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Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices; provided sterile and non-sterile.

Device Description

The Cardinal Health™ Non-Reinforced Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Non-Reinforced Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993.

The chest front and sleeve critical zones of the Cardinal Health™ Non-Reinforced Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Cardinal Health™ Non-Reinforced Surgical Gown is a single use, disposable medical device that will be provided in a variety of sterile and nonsterile packaging configurations.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Cardinal Health™ Non-Reinforced Surgical Gown (K170762). This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (Convertors® SMS Polyolefin Standard Gown (K020593)) through performance testing against established standards for surgical gowns. This is not a study of a device employing AI or machine learning.

Therefore, many of the requested fields are not applicable (N/A) to this type of medical device submission. However, I can extract information related to acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Element of Comparison	Predicate Device (K020593) Test Results	Proposed Device (Cardinal Health™ Non-Reinforced Surgical Gown) Test Results (Mean)	Specification/Acceptance Criteria (for Proposed Device)
Physical Properties
Basis weight (oz/yd2) - ASTM D3776	N/A (older standard used)	1.32 oz/yd2	Target Mean= 1.30; Mean Min = 1.20; Ind Min = 1.07
Grab tensile, MD (lbs) - ASTM D5034	N/A (older standard used)	21.57 lbs	N/A (no specific specification provided for proposed mean)
Grab tensile, CD (lbs) - ASTM D5034	N/A (older standard used)	13.60 lbs	Target Mean = 15.00; Mean Min = 11.00; Ind Min = 9.50
Trap Tear, MD (lbs) - ASTM D5587-15	3.2-7.4 lbs	3.47 lbs	Target Mean = 4.00; Mean Min = 2.40; Ind Min = 2.00
Trap Tear, CD (lbs) - ASTM D5587-15	7.0-11.8 lbs	5.63 lbs	N/A (no specific specification provided for proposed mean)
Flammability (sec) - CPSC, Part 1610	Class I	Class I	Class I
Alcohol Repellency (rating) - NWSP	>6	9	Target Mean = 7; Mean Min = 6; Ind Min = 5
Hydrostatic Head (cm) - AATCC-127	65-92 cm	89.90 cm	Target Mean = 70; Mean Min = 60; Ind Min = 53
Water Impact (g) - AATCC-42	0.0-0.10 g	0.10 g	Target Mean = 0.10; Mean Max = 0.30; Ind Max = 1.0
Liquid Barrier Performance
AAMI Level 3 barrier protection	Met equivalent AAMI Level 3	Meets AAMI Level 3 barrier protection requirements	AAMI Level 3 barrier protection
Biocompatibility
Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity (ISO 10993-1)	Met requirements and acceptable	Non-cytotoxic, non-irritating, and non-sensitizing	Non-cytotoxic, non-irritating, and non-sensitizing

2. Sample size used for the test set and the data provenance
The document states that for Liquid Barrier Performance Classification Properties, "Testing was performed using 3 lots and 32 samples per lot in each critical zone area." The critical zones tested were the body and sleeve (same fabric), the sleeve seam, and front belt attachment.
For other physical properties (e.g., basis weight, grab tensile), test results are reported as "Test Results (3 Lots)," indicating multiple samples were taken from three different production lots. The data provenance is not explicitly stated, but it can be inferred that these are prospective tests conducted by the manufacturer (Cardinal Health) on their proposed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This device submission does not involve clinical data that would require expert-established ground truth. The "ground truth" for this device is based on standardized physical and barrier performance tests.

4. Adjudication method for the test set
N/A. This device submission does not involve clinical data or interpretations that require 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
N/A. This is a surgical gown, not an AI/ML-enabled diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a surgical gown, not an AI/ML-enabled device.

7. The type of ground truth used
The "ground truth" for this device is based on objective, standardized laboratory test methods and specifications as defined by organizations like ASTM, AATCC, NWSP, CPSC, and ANSI/AAMI PB70:2012. For biological safety, it's based on the requirements of ISO 10993-1.

8. The sample size for the training set
N/A. This is a surgical gown, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
N/A. This is a surgical gown, not an AI/ML device that requires a training set with ground truth.

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