(242 days)
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices: provided non-sterile.
Surgical Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is SMS compound non-woven fabric. It is a kind of Non- Reinforced surgical isolation gown. Disposable Surgical Isolation Gowns are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Surgical Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S, M, L, XL, XXL, and XXXL.
This document is a 510(k) premarket notification for a medical device called "Disposable Surgical Isolation Gowns." It aims to demonstrate that the device is substantially equivalent to a previously cleared predicate device.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Test Item | Test standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength(sleeve seam) | ASTM D1683/D1683M-2017(2018)Method A | ≥30N (7lbf) per standard F2407-20 for level 3 | Pass |
| Breaking strength | ASTM D 5034-2009(2017), Grab method | ≥30N (7lbf) per standard F2407-20 for level 3 | Pass |
| Tear strength(N) | ASTM D 5587-2015(2019), trapezoid method | ≥20N | Pass |
| Water-Vapour Resistance | ASTM F 1868-2017, Sweating guarded-hotplate test | ≥30cmH2O (0.00294Kpa) | Pass |
| Lint and other particles generation in the dry state (material) | ISO 9073-10:2003, Size of particles counted: 3μm-25 μm | Critical area ≤4.0; Less critical area ≤4.0 | Pass |
| Lint and other particles generation in the dry state (sleeve seam) | ISO 9073-10:2003, Size of particles counted: 3μm-25 μm | Critical area ≤4.0; Less critical area ≤4.0 | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Pass |
| Water proof property (material, seam) | AATCC42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Pass |
| Static hydrostatic resistance (material, seam) | AATCC 127-2018 | ≥50 cmH2o per standard ANSI/AAMI PB70:2012 for level 3 | Pass |
| Cytotoxicity | ISO 10993-5: 2009 | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | ISO 10993-10: 2010 | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | ISO 10993-10: 2010 | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test conducted on the "Disposable Surgical Isolation Gowns." However, it references various ASTM, ISO, AATCC, and CPSC standards, which would typically define the required sample sizes for each test method. The provenance of the data (country of origin, retrospective/prospective) is not provided. These are non-clinical bench tests performed on the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "Disposable Surgical Isolation Gowns" device is a physical product, and its performance is evaluated through standardized laboratory tests (non-clinical tests) against predefined acceptance criteria, not through expert interpretation of data or images. Ground truth here is based on the objective results of these physical and chemical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As mentioned above, the evaluation involves objective laboratory measurements against set standards, not subjective assessments requiring adjudication by multiple experts.
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 section is not applicable. The device is a physical medical garment (isolation gown), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical garment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the Disposable Surgical Isolation Gowns is based on objective measurements obtained from standardized physical, chemical, and biological tests as defined by national and international standards (e.g., AAMI, ASTM, ISO, CPSC). These standards specify the test methods and the criteria for acceptable performance. For example:
- Mechanical properties: Breaking strength, tear strength, seam strength.
- Barrier properties: Water-proof property (liquid penetration), static hydrostatic resistance.
- Safety/Biocompatibility: Cytotoxicity, irritation, sensitization.
- Flammability: Flammability class.
- Particulate generation: Lint and other particles generation.
8. The sample size for the training set
This section is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for a machine learning model, this information is not relevant.
§ 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.