(139 days)
Not Found
No
The device description and performance studies focus on the physical construction and material properties of a surgical mask, with no mention of AI or ML technologies.
No
This device is a surgical mask intended for protection and not for treating a disease or condition.
No
The device is a surgical and procedure mask, intended for protection against microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical mask constructed of materials and includes components like ties, 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 protect healthcare workers and patients from 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 a mask, not a device that analyzes samples or provides diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would lead to a diagnosis or provide information about a patient's health status.
- Performance Studies: The performance studies focus on barrier properties (meeting ASTM F2100-11 Level 1 requirements), which are relevant to protective equipment, not diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-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 Insta-Gard® surgical and procedure masks are constructed of varying materials (see Table 3). The three 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)
Device was tested in accordance with ASTM F2100-11, and meets Level 1 requirements. All results of testing met ASTM F2100-11 Level 1 acceptance criteria. ASTM F2100-11 Level 1 was performed at an AQL of 4% (32 samples tested, accept on 3 failures and reject on 4 failures).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
Cardinal Health 200, LLC Ms. Lavenia Ford Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K142990
Trade/Device Name: Cardinal Health Insta-Gard® Surgical and Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 4, 2015 Received: February 5, 2015
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.
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/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
2
Indications for Use
510(k) Number (if known) K142990
Device Name
Cardinal Health Insta-Gard® surgical and procedure masks
Indications for Use (Describe)
Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table I below. Each model is a three-laver mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.
Table 1: Product Description and Catalog Number
Catalog # Description, Color
AT771145 Insta-Gard® surgical mask Ties Dancing Bandages Print AT71235 Insta-Gard® surgical mask Anti-fog foam strip, and tiesBlue AT71035 Insta-Gard® surgical mask ties Blue AT71039 Insta-Gard@ surgical mask Horizontal ties Blue AT73035Insta-Gard® surgical maskTiesWhite AT752007 Insta-Gard® surgical mask Anti-fog foam strip, vapor barrier, and ties Green AT752005 Insta-Gard® surgical mask Anti-fog foam strip, vapor barrier, and ties Green AT73835 Insta-Gard® surgical mask Anti-fog foam strip, and ties Green AT72835 Insta-Gard® surgical mask Anti-fog foam strip, and ties Green AT7505P Insta-Gard® surgical mask Ties Blue AT73335 Insta-Gard® surgical mask Ties White AT71021 Insta-Gard® procedure mask Earloops Blue AT70021 Insta-Gard® procedure mask Earloops Yellow AT7511-WE Insta-Gard® procedure mask Eye shield, anti-fog foam strip, and earloops Blue AT771141 Insta-Gard® procedure mask Earloops Dancing Bandages Print
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
1500 Waukegan Road Waukegan, IL 60085
510(k) SUMMARY Insta-Gard® Surgical and Procedure Masks
Manufacturer:
Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085
1500 Waukegan Road
Lavenia Ford
(847) 887-3323
December 31, 2014
Regulatory Affairs Contact:
Waukegan, IL 60085
Telephone Number:
Fax Number: (847) 785-2461
Date summary Prepared:
Trade Name:
Insta-Gard® Surgical Mask
Insta-Gard® Procedure Mask
Regulation Number/Device Class: Class II per 21 CFR § 878.4040
FXX
Surgical Apparel Regulation Name:
Common Name:
Surgical Mask Procedure Mask
Product Code:
K110455 -Kimberly-Clark, KC100 Face Mask(s)
Predicate Device:
4
Description
The Cardinal Health Insta-Gard surgical and procedure masks are identified by Regulation 21 CFR 878.4040 with product code FXX.
The Cardinal Health Insta-Gard® surgical and procedure masks are constructed of varying materials (see Table 3). The three 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 Insta-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 Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table 1 below. Each model is a three-layer mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.
| Catalog # | Trade Name | Design Features | Color |
|---|---|---|---|
| AT771145 | Insta-Gard® surgical mask | Ties | Dancing |
| Bandages Print | |||
| AT71235 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Blue |
| AT71035 | Insta-Gard® surgical mask | ties | Blue |
| AT71039 | Insta-Gard® surgical mask | Horizontal ties | Blue |
| AT73035 | Insta-Gard® surgical mask | Ties | White |
| AT752007 | Insta-Gard® surgical mask | Anti-fog foam strip, vapor | |
| barrier, and ties | Green | ||
| AT752005 | Insta-Gard® surgical mask | Anti-fog foam strip, vapor | |
| barrier, and ties | Green | ||
| AT73835 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Green |
| AT72835 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Green |
| AT7505P | Insta-Gard® surgical mask | Ties | Blue |
| AT73335 | Insta-Gard® surgical mask | Ties | White |
| AT71021 | Insta-Gard® procedure mask | Earloops | Blue |
| AT70021 | Insta-Gard® procedure mask | Earloops | Yellow |
| AT7511-WE | Insta-Gard® procedure mask | Eye shield, anti-fog foam strip, | |
| and earloops | Blue | ||
| AT771141 | Insta-Gard® procedure mask | Earloops | Dancing |
| Bandages Print |
Table 1: Product Description and Catalog Number
5
Device and Predicate Device Technical Characteristics
The Cardinal Health Insta-Gard® surgical and procedure masks are substantially equivalent to the Kimberly Clark surgical and procedure mask with regards to claims, safety and effectiveness, design, technology, and intended use. See Table 4 below.
