(416 days)
BAM STANDARD. REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAM Liguid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized.
BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns are full-length, nonwoven SMS polypropylene gowns. They are constructed with hook and loop neck closures and tie waist closures. The BAM Standard Surgical Gown has an extra layer of SMS fabric reinforcement in the sleeves and BAM Reinforced Surgical Gown has an extra layer of fabric in critical areas. The Ultra Reinforced Gown has an extra layer of film Reinforced fabric in the critical areas for higher Barrier protection. BAM Standard and Reinforced Surgical Gowns meet the requirements for the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the BAM Surgical Gowns:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Type | Acceptance Criteria (AAMI Level) | Reported Device Performance (AAMI Level) |
|---|---|---|
| BAM Standard Surgical Gown | Level 3 (Liquid Barrier) | Level 3 (Liquid Barrier) |
| BAM Reinforced Surgical Gown | Level 3 (Liquid Barrier) | Level 3 (Liquid Barrier) |
| BAM Ultra-Reinforced Surgical Gown | Level 4 (Liquid Barrier, Critical Areas) | Level 4 (Liquid Barrier, Critical Areas) |
| All Gowns | Class 1, "normal flammability" (16 CFR Part 1610) | Meet Class 1, "normal flammability" |
| All Gowns | Biocompatibility (ISO 10993-10) | Meet Biocompatibility requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (liquid barrier, flammability, biocompatibility). It only mentions that the gowns "have been tested in compliance with the requirements" of the respective standards.
Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies the testing was conducted by or for BAM Corporation Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for surgical gowns like these is established by standardized, objective laboratory tests (e.g., AAMI liquid barrier tests, flammability tests) against defined performance criteria, not by expert consensus or interpretation of images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation relies on objective laboratory testing against established standards, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
Not applicable. This is a medical device performance study, not an AI-assisted diagnostic or interpretative study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical gown), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the surgical gowns' performance is based on objective, standardized laboratory test results as defined by:
- AAMI PB70:2003 "Liquid barrier performances and classification of protective apparel and drapes intended for use in healthcare facilities" for liquid barrier performance.
- 16 CFR Part 1610 for flammability.
- ISO 10993-10 for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.