(109 days)
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room.
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.
The Cardinal Health™ ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are classified as Class II medical devices under Regulation 21 CFR 878.4040, General & Plastic Surgery Panel, FDA product code FYA, Surgical Gown.
The ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are made of a laminate with adhesive taped seams. Both closed and open back gowns have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.
The provided text is a 510(k) Summary for the Cardinal Health™ ChemoPlus™ Full Coverage Gowns, indicating that these are medical devices subject to FDA regulation. The document describes non-clinical performance testing for these gowns.
It's important to note that this document pertains to physical medical devices (gowns), not an AI/ML powered device or a software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this context.
The study described is a series of non-clinical, laboratory-based performance tests conducted on the gowns themselves, adhering to specific industry standards.
Here's the information from the document relevant to acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Standards Type | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Liquid Barrier | |||
| AATCC 42 | Spray Impact | Water Resistance | PASS |
| AATCC 127 | Hydrostatic Pressure | Water Resistance | PASS |
| ANSI/AAMI PB70:2012 AAMI Level 3 | Liquid Barrier Performance | Water Resistance (AAMI Level 3 requirements) | PASS |
| Chemical Permeation | |||
| ASTM F739-12 | Permeation of Liquids and Gases through Protective Clothing | Chemical Permeation Under Continuous Contact | PASS (>480 minutes breakthrough for specified chemotherapy drugs with no permeation detected at minimum detectable permeation or 0.1 µg/cm²/min) |
| Material Properties | |||
| ASTM D3776/D3776M-17 | Weight of Woven Fabric | Material Weight | PASS |
| ASTM D5034 - 9 2017 | Grab Tensile, Peak Stretch, and Peak Energy – Nonwovens | Tensile Strength | PASS |
| ASTM 1683-17 (2018) | Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics | Seam Strength | PASS |
| ASTM D5587-15 (2019) | Standard Test Method for Tearing Strength of Fabrics by the Trapezoid Procedure | Trapezoid Tear | PASS |
| NWSP 160.1 | Resistance to Linting of Nonwoven Fabrics (Dry) | Particulate | PASS |
| Flammability | |||
| 16 CFR 1610 | Standard for the Flammability for Clothing Textiles | Flammability (Meet Class I) | PASS |
| Biocompatibility | |||
| ISO 10993-5:2009 | ISO MEM Elution Cytotoxicity | Cytotoxicity (Non-cytotoxic) | PASS |
| ISO 10993 10:2010 | ISO Indirect Primary Skin Irritation Test | Irritation (Non-irritating) | PASS |
| ISO 10993-10:2010 | Guinea Pig Maximization Test | Sensitization (Non-sensitizing) | PASS |
| Sterilization Residuals | |||
| ISO 10993-7:2008 (R) 2012 | EO Sterilization Residuals (Sterile Catalog Numbers) | EO and ECH Residuals | PASS |
Study Proving Acceptance Criteria:
The study involved "Non-Clinical Performance Testing" of the Cardinal Health™ ChemoPlus™ Full Coverage Gowns (both closed and open back). This testing was conducted according to various recognized industry standards (AAMI, ASTM, AATCC, NWSP, CFR, ISO) to evaluate specific properties of the gowns. The results for all tests, as reported in the document, uniformly indicated "PASS," demonstrating that the proposed devices meet the acceptance criteria for their intended use.
Specific details for the chemical permeation test (ASTM F739-12) include:
- Chemotherapy drugs tested: Carmustine, Cisplatin, Cyclophosphamide, Cytarabine Hydrochloride, Dacarbazine, Daunorubicin Hydrochloride, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Thiotepa, Vincristine Sulfate.
- Reported performance: Average standardized breakthrough time for all tested chemotherapy drugs was ">480 minutes."
- Detection limit: No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min for any of the tested drugs.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical, material performance tests, where "sample size" would refer to the number of gown material specimens tested according to the specific test standard's requirements, rather than patient data. Data provenance (country, retrospective/prospective) is not relevant for this type of materials testing.
3. 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)
This is not applicable. The "ground truth" for material performance criteria is established by the accepted scientific and engineering principles embedded in the referenced ASTM, ISO, AAMI, etc., standards, and the measurement equipment used for testing. It does not involve human expert consensus in the way an AI/ML medical image analysis device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation is based on objective measurements against defined technical standards, not subjective human interpretations.
5. 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
This is not applicable. This is not an AI/ML device, nor does it involve human readers or diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective measurement protocols and acceptance limits set forth in the various referenced international and national standards (e.g., AATCC 42, ASTM F739-12, ISO 10993-5:2009). For example, chemical permeation is measured directly using analytical methods, not expert consensus or pathology.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
§ 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.