(103 days)
The Medline Orbis LVL 3 Surgical Gown is intended to be worn by healthcare professionals during surgical procedures to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.
The Medline Orbis LVL 3 Surgical Gown meets the Level 3 requirements of ANSI/AAMIPB70:2012 Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities.
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 the end users after EtO sterilization validation to ISO 11135-1.
The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.
The provided text is a 510(k) clearance letter from the FDA for a surgical gown (Medline Orbis LVL 3 Surgical Gown). It states the device's indications for use and confirms its substantial equivalence to a predicate device.
However, the document does NOT contain information regarding:
- Acceptance criteria for device performance based on a study. (The text only mentions meeting Level 3 requirements of ANSI/AAMI PB70:2012 for liquid barrier and performance, which is a standard, not specific acceptance criteria from a study).
- Reported device performance from a specific study.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document is a regulatory clearance letter, not a clinical or performance study report. Therefore, I cannot extract the detailed information requested about acceptance criteria and a study proving those criteria are met.
§ 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.