(259 days)
No
The device is a physical isolation gown and the summary describes its material properties and barrier performance, with no mention of software, algorithms, or data processing.
No
The device is described as an isolation gown intended to protect healthcare personnel from exposure to microorganisms, body fluids, particulates, and chemotherapy drugs. It is a protective apparel, not a device used for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
This device is a protective gown, primarily intended to protect healthcare personnel from exposure to chemotherapy drugs and microorganisms. It does not perform any diagnostic function (e.g., detecting, analyzing, or identifying diseases or conditions).
No
The device described is a physical isolation gown made of polypropylene and polyethylene, not a software application.
Based on the provided information, the Copioumed Chemotherapy Isolation Gown is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the gown is for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulates, and specifically for protecting healthcare personnel from exposure to chemotherapy drugs. This is a protective barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the gown, reinforcing its role as a protective garment.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on barrier protection and resistance to chemotherapy drug permeation, which are relevant to its protective function, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Copioumed Chemotherapy Isolation Gown does not perform any of these functions.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
FYC, QSO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel/Health Care Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The conclusions drawn from the non-clinical testing demonstrate that the subject device, Copioumed Chemotherapy Isolation Gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K190306.
Non-Clinical Testing:
- AATCC 42: To demonstrate resistance to penetration of sprayed water, Criteria: =50 cm H2O, Results: Pass
- ANSI/AAMI PB70:2012 AAMI Level 3: To demonstrate adequate liquid barrier performance, Criteria: Level 3, Results: Pass
- ASTM F739-20: To demonstrate resistance to penetration of chemotherapy drugs, Criteria: >=480 minutes, Results: Pass
- ASTM D3776/D3776M-17: To determine the mass of the fabric, Criteria: Informative, Results: Pass
- ASTM D5034 - 9 2017: To demonstrate adequate tensile strength of the material, Criteria: >=30 N, Results: Pass
- ASTM 1683-17 (2018): To demonstrate adequate seam strength, Criteria: >=30 N, Results: Pass
- ASTM D5587-15 (2019): To demonstrate adequate tear strength of the material, Criteria: >=10 N, Results: Pass
- NWSP 160.1: To determine the linting properties, Criteria: Informative, Results: Pass
- ISO 9073-10:2003: To determine linting properties, Criteria: Informative, Results: Pass
- 16 CFR 1610: Standard for the Flammability for Clothing Textiles, Criteria: Class 1, Results: Pass
- ISO 10993-5:2009: To assess the potential cytotoxicity of the gown, Criteria: Under the conditions of the testing, non-cytotoxic, Results: Pass
- ISO 10993- 10:2021: To assess the sensitization potential of the gown, Criteria: Under the conditions of the testing, not a sensitizer, Results: Pass
- ISO 10993- 23:2021: To assess the irritation potential of the gown, Criteria: Under the conditions of the testing, not an irritant, Results: Pass
No clinical testing was performed in support of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 4, 2023
Copioumed International Inc. % Ming-Yie Jan Principle Consultant RusCert Technology Co., Ltd. 8F., No. 187, Lequn 2nd Rd., Zhongshan Dist. Taipei City, 10462 Taiwan
Re: K230135
Trade/Device Name: Copioumed Chemotherapy Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC, QSO Dated: August 28, 2023 Received: September 5, 2023
Dear Ming-Yie Jan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Bifeng Qian -S
BiFeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230135
Device Name Copioumed Chemotherapy Isolation Gown
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
新 萬 盟 有 限 公 司
510(k) SUMMARY
| A. 510(K) NUMBER | K230135 |
|---|---|
| B. DATE PREPARED | September 27, 2023 |
| C. SUBMITTER | COPIOUMED INTERNATIONAL INC. |
| D. CONTACT PERSON | Primary Contact |
| Title: General Manager | |
| Name: James Liu | |
| Tel: + 886 928 644 966 | |
| E-Mail: james.liu@gcv.com.tw | |
| Official Correspondent | |
| Title: Principal Consultant | |
| Name: Ming-Yie Jan | |
| Tel: + 8886 2 8785 8989 | |
| E-Mail: mingyie.jan@ruscert.net | |
| E. SUBJECT DEVICE | Proprietary Name: Copioumed Chemotherapy Isolation Gown |
| Product Code: FYC, QSO | |
| Classification Names: Gown, Isolation, Surgical; Medical Gowns With | |
| Chemotherapy Labeling Claims - Tested For Use With | |
| Chemotherapy Drugs | |
| Regulation Number 21 CFR 878.4040 | |
| Regulation Name: Surgical Apparel | |
| Device Class: Class II | |
| Review Panel: General Hospital | |
| F. INDICATIONS FOR | |
| USE | 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." |
6
新 萬 盟 有 限 公 司
| | | 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
µg/cm2/min |
| | G. PREDICATE
DEVICE | Proprietary Name: AMD Ritmed AssureWear VersaGown
Product Code: FYC
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
510(k) Number: K190306
510(k) Submitter: AMD Medicom Inc.
