(259 days)
Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only.
Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration.
The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact." Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes. *:
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
Etoposide [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
*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. This device is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gown laminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcro neck closure and Sticker neck closure.
This document pertains to the 510(k) premarket notification for the "Copioumed Chemotherapy Isolation Gown," a Class II medical device. The information provided outlines the device's technical specifications, indications for use, and a comparison to predicate and reference devices, supported by non-clinical testing.
Here's an analysis of the acceptance criteria and study proving the device meets these criteria, as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily evaluated against recognized standards for protective apparel and chemotherapy drug permeation. The criteria and results are summarized in section "L. SUMMARY OF NON-CLINICAL TESTING" on page 14.
| No. | Standards | Purpose | Criteria | Results |
|---|---|---|---|---|
| 1. | AATCC 42 | To demonstrate resistance to penetration of sprayed water | ≤1.0 g | Pass |
| 2. | AATCC 127 | To demonstrate resistance to penetration of pressurized water | ≥50 cm H2O | Pass |
| 3. | ANSI/AAMI PB70:2012 AAMI Level 3 | To demonstrate adequate liquid barrier performance | Level 3 | Pass |
| 4. | ASTM F739-20 (For specified chemotherapy drugs) | To demonstrate resistance to penetration of chemotherapy drugs | ≥480 minutes (for each listed drug) | Pass |
| 5. | ASTM D3776/D3776M-17 | To determine the mass of the fabric | Informative (This standard does not have a pass/fail criterion; it's for characterization) | Pass (meaning the test was conducted) |
| 6. | ASTM D5034 - 9 2017 | To demonstrate adequate tensile strength of the material | ≥30 N | Pass |
| 7. | ASTM 1683-17 (2018) | To demonstrate adequate seam strength | ≥30 N | Pass |
| 8. | ASTM D5587-15 (2019) | To demonstrate adequate tear strength of the material | ≥10 N | Pass |
| 9. | NWSP 160.1 | To determine the linting properties | Informative | Pass (meaning the test was conducted) |
| 10. | ISO 9073-10:2003 | To determine linting properties | Informative | Pass (meaning the test was conducted) |
| 11. | 16 CFR 1610 | Standard for the Flammability for Clothing Textiles | Class 1 | Pass |
| 12. | ISO 10993-5:2009 | To assess the potential cytotoxicity of the gown | Under the conditions of the testing, non-cytotoxic | Pass |
| 13 | ISO 10993-10:2021 | To assess the sensitization potential of the gown | Under the conditions of the testing, not a sensitizer | Pass |
| 14 | ISO 10993-23:2021 | To assess the irritation potential of the gown | Under the conditions of the testing, not an irritant | Pass |
Chemotherapy Drug Permeation Resistance (detailed from page 3, 6, and 8):
The device was evaluated for resistance to permeation based on ASTM F739-20. The acceptance criterion for each drug was a breakthrough time of >480 minutes, with "No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm²/min." The device met this criterion for all 16 listed chemotherapy drugs:
- Carmustine [3.3 mg/ml]: >480 min
- Cisplatin [1.0 mg/ml]: >480 min
- Cyclophosphamide [20 mg/ml]: >480 min
- Cytarabine Hydrochloride [100 mg/ml]: >480 min
- Dacarbazine [10 mg/ml]: >480 min
- Daunorubicin Hydrochloride [5 mg/ml]: >480 min
- Doxorubicin Hydrochloride [2 mg/ml]: >480 min
- Etoposide [20 mg/ml]: >480 min
- Fluorouracil [50 mg/ml]: >480 min
- Ifosfamide [50 mg/ml]: >480 min
- Methotrexate [25 mg/ml]: >480 min
- Mitomycin C [0.5 mg/ml]: >480 min
- Mitoxantrone [2.0 mg/ml]: >480 min
- Paclitaxel [6 mg/ml]: >480 min
- Thiotepa [10 mg/ml]: >480 min
- Vincristine Sulfate [1 mg/ml]: >480 min
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of gowns or material samples) used for each specific non-clinical test. It only states that the tests were performed "under the test conditions" for biocompatibility and that results for physical tests (e.g., breaking strength, tearing strength) are given as means and standard deviations, implying multiple samples were tested.
The data provenance is from non-clinical laboratory testing. The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond acknowledging that these are test results supporting a 510(k) submission. Given it's a 510(k) submission to the US FDA from a Taiwanese company (Copioumed International Inc.), the testing would have been conducted to meet US regulatory requirements, likely in certified labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is for a physical medical device (isolation gown) and relies entirely on non-clinical laboratory testing against recognized industry standards (ASTM, AAMI, ISO, AATCC, CFR). Therefore:
- No human experts were used to establish ground truth in the context of clinical interpretation (e.g., radiologists for imaging data).
- The "ground truth" is defined by the numerical criteria outlined in the referenced performance standards. The qualifications of the personnel conducting these laboratory tests would be that they are trained and competent in performing the specific standard tests in accredited laboratories. The document does not provide details on these personnel.
4. Adjudication Method for the Test Set
Not applicable. Since the evaluation is based on non-clinical, objective laboratory tests with defined quantitative pass/fail criteria, there is no team of experts adjudicating results in the way one would for clinical data or imaging interpretations. The tests yield objective measurements that are compared against a pre-defined standard's requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for an isolation gown, not a software or AI-assisted diagnostic tool. MRMC studies are not relevant for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "performance" of this device is its physical and chemical barrier properties and material strength. These are assessed in laboratory settings without human intervention in the loop beyond the initial setup and analysis of the test apparatus. The tests are designed to measure the inherent properties of the gown material and construction.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on defined quantitative and qualitative criteria set by recognized consensus standards (e.g., AAMI PB70:2012 for liquid barrier performance, ASTM F739-20 for chemotherapy drug permeation, various ASTM standards for material strength, and ISO 10993 for biocompatibility). These standards specify the methodology and acceptance criteria for demonstrating the device's protective capabilities.
8. The Sample Size for the Training Set
Not applicable. This device is an isolation gown, not an AI/ML-based device that requires a training set. The evaluation is based on physical and chemical testing of the final product.
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.