(391 days)
The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.
The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.
The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.
The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.
The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.
The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.
The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock.
The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.
This document describes the 510(k) premarket notification for several subcutaneous infusion sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning a change in the sterilization facility and the adoption of a PFOA-free PTFE soft cannula.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow Test | Tubing Set: 40 ml/min at 1 bar pressure | Devices "passed all testing" (implied criteria met) |
| Leak Test | Luer-Lock: No Leaks at 3 bar pressure for 30 seconds | Devices "passed all testing" (implied criteria met) |
| Pcap: No Leaks at 1.4 bar pressure for 30 seconds | Devices "passed all testing" (implied criteria met) | |
| Asante Hub: No Leaks at 0.56 bar pressure for 30 seconds | Devices "passed all testing" (implied criteria met) | |
| Pull Tests | Soft Cannula to Cannula housing: 3 N, Dynamic Pull | Devices "passed all testing" (implied criteria met) |
| Tubing to tubing Luer-lock: 15 N, Dynamic pull | Devices "passed all testing" (implied criteria met) | |
| Tubing to Needle Connector: 15 N, Dynamic pull | Devices "passed all testing" (implied criteria met) | |
| Cannula housing to Needle Connector: 15 N, Dynamic pull | Devices "passed all testing" (implied criteria met) | |
| Cannula housing to Adhesive: 15 N, Dynamic pull | Devices "passed all testing" (implied criteria met) | |
| Bend Test | No leaks and no break at the tubing after 3000 bendings | Devices "passed all testing" (implied criteria met) |
| Biocompatibility (PFOA-Free PTFE) | Substantial equivalence to the previous PTFE material, per ISO 10993 for extraction and analysis | New material "found to substantially equivalent to the PTFE material" |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "The following verification testing was performed" but does not provide specific sample sizes for each test. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in this context. The study is a series of engineering/performance verification tests for a medical device (infusion sets), not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements (e.g., flow rate, leak detection, pull force, bend cycles) with clear pass/fail criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI-assisted clinical decision support systems, which is not the nature of this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical medical device (infusion set), not an algorithm or AI system. Its performance is inherent to the device itself.
7. The Type of Ground Truth Used:
The ground truth or reference standard for these tests are the established engineering specifications and physical properties of the materials and assembled device. For example:
- Flow/Leak/Pull Tests: Engineering specifications for flow rates, pressure resistance, and tensile strength.
- Bend Test: Durability and integrity requirements under mechanical stress.
- Biocompatibility: Established ISO standards (ISO 10993) for material safety and equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to internal manufacturing process optimization and quality control, not data for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm. The "ground truth" for manufacturing and quality (if considered analogous) would be established through industry standards, regulatory requirements, and internal design specifications, often validated by extensive testing and risk analysis during the device development lifecycle.
§ 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.