(28 days)
The SCIg60 Infusion System is intended for the subcutaneous infusion of indicated fluids in the home or hospital environment for adult or pediatric (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional.
The SCIg60 Infusion System is indicated for the subcutaneous infusion of:
- · Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda.
- · Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda,
- · Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring,
- · Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics
- · Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and
- Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG
The SCIg60 Infuser Pump is intended for single patient, multiple use only, while flow controller and patient administration sets are single-use only.
The EMED SClg60 Infusion System consists of the SClg60 Infuser (Pump), a 50 mL Luer lock syringe, a flow rate influset [fixed rate] flow control infusion set, VersaRate adjustable flow rate infusion set, or VersaRate Plus adjustable flow rate infusion set), and a commercially available subcutaneous (SUB-Q) infusion sets that utilize a standard Luer Lock style connector.
The SClg60 Infuser is a reusable mechanicambulatory infusion pump that does not require batteries or any electrical source. The SClg60 Infuser uses a spring as a source of energy to the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SClg60 Infuser is provided with a carrying case and User Manual. The SCIg60 Infuser enclosure is made of synthetic polymer blend of glass reinforced polystyrene, the spring is made of stainless steel, and the spring enclosure is made of a blend of modified polyphenylene oxide and fibrous glass.
The Infuset flow control infusion set is an individually packaged, sterile, single-use device. It is assembled from standard Luer lock components and specified lengths of PVC microbore tubing. The tubing results in fixed flow rates when used with the SCIg60 Infuser, and include side-clamps for stopping and starting the SCIg60 Infusion System User Manual includes information to quide users in the selection of Infuset flow control infusion sets to achieve the desired infusion rates.
The VersaRate or VersaRate Plus adjustable flow rate individually packaged, sterile, single-use devices. It is assembled from standard Luer lock components, PVC microbore tubing and a dial made of polycarbonate, styrene-ethylene (VersaRate) or polycarbonate, polyoxymethylene (VersaRate Plus). They may be used with the SCIg60 Infuser to provide convenient control of the flow rate without having to select specific Infusion set. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The SClg60 Infusion System User Manual includes information to guide users in the selection of Infuset, VersaRate Plus settings and SUB-Q infusion sets to achieve the desired infusion rates.
The following commercially available syringes not sold or distributed by EMED are compatible with SClg60 Infusion System: - BD 50 mL syringe (model no. 309653)
- Hizentra® 50 mL Prefilled Syringe (Model / Carton NDC# 44206-455-25)
The provided text is a 510(k) summary for the SCIg60 Infusion System. It describes the device, its intended use, and comparisons to a predicate device. However, it does not contain the requested detailed information about acceptance criteria and a study that proves the device meets those criteria, particularly for an AI/ML device.
The document explicitly states: "Clinical testing is not applicable for this submission." This indicates that a study demonstrating performance against specific acceptance criteria for a new AI/ML device (which would typically involve performance metrics like sensitivity, specificity, or F1-score) was not conducted or presented in this 510(k). The tests mentioned are functional and system flow rate performance verifications, which are engineering/bench tests rather than clinical performance studies against defined acceptance criteria in the context of an AI/ML diagnostic or assistive device.
Therefore, many of the requested fields cannot be extracted from this document, as they pertain to the evaluation of an AI/ML driven diagnostic or predictive system, which this device is not.
Here's a breakdown based on the information available in the document, acknowledging the limitations:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document in the context of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device. The document mentions "flow rate accuracy" as being verified, but it does not provide acceptance criteria or specific performance values for this.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for specific performance metrics (e.g., accuracy, sensitivity) in the context of an AI/ML device. | "infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling" (for flow rate performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is "Functional/Syringe Fitment Verification" and "System Flow Rate Performance Verification" with a specific prefilled syringe (Hizentra 50 mL). These are bench tests, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically established by experts for AI/ML performance evaluation (e.g., diagnosis, segmentation) is not relevant to the functional and flow rate bench testing performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods for expert consensus are not relevant to the functional and flow rate bench testing performed.
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. The document explicitly states: "Clinical testing is not applicable for this submission." This device is an infusion system, not an AI-assisted diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infusion pump system, not an algorithm, and does not have a "standalone" algorithmic performance in the sense of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For flow rate performance, the "ground truth" would be the expected flow rates based on the FDA-approved immunoglobulin labeling and the physical properties of the system. This is a technical standard, not expert consensus or pathology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that utilizes a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system that utilizes a training set.
Summary of what the document does say about testing:
The submission included "Non-Clinical Tests Summary & Conclusions" with the following testing performed:
- Functional/Syringe Fitment Verification with the Hizentra 50 mL Prefilled Syringe.
- System Flow Rate Performance Verification with the Hizentra 50 mL Prefilled Syringe.
The conclusion of these tests was that the device "is substantially equivalent to the predicate device and provides infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed." This indicates that the functional and flow rate tests met the expectation of consistency with predicate device performance and labeled immunoglobulin infusion rates.
§ 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).