(122 days)
Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is 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. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user
Not Found
This FDA 510(k) clearance letter pertains to a surgical gown, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not present in the provided text.
The document discusses the regulatory clearance of a physical medical device: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets.
Here's what the document does provide regarding the device and its compliance:
- Regulation Number: 21 CFR 878.4040
- Regulation Name: Surgical Apparel
- Regulatory Class: Class II
- Product Code: FYA
- Intended Use: 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.
- Performance Standard: The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. This reference to AAMI Level 4 and ANSI/AAMI PB70 is the primary "acceptance criterion" mentioned, indicating the device's barrier performance.
Since this is a traditional medical device, not an AI/ML product, the questions related to AI/ML specific criteria (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.
§ 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.