Device Class: Class II
Review Panel: General Hospital |
| | H. REFERENCE
DEVICE | Proprietary Name: CoverU Disposable Gown with Tape - Chemo Gown
Product Code: FYC, QSO
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
510(k) Number: K210414
510(k) Submitter: Medtecs (Taiwan) Corp.
Device Class: Class II
Review Panel: General Hospital |
| | I. DEVICE
DESCRIPTION | 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. |
7
新 萬 盟 有 限 公 司
| Elements of
Comparison | Proposed Device:
Copioumed Chemotherapy
Isolation Gown
K230135 | Predicate Device:
AMD Ritmed AssureWear
VersaGown
K190306 | Comparisons |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FYC, QSO | FYC | Same for FYC |
| Intended
Use/Indications
for Use | 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 " | AMD Ritmed Assure Wear™
VersaGown 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 material.
AssureWear™ VersaGown
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). AMD Ritmed
AssureWear™ VersaGown is
a single use, non-sterile
disposable medical device and
not intended for use in
operating rooms. The medical
device will be available in 18
models in large and X-large
sizes.
Flexneck Models Flexneck
Plus Models Tie Models
A69964 A69933 A8300
A69965 A69934 A8301
A69966 A69935 A8302
A69967 A69936 A8303
A69968 A69937 A8304
A69969 A69938 A8305 | Same:
- AAMI
Level 3
Isolation
Gowns - Meet the
requirements
of level 3
Liquid Barrier
Performance
as per AAMI
PB70:2012 - Non-
sterile and
single use
only.
Similar¹: - Protection
description
Different¹: - Evaluated
for resistance
to permeation
of various
chemotherapy |
J. COMPARISON OF CHARACTERISTICS WITH THE PREDICATE DEVICE
8
新 萬 盟 有 限 公 司
| | 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 µg/cm2/min | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
Composition | Polypropylene Gown laminated
with polyethylene | PP SMS non-woven + PE | Similar2 |
| Design Features | Knit cuff in three style(model) Tie
neck closure, Velcro neck closure
and Sticker neck closure | Thumb loop Elastic cuffs
Extended cuff (Thumb loop)
Flexneck™
Tie (neck)
Straight sleeve Inclined sleeve
Blue belt tie | Similar3 |
| Sterility | Non-sterile | Non-sterile | Same |
| Color | Blue | Blue | Same |
| Use | OTC | OTC | Same |
| Contact Durations | Surface, 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 | have 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. 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
Etopside [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
lfosfamide [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
Docetaxel [10mg/ml] >480
Oxaliplatin [5mg/ml] >480
Leucovorin [1 0mg/ml] >480
*No permeation was detected at
either the minimum detectable
permeation or 0.1 g/cm2/min | | |
| | Vincristine Sulfate [1 mg/ml]
480 | | |
| | No permeation was detected at
either the minimum detectable
permeation or 0.1 µg/cm2/min | | |
| Material
Composition | Polypropylene Gown laminated
with polyethylene | Spunbonded Polypropylene
coated with Polyethylene
(PPSB Coated PE materials) | Different2 |
| Design Features | Knit cuff in three style(model)
Tie neck closure, Velcro neck
closure and Sticker neck closure | Close-back | Similar12 |
| Sterility | Non-sterile | Non-sterile | Same |
| Color | Blue | Yellow | Different3 |
| Use | OTC | OTC | Same |
| Disposable | Disposable | Disposable | Same |
| Single
Use/Reusable | Single Use | Single Use | Same |
| Performance per
AAMI PB70:2012 | AAMI Level 3 | AAMI Level 4 | Different4 |
| Resistance to
permeation of
chemotherapy
drugs testing | ASTM F739-20 | ASTM F739-12 | Similar13 |
| | Results showed no average
Standardized breakthrough for up
to 480 minutes for claimed 16
drugs.
