(76 days)
The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.
The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
The SML is a sealed male luer. The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.
The SML is a passive device – it requires no cap and automatically seals upon disconnection. An optional female cap will be provided for transport and an optional priming cap will be provided to allow the user to prime as necessary.
The Safety Male Luer (SML) is a unique male luer connector that is intended to be used with the currently marketed SmartSite® Needle Free Valve port and standard open female luers. The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products. Furthermore, the SML reduces environmental surface contamination of the work surface when used to reconstitute, dispense/transfer, administer, and dispose of hazardous or non-hazardous fluids when used in conjunction with SmarSite® Needle-Free Valve port.
The provided text describes the regulatory submission for the Alaris® Safety Male Luer (SML), focusing on its substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria and their results. The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly claims:
- "The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port."
- "The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer."
- "Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids..."
- "Furthermore, the SML reduces environmental surface contamination of the work surface..."
- "The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices."
These are statements of intended function and general conclusions, not specific, measurable acceptance criteria with corresponding performance data. The FDA letter confirms the device is "substantially equivalent" which often relies on demonstrating that the new device performs at least as well as a legally marketed predicate, rather than meeting novel, pre-defined quantitative acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific "test set" in terms of patient data or clinical trials for device performance. The "performance data" mentioned is not described in detail. Given the nature of a 510(k) for a passive medical device, the "test set" likely consisted of in-vitro bench testing, rather than human subject data.
There is no information regarding:
- Sample size for any test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. For a passive mechanical device like a luer connector, "ground truth" would typically refer to objective measurements of leakage, sealing force, compatibility, etc., rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This type of study is typically relevant for interpretative devices (e.g., imaging devices analyzed by multiple clinicians), not for a passive mechanical connector.
6. Standalone Performance Study (Algorithm Only)
This concept is not applicable. The Alaris® Safety Male Luer is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The document implies the ground truth for performance was established through objective measurements and testing demonstrating the device's ability to prevent leakage and reduce spillage, thereby showing it "meets specified requirements." This would primarily involve:
- Mechanical testing (e.g., force to connect/disconnect, burst pressure, sealing integrity).
- Fluid leakage tests.
- Compatibility testing with specified predicate devices (SmartSite® Needle Free Valve port and standard open female luers).
It's likely based on bench testing and engineering validation rather than pathology, outcomes data, or expert consensus in a clinical setting.
8. Sample Size for the Training Set
This information is not provided and is not directly relevant for a physical medical device. "Training set" usually refers to data used to train an algorithm or AI model. For a mechanical device, iterative design and testing might occur, but it's not typically framed as a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no "training set" in the AI sense. Design validation and verification for a mechanical device involve testing prototypes against design specifications and relevant standards.
§ 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.