(439 days)
Surgical gowns are sterile, disposable, and single use 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. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).
The Sterile Level 4 Surgical Gown is 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. The proposed devices are single use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL. The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and blue color.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
The document is a 510(k) Summary for a "Surgical Gown" (K212812). It focuses on demonstrating substantial equivalence to a predicate device (K121152) through non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The table below summarizes the acceptance criteria and the claimed performance of the subject device, as presented in the "Comparison of technological characteristics with the Predicate" section and the "Test Method" table.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 127 | Hydrostatic pressure | >50 cm | Pass |
| AATCC 42 | Impact penetration | ≤1g | Pass |
| ASTM D 5034 | Tensile Strength | Length(lbf): ≥37.6 | |
| Width(lbf): ≥24.2 | Pass | ||
| ASTM D 5733 | Tearing strength | Length yarns torn(lbf):14.3 | |
| Width yarns torn(lbf):8.1 | Pass | ||
| ASTM D 1683 | Seam strength | Arm Opening sleeves: 23.5 lbf (FTS), 24.2lbf (FR) | |
| Shoulder: 37.0 lbf (FR) | Pass | ||
| 16 CFR Part 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ASTM F1671 | Bacteriophage Phi-X174 penetration | No penetration | Pass |
| Biocompatibility (ISO 10993-5:2009) | Cytotoxicity | ISO 10993-5 (non-cytotoxic) | Passed (non-cytotoxic) |
| Biocompatibility (ISO 10993-10:2002) | Irritation | ISO 10993-10 (non-irritating) | Passed (non-irritating) |
| Biocompatibility (ISO 10993-10:2002) | Sensitization | ISO 10993-10 (non-sensitizing) | Passed (non-sensitizing) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual non-clinical test. It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications." Without further detail, it is assumed that appropriate sample sizes, as typically required by the referenced ASTM and ISO standards for material testing, were used.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that the submitter is "Xianning Marveldas Protective Articles CO.,Ltd." from China and the tests are for a new device submission, these would be prospective tests performed by the manufacturer, likely at their own facilities or contracted testing labs, to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to this submission. The "ground truth" for the performance tests of a surgical gown is established by the specified acceptance criteria of recognized international standards (ASTM, AATCC, ISO, 16 CFR). These standards define objective, measurable physical and chemical properties, rather than subjective interpretations by human experts.
4. Adjudication Method for the Test Set
This section is not applicable. The tests are objective measurements against defined standards. There is no mention of "adjudication" in the context of expert review for establishing ground truth, as the ground truth is the numerical outcome of the physical/chemical tests and comparison against the specified acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This section is not applicable. This submission is for a medical device (surgical gown) that is evaluated based on its physical properties and biocompatibility, not on a diagnostic or therapeutic function requiring human-in-the-loop performance or clinical effectiveness studies with human readers. The document explicitly states: "No clinical study is included in this submission."
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 surgical gown, not an AI algorithm or a device with an algorithmic component. The performance evaluated is the physical and biological characteristics of the material.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical performance tests is based on established international and national standards and their defined acceptance criteria. These standards specify the methodology and the expected performance thresholds for various properties of surgical apparel, such as:
- Physical Property Standards: AATCC 127 (Hydrostatic pressure), AATCC 42 (Impact penetration), ASTM D 5034 (Tensile Strength), ASTM D 5733 (Tearing strength), ASTM D 1683 (Seam strength), 16 CFR Part 1610 (Flammability of Textiles), ASTM F1671 (Bacteriophage Phi-X174 penetration).
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
For each test, the "ground truth" is whether the device's measured performance meets or exceeds the specified numerical or categorical acceptance criteria set forth in these standards.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a surgical gown submission; this term is typically relevant for machine learning or AI algorithm development. The device's characteristics are evaluated directly through testing, not through a model trained on data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.