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 µg/cm2/min | Results showed no average
standardized breakthrough for
up to 480 minutes for claimed
19 drugs
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
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
Docetaxel [10mg/ml] >480
Oxaliplatin [5mg/ml] >480
Leucovorin [1 0mg/ml] >480
*No permeation was detected at
either the minimum detectable
permeation or 0.1 g/cm2/min | |
9
Similarity': The proposed device and predicate device have the same isolation protection. The proposed device also emphasizes on the protection of chemotherapy drugs. This difference does not affect the safety and efficacy of the proposed gown.
Similarity-2: Even though the description of materials for proposed device are slightly different, it shall be the same materials. Therefore, this difference does not raise any concerns on safety and efficacy.
10
新 萬 盟 有 限 公 司
Similarity3 The predicate device has more various designs on gowns and the main different designs of proposed device are on the neck. The design of the gown has been evaluated in different tests which does not raise any concerns about safety and efficacy.
Similarity5: Theses gowns were tested using the ASTM D3776 standard testing methods. As there were no limit or criteria for this test, the test values of proposed device passed the criteria set by Copioumed International INC. The bigger values of testing results do not raise extra concerns of safety and efficacy.
Similarity. The testing targets of proposed device have covered the testing targets of predicate device. The proposed device also tested the armpit and shoulder seam. All the testing results of proposed device met the criteria of standard.
Similarity 3. The proposed device and predicate device were tested for "breaking strength" using ASTM D5034. The breaking strength of the proposed device differed from the predicate device but were within the acceptance criteria. Therefore, the difference does not raise any questions on the safety and effectiveness of the proposed device. Similarity 300. The proposed device and predicate device were tested for "breaking strength" using ASTM D5587. The breaking strength of the proposed device differed from the predicate device but were within the acceptance criteria. Different : The predicate device does not test the resistance to permeation of various chemotherapy drugs.
K. COMPARISON TO REFERENCE DEVICE
In order to compare with the legal marketed Chemo gown, another cleared device, K210414, CoverU Disposable Gown with Tape - Chemo Gown, was selected for reference to demonstrate the evaluated for
11
12
新 萬 盟 有 限 公 司
13
COPIOUMED INTERNATIONAL INC. 新 萬 盟 有 限 公 司
Similar ! The reference device is only chosen to demonstrate the evaluated for resistance to permeation of various chemotherapy drugs. Both proposed device and reference device were tested for resistance to permeation of various chemotherapy drugs per the Consensus Standard ASTM F739-20, Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. The reference device was tested for three more drugs than the subject device. The tested drugs are listed clearly in labeling with the proposed device.
Similar12: The reference device has similar designs, offering protective backs.
Different23: The proposed device and reference device utilize different textiles and are different colors. Both meet their respective performance test requirements.
14
新 萬 盟 有 限 公 司
Different4: Even the proposed device and reference device are different level of protection, the main reason to choose the reference device is to demonstrate the evaluated for resistance to permeation of various chemotherapy drugs.
The reference device, a chemo gown meeting AAMI PB70 Level 4 barrier performance, relies upon ASTM F739-12 to demonstrate its resistance to listed chemotherapy drug permeation. ASTM F739-20, the version of the standard currently recognized, is used to demonstrate the barrier performance for tested chemotherapy drugs in the subject AAMI PB70 Level 3 chemotherapy isolation gown.
| 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 | To demonstrate resistance to penetration of chemotherapy drugs | ≥480 minutes | Pass |
| 5. | ASTM | |||
| D3776/D3776M- | ||||
| 17 | To determine the mass of the fabric | Informative | Pass | |
| 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 |
| 10. | ISO 9073-10:2003 | To determine linting properties | Informative | Pass |
| 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 |
L. SUMMARY OF NON-CLINICAL TESTING
M. SUMMARY OF CLINICAL TESTING
No clinical testing was performed in support of this 510(k)
15
COPIOUMED INTERNATIONAL INC. 新 萬 盟 有 限 公 司
N. CONCLUSION
The conclusions drawn from the non-clinical testing demonstrate that the subject device, Copioumed Chemotherapy Isolation Gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K190306.