(329 days)
The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
Here's a breakdown of the acceptance criteria and the study details for the Fluid Barrier Knee-High Boots:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Viral Penetration | All 32 tested samples passed the "Viral Penetration Test" ASTM Method F1671-95, showing no ΦX174 on assay plates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 35 samples were initially prepared, with 32 samples used for the passing/failing assessment.
- Data Provenance: Not explicitly stated, but the test (ASTM Method F1671-95) is a standardized laboratory test; it's retrospective in the sense that the test was conducted on manufactured samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This device is a physical barrier product, and its performance is assessed through a standardized laboratory test (ASTM Method F1671-95). Therefore, there is no "expert" involvement in establishing ground truth in the traditional sense of clinical interpretation. The ground truth is determined by the objective results of the viral penetration assay.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1) was used. The test results are objective and based on the presence or absence of ΦX174 on assay plates following the ASTM F1671-95 methodology.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This is not applicable for a physical barrier product being tested for viral penetration.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- This is not applicable as the device is a physical product, not an algorithm. The performance described is inherently "standalone" in the sense that it's the product's performance under specific test conditions, without human interpretation influencing the result.
7. Type of Ground Truth Used
- The ground truth used is based on objective laboratory test results from the "Viral Penetration Test" ASTM Method F1671-95, which measures the passage of a surrogate virus (ΦX174) through the material.
8. Sample Size for the Training Set
- This information is not applicable. The device is a manufactured physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable, as there is no training set for this type of device.
§ 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.