(97 days)
The Aero Blue* Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue* Performance Surgical Gowns meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications. The Aero Blue* Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
A Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 3 liquid barrier protection in the critical zone of the gown. The back of the gown is a SMS (spunbond/meltblown/spunbond fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection.
Acceptance Criteria and Device Performance Study for Aero Blue* Performance Surgical Gowns
This document outlines the acceptance criteria and the study that demonstrates the Aero Blue* Performance Surgical Gowns meet these criteria, based on the provided 510(k) summary (K140539).
1. Acceptance Criteria and Reported Device Performance
The Aero Blue* Performance Surgical Gowns are designed to meet the Level 3 requirements of the AAMI PB70: 2012 Liquid Barrier classifications in the critical zone, and Level 1 in the non-critical back zone. The non-clinical testing performed demonstrated compliance with these and other relevant standards.
| Standard or Reference | Test Method | Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance |
|---|---|---|---|
| Standard for the Flammability for Clothing Textiles | 16 CFR 1610 | Meet Class 1 Flammability requirements. | Pass |
| ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5 | Cytotoxicity | No significant cytotoxic effects. | Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10 | Skin Irritation Study | No significant skin irritation. | Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10 | Sensitization Test | No significant sensitization. | Pass |
| ISO 10993-7:2008, Ethylene Oxide sterilization residuals | EO residuals | EO residuals within acceptable limits for a surface device with limited contact with breached or compromised surfaces. | Pass |
| Laser Ignition Resistance | ISO 11810-1 (2005) | Demonstrate resistance to laser ignition. | Pass |
| Spray Impact (critical zones) | AATCC 42:2007 | Demonstrate water resistance in the critical zones consistent with AAMI Level 3. | Pass |
| Liquid Barrier Performance | AAMI PB70:2012 Level 3 | Critical Zone: Meet Level 3 liquid barrier performance (SFSMS design). (Implied: Resist liquid penetration under specific conditions, including spray impact and hydrostatic pressure.) | |
| Non-Critical Zone (back): Meet Level 1 liquid barrier performance (SMS fabric). (Implied: Provide minimum liquid barrier protection.) | Pass | ||
| Hydrostatic Head (critical zones) | AATCC 127:2008 | Demonstrate water resistance under hydrostatic pressure in the critical zones consistent with AAMI Level 3. | Pass |
| Spray Impact (non-critical zones) | AATCC 42:2007 | Demonstrate water resistance in the non-critical zones consistent with AAMI Level 1. | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens | ASTM D5034 (2009) | Possess adequate tensile strength for intended use. | Pass |
| Abrasion Resistance and Surface Bonding of SMS Laminates | WSP 20.5 (2008) | Demonstrate adequate abrasion resistance and surface bonding. | Pass |
| Synthetic Blood Penetration | ASTM-1670-08 (2008) | Resist penetration by synthetic blood in the critical zone. | Pass |
| Mass Per Area (Basis Weight) of Materials | D3776 (2009) | Maintain consistent fabric basis weight as specified. | Pass |
| Water Vapor Transmission Rate Through Nonwovens and Plastic Films | WSP 70.4 (2008) | Demonstrate appropriate water vapor transmission rate for breathability. | Pass |
| Degree Peel Strength of Laminated Nonwovens - Raw Materials | STM-00197(2010) | Achieve adequate peel strength for laminated components. | Pass |
| Resistance to Linting Dry Particle Generation | INDA WSP 160.1 (2009) | Demonstrate resistance to linting and dry particle generation. | Pass |
Note: The document explicitly states "All results of testing met acceptance criteria." This implies that the device performed within the established limits for each test.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the exact sample sizes used for each individual non-clinical test. It lists the standards and test methods applied. For instance, for liquid barrier and blood penetration, it refers to standards like AAMI PB70:2012 and ASTM F-1670-08. These standards typically define minimum sample sizes for testing to ensure statistical validity.
The data provenance is retrospective, as the tests were conducted on the manufactured Aero Blue* Performance Surgical Gowns to demonstrate compliance with established standards. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer's testing facilities or accredited third-party labs where these standards are tested, likely within the US given the submission to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable for this medical device. The "ground truth" for the performance of a surgical gown is established by objective, standardized test methods and criteria defined by recognized national and international standards organizations (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the methodology, equipment, and acceptable limits for performance. There is no human expert "ground truth" to be established in the context of device performance testing for surgical gowns.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where expert consensus is needed to establish ground truth. As noted above, the performance of a surgical gown is evaluated against predefined objective criteria and standardized test results. Therefore, no human adjudication method was employed or is relevant for this type of device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable and was not done. This type of study assesses the impact of a device (often an AI algorithm) on human reader performance, typically in diagnostic imaging. The Aero Blue* Performance Surgical Gowns are barrier garments, not diagnostic tools, and do not involve human "readers" or AI assistance in their function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study of an algorithm is not applicable and was not done. The Aero Blue* Performance Surgical Gown is a physical medical device, not an algorithm or software. Its performance is evaluated directly through physical and material property tests.
7. The Type of Ground Truth Used
The ground truth used for the device's performance claims is based on objective, quantitative measurements and qualitative assessments derived from recognized industry standards and test methods. Specifically:
- Standardized Test Data: The "Pass" results in the "Summary of Non-Clinical Testing" indicate that the device met the precise, objective criteria set forth by each referenced standard (e.g., AAMI PB70:2012 for liquid barrier, ASTM-1670-08 for synthetic blood penetration, ISO 10993 for biocompatibility).
- Performance Metrics: The "ground truth" is defined by specific physical and material properties (e.g., water resistance, tensile strength, flammability, cytotoxicity) measured against predefined thresholds in the standards.
8. Sample Size for the Training Set
A "training set" is not applicable to this device. Training sets are used in the development of machine learning algorithms. The Aero Blue* Performance Surgical Gowns are physical products whose performance is determined by their material composition, design, and manufacturing processes, and subsequently validated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device. The physical and chemical properties of the materials, and thus the performance characteristics of the gown, are established through material science, engineering, and validated test methods, not through an iterative process of training an algorithm on a dataset with established 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.