| Table 4: Comparison of Predicate device and Cardinal Health Insta-Gard® Surgical and
| Procedure Masks | ||
|---|---|---|
| Element of Comparison | Kimberly-Clark (KC100) | Cardinal Health Insta-Gard® |
| Surgical and Procedure Masks |
| Element of Comparison | Kimberly-Clark (KC100) | Cardinal Health Insta-Gard Surgical and Procedure Masks |
|---|---|---|
| Intended Use | The Kimberly Clark KC100 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 KC100 face mask(s) is a | ||
| single use, disposable device(s), | ||
| provided non-sterile. | Insta-Gard® Surgical Mask | |
| Cardinal Health Insta-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 Insta-Gard® | ||
| surgical masks are single use, | ||
| disposable devices provided non- | ||
| sterile. |
Insta-Gard® Procedure Mask
Cardinal Health Insta-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 Insta-Gard®
procedure masks are single use,
disposable devices provided non-
sterile |
| Material Composition | 3 layer mask made from
nonwoven polyester blends,
tissue, cellulose, and
polypropylene materials | Insta-Gard® Surgical Mask
3 layer mask made from
nonwoven tissue, cellulose, and
polyolefin materials
Insta-Gard® Procedure Mask
3 layer mask made from
nonwoven tissue, cellulose, and
polyolefin materials |
| Specifications and Dimensions | KC100 Surgical Mask
6.875"x3.75"
KC100 Procedure Mask
6.9"x4.5" | Insta-Gard® Surgical Mask
AT771145 – 7"x4"
AT71235 – 7"x4"
AT71035 – 7"x4"
AT71039 – 7.5"x7.5"
AT73035 |
6
| | | | AT752007 – 7"x4"
AT752005 – 7"x4"
AT73835 – 7"x4"
AT72835 – 7"x4"
AT7505P – 7"x4"
AT73335 – 7"x4" | |
|------------------|--|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Insta-Gard® Procedure Mask
AT7511-WE – 7"x3.375"
AT771141 – 7"x3.375"
AT71021 – 7"x3.375"
AT70021 – 7"x3.375" | |
| | | | See Appendix I for mask
specifications | |
| Mask Style | | Pleated | Insta-Gard® Surgical Mask
Pleated
Insta-Gard® Procedure Mask
Pleated | |
| Design Features | | KC100 Surgical Mask
Fog-Free | Insta-Gard® Surgical Mask
AT771145 – Ties
AT71235 – Anti-fog foam strip
and Ties
AT71035 – Ties
AT71039 – Horizontal Ties
AT73035 – Ties
AT752007 – Anti-fog foam strip,
Vapor barrier, and Ties | |
| | | KC100 Procedure Mask
Fog-Free | AT752005 – Anti-fog foam strip,
Vapor barrier, and Ties
AT73835 – Anti-fog foam strip
and Ties
AT72835 – Anti-fog foam strip
and Ties
AT7505P – Ties
AT73335 – Ties | |
| | | | Insta-Gard® Procedure Mask
AT7511-WE – Eye shield, Anti-
foam fog strip, and Earloops
AT771141 – Earloops
AT71021 – Earloops
AT70021 – Earloops | |
| Physical Testing | | | Predicate device was tested
according to ASTM F2100-11
Level 1 in previous 510(k)
submission K110455. | Insta-Gard® Surgical Mask
Device was tested in accordance
with ASTM F2100-11, and meets
Level 1 requirements.
Insta-Gard® Procedure Mask
Device was tested in accordance
with ASTM F2100-11, and meets
Level 1 requirements. |
. . . .
7
All results of testing met ASTM F2100-11 Level 1 acceptance criteria. ASTM F2100-11 Level 1 was performed at an AQL of 4% (32 samples tested, accept on 3 failures and reject on 4 failures).
Conclusion Statement
The Insta-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.