(366 days)
The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60ml syringe (model no. 309653)
To pump fluids from a reservoir into an adult or pediatric patients (2 years and older) in a controlled manner in a home or hospital environment.
The EMED SCIg60 Infusion System consists of: SCIg60 Infuser, fixed-rate Infuset flow control extension set, VersaRate variable-rate flow regulator, SUB-O patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset flow control extension sets, VersaRate flow regulator, and SUB-Q patient administration sets are also manufactured by EMED Technologies. The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions. The Infuset flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stoping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates. The change proposed in this 510(k) includes the addition of the VersaRate flow regulator. The VersaRate flow regulator consists of a barrel-type regulator component, medium-density PVC standard luer lock connectors. Snap-fit design elements of the regulator halves hold the gasket in place and allow the VersaRate to withstand fluid pressures up to 18 psi. The rotation of the flow regulator component alters internal fluid path dimensions.
This document is a 510(k) Summary for the EMED SCIg60 Infusion System, intended for the subcutaneous infusion of specific immunoglobulin solutions. It describes the device, its intended use, and argues for substantial equivalence to a predicate device (K161906, SCIg60 Infuser). As such, it focuses on bench testing and a safety assurance case rather than clinical studies with human participants. Therefore, several aspects of your request (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth for training set) are not applicable or not explicitly detailed in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison of technological characteristics and performance specifications between the subject device (SCIg60 Infusion System, K173783) and its predicate (SCIg60 Infuser, K161906). The acceptance criteria are generally implied by the predicate device's performance, with deviations justified through safety and effectiveness arguments.
| Technological Characteristic | Predicate Device (K161906) Performance | Subject Device (K173783) Performance | Acceptance Criteria (Implied) | Comment/Justification for Differences |
|---|---|---|---|---|
| Infuser Material(s) | PPE Resin, Delrin, Stainless Steel | PPE Resin, Delrin, Stainless Steel | Same as predicate | Same |
| Infuser Weight | 1 lb | 1 lb | Same as predicate | Same |
| Infuser Dimensions (L x H x D) | 10.2" x 2.6" x 2.6" | 10.2" x 2.6" x 2.6" | Same as predicate | Same |
| Syringe/Fluid Container | BD 60ml Syringe (model no. 309653) | BD 60ml Syringe (model no. 309653) | Same as predicate | Same |
| Principle of Action | Spring force, no batteries | Spring force, no batteries | Same as predicate | Same |
| Pressure Source | Spring | Spring | Same as predicate | Same |
| Principle of Flow Control | Internal dimensions of flow control set | Internal dimensions of flow control set | Same as predicate | Same |
| Materials (Flow Controller) | PVC (Infuset) | PVC (Infuset), PVC, Polycarbonate, Styrene-ethylene-butylene (VersaRate) | Biocompatibility equivalent to predicate and previous cleared device (K123729) | Subject device includes VersaRate with additional materials. Biocompatibility deemed equivalent. |
| Flow Controller Residual Volume | 0.10 - 0.20 ml (Infuset) | 0.10 – 0.20 ml (Infuset), 0.20 ml (VersaRate) | No clinically significant difference from predicate | VersaRate has up to 0.10mL higher residual volume, not clinically significant. |
| Flow Controller Sterilization | Ethylene Oxide | Ethylene Oxide | Same as predicate | Same |
| Maximum Operating Pressure (psi) | 16.8 | 16.8 | Same as predicate | Same |
| Average Operating Pressure (psi) | 14.4 | 14.4 | Same as predicate | Same |
| Total Flow Rate Range (ml/hr) | 11 - 145 | 9 – 145 | Ranges are within comparable limits. | Achieved flow rates with subject device are substantially equivalent to predicate when used as recommended. |
| Flow Rate Accuracy (%) | +/- 15 (Infuset only) | +/- 15 (Infuset only), Up to +/- 37 (VersaRate, Positions ½ - 1), Up to +/- 26 (VersaRate, Positions 2-3), Up to +/- 15 (VersaRate, Positions 4-6) | Performance within immunoglobulin manufacturer recommendations when used as per instructions. | Increased variability at low flow rates with VersaRate, explained by small absolute differences resulting in larger % differences. Labeling ensures compliance with manufacturer recommendations. |
| Vertical Sensitivity at +12" | Up to +6% from target flow rate | Up to +6% from target flow rate | Same as predicate | Same |
| Vertical Sensitivity at -12" | Up to -4% from target flow rate | Up to -4% from target flow rate | Same as predicate | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a bench testing summary, not a clinical trial. Performance testing typically involves a sufficient number of samples to ensure statistical validity for the specific test (e.g., flow rate, pressure).
- Data Provenance: Bench testing data, conducted by the manufacturer (EMED Technologies Corporation). The document does not specify country of origin for the data (beyond the manufacturer's location in California), and it is inherently prospective for the device under review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the evaluation primarily involved objective bench testing on the device's physical and functional performance against technical specifications and predicate device performance. Expert consensus would typically be for subjective assessments in clinical settings (e.g., image interpretation).
4. Adjudication Method for the Test Set
- Not applicable for bench testing. Go/no-go criteria based on engineering specifications and comparison to the predicate device's performance.
5. 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
- No MRMC study was done. This device is an infusion system, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No AI component is indicated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a mechanical infusion system, not an algorithm. Bench testing evaluated the standalone functional performance of the device components.
7. The Type of Ground Truth Used
- For performance testing, the "ground truth" was established by engineering specifications, direct measurements, and comparison to the performance characteristics of the legally marketed predicate device (K161906). Additionally, adherence to relevant international standards (e.g., ISO 85368:2015, ANSI/AAMI HE75:2009) and FDA guidance documents played a role in defining acceptable performance. For biocompatibility, the ground truth was based on previous clearances for similar materials and intended uses (e.g., K123729 for VersaRate Controller).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. The design and manufacturing processes are refined through engineering development, not machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for an AI/ML model for this type of device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).