(449 days)
The ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The ViVi® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood.
The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.
The ViVi" Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The ViVi" Surgical Helmet System is composed of sterile ViVi" Hood, which is used with the unsterile ViVi" Helmet or the unsterile ViVi" Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The components include a top-covering sterile surgical hood (ViVi" Hood), an air-exchanging surgical helmet (ViVi" Helmet), and an air-exchanging surgical helmet with LED light (ViVi" Helmet HPL). The surgical hood is sterilized with Ethylene Oxide (EO). The surgical hood is worn over the helmets. The unsterile accessories include a rechargeable Lithium lon battery pack, a battery holster, a 1-bay battery charger, a 4-bay battery charger, and a non-sterile set of three foam pads (ViVi® Muffle).
The provided document is a 510(k) Premarket Notification from the FDA regarding the ViVi® Surgical Helmet System. It details the device's characteristics, indications for use, and a summary of non-clinical testing. It is crucial to understand that this document describes a medical device, specifically surgical apparel, and not an AI/ML powered device or a diagnostic/imaging device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI/ML or diagnostic devices (e.g., ground truth establishment, expert adjudication, MRMC studies, standalone performance of an algorithm) are not relevant to this product.
The "study" described herein refers to non-clinical laboratory testing to ensure the safety and performance of the surgical helmet system, rather than typical clinical studies for diagnostic accuracy or treatment efficacy.
Here's an attempt to answer your questions based on the provided text, highlighting the differences where your questions pertain to AI/ML or diagnostic devices:
1. A table of acceptance criteria and the reported device performance
The document provides two tables outlining acceptance criteria and test results for the Helmet and Hood components.
Table 1: ViVi® Surgical Helmet System - Acceptance Criteria and Performance (Non-Clinical Testing)
| Characteristic (Component) | Requirement (Acceptance Criteria) | Reported Performance (Test Result) |
|---|---|---|
| HELMET TESTING | ||
| Weight | ≤ 500g (helmet) | PASS |
| Air Quality | ≤ 3°C temperature increase | PASS |
| ≤ 0% RH increase | PASS | |
| Below 5000 ppm CO2 concentration (at ≤ 800 ppm ambient concentration) | PASS | |
| No fogging of face shield | PASS | |
| System Size | Significant lower crown line profile than predecessor product | PASS |
| Noise | Noise level ≤ predecessor product | PASS |
| Operational runtime | Battery runtime ≥4 hours (without LED light) | PASS |
| Gesture Control | Average score for 'ease of use': ≥ "4-good" (Score table: 5 'very good' - 1 'not sufficient') | PASS |
| No score for 'ease of use' below "2-sufficient" | PASS | |
| HOOD TESTING | ||
| Tear Resistance | >10 N | PASS |
| Tensile Strength | >30 N | PASS |
| Fire protection Flammability of Clothing Textiles | Fulfil requirements for Class 1 | PASS |
| Laser resistance | No ignition | PASS |
| Ethylene Oxide residuals | EO: |
§ 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.