(243 days)
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.
| Parameter | Acceptance Criteria (Inferred from Predicate/Notes) | Reported Device Performance (VersaPump Infusion System) |
|---|---|---|
| Flow Rate Accuracy (%) | Within the predicate's worst-case flow rate tolerances (±41%). Consistent with immunoglobulin administration limits. | Worst-case: ±30% (Overall system performance, ±30-40% for specific configurations) - Noted as similar to predicate's ±41% |
| Vertical Sensitivity | Similar to predicate's "Up to +6% from target flow rate / Up to -4% from target flow rate" | Up to +5% from target flow rate / Up to -5% from target flow rate (at ±12") - Noted as similar to predicate |
| Useful Life | Adequate useful life to infuse intended fluids (predicate: 4,200 cycles) | 2,000 cycles (Equivalent to 5.5 years if used daily, or 19 years if used twice weekly) - Noted as adequate and not raising new safety questions |
| Infuser Max Force | No explicit acceptance criterion, but difference from predicate ($15.75$ lbf) evaluated. | 36 N (8 lbf) - Performance testing confirmed this difference does not impact safety/effectiveness. |
| Biocompatibility | Acceptable for intended use, in accordance with EN ISO 10993-1. | Evaluated and acceptable for intended use. |
| Design Verification (General) | Meets essential performance requirements, mitigated potential risks. | Visual/Functional, System Flow Rate Characterization, Life Cycle, Drop Test, Cleaning, Usability Evaluation tests performed. |
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.
§ 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).