(149 days)
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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (Current device test results) | Average Performance |
|---|---|---|---|
| ASTM F1862 Synthetic Blood (Resistance to Penetration) | 160 mmHg | 32/32 Pass | Not Applicable |
| ASTM F2101 BFE (Bacterial Filtration Efficiency) | ≥ 98% | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299 PFE at 0.1 micron (Particle Filtration Efficiency) | ≥ 98% | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-36954C Delta P (Differential Pressure / Breathability) | < 5.0 mmH₂O/cm² | 32/32 Pass | 3.1- 3.5 mmH₂O/cm² |
| CPSC 1610 Flammability | Class 1 | 32/32 Pass (Class 1) | Not Applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 32 samples were tested for each performance criterion.
- Data Provenance: The data is prospective, generated from testing the "current device" (Cardinal Health Secure-Gard® surgical and procedure masks) according to the specified ASTM standards. The country of origin for the testing facilities is not explicitly stated in the provided text.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This type of information is generally not applicable to the performance testing of medical face masks. The "ground truth" for mask performance is established by standardized, objective laboratory tests (e.g., bacterial filtration, particle filtration, fluid resistance) defined by consensus standards like ASTM F2100-11. These tests produce quantitative results, not subjective expert opinions. Therefore, no "experts" in the traditional sense (like radiologists or pathologists) were used to establish ground truth for this device's performance claims.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective, quantitative measurements from standardized laboratory tests. There is no subjective interpretation or "adjudication" by experts required for determining pass/fail criteria for these specific performance metrics. The text states an AQL (Acceptance Quality Limit) of 4.0%, indicating that for 32 samples tested, acceptance on 3 failures and rejection on 4 failures was the statistical method used for determining lot acceptance, not expert adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for evaluating the performance of medical face masks. These studies are typically used to assess diagnostic accuracy or the impact of AI assistance on human readers in interpreting medical images or data. The performance of a surgical mask is evaluated through objective physical and material tests, not through human interpretation or a diagnostic task.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device (surgical mask) is a physical product, not an algorithm or AI system. Its performance is inherent in its physical properties and design, tested directly in a standalone manner (the mask itself is tested without human interaction beyond handling for the test).
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on objective, quantitative results from standardized laboratory tests as defined by ASTM F2100-11, such as direct measurements of bacterial filtration efficiency, particle filtration efficiency, fluid resistance, differential pressure, and flammability.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical mask), not an AI or machine learning model. Therefore, there is no "training set" in the context of AI development. The masks are manufactured according to specifications and then tested for performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical device.
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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)
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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 stripand 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-fogstrip and ties | Teal and Purple |
| AT744335 | Secure-Gard® surgical mask | Light weight anti-fogstrip with eye shieldand ties | Teal and Purple |
| AT74531 | Secure-Gard® procedure mask | Earloops | Teal and Purple |
| AT74631 | Secure-Gard® procedure mask | Eye shield andearloops | Teal and Purple |
Table 1: Product Description and Catalog Number
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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 MaskCardinal 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-sterileSecure-Gard Procedure MaskCardinal 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 Mask4 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 Mask4 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 |
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| layer of nonwovenpolyester/polyethylene blends(media), and 1 layer polyolefinspunbond material (outer facing) | ||
|---|---|---|
| Specifications and Dimensions | KC300 Surgical Mask7.0"x3.7" | Secure-Gard Surgical MaskAT74535 - 7"x4" |
| KC300 Procedure Mask6.9"x3.8" | AT74635 - 7 ¼"x4 1/8"AT74635-1 - 7 ¼"x4 1/8"AT744235 - 7"x4"AT744335 - 7"x4" | |
| Secure-Gard Procedure MaskAT74531 - 7"x3 3/8"AT74631 - 7"x3 3/8" | ||
| See Appendix I for maskspecifications | ||
| Mask Style | Pleated | Secure-Gard Surgical MaskPleated |
| Secure-Gard Procedure MaskPleated | ||
| Design Features | KC300 Surgical MaskFluidshield Fog-Free | Secure-Gard Surgical MaskAT74535 - Anti-fog foam stripand TiesAT74635 - Anti-fog foam strip,Eye shield, and TiesAT74635-1 - Anti-fog foam strip,Anti-glare eye shield, and TiesAT744235 - Lightweight anti-fogstrip and TiesAT744335 - Lightweight anti-fogstrip, Eye shield, and Ties |
| KC300 Procedure MaskFluidshield Fog-Free | Secure-Gard Procedure MaskAT74531 - EarloopsAT74631 - Eye shield andEarloops | |
| Physical Testing | Predicate device was testedaccording to ASTM F2100-11Level 3 in previous 510(k)submission K111402. | Secure-Gard Surgical MaskDevice was tested in accordancewith ASTM F2100-11, and meetsLevel 3 requirements |
| Secure-Gard Procedure MaskDevice was tested in accordancewith ASTM F2100-11, and meetsLevel 3 requirements | ||
| See Appendix G for all test data | ||
| Biocompatibility | Predicate device was testedaccording ISO 10993 | Secure-Gard Surgical MaskDevice was tested in accordanceto ISO 10993 and passed |
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| acceptance criteria |
|---|
| Secure-Gard Procedure MaskDevice was tested in accordanceto ISO 10993 and passedacceptance 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 | AcceptanceCriteria perASTM F2100-11 Level 3(AQL = 4.0%) | Predicatedevice testresultsK111402(KC300) | Current device test results | |
|---|---|---|---|---|
| ASTMF2100-11Level 3 | Average | |||
| ASTM F1862SyntheticBlood | 160 mmHg | Pass | 32/32 Pass | Not Applicable |
| ASTM F2101BFE | ≥ 98% | Pass | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299PFE at 0.1micron | ≥ 98% | Pass | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-36954CDelta P | < 5.0mmH₂0/cm² | Pass | 32/32 Pass | 3.1- 3.5mmH₂0/cm² |
| CPSC 1610Flammability | Class 1 | Pass | 32/32 PassClass 1 | Not Applicable |
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).
Summary of Testing
Based on the results of the biocompatibility and physical performance testing the Secure-Gard® surgical and procedure masks are as safe and as effective for their intended use as the predicate. The Secure-Gard® surgical and procedure masks are substantially equivalent to the predicate device, in terms of general intended use performance testing, material composition, configurations/dimensions, and safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
June 20, 2014
Cardinal Health 200, LLC Ms. Lavenia Ford Manager, Regulatory Affairs 1430 Waukegan Road Waukegan, Illinois 60085
Re: K140155
Trade/Device Name: Secure-Gard® Surgical and Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: Class II Product Code: FXX Dated: May 21, 2014 Received: May 22, 2014
Dear Ms. Ford,
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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Page 2 - Ms. Ford
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/Resourcesfor You/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/MedicalDeyices/Safety/ReportalProblem/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,
Tejashri Purohit-Sheth, M.D.
Tejashri Tejashri Purohit-Sheth Purohit Sheth M.D M.D. Cusical Deputy Director
GRODE/CDRH FOR
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140155
Device Name
Secure-Gard® surgical and procedure masks
Indications for Use (Describe)
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 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-layer mask constructed of I 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) and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks
Table 1: Product Description and Catalog Number
| 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-I | 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 |
Type of Use (Select one or both, as applicable)
L 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.
A MARK LE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR THE CHILL Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gu
ly signed by Sreekanth Gutala -S
JS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 9200300.100.1.1=2000540490. cn=Sreekanth Gutala -S 2044.06.19 21:59:43 -04'00'
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§ 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.