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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.

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.

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The SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications:

• · Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring),
  • Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta).

· Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta)

• · Gamunex-C Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.),
• · Gammaked Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.)
• · Xembify Immune Globulin Subcutaneous (Human), 20% (manufactured by Grifols Therapeutics, Inc.), and
• · Cutaquig Immune Globulin Subcutaneous (Human), 16.5% (manufactured by Octapharma AG)

with the BD 50 ml syringe (model no. 309653) in the home or hospital environment.

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser Pump, a flow rate controller (Infuset fixed rate flow control extension set. VersaRate variable flow rate controller, or VersaRate Plus variable flow rate controller), and can be used with commercially available SUB-Q administration sets that utilize a standard Luer Lock style connector. The SCIg60 Infuser Pump must be used with the BD 50 mL syringe (model no. 309653 manufactured by Becton Dickinson (BD)), which was formerly labeled as a 60 mL syringe.

The SCIg60 Infuser pump is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The SCIg60 Infuser Pump uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SCIg60 Infuser Pump is provided with a carrying case and User Manual.

The Infuset flow rate controller is an individually packaged, sterile, single use device. It is assembled from standard Luer components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in fixed flow rates when used with the SCIg60 Infuser Pump, and include side-clamps for stopping the flow of fluid. The SCIg60 Infusion System User Manual includes information to guide users in the selection of Infuset flow rate controller and SUB-Q patient administration sets to achieve the desired infusion rates.

The VersaRate or VersaRate Plus variable flow rate controllers are individually packaged, sterile, single use devices. They may be used with the SCIg60 Infuser Pump to provide convenient control of the flow rate without having to select specific Infuset flow rate controller. 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 SCIg60 Infusion System User Manual includes information to guide users in the selection of VersaRate (or VersaRate Plus) settings and SUB-Q patient administration sets to achieve the desired infusion rates.

The document provided is a 510(k) premarket notification for a medical device called the SCIg60 Infusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo studies with specific acceptance criteria and detailed performance metrics as one might find for novel AI/ML devices or pharmaceutical trials.

Based on the provided text, the acceptance criteria and study information are presented in terms of equivalence to the predicate device and verification of performance with additional biologics. It does not describe an AI/ML device, nor does it contain information typically found in studies involving AI/ML performance metrics such as sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis of the available information in the context of the requested parameters, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (Analogous to)

The document frames "acceptance criteria" and "device performance" in terms of demonstrating that the modified SCIg60 Infusion System (with expanded biologics and the VersaRate Plus controller) performs equivalently to the predicate device (K161906) and within the recommendations of the immunoglobulin manufacturers.

