(354 days)
Disposable Surgical Gowns are 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. 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 Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary color. The gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown. The chest front and sleeve critical zones of the Disposable 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 Disposable Surgical Gown is a single use, disposable medical device that will be provided in a variety of nonsterile packaging configurations.
The provided text describes the 510(k) summary for Disposable Surgical Gowns (K202532). It details non-clinical testing conducted to demonstrate substantial equivalence to a predicate device (K170762).
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Disposable Surgical Gowns are primarily based on meeting the performance requirements for AAMI Level 3 barrier protection as per ANSI/AAMI PB70:2012, along with other physical properties and biocompatibility.
| Testing Methodology / Parameter | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Barrier Protection | |||
| Hydrostatic Pressure (AATCC 127:2014) | ≥ 50 cm H2O | Average of 203 cm on Front body material, 168 cm on back body material, and 60 cm on seam. | PASS |
| Water Impact (AATCC 42:2013) | ≤ 1.0 g | 0g on Critical Zone (Body material, Sleeve seam and Adhesive part of belt) | PASS |
| Level (AAMI PB70) | Level 3 | Level 3 | Same as Predicate |
| Resistance to blood and liquid penetration (AAMI PB70) | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same as Predicate |
| Physical Properties | |||
| Tear strength (N) (Trapezoid Method, ASTM D 5587-2015) | MD/CD ≥ 10N | MD Mean 60.4N, CD Mean 40.2N | PASS |
| Breaking Strength (ASTM D 5034-2009(2017)) | MD/CD ≥ 30N | MD Mean (not reported for proposed device), CD Mean 88.2N | PASS |
| Sewn seam strength (sleeve seam) (ASTM D1683/D1683M-2017(2018)) | Seam Strength ≥ 30N | Seam Strength Mean: 64.5 N | PASS |
| Water-vapor resistance (ASTM F 1868-2017) | ≤ 3.0 Pa·m²/W | Mean: 2.42 Pa·m²/W | PASS |
| Lint and other particles generation in dry state (ISO 9073-10: 2003) | Coefficient of linting Log10 ≤ 4.0 | Log10 Mean: 3 | PASS |
| Burning Behavior (16 CFR Part 1610) | Class I | Class I | PASS |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5: 2009) | Non-Cytotoxic | Device is non-cytotoxic. | PASS |
| Irritation (ISO 10993-10: 2010) | Non-Irritating | Device is non-irritating. | PASS |
| Sensitization (ISO 10993-10: 2010) | Non-Sensitizing | Device is non-sensitizing. | PASS |
2. Sample sizes used for the test set and the data provenance
The document specifies the following sample sizes for the non-clinical tests:
- Hydrostatic Pressure (AATCC127:2014): 3 non-consecutive lots tested, using a sample size of 32/lot.
- Water-proof Property (AATCC42:2013): 3 non-consecutive lots tested, using a sample size of 32/lot.
- Tear strength (Trapezoid Method, ASTM D 5587-2015): Sample size of 5 pcs.
- Breaking Strength (ASTM D 5034-2009(2017)): Sample size of 8 pcs.
- Sewn seam strength (sleeve seam) (ASTM D1683/D1683M-2017(2018)): Sample size of 5 pcs.
- Water-vapor resistance (ASTM F 1868-2017): Sample size of 3 pcs.
- Lint and other particles generation in the dry state (ISO 9073-10: 2003): Sample size of 5 pcs.
- Mass per unit area (ASTM D3776/D3776M-2009(2017)): Sample size of 5 pcs.
- Burning Behavior (16 CFR Part 1610): Sample size of 5 pcs.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Specific sample sizes are not explicitly stated, but the tests were performed according to ISO 10993-5 and ISO 10993-10.
Data Provenance: The document states that the non-clinical tests were conducted to verify that the proposed device met design specifications. Given the applicant's address (Anhui Medpurest Medical Technology Co.,Ltd, China) and the submission correspondent's address (Shanghai SUNGO Management Consulting Co., Ltd, China), it can be inferred that the testing was performed in China or by labs contracted by the applicant. The data is retrospective in nature, as it's a summary of tests already performed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes non-clinical performance and biocompatibility testing for a physical medical device (surgical gowns). It does not involve diagnostic image analysis or clinical interpretation. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image analysis or similar tasks is not applicable here. The ground truth for these tests is established by standardized testing methodologies and instruments as defined by the listed ASTM, AATCC, ISO, and CPSC standards.
4. Adjudication method for the test set
As this is non-clinical performance and material property testing, an adjudication method (like 2+1 or 3+1) is not applicable. The results are quantitative measurements obtained through defined protocols. Pass/Fail criteria are based on exceeding or falling below specified thresholds in the relevant standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by AI. This submission is for a physical medical device (surgical gowns), and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done in the context of an algorithm. This submission is for a physical medical device (surgical gowns) and does not involve an algorithm. The "standalone" performance here refers to the physical and barrier properties of the gown itself, which are measured directly through the non-clinical tests.
7. The type of ground truth used
The ground truth for this device's performance is established by standardized laboratory testing and measurements based on the referenced national and international standards (e.g., AAMI, ANSI, ASTM, AATCC, ISO, CPSC). For example:
- For barrier protection, the ground truth is the measured hydrostatic pressure and water impact performance against the specified level (AAMI Level 3).
- For physical properties like tear strength and breaking strength, the ground truth is the force required to tear or break the material as measured by testing machines.
- For biocompatibility, the ground truth is the measured biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization) compared to established toxicity thresholds.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device (surgical gowns) and does not involve AI/machine learning, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned or implied for this device, the method for establishing ground truth for a training set is irrelevant.
§ 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.