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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.

Ask a specific question about this device

The VersaPump Infusion System is intended for the subcutaneous infusion of indicated fluids for patients in the home or hospital environment when administered by an adult according to the indicated fluid's product labeling and with specified models of subcutaneous infusion sets, flow controllers, and syringes. The system is intended for single patient, multiple use only.

The VersaPump Infusion System is indicated for adult and pediatric patients (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional. The infusion system must be operated by an adult for use with pediatric patients.

The VersaPump 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 VersaPump Infusion System consists of the VersaPump Infuser designed to be used as a system with a flow rate controller (Infuset™ fixed flow rate control infusion set or VersaRate Plus™ variable flow rate control infusion set) and SUB-Q administration sets that utilize a standard Luer lock connector.

The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).

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 rate when used with the VersaPump Infuser and include side-clamps for stopping the flow of fluid. The VersaPump Infusion System User Manual includes information to guide users in the selection of Infuset flow rate controller and SUB-O patient administration sets to achieve the desired infusion flow rate.

The VersaRate Plus variable flow rate controller is individually packaged, sterile, single use device. It may be used with the VersaPump Infuser to provide convenient control of the flow rate without having to select specific Infuset flow rate controller. The flat dial of the VersaRate Plus can be adjusted to set an appropriate flow rate of immune globulin solution or stop the fluid flow entirely. The VersaPump Infusion System User Manual includes information to guide users in the selection of the VersaRate Plus settings and SUB-Q patient administration sets to achieve the desired infusion flow rate.

The SUB-Q Administration Sets consist of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place while in use. The infusion set has a rigid PVC standard Luer lock at one end and a 90° 304 stainless steel needle mounted by a butterfly stabilizer at the other end. The two ends are connected by medical grade PVC tubing.

The main subject of this submission is VersaPump Infuser. The rest of the components of the VersaPump Infusion System are identical to the components used as part of the EMED SCIg60 Infusion System previously cleared by the FDA. Therefore, this submission contains safety and effectiveness data only for the VersaPump Infuser when used as a system utilizing the following commercially available syringes not sold or distributed by EMED:

• 20 mL BD syringe (model no. 302830)
• 20 mL Hizentra Prefilled Syringe (NDC 44206-458-96)
• 30 mL BD syringe (model no. 302832)
• 30 mL B. Braun syringe (model no. 4617304F)
• 35 mL Monoject syringe (model no. 1183500777 or 8881535762)

For the VersaPump to operate as a system, the flow rate controller (Infuset™ fixed flow rate control infusion set or VersaRate Plus ™ variable flow rate control infusion set) is connected to one of the above syringes via the Luer Lock. The patient administration set is then connected via Luer Lock connector to the flow controller. The patient administration set provides one or more needles that can be placed into subcutaneous tissue for the infusion. Depending on the number and gauge of the needle(s), and the selection/setting of the flow controller, the desired flow rate is provided. The VersaPump User Manual provides information on flow rates obtainable with various combinations of the VersaPump, EMED flow rate controllers, subcutaneous administration sets, and biologics.

The provided FDA 510(k) summary for the VersaPump Infusion System (K230883) does not contain the detailed acceptance criteria for the device's specific performance parameters (like flow rate accuracy) or the comprehensive study data that directly proves the device meets those criteria.

Instead, it provides:

• A comparison of technological characteristics with a predicate device (EMED SCIg60 Infusion System, K222087).
• Statements about conducted performance tests and adherence to standards.
• A claim that the device provides infusion rates consistent with FDA approved immunoglobulin labeling.

Therefore, much of the requested information regarding specific acceptance criteria and the detailed study results to prove those criteria are met is not explicitly available in the provided text. The document refers to "performance testing" and "bench testing" but does not elaborate on the specific methodologies, sample sizes for test sets, ground truth establishment, or expert involvement for those tests.

However, I can extract and infer some information based on the provided text, particularly from the "Table 2: Comparison of Technological Characteristics with the Predicate" and the accompanying notes.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the closest we can get to "acceptance criteria" and "reported device performance" are the comparative specifications for the flow rate accuracy and vertical sensitivity, which are compared against the predicate device. The document implies that the "acceptance criteria" for the subject device are met if its performance is similar to or within acceptable limits compared to the predicate, and consistent with the indicated immunoglobulin manufacturer recommendations.

The document states: "Worst-case flow rate tolerances for the VersaPump Infusion System (up to ±40%) are within the worst-case flow rate tolerances of the predicate SCIg60 Infusion System (up to ±41%). Therefore, any differences in flow rate performance for specific system configurations are minor (i.e., fall within the predicate's maximum tolerance and the immunoglobulin administration limits) and do not raise different questions of safety or effectiveness of the device when the VersaPump Infusion System is used as intended." This statement implies that meeting or falling within the predicate's established tolerance (or the immunoglobulin administration limits) serves as the de facto acceptance criterion for flow rate accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The document states "rigorously tested during bench testing" for flow rate performance and "bench top performance testing was conducted" for vertical sensitivity. However, it does not specify the sample size (e.g., number of tests, number of devices tested, number of infusion runs) used for these test sets.

The data provenance is bench testing, meaning it was conducted in a laboratory setting, not on patient data. There is no indication of country of origin for this testing, but it's typically performed by the manufacturer or contracted labs. The testing appears to be prospective in the sense that it was conducted specifically to support this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For this type of mechanical infusion pump, "ground truth" and "expert evaluation" (in the sense of medical professionals diagnosing or assessing images/patient data) are not typically used for these performance metrics (flow rate, mechanical life, drop testing). The ground truth for these engineering tests is established by calibrated measurement instruments and engineering specifications.

