(124 days)
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No
The document describes surgical masks and does not mention any AI or ML components or functionalities.
No
The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for diagnosing medical conditions.
No
The device is a physical surgical mask, not a software-only medical device. The description clearly states it is a "Surgical Mask" and mentions physical characteristics like "Anti-fog Hydrogel" and being "single use, disposable devices".
Based on the provided information, these Cardinal Health™ Surgical Masks are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that 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 function.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Lack of Diagnostic Elements: There is no mention of the masks being used to test samples (like blood, urine, tissue), detect specific substances, or provide information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Surgical masks do not perform this function.
N/A
Intended Use / Indications for Use
Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.
Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel and other general healthcare workers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2023
Cardinal Health Ms. Emily Hunter Senior Specialist, Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K230569
Trade/Device Name: Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 1, 2023 Received: June 1, 2023
Dear Ms. Hunter:
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
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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 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 (QS) 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 medical devices and radiation-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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
Indications for Use (Describe)
Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.
Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel 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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