(163 days)
The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.
The EXELINT Aluminum Hub Blunt Needles are sterile, non-pyrogenic, single use fluid transfer needles consisting of blunt Type 304 stainless steel cannulas staked into aluminum luer lock hubs. The gauge and length of the cannula determines the final gauge and length of the product. The hubs are identical for all of the needles. Each needle is packaged into a Polypropylene tube and sealed with a polypropylene cap. The needles are final packaged into a multineedle box and ETO sterilized.
The provided text is a 510(k) summary for the EXELINT Aluminum Hub Blunt Needles. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating performance against those criteria in the way that would typically be expected for an AI/ML medical device.
The "Performance Data" section states: "The devices were tested and found in compliance with the ISO standards for Needles (ISO 7864) and Stainless Steel Tubing (ISO 9626). The packaging was tested for seal strength. These tests demonstrated that the EXELINT Aluminum Hub Blunt Needles are safe and effective and that their performance meets the requirements of their pre-defined acceptance criteria and intended use."
This indicates that the acceptance criteria are based on compliance with specific ISO standards (ISO 7864 for Needles and ISO 9626 for Stainless Steel Tubing) and also included packaging seal strength. However, the document does not provide the specific numerical acceptance criteria (e.g., maximum force for needle bending, specific burst pressure for packaging) nor the reported performance data in a quantitative format.
Given the information, I can only provide a generalized response based on what is stated, acknowledging the lack of detailed quantitative data.
Acceptance Criteria and Study Overview for EXELINT Aluminum Hub Blunt Needles
Based on the provided 510(k) summary, the EXELINT Aluminum Hub Blunt Needles were evaluated for compliance with relevant ISO standards and packaging integrity. The document asserts that the device's performance meets pre-defined acceptance criteria, thereby demonstrating safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states compliance with international standards.
| Acceptance Criterion Category | Specific Acceptance Criteria (Not detailed in document) | Reported Device Performance (Not detailed in document) |
|---|---|---|
| Needle Performance | Compliance with ISO 7864 (Sterile hypodermic needles for single use) | Achieved compliance with ISO 7864. |
| (e.g., Bending resistance, break force, corrosion resistance, cap retention, lumen patency) | (Specific values not reported.) | |
| Tubing Material | Compliance with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Achieved compliance with ISO 9626. |
| (e.g., Material composition, surface roughness, dimensional tolerances) | (Specific values not reported.) | |
| Packaging Integrity | Seal strength requirements (Specific values not detailed) | Demonstrated adequate seal strength. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for testing, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in a full test report, not usually summarized in a 510(k) submission to this extent for a non-AI/ML device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this device. The EXELINT Aluminum Hub Blunt Needles are a physical medical device, not an AI/ML algorithm that requires expert-established ground truth for performance evaluation. Performance for such devices is typically determined through physical and material testing against established engineering standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective evaluations, typically in clinical studies or for AI output, involving human interpretation. The testing described for this device is objective, based on physical properties and adherence to standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. An MRMC study is designed to assess the diagnostic performance of AI-assisted human readers compared to human readers without AI assistance. This device is a physical fluid transfer needle, not a diagnostic or imaging AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This question is not applicable. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective engineering standards (ISO 7864 for needles, ISO 9626 for stainless steel tubing) and defined physical properties testing (e.g., seal strength). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of an AI/ML device.
8. Sample Size for the Training Set
This question is not applicable. This device is a physical product and does not involve AI/ML, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no training set for a physical device, the concept of establishing ground truth for it does not apply.
§ 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.