• Biologics assessed for similarity in protein concentration, pH, osmolarity, viscosity, and density; minor differences do not alter intended therapeutic effect.
• Performance tests, labeling, and risk management activities qualify the SCIg60 Infusion System for use with the new biologics. |
  | Equivalence in SCIg60 Infuser: Materials, weight, dimensions, syringe/fluid container, principle of action, and static operating pressure should be identical to the predicate. | - Infuser materials, weight, dimensions, syringe (BD 50ml model 309653), principle of action, and static operating pressure are identical to the predicate. |
  | Equivalence/Similarity in Flow Controllers: Materials, dimensions, design, principles of action, manufacturing, sterilization of single-use accessories, and biocompatibility profiles should be similar. Flow rates and settings should be comparable and within drug PI limits. | - Materials, dimensions, design, principles of action, manufacturing, and sterilization are similar to the predicate. VersaRate Plus™ is identical to VersaRate™ except for new flow rate regulator module and diverter/gasket material.
• VersaRate Plus™ has 13 dial positions (vs. 7 for VersaRate); additional positions enable use with more needle sets.
• Flow rates for VersaRate Plus (20-356 ml/h saline; 9-271 ml/h IgG system) are comparable to VersaRate (13-285 ml/h saline; 9-156 ml/h IgG system) when tested as a system.
• All flow rates in the User Manual are within drug product information (PI) limits.
• VersaRate Plus™ meets chemical requirements of ISO 8536-9:2015. |
  | Flow Rate Performance with New Biologics: The system must fully characterize flow rates for the proposed immunoglobulin solutions, demonstrating equivalence to Hizentra's performance in the predicate, and ensuring provided flow rate combinations do not exceed manufacturer recommendations. | - Flow rates for new biologics were fully characterized and are equivalent to Hizentra performance in K161906.
• Minor differences are expected due to fluid characteristics (density, viscosity); e.g., 10% solutions show higher flow rate than 20% solutions.
• Only combinations providing flow rates in line with manufacturer recommendations are included; combinations exceeding recommendations are not provided. |
  | Sterility and Manufacture/Processing: Sterilization method, cycle, Sterility Assurance Level (SAL), pyrogenicity test method, and residual limits for EO and ECH should remain compliant. | - No changes to sterilization method, cycle, SAL, or pyrogenicity test method.
• Sterilization validation per ISO 11135:2014 confirmed reliability at SAL of 10-6.
• Residual results for EO and ECH evaluated per ISO 10993-7:2008/Amd 1:2019 and confirmed to not exceed allowable limits. |
  | Labeling and User Instructions: Updated to reflect expanded indications; follow same format and structure as original. | - Product packaging, labeling, and User Instructions are identical to the predicate, with pertinent sections updated for the new biologics. |

Regarding AI/ML Specific Information (NOT APPLICABLE)

The provided text describes a mechanical infusion pump and its accessories. There is no indication that this device uses artificial intelligence or machine learning. Therefore, the following requested points are not relevant to this document and cannot be extracted:

2. Sample size used for the test set and the data provenance: Not an AI/ML device. Performance testing on the infusion system itself was conducted, but details like sample sizes of units tested are not provided, nor is data provenance for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not an AI/ML device.
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: Not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not an AI/ML device. The "ground truth" for this device would be its own mechanical performance (e.g., flow rate accuracy, material compatibility) and comparison to established predicate properties and drug manufacturer guidelines.
8. The sample size for the training set: Not an AI/ML device.
9. How the ground truth for the training set was established: Not an AI/ML device.

Summary of the Study (Non-Clinical Performance Testing)

The "study" described in the document is a series of non-clinical performance tests and analyses to demonstrate the substantial equivalence of the modified SCIg60 Infusion System to its predicate (K161906). This involved:

• Comparison of Device Characteristics: Detailed comparison of the infuser components (materials, dimensions, principle of action) and flow controllers (materials, design, settings, flow rates) to the predicate.
• Assessment of Biologic Compatibility: Evaluation of the physiochemical properties (protein concentration, pH, osmolarity, viscosity, density) of the newly indicated immunoglobulin solutions to determine similarity to previously approved ones and ensure no adverse interactions with the device.
• Flow Rate Performance Testing: Bench testing to characterize the flow rates provided by the SCIg60 Infusion System when used with the additional immunoglobulin solutions, various flow controllers (Infuset, VersaRate, VersaRate Plus), and SUB-Q administration sets. This testing strategy was identical to that used for the predicate.
• Material Compatibility and Sterilization Validation: Assessment of new materials in the VersaRate Plus for compliance with chemical requirements (ISO 8536-9:2015) and confirmation that sterilization processes and residual levels meet ISO 11135:2014 and ISO 10993-7:2008/Amd 1:2019 standards.
• Risk Management and Labeling Review: Updates to risk management matrices and labeling/instructions for use to incorporate the expanded indications and the new VersaRate Plus controller.

Conclusion stated in the document:
"The data generated by the performance tests demonstrates that the EMED Technologies Corporation SCIg60 Infusion System... is substantially equivalent to the predicate devices and provides infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed." (Page 9)

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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), 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.

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.

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