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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) with the BD 60 ml syringe (model no. 309653).

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies (see K140133 and K140131).

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 Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring).

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 stopping 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.

SCIg60 Infusion System should be used in accordance with its directions for use.

Please find the requested information regarding the acceptance criteria and study details for the SCIg60 Infusion System below.

Acceptance Criteria and Reported Device Performance

• Account for the characteristics of Hizentra in flow rate accuracy. | Performance data demonstrated that the SCIg60 Infusion System provides infusion rates consistent with the FDA-approved Hizentra labeling when used as directed. The study included:
  • Infusion accuracy testing with SCIg60 Infusion System and Hizentra.
  • Infusion accuracy testing with combinations of SCIg60 Infuser, Infuset™ extension sets, and SUB-Q patient administration sets and Hizentra simulated test fluid.
  • Validation of simulated Hizentra test fluid. |
    | Influence of Elevation | - Demonstrate consistent flow rates across varying elevations. | Influence of elevation on flow rate was tested. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Residual Volume | - Minimize residual volume of Hizentra at the end of infusion. | Residual volume of Hizentra remaining at the end of infusion was measured. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Reliability | - Maintain performance over the labeled shelf life (accelerated aging). | Reliability testing of SCIg60 Infuser devices that were aged (accelerated aging) to the labeled shelf life was conducted. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Biocompatibility | - Be biocompatible for components in contact with the patient. | Biocompatibility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Sterility | - Ensure sterility of relevant components. | Sterility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Shelf Life | - Maintain integrity and function over the specified shelf life. | Shelf life data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Human Factors | - Ensure safe and effective use by intended users. | Human factors testing was conducted to validate the SCIg60 Infusion System, implying that the device was found to be safe and effective for its intended users. The specific acceptance criteria are not detailed. |
    | Hizentra Compatibility | - Demonstrate no adverse effects on Hizentra after infusion through the system regarding appearance, particulates, protein concentration, IgG fragments/polymers/aggregates, anti-complementary activity (ACA), density, and Fc-function. | Compatibility of Hizentra with the SCIg60 Infusion System was conducted. The characteristics of Hizentra (appearance, particulates, protein concentration, amount of IgG fragments, polymers or aggregates, anti-complementary activity (ACA), density, and Fc-function) were evaluated after being infused through the SCIg60 Infusion System and compared to a control. The document does not explicitly state quantitative acceptance criteria, but the overall conclusion of substantial equivalence suggests the device did not adversely affect Hizentra. |
    | Safety Assurance | - Provide a safety assurance case as recommended by FDA guidance. | A safety assurance case for the SCIg60 Infusion System was provided, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle. This indicates that a comprehensive assessment of potential risks and their mitigation was performed to ensure the safety of the device. The explicit acceptance criteria for this case are not detailed. |

Study Details:

1. Sample Size used for the test set and the data provenance:
   The document does not specify the exact sample sizes for each performance test (e.g., number of infusers, sets, or Hizentra samples tested).
   The data provenance is implied to be from laboratory testing conducted by EMED Technologies Corporation, likely within the United States. The data is retrospective in the sense that it was collected as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. Given that the testing involves technical performance characteristics of an infusion pump, the "ground truth" would generally be established through calibrated laboratory measurements and validated test methods, rather than expert consensus on clinical findings. For the Hizentra compatibility testing, the "ground truth" would be the known properties of Hizentra before infusion and comparison to a control, likely measured by qualified laboratory personnel.

3. Adjudication method for the test set:
   Not applicable. The testing primarily involves objective measurements of device performance characteristics (flow rate, residual volume, material properties, etc.) against pre-defined technical specifications. These types of tests do not typically require adjudication by multiple experts in the way clinical diagnostic studies might.

4. 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:
   Not applicable. The SCIg60 Infusion System is an infusion pump, a mechanical device for drug delivery, not a diagnostic imaging device or an AI-powered system that assists human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The SCIg60 Infusion System is a mechanical infusion pump. It does not contain algorithms for diagnostic interpretation or decision-making that would require a "standalone" algorithm performance study. Its performance is inherent in its mechanical design and function.

6. The type of ground truth used:
   The ground truth for the performance testing was based on:

   • Objective Laboratory Measurements: Calibrated instruments and established test methods to measure flow rates, residual volumes, and material properties.
   • Predicate Device Performance: Comparison to the performance and characteristics of legally marketed predicate infusion systems.
   • Hizentra Labeling and Properties: The known and approved properties of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid directly from the manufacturer and its FDA-approved labeling.
   • FDA Guidance Documents: Compliance with recommendations from relevant FDA guidance, such as "Infusion Pumps Total Product Life Cycle," for the safety assurance case.

7. The sample size for the training set:
   Not applicable. This device is a mechanical infusion pump and does not involve AI or machine learning algorithms that require a "training set" of data.

8. How the ground truth for the training set was established:
   Not applicable, as no training set was used.

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