(139 days)
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.
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.
This document describes the 510(k) premarket notification for Cardinal Health Insta-Gard® Surgical and Procedure Masks. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (Kimberly-Clark KC100 Face Masks) by meeting the acceptance criteria of ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks.
Here's an analysis of the provided information regarding acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Cardinal Health Insta-Gard® Surgical and Procedure Masks) was tested against the ASTM F2100-11 Level 1 acceptance criteria. The document states that "All results of testing met ASTM F2100-11 Level 1 acceptance criteria." While the specific numerical acceptance criteria for each test and the device's performance values are not explicitly laid out in a table within this document, it confirms that all required Level 1 criteria were satisfied.
| Test Element (from ASTM F2100-11 Level 1) | Acceptance Criteria (Level 1) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | (Not specified in document) | Meets Level 1 criteria |
| Particulate Filtration Efficiency (PFE) | (Not specified in document) | Meets Level 1 criteria |
| Differential Pressure (Delta P) | (Not specified in document) | Meets Level 1 criteria |
| Fluid Resistance | (Not specified in document) | Meets Level 1 criteria |
| Flammability | (Not specified in document) | Meets Level 1 criteria |
Note: The document implicitly refers to meeting all Level 1 criteria for all tests within ASTM F2100-11, even though the specific numerical thresholds for BFE, PFE, Delta P, fluid resistance, and flammability are not listed in this excerpt.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "32 samples tested"
- Data Provenance: The document does not specify the country of origin of the data. It is a report from Cardinal Health for FDA submission, implying the testing was conducted to support this submission. The study is prospective in nature for regulatory submission, as it involves testing the specific Insta-Gard® masks to demonstrate their performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the study involves physical performance testing of medical masks against a standard (ASTM F2100-11), not an AI or diagnostic device that requires expert ground truth establishment.
4. Adjudication Method for the Test Set
- This information is not applicable as the study involves physical performance testing with objective measurements, not subjective evaluations requiring adjudication. The acceptance criteria specify "accept on 3 failures and reject on 4 failures" for the AQL (Acceptable Quality Limit) of 4%, which is part of the statistical sampling plan for quality control rather than an adjudication method for ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- This information is not applicable as the device is a surgical mask, not an AI or diagnostic tool requiring human interpretation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable as the device is a surgical mask, not an algorithm. The performance testing is analogous to a "standalone" test as it assesses the intrinsic properties of the mask without human interaction beyond conducting the test.
7. The Type of Ground Truth Used
- The "ground truth" for this study is defined by the objective, quantitative performance criteria outlined in the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks, Level 1. The tests evaluate physical properties like filtration efficiency, breathability, fluid resistance, and flammability.
8. The Sample Size for the Training Set
- This information is not applicable as the device is a physical product (surgical mask) and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the device is a physical product and not an AI algorithm.
§ 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.