(379 days)
ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids across critical areas of the gown.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable medical devices that are intended to be processed through 100 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
All the components used in these ComPel® Gowns are made from 100% Dacron. All the ouripented acomPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 100 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
This document describes the regulatory submission for the "ComPel 1-Ply Surgical Gowns." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices. The study conducted is a series of laboratory tests to confirm the physical properties and performance characteristics of the surgical gowns against established standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Standard / Method | Reported Device Performance | Comments |
|---|---|---|---|
| Barrier Properties | |||
| Liquid Barrier (Hydrostatic) Test | AATCC #127-1980 | Not explicitly quantified, but stated to meet the "Level 2 Barrier" classification. | Per ANSI/AAMI PB70:2003 standard, the 1-ply surgical gowns with flat felled seam design are classified as a Level 2 Barrier after successful testing. |
| Impact Penetration Test | AATCC 42-2000 | Not explicitly quantified. | Successfully completed. |
| Durability | |||
| Durability through Processing | Through 100 processings (wash, dry and sterilization) | Gowns will function and perform as protective apparel through 100 complete cycles. | This indicates the gowns maintained their functional integrity after 100 cycles of washing, drying, and sterilization. |
| Material Strength | |||
| Strength Test | ASTM D-1682-75 | Not explicitly quantified. | Successfully completed. |
| Other Properties | |||
| Flammability | Code of Federal Regulations 1610 (CS-191-53) | Not explicitly quantified. | Successfully completed. |
| Lint | IST 160.0-83 | Not explicitly quantified. | Successfully completed. |
| Biocompatibility/Safety | |||
| Cytotoxicity (MEM Elution) | MG023 | Not explicitly quantified. | Successfully completed. |
| Primary Skin Irritation | FHSA | Not explicitly quantified. | Successfully completed. |
| Sterilization Compatibility | |||
| Compatibility with Steam Sterilization | Not specified | Not explicitly quantified. | Successfully completed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each individual test. It refers to "the tests that have been successfully completed," implying that a sufficient number of samples were tested to demonstrate compliance.
- Sample Size: Not specified in the provided text for individual tests.
- Data Provenance: The data is generated from laboratory testing of the ComPel 1-Ply Surgical Gowns, conducted by the manufacturer (Standard Textile Company 1). This is prospective data generation for the purpose of regulatory submission. The country of origin for the data generation would be the United States, as the manufacturer is based in Ohio.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this device. The "ground truth" for a surgical gown is adherence to established industry standards and test methods for physical and biological properties. These standards themselves are developed by expert consensus, but the testing itself does not require expert adjudication of "ground truth" for individual samples in the way a diagnostic AI might. The results are objective measurements against predefined thresholds within the standards.
4. Adjudication Method for the Test Set
This is not applicable. The tests are objective laboratory measurements against predefined standards. There is no human "adjudication" in the sense of multiple reviewers making subjective decisions. The results of the tests are either within the acceptance criteria for the standard or they are not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation plays a significant role, often comparing AI-assisted human performance against unaided human performance. A surgical gown is a protective barrier, not a diagnostic tool requiring image interpretation or similar cognitive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical product (a surgical gown), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on performance against established industry standards and test methods.
- For barrier properties: Adherence to AATCC #127-1980 and AATCC 42-2000, which then correlates to a classification like "Level 2 Barrier" as per ANSI/AAMI PB70:2003.
- For physical properties (strength, durability, flammability, lint): Meeting thresholds defined in ASTM D-1682-75, CFR 1610, IST 160.0-83, and manufacturer's internal durability specifications (lasting 100 cycles).
- For biocompatibility: Meeting criteria in MEM Elution (MG023) and Primary Skin Irritation (FHSA).
- For sterilization: Compatibility with steam sterilization implies the material structure and performance are not negatively affected.
These standards and methods represent a consensus of scientific and technical understanding for the performance of surgical attire.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set." The materials used in the gowns (100% Dacron, fluorocarbon finish) are known materials with established properties.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this physical 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.