(281 days)
The Safety Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external infusion pump or syringe.
The Safety Subcutaneous Infusion Set is an intravascular administration set used to administer medication subcutaneously. The device consists of subcutaneous stainless-steel needle mounted to a wing stabilizer at 90° at the distal end of the infusion set. The subject device has closing type wings to allow the user to insert the needle into the subcutaneous tissue and also secure the needles on the infusion site. A female luer connector is provided at the proximal end to allow connection to external devices. Each set consists of the administration set and standard medical dressing to secure the needles on the infusion site. The subject device is provided in various needle gauges and lengths. Each needle is equipped with an open end slide clamp on the tubing to facilitate stop flow when required during priming of individual needles.
This document is a 510(k) summary for the "Safety Subcutaneous Infusion Set" and does not contain information related to an AI/ML powered device. As such, it does not include acceptance criteria directly applicable to AI/ML performance, nor a study proving that an AI/ML device meets such criteria.
The information provided pertains to the substantial equivalence determination for a medical device that facilitates subcutaneous infusion of medication. Therefore, I cannot extract the requested information regarding AI device acceptance criteria or studies from this document.
However, I can provide the acceptance criteria and performance data for the physical device described in this document, which are based on non-clinical tests:
Acceptance Criteria and Device Performance (Non-Clinical for Physical Device):
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 | Biocompatibility studies performed |
| Particulate Matter | USP | Particulate matter testing performed |
| Sterilization | ETO, SAL of 10-6 | Sterilization validation performed, achieved SAL of 10-6 (Same as predicate) |
| Ethylene Oxide Residuals | ISO 10993-7:2008 | Ethylene oxide residuals testing performed |
| Shelf Life | ASTM F1980-16 | Shelf life testing performed |
| Sharps Protection | ISO 23908:2011 | Sharps protection compliant to ISO 23908:2011 (Same as predicate) |
| Tensile Strength & Water Tightness | ISO 8536-8:2015 | Tensile strength and water tightness testing performed |
| Luer Lock Connection | ISO 80369-7 | Luer lock connection test performed |
| Comparison to Predicate (Technological Characteristics) | (See detailed comparison table in document) | Found to have similar design, intended use, proximal interface, needle lengths, number of needles, needle safety feature, wing type, and sterilization method. Differences in protective cap design, priming volume, and materials did not raise new safety/effectiveness questions. |
The following requested information is not applicable to this document as it describes a physical medical device, not an AI/ML product:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.