(128 days)
The Medline Orbis Chemo Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect operating room personnel from transfer of microorganisms, body fluids, and particulate material. Additionally the gown is intended to protect healthcare personnel from exposure to chemotherapy drugs during their preparation, handling, and administration. Non-sterile gowns are to be sold in bulk 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 users after EtO sterilization validation to ISO 11135-1.
The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities"
The Medline Orbis Chemo Surgical gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact."
Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480
Gown selection should be specifically chosen for the type of chemotherapy agent used. Users are recommended to review Material Safety Data Sheets for Chemotherapy Drugs being used to determine the required level of protection.
The Medline Orbis Chemo Surgical Gown is a single-use, disposable, level 3 surgical gown available in sterile and non-sterile configurations. The multiple configurations and sizes are described in Table 1 below. The Medline Orbis Chemo Surgical Gown is manufactured using a nonwoven polypropylene spunbond. Each gown is designed with a hook and loop closure at the neck, four ties at the waist, knitted polyester cuffs at the end of the sleeves as well as a transfer tab for ease in donning.
The document describes the acceptance criteria and the performance studies for the Medline Orbis Chemo Surgical Gown. Since this is a physical medical device (surgical gown), the studies are non-clinical (laboratory testing) rather than clinical studies involving human or AI readers. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable in the context of this device.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Standard | Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5 | ISO MEM Elution Using L-929 Mouse Fibroblast Cells | Cytotoxicity | Pass |
| ISO 10993-10 | ISO Intracutaneous Irritation Test | Irritation and Sensitization | Pass |
| AATCC 42-17 | Water Resistance | Water Resistance | Pass |
| AATCC 127-18 | Hydrostatic Pressure | Water Resistance | Pass |
| ASTM D5034-09 | Breaking Strength and Elongation of Textile Fabrics (Grab Test) | Tensile Strength | Pass |
| ASTM D5587-15 | Tearing Strength of Fabrics by Trapezoid Procedure | Trapezoid Tear | Pass |
| ASTM D3776/D3776M-09a | Basis Weight-Mass Per Unit Area (Weight) of Fabric | Material Weight | Pass |
| ASTM D3786/D3786M-13 | Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method | Burst Strength | Pass |
| ASTM D1683-17 | Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics | Seam Strength | Pass |
| 16 CFR 1610 | Flammability of Clothing Textiles | Flammability | Pass |
| ANSI/AAMI/ISO 10993-7: 2008(R)2012 | Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals | EO and ECH Residuals | Pass |
| ANSI AAMI PB70:2012 | Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Healthcare Facilities | Fluid Resistance (AAMI Level 3) | Pass (Meets Level 3) |
| ASTM F739-12 | Permeation of Liquids and Gases Through Protective Clothing | Chemical Penetration (various chemotherapy drugs, >480 minutes breakthrough time) | Pass (>480 minutes without breakthrough) |
| ISO 9073-10-2004 | Test methods for nonwovens Lint and other particles generation in the dry state | Particulate | Pass |
Specific Chemotherapy Drug Permeation Results (ASTM F739-12):
For the following chemotherapy drugs, the device showed no average standardized breakthrough for up to 480 minutes:
- Carmustine [3.3 mg/ml]
- Cisplatin [1.0 mg/ml]
- Cyclophosphamide [20 mg/ml]
- Cytarabine Hydrochloride [100 mg/ml]
- Dacarbazine [10 mg/ml]
- Daunorubicin Hydrochloride [5 mg/ml]
- Doxorubicin Hydrochloride [2 mg/ml]
- Etopside [20 mg/m1]
- Fluorouracil [50 mg/ml]
- Ifosfamide [50 mg/ml]
- Methotrexate [25 mg/ml]
- Mitomycin C [0.5 mg/ml]
- Mitoxantrone [2.0 mg/ml]
- Paclitaxel [6 mg/m]]
- Thiotepa [10 mg/ml]
- Vincristine Sulfate [1 mg/m]]
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in terms of number of gowns, but standard testing for such products involves a specific number of samples as dictated by each ASTM/ISO/AATCC standard. The tests are laboratory-based, not based on a "test set" of patient data.
- Data Provenance: Not specified, but generally, such non-clinical tests are performed in certified laboratories, likely within the manufacturer's operational region or by contract testing facilities. The tests are prospective in nature, as they are performed specifically to evaluate the device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a non-clinical device that relies on standardized laboratory test methods for performance evaluation, not expert-derived ground truth from human observations or medical imaging.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. The performance is determined by objective laboratory measurements against defined acceptance criteria, not through expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical medical device (surgical gown), not an AI-powered diagnostic or assistive tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Test Standards and Criteria: The "ground truth" for this device's performance is established by the specific, objective measurement methods and acceptance criteria defined within internationally recognized standards (e.g., ISO, ASTM, AATCC, ANSI/AAMI). For example, "Pass" for cytotoxicity per ISO 10993-5 means the material did not exhibit cytotoxic effects according to that standard's defined procedure.
-
The sample size for the training set:
- Not Applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a physical device, this question is irrelevant.
§ 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.