The document does mention "Usability Evaluation" and "Human Factors Validation Testing." While these types of evaluations could involve experts (e.g., human factors specialists, nurses, doctors), the document does not specify the number or qualifications of any experts involved in establishing ground truth for these usability aspects or for interpreting the general performance test results.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" (two readers agree, third is tie-breaker) are relevant for subjective assessments, often in imaging studies. For the objective performance tests (flow rate accuracy, life cycle, drop test, biocompatibility) described, performance is measured against established engineering specifications or standards, not through adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a mechanical infusion pump, not an AI algorithm. Therefore, this concept is not applicable. The "performance data" presented relates to the physical and mechanical operation of the device itself.

7. Type of Ground Truth Used

For the performance tests described (Flow Rate Characterization, Life Cycle, Drop Test, etc.), the ground truth is based on engineering specifications, calibrated measurements, and adherence to relevant industry standards (e.g., against a known reference flow rate, number of cycles, impact resistance, or biocompatibility standards). For biocompatibility, it's adherence to EN ISO 10993-1. For flow rate, it would be a reference measurement from a calibrated flow meter.

8. Sample Size for the Training Set

Not applicable. The device is a mechanical infusion pump, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a mechanical device, there is no ground truth establishment for a training set.

Ask a specific question about this device

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)

Ask a specific question about this device

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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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 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.

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 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.

The provided text describes a 510(k) submission for the SCIg60 Infusion System, primarily to expand its indications for use to include Gammagard and Cuvitru in addition to Hizentra. The document focuses on demonstrating that the device's performance with these new indications is substantially equivalent to its performance with the predicate indication (Hizentra) and aligns with the drug manufacturers' recommended infusion rates.

The acceptance criteria for this device are implicitly tied to maintaining the safety and effectiveness of the infusion system, specifically its ability to deliver the indicated human plasma-derived immunoglobulin solutions at appropriate flow rates. The study proving the device meets these criteria is a performance testing study, summarized within the "Summary of Performance Testing" section.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are not explicitly stated as quantitative thresholds (e.g., "flow rate must be within +/- X% of target"). Instead, the acceptance is based on the device's ability to achieve flow rates that are consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed.

The reported device performance is demonstrated through tables that specify:

• Needle Gauge
• Number of needles
• Total Flow Rate (ml/hr)
• Approx. Per Site Flow Rate (ml/hr)
• Infuset™ Reorder Number
• SUB-Q Set

These tables are provided for:

• Hizentra (First Infusion and Standard Infusions)
• Gammagard (Initial Infusion for patients =40kg; Maintenance Infusions for patients =40kg)
• Cuvitru (First 2 Infusions and Subsequent Infusions)

The "reported device performance" is the achievement of these specific flow rates for various configurations, which are then stated to be consistent with the respective drug manufacturers' recommendations.

Example Excerpt for Hizentra (Standard Infusions) as an illustration of reported performance:

The general acceptance criterion is that the device, when used with the specified Infuset and SUB-Q sets, delivers flow rates that fall within the ranges published by the drug manufacturers for the given immunoglobulin solutions. The full set of tables across pages 6-10 represents the reported performance data that meets this criterion.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes (e.g., number of tests, number of devices tested) for the infusion flow rate testing. It mentions "Infusion flow rate testing with SCIg60 Infusion System and indicated human plasma-derived immunoglobulin solutions" and "Infusion flow rate testing with combinations of SCIg60 Infuser. Infuset 100 extension sets, and . SUB-Q patient administration sets with simulated test fluid."

Given this is a 510(k) submission, the data provenance is likely from laboratory testing conducted by the manufacturer (EMED Technologies Corporation) in the USA, and it would be prospective for the specific tests performed to support this submission. However, some data (e.g., reliability, biocompatibility, sterility, shelf life) were "incorporated by reference to data from K142319," which means they were likely established during the predicate device's clearance and are thus retrospective in the context of this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (number and qualifications of experts) is typically relevant for studies involving human interpretation (e.g., image reading). For this device, which performs a mechanical function (fluid infusion), the "ground truth" is based on engineering specifications and established fluid dynamics principles (Poiseuille equation) along with the manufacturer-recommended infusion rates for the pharmaceutical products. There is no indication of "experts" in the sense of human adjudicators for the test set results; rather, the "ground truth" is adherence to known physical laws and pharmaceutical labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No human adjudication method is mentioned or relevant for this type of performance testing. The "adjudication" is based on direct measurement of flow rates and comparison against established product specifications.

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

An MRMC study is not relevant to this device. This is a medical device (infusion pump), not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to the performance of the infusion system itself (the "algorithm" in this context is the mechanical and fluid dynamic operation), without direct human-in-the-loop performance influencing the measurement of its function. The "Infusion flow rate testing" described is indeed a standalone performance test of the device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for this performance study is based on:

• Engineering principles and physical laws: The flow control properties follow the Poiseuille equation.
• Manufacturer specifications for the device: The design, materials, and functionality of the SCIg60 Infuser, Infuset, and SUB-Q sets.
• Pharmaceutical product labeling: The "manufacturer-recommended total flow rates of the additional indicated immunoglobulin biologics" (Hizentra, Gammagard, Cuvitru) serve as the target "ground truth" for the flow rate performance.

8. The sample size for the training set

This concept (training set) is typically applicable to machine learning or AI models. The SCIg60 Infusion System is a mechanical device, not an AI. Therefore, there is no "training set" in the context of artificial intelligence. Its design and performance are based on engineering principles and testing.

9. How the ground truth for the training set was established

As there is no training set for an AI model, this question is not applicable. The "ground truth" for the device's design and expected performance (as mentioned in point 7) is derived from established scientific and engineering principles, and the specific requirements of the drug products it is designed to administer.

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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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