(268 days)
Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs
The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs.
EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below:
| Name | Description |
|---|---|
| Syringe Unit | Syringe for drug transfer |
| Vial Adaptor | Adaptor to the drug vial |
| Spike Adaptor & Spike Adaptor | |
| 180 | Adaptor for the IV bag for injection and for infusion |
| administration | |
| Spike Adaptor W & Spike Adaptor | |
| W180 | Adaptor for the IV bag for withdrawal |
| Luer Lock Adaptor 1 | Adaptor for injection into IV lines |
| Luer Lock Adaptor 2 | Adaptor for injection and withdrawal for IV lines |
| Female Luer Lock connector | Connector for standard IV tubing set ports |
| Protective Plug | A plug to protect connectors during transportation |
| Tubing sets | Accessory for injection into an IV line |
| Reconstitution Set Accessory | Accessory for reconstituting powdered drugs |
| Luer Lock Adaptor 1C | Adaptor for injection into catheters |
| Luer Lock Adaptor 1DC | Adaptor for medication transfer between |
| EQUASHIELD® Syringe Units | |
| Male Priming Connector | Connector for priming of IV line |
The above components are combined to create a system and are not intended to be used individually.
The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.
Here's a breakdown of the acceptance criteria and the study information for the EQUASHIELD® Closed System Transfer Device (K221513) based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Compliance with ISO 8536-4, ISO 8536-10, ISO 80369-7, ISO 1135-4, USP, USP | Verified/Meets design specifications and complies with applicable standards. |
| Biocompatibility | Compliance with FDA Guidance "Use of International Standard ISO 10993-1" and ISO 10993-1 for an Externally Communicating Device (Blood Path Indirect, Prolonged Contact >24hrs to 30days). | All tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility, Subacute Toxicity) were performed and likely met acceptance criteria as no issues were reported, supporting substantial equivalence. |
| Sterilization (SAL) | Sterility assurance level (SAL) of at least 10^-6 | Achieved a SAL of at least 10^-6 following "overkill" approach per ISO 11135:2014. |
| Bacterial Endotoxin | Compliance with USP | Performed and passed the acceptance criteria of USP. |
| Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) Residuals | Compliance with ISO 10993-7:2008 for prolonged exposure devices. | Found to comply with ISO 10993-7:2008. |
| Shelf Life (Accelerated Aging) | Device performance, functional integrity, and package integrity maintained after accelerated aging to equivalent of 3 years. | Performance, functional, and package integrity tests were conducted following accelerated aging and transportation simulation, and passed acceptance criteria. |
| Packaging Integrity (After Sterilization, Accelerated Aging, Transportation Simulation) | Compliance with ASTM D4169-16 under DC13 for: Visual inspection (ASTM F1886), Dye test (ASTM F1929), Pell test (ASTM F88), Burst test (ASTM F2054), Bubble emission test (ASTM D3078), Sterility (USP), Microbiological Barrier Test (ASTM F1608). | All listed tests were conducted and passed acceptance criteria. |
| Microbial Ingress | No bacterial growth in any tested samples after 10 accesses over 7 days. | None of the tested samples showed growth, meeting acceptance criteria. Verified to prevent microbial ingress after aging as labeled. |
| Drug Compatibility | No effect on drug stability; drugs do not negatively impact device mechanical, functional, or performance characteristics. | Study results showed no impact on drug stability and no negative impact on device characteristics. |
2. Sample Size Used for the Test Set and the Data Provenance
- Non-Clinical Testing: No specific sample sizes are mentioned for the non-clinical tests (ISO standards, USP). However, these are typically bench-top tests performed on sufficient samples to demonstrate compliance.
- Biocompatibility: Not explicitly stated, but common for such tests to use a reasonable number of samples to ensure robust results.
- Sterility Shelf Life and Shipping Simulation: "Sterilized samples" were used for accelerated aging, and "final, packed, and sterile samples" were used for packaging integrity. The exact number is not specified but implicitly sufficient for the standards cited.
- Microbial Ingress: "Sterile and aged EQUASHIELD® CSTD samples" were used. The study explicitly states there were 10 repeated accesses for a period of 7 days, implying multiple devices were tested to draw a conclusion on "None of the tested samples showed growth." The exact number of CSTD samples is not specified.
- Drug Compatibility: Not explicitly stated, but "chemical analytic experiments and mechanical, functional and performance testing" would involve a sufficient number of devices.
- Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the data would have been generated to meet U.S. regulatory requirements. It is a prospective study as new testing was conducted specifically for this submission to support the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of medical device submission (510(k) for a Closed System Transfer Device) does not typically involve expert review for establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is defined by established scientific standards (ISO, USP, ASTM) and benchmark compliance rather than expert consensus on diagnostic images or pathology. Therefore, there were no experts in the context of diagnostic interpretation establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a consensus ground truth, typically for diagnostic performance.
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
Not applicable. This device is a Closed System Transfer Device, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. 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 or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the EQUASHIELD® CSTD is established by:
- Compliance with International and National Standards: ISO, USP, and ASTM standards define the acceptance criteria for various physical, chemical, and biological properties.
- Defined Performance Specifications: Each test verified that the device met its design specifications (e.g., preventing microbial ingress, maintaining sterility, drug compatibility).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.