(203 days)
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room.
The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.
The document describes the non-clinical performance testing of the Cardinal Health™ Poly-Coated Open-Back Protective Gown. It evaluates the device against specific acceptance criteria and details the study methods used.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Element of Comparison | Specification (Acceptance Criteria) | Reported Device Performance (Mean (min/max)) |
|---|---|---|
| Basis Weight (ASTM D3776/D3776M-17) | 39.0 gsm min (average) | |
| 42.0 gsm target | ||
| 45.0 gsm max (average) | 43.3 (39.9 / 46.1) gsm (Sleeve and Body material) | |
| Tensile Strength, CD (ASTM D5034-17) | 5.8 lb min (individual) | |
| 3.5 lb min (average) | 14.2 (12.6 / 16.1) lb | |
| Tear Strength, MD (ASTM D5587-15) | 6.7 lb min (individual) | |
| 2.8 lb min (average) | 6.0 (4.4 / 7.5) lb | |
| Flammability (CPSC, Part 1610) | Class 1 | Class 1 |
| Hydrostatic Head (AATCC 127:2017) | 140 cmH20 target | |
| 100 cmH20 min (individual) | >130 (130 / >130) cmH20 |
51 (51 / >51) inH20 |
| Viral barrier (ASTM F1671-13) | Pass | Pass |
| Liquid Barrier Performance Classification Properties (ANSI/AAMI PB70:2012 / ASTM F1671) | Meets AAMI Level 4 performance requirements | All areas tested meet Level 4 performance requirements |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing per ISO-10993-1 | Non-cytotoxic, non-irritating, non-sensitizing and met requirements per ISO-10993-1 |
2. Sample size used for the test set and the data provenance
- Liquid Barrier Performance Classification Properties: Testing was performed using 3 lots and 32 samples per lot in each critical zone area (body or sleeve, and heat sealed seam(s)).
- Other tests (Basis Weight, Tensile Strength, Tear Strength, Hydrostatic Head): The document provides mean and min/max values, but a specific sample size for these individual tests beyond the "Finished Good Test Results" is not explicitly stated.
- Data Provenance: The document implies that the testing was conducted internally by the manufacturer, Cardinal Health, or by a contracted lab. The data is presented as "Finished Good Test Results" for the "Subject Device: Cardinal Health™ Poly-Coated Open-Back Protective Gown." This data would be considered prospective as it's generated specifically for the device submission. The country of origin for the data is not specified, but the submission is to the U.S. FDA by a company based in Illinois, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The tests described are non-clinical performance tests that use standardized methodologies (e.g., ASTM, AATCC, ISO standards) to measure physical and barrier properties. These types of tests do not typically involve human expert interpretation or "ground truth" in the same way clinical studies or diagnostic device evaluations would. The "ground truth" is established by the test method itself and the specified performance criteria. Therefore, no human experts were used to establish ground truth for this test set in the context of diagnostic interpretation.
4. Adjudication method for the test set
Not applicable. As noted above, these are non-clinical, objective performance tests following standardized methods, not subjective clinical assessments requiring adjudication.
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
Not applicable. This is a submission for a protective gown, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the non-clinical performance tests is based on predefined objective standards and specifications (e.g., AAMI Level 4 for barrier protection, specific tensile strength values, flammability classes). These standards define what constitutes a "pass" or "fail" for each characteristic.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.