(172 days)
The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and reinforced with guider). Therefore there are total eight different models involved in this submission. They are: Jincheng SMS Gowns (SMS Reinforced Gown, SMS Reinforced Gown with Guider), Jincheng Spunlace Gowns (Spunlace Regular Gown, Spunlace Regular Gown with Guider, Spunlace Reinforced Gown, Spunlace Reinforced Gown with Guider), Jincheng SFT Gowns (SFT Gown, SFT Gown with Guider). Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL). All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
The provided text describes the acceptance criteria and study for a Surgical Gown, not a medical device in the typical sense of AI/software or diagnostic tools. Therefore, several of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.
Here's the information extracted from the provided 510(k) summary for the "Jincheng Surgical Gowns":
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO10993-5 (No Toxic Effect) | No Toxic Effect |
| Skin Irritation and Sensitization | ISO 10993-10 (No Effect) | No Effect |
| Hydrostatic Pressure: Water Resistance | AATCC Test Method 127: 1998 (Hydrostatic Pressure Test) | Met requirements per AATCC Test Method 127: 1998 |
| Impact Penetration Test : Water Resistance | AATCC 42: 2007 (Water Resistance: Impact Penetration Test) | Met requirements per AATCC 42: 2007 |
| Breaking Strength | ASTM D5034: 2008 (Standard Test Method for Breaking Strength and Elongation) | Met requirements per ASTM D5034 |
| Elmendorf Tear | ASTM - D5734-95:2001 (Standard Test Method for Tearing Strength of Nonwoven Fabrics) | In-house method similar to ASTM - D5734-95:2001, met requirements |
| Flammability | 16 CFR 1610 (Flammability Test Method - CPSC CS-191-53) | Met requirements per 16 CFR 1610 |
| Lint | ISO 9073-10 (Lint and Other Particles Generation in the Dry State) | Met requirements per ISO 9073-10 |
| Sterilization (for non-sterile gowns sold to OEMs) | ISO 11135 (EtO sterilization) | For OEMs to perform; validation to ISO 11135 |
| Sterilization (for sterile gowns sold directly) | ISO 11135 (EtO sterilization validation) | Validation to ISO 11135 |
| Overall Safety and Effectiveness | Meets requirements of predefined acceptance criteria and intended uses | "Safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. The submission implies that sufficient samples were tested to meet the standards.
- Data Provenance: The tests were conducted by Hangzhou Jincheng Medical Supplier Manufacture Co., Ltd in China. The data would be considered retrospective as it was collected before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for surgical gowns is established through adherence to recognized international and national consensus standards for materials and performance, not expert human interpretation.
4. Adjudication method for the test set
Not applicable. The performance is objectively measured against established standards, not through human adjudication of results.
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
Not applicable. This is a physical product (surgical gown), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product (surgical gown), not an algorithm or AI device.
7. The type of ground truth used
The ground truth used is based on consensus standards and regulations (e.g., ISO, AATCC, ASTM, CFR) which define the acceptable physical, mechanical, and biological properties for surgical gown materials and performance.
8. The sample size for the training set
Not applicable. This is a physical product (surgical gown), not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical product (surgical gown), not an AI/machine learning model.
§ 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.