(88 days)
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.
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.
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.
§ 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.