"x3 3/8"
AT74631 - 7"x3 3/8" |
| | | See Appendix I for mask
specifications |
| Mask Style | Pleated | Secure-Gard Surgical Mask
Pleated |
| | | Secure-Gard Procedure Mask
Pleated |
| Design Features | KC300 Surgical Mask
Fluidshield Fog-Free | Secure-Gard Surgical Mask
AT74535 - Anti-fog foam strip
and Ties
AT74635 - Anti-fog foam strip,
Eye shield, and Ties
AT74635-1 - Anti-fog foam strip,
Anti-glare eye shield, and Ties
AT744235 - Lightweight anti-fog
strip and Ties
AT744335 - Lightweight anti-fog
strip, Eye shield, and Ties |
| | KC300 Procedure Mask
Fluidshield Fog-Free | Secure-Gard Procedure Mask
AT74531 - Earloops
AT74631 - Eye shield and
Earloops |
| Physical Testing | Predicate device was tested
according to ASTM F2100-11
Level 3 in previous 510(k)
submission K111402. | Secure-Gard Surgical Mask
Device was tested in accordance
with ASTM F2100-11, and meets
Level 3 requirements |
| | | Secure-Gard Procedure Mask
Device was tested in accordance
with ASTM F2100-11, and meets
Level 3 requirements |
| | | See Appendix G for all test data |
| Biocompatibility | Predicate device was tested
according ISO 10993 | Secure-Gard Surgical Mask
Device was tested in accordance
to ISO 10993 and passed |
'
. .
:
4
| acceptance criteria |
|---|
| Secure-Gard Procedure Mask |
| Device was tested in accordance |
| to ISO 10993 and passed |
| acceptance criteria |
| Appendix H for all test data |
Summary of Testing
The Cardinal Health Secure-Gard® surgical and procedure masks have been tested according to ASTM 2100-11 and standards which comprise ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks, see Table 11 below.
Table 11: Summary of ASTM F2100-11 Testing - Cardinal Health Secure-Gard® Surgical and Procedure Masks compared to Predicate
| Test | Acceptance
Criteria per
ASTM F2100-
11 Level 3
(AQL = 4.0%) | Predicate
device test
results
K111402
(KC300) | Current device test results | |
|------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------|-----------------------|
| | | | ASTM
F2100-11
Level 3 | Average |
| ASTM F1862
Synthetic
Blood | 160 mmHg | Pass | 32/32 Pass | Not Applicable |
| ASTM F2101
BFE | ≥ 98% | Pass | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299
PFE at 0.1
micron | ≥ 98% | Pass | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-
36954C
Delta P | 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."