(130 days)
The EQUASHIELD™ System reconstitution and transfer system is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs for intravenous infusion or injection.
The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.
The EQUASHIELD™ System Protective Plug is used as a "cork" for blocking EQUASHIELD™ connector openings, thus providing the system with further protection, mainly during the transportation and conveying of the EQUASHIELD™ System together with other accompanied items (used routinely by the hospital), where EQUASHIELD™ components might be squeezed in a transportation container together with other items which could accidently cause damage due to penetration of such items into the EQUASHIELD™ System's connector ports. The Protective Plug is inserted into the EQUASHIELD™ connector ports' openings and mechanically prohibits entrance of any accompanied items.
The provided text describes the EQUASHIELD™ System Protective Plug and its clearance process, but it does not contain the detailed information typically found in a study proving device performance against acceptance criteria. Instead, it is a 510(k) Summary.
Here's a breakdown of what can be extracted and what information is missing based on your request:
Acceptance Criteria and Reported Device Performance
The document states that "All functional tests results, post mimicking the actual conditions, met the specification predetermined acceptance criteria". However, the specific quantitative or qualitative acceptance criteria themselves are not explicitly listed in the provided text. Similarly, the detailed "reported device performance" against these criteria is only summarized as having "met the specification predetermined acceptance criteria."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Visual Tests | (e.g., No visible damage, integrity maintained after conveyance) | Met specification predetermined acceptance criteria. |
| Detachment Tests | (e.g., Protective Plug remains securely attached during conveyance, detaches easily when intended) | Met specification predetermined acceptance criteria. |
| Fluid Flow through the Entire System | (e.g., Unimpeded fluid flow after protective plug removal, no leaks) | Met specification predetermined acceptance criteria. |
| Prevention of Penetration | (e.g., No objects breach the connector ports during conveyance) | Prevented the penetration of accompanying parts into EQUASHIELD™ ports during conveying. |
| Overall System Functionality | (e.g., EQUASHIELD™ System components functioned appropriately after Protective Plug assembly and detachment) | EQUASHIELD™ System components functioned appropriately after Protective Plug assembly and detachment. |
Missing Information from the Provided Text:
Below is a list of the specific points from your request that are not present in the provided 510(k) summary:
- Specific Acceptance Criteria: The document only states that tests "met the specification predetermined acceptance criteria" but does not detail what these criteria were (e.g., what constitutes an acceptable visual inspection, specific force requirements for detachment, flow rates, etc.).
- Sample size used for the test set: The document mentions "a conveyance simulation was performed by exposing the new device to the actual use conditions," but does not specify the number of devices or components tested.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The applicant is from Israel, but the location of testing is not explicitly stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of study involved non-clinical performance data (physical tests), not expert review of medical images or data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is for AI/human reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is the performance of the device against engineering specifications and functional requirements in a simulated environment, rather than a clinical ground truth like pathology.
- The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Study Information (Based on Available Text):
- Study Type: Non-clinical performance testing, specifically a "conveyance simulation."
- Purpose: To verify that the EQUASHIELD™ Protective Plug performs as intended and does not compromise the safe use of the entire EQUASHIELD™ system, and to demonstrate substantial equivalence to predicate devices.
- Tests Conducted: Visual tests, detachment tests, and fluid flow through the entire system.
- Conditions: The device was exposed to "actual use conditions" mimicking conveyance.
- Outcome: All functional tests met predetermined acceptance criteria. The tests demonstrated that the system components functioned appropriately after Protective Plug assembly and detachment, and that the plug prevented penetration into the system's ports during conveying.
- Predicate Devices: The original EQUASHIELD™ System (K083152) and the EQUASHIELD™ Luer Lock Connector Pair (K091389). The new device was considered substantially equivalent to these devices.
§ 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.