(89 days)
The Caresite Luer Access Device (LAD) is a needleless connector intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device (LAD) may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.
The Caresite Luer Access Device (LAD) is a positive displacement needleless connector intended to provide needle-free access to IV gravity sets, extension sets and catheters for the administration of IV fluids and blood. The Caresite Luer Access Device (LAD) is a 3-piece assembly containing an elastomeric piston with a slit septum, which is housed within a clear, rigid body. The Caresite Luer Access Device (LAD) requires swabbing to disinfect prior to insertion of a male luer connector. The Caresite Luer Access Device (LAD) does not require a specific clamping sequence or technique in order to be used safely. The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.
The input document describes a 510(k) submission for a medical device (Caresite Luer Access Device), which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).
Crucially, a 510(k) filing for a device like a needle-free luer access device typically does NOT involve the kind of elaborate clinical studies (MRMC, expert consensus for AI training/testing, etc.) that would lead to the specific information requested in your prompt. These studies are far more common for novel, high-risk devices, or AI-driven diagnostic/therapeutic tools.
The document states:
- "Performance testing was performed to demonstrate safety and effectiveness."
- "Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use."
The performance testing mentioned here likely refers to bench testing, engineering verification, and perhaps some in-vitro studies to confirm properties like:
- Pressure resistance (e.g., 400 psi)
- Flow rate (e.g., 15 mL/sec)
- Durability (e.g., number of activations)
- Leakage prevention
- Microbial ingress prevention
- Biocompatibility (in accordance with ISO 10993-1)
Therefore, many of your requested points cannot be directly answered from the provided text. The document is for a physical medical device, not an AI/algorithm-driven one, hence the absence of metrics like "effect size of how much human readers improve with AI vs without AI assistance" or "number of experts used to establish ground truth."
Here's an attempt to address your prompt based on the provided text, and explicitly stating where the information is not applicable (N/A) or not provided (N/P) given the nature of a 510(k) for this type of device:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Principle)
The acceptance criteria for a 510(k) submission like this are primarily to demonstrate substantial equivalence to a predicate device in terms of:
- Indications for Use: The Caresite Luer Access Device has similar indications for use to the predicate device.
- Technological Characteristics: Similar physical and technical characteristics, materials, and components as the predicate.
- Performance: Safety and effectiveness demonstrated through performance testing, showing it performs at least as well as the predicate for its intended use, and meets specific functional requirements.
Given the absence of specific quantitative acceptance thresholds in the provided text for "performance testing," the table below reflects what can be inferred or is explicitly stated as characteristics of the device. The "acceptance criteria" here are implied by the device's functional specifications and the successful 510(k) clearance, meaning it performs acceptably for its intended use compared to the predicate.
| Acceptance Criterion (Implied/Stated from text) | Reported Device Performance (from text) |
|---|---|
| Indications for Use Equivalence | Intended for aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Similar to predicate. |
| Power Injector Compatibility | Max pressure rating of 400 psi. |
| Flow Rate Compatibility | Max flow rate of 15 mL/sec. |
| Sterility | Must be supplied as sterile. |
| Biocompatibility | Must meet biocompatibility standards (e.g., ISO 10993-1). |
| Disinfection Procedure | Requires swabbing to disinfect. |
| Clamping Sequence Requirement | No specific clamping sequence. |
Study Details (As Applicable for this Device Type)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/P. For a physical device of this nature, "test set" would refer to the number of devices tested during performance (bench) and biocompatibility testing. This information is not typically detailed in the 510(k) summary provided, but would be in the full submission. The data provenance would be from manufacturing/testing facilities, likely in the US (where the applicant is based). These would be prospective tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. This device is not an AI/diagnostic imaging device, so the concept of "experts establishing ground truth" in the context of clinical images or algorithmic output is not applicable. The "truth" here is engineering specification, material safety, and functional performance as observed in bench tests.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations of data (e.g., radiological reads) or clinical outcomes. Not applicable for this physical device's performance testing.
-
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:
- N/A. This is a physical medical device, not an AI/diagnostic tool. MRMC studies are not relevant for its clearance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device, "ground truth" would be established through:
- Engineering Specifications/Standards: Performance measured against predefined industry standards (e.g., ISO for biocompatibility) and engineering design specifications (e.g., pressure, flow rates).
- Predicate Device Performance: The predicate device's established performance serves as a benchmark for substantial equivalence.
- Biocompatibility Standards: Adherence to ISO 10993-1.
- For this type of device, "ground truth" would be established through:
-
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- N/A. There is no "training set" as this is not an AI/machine learning device.
§ 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.