(94 days)
Not Found
No
The device is a surgical mask and the description focuses on its physical construction and filtration performance, with no mention of AI or ML.
No
A surgical mask is a protective barrier device, not intended to directly treat or cure a disease or condition, which is the definition of a therapeutic device. Its purpose is to prevent the transfer of microorganisms and fluids.
No.
Explanation: The device is a surgical mask intended for protection against the transfer of microorganisms, blood, and body fluids. Its function is to create a barrier, not to diagnose any medical condition or disease.
No
The device description clearly outlines a physical, multi-layered surgical mask with a foam strip, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the Cardinal Health™ Level 3 surgical mask is to protect both patients and healthcare workers from the transfer of microorganisms, blood, body fluids, and airborne particulates. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask, which is designed for filtration and barrier protection. There are no components or mechanisms described that would be used for analyzing biological specimens.
- Performance Studies: The performance studies focus on the mask's ability to filter particles and resist fluid penetration, which are relevant to its barrier function, not diagnostic capabilities.
Therefore, based on the provided information, the Cardinal Health™ Level 3 surgical mask is a personal protective equipment (PPE) device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip 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™ Level 3 surgical 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™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a Class II medical device under Regulation 21 CFR 878.4040, Surgical apparel and the FDA product code of FXX. The device description of the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is in accordance with the Guidance on Surgical Masks - Premarket Notification [510(k)] Submissions, issued on March 5, 2004.
The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), 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 attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.
This submission is for one (1) surgical mask model:
Catalog Number: AT73635 Description: Surgical Mask with Anti-Fog Foam Strip Color: White
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™ Level 3 Surgical Masks with Anti-Fog Foam Strip 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.
Test: ASTM F1862 Synthetic Blood
Purpose: Determine synthetic blood penetration resistance
Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%): 160 mmHg
Subject Device Test Results: Pass (31/32)
Test: ASTM F2101 BFE
Purpose: Determine the bacterial filtration efficiency
Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%): ≥ 98%
Subject Device Test Results: Pass (32/32), Average 99.7%
Test: ASTM F2299 PFE at 0.1 micron
Purpose: Determine sub-micron particulate filtration efficiency
Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%): ≥ 98%
Subject Device Test Results: Pass (32/32), Average 99.2%
Test: Mil-M-36954C Delta P
Purpose: Determine breathing resistance or differential pressure
Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%):
§ 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Cardinal Health 200, LLC Dominic Tunzi Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K192374
Trade/Device Name: Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 29, 2019 Received: August 30, 2019
Dear Dominic Tunzi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
Indications for Use (Describe)
The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip 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™ Level 3 surgical masks are single use, disposable devices provided non-sterile.
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) |
===
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3
Image /page/3/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font, with the "C" capitalized and the rest of the letters in lowercase.
3651 Birchwood Drive Waukegan, IL 60085 www.cardinalhealth.com
510(k) SUMMARY Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip K192374
| Manufacturer: | Cardinal Health 200, LLC
3651 Birchwood Drive
Waukegan, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Dominic Tunzi
300 South Riverside Plaza
Suite 2010
Chicago, IL 60606 |
| Telephone Number: | (312) 270-2172 |
| Fax Number: | (312) 775-9324 |
| Date Summary Prepared: | Nov 22, 2019 |
| Trade Name: | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog
Foam Strip |
| Regulation Number: | 21 CFR §878.4040 |
| Device Class: | Class II |
| Regulation Name: | Surgical Apparel |
| Common/Classification Name: | Surgical Mask |
| Product Code: | FXX |
| Predicate Device: | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog
Foam Strip (Catalog # AT74535; K140155) |
4
Description
The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a Class II medical device under Regulation 21 CFR 878.4040, Surgical apparel and the FDA product code of FXX. The device description of the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is in accordance with the Guidance on Surgical Masks - Premarket Notification [510(k)] Submissions, issued on March 5, 2004.
The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), 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 attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.
This submission is for one (1) surgical mask model:
Catalog Number: AT73635 Description: Surgical Mask with Anti-Fog Foam Strip Color: White
Indications for Use/Intended Use
Cardinal Health™ Level 3 Surgical Masks with Anti-Fog Foam Strip 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™ Level 3 surgical masks are single use, disposable devices provided non-sterile.
5
Technical Characteristics
Table 5.1
Comparison of Predicate and Proposed devices
| Element of
Comparison | Predicate Device (K140155):
Cardinal Health™ Level 3 Surgical
Mask with Anti-Fog Foam Strip | Subject Device (K192374):
Cardinal Health™ Level 3
Surgical Mask with Anti-Fog
Foam Strip | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Cardinal Health™ Level 3 Surgical
Masks with Anti-Fog Foam Strip 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™
Level 3 surgical masks are single
use, disposable devices provided
non-sterile. | Cardinal Health™ Level Surgical
Masks with Anti-Fog Foam Strip
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™ Level 3
surgical masks are single use,
disposable devices provided non-
sterile. | Identical |
| Material Composition | Four-layer mask constructed of:
1 layer of nonwoven cellulose
(inner facing)
1 layer of nonwoven polyolefin melt
blown (filter media)
1 layer of nonwoven
polyester/polyethylene blend (middle
layer)
1 layer of polyolefin spunbond
material (outer facing) | Four-layer mask constructed of:
1 layer of nonwoven
polyester/polyethylene blend
(inner facing)
1 layer of nonwoven polyolefin
melt blown (filter media)
1 layer of nonwoven
polyester/polyethylene blend
(middle layer)
1 layer of polyolefin spunbond
material (outer facing) | Similar |
| Dimensions | 7 inches x 4 inches | 7 inches x 4 inches | Identical |
| Mask Style | Pleated | Pleated | Identical |
| Design Features | Blue Anti-fog foam strip, ties and
malleable nosepiece | White Anti-fog foam strip, ties
and malleable nosepiece | Similar |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use; Disposable | Single Use; Disposable | Identical |
| Color | Multicolor | White | Different |
| Biocompatibility | The predicate device was tested in
accordance with ISO 10993 and
passed acceptance criteria. | The Cardinal Health™ Level 3
Surgical Mask with Anti-Fog
Foam Strip was tested in
accordance with ISO 10993 and
passed acceptance criteria. | Similar |
6
Summary of Nonclinical Testing
The Cardinal Health™ Level 3 Surgical Masks with Anti-Fog Foam Strip 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 5.2 for a testing summary.
Table 5.2
| Test | Purpose | Acceptance Criteria
per ASTM F2100-11
Level 3 (AQL = 4.0%) | Subject Device
Test Results | |
|---------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------|----------------|
| | | | Test Results
ASTM F2100-11
Level 3 | Average |
| ASTM F1862
Synthetic Blood | Determine synthetic
blood penetration
resistance | 160 mmHg | Pass (31/32) | N/A |
| ASTM F2101
BFE | Determine the
bacterial filtration
efficiency | ≥ 98% | Pass (32/32) | 99.7% |
| ASTM F2299
PFE at 0.1 micron | Determine sub-
micron particulate
filtration efficiency | ≥ 98% | Pass (32/32) | 99.2% |
| Mil-M-36954C
Delta P | Determine breathing
resistance or
differential pressure |