(163 days)
The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
The Repeater Pump II tube set provides the fluid pathway, pump cavity, valving, and tube set for the Repeater Pump II system. The tube set and pump platform work together to provide sterile transfer and reconstitution of pharmaceutical liquids. The tube set utilizes a plastic piston to mechanically pump required amounts of fluid from 0.2mL to 10mL with each piston stroke. A plastic pump core works in conjunction with the piston to provide appropriate fluid pathways for the draw and discharge strokes. There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.
This is an interesting case where the provided text is a 510(k) summary for a medical device, which means it describes the device itself and its equivalence to a predicate device, but it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study report would. Instead, it lists various types of testing that will be included to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested items regarding specific study methodologies (sample size for test/training sets, data provenance, number of experts, adjudication, MRMC studies, standalone performance) cannot be extracted directly from this document. This summary outlines the plan for testing and the performance characteristics of the device, rather than the results of a conducted study with defined acceptance criteria.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for a study in the form of pre-defined thresholds. Instead, it provides performance specifications for the submitted device and compares them to the predicate device. The implicit acceptance criterion is that the new device performs at least as well as, or better than, the predicate device, especially regarding volume accuracy and pumping life.
It's crucial to understand that for a 510(k) submission, the "study" is often a series of verification and validation activities (testing) to demonstrate substantial equivalence to a predicate device, rather than a single clinical trial with pre-defined primary and secondary endpoints.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & New Device Specs) | Reported Device Performance (New Device) |
|---|---|---|
| Minimum Dispensing Volume | Predicate: 0.2 mL | 0.2 mL |
| Volume Accuracy (0.2-2mL) | Predicate: +/- 10% @ 0.2 mL, +/- 5% @ 0.5 mL, +/- 3% @ 1.0 mL | +/- 0.02 mL |
| Volume Accuracy (>2mL) | Predicate: +/- 3% @ 1.0 mL (implied threshold from predicate) | +/- 1% |
| Maximum Flow Rate | Predicate: Over 14 mL per second at highest speed | Over 21 mL per second at highest speed |
| Pumping Life | Predicate: Up to 150 Liters of fluid | Up to 200 Liters of fluid |
| Sterilization Method | Predicate: Ethylene Oxide (ETO) | Gamma Radiation |
| Calibration Need | Predicate: Frequent calibration and flow factor adjustments normally required with peristaltic pumping (implying need for calibration) | Eliminates the need for frequent calibration and flow factor adjustments |
Study Details (Based on the provided K062909 Summary)
As noted, the document outlines the types of testing that will be included, rather than presenting the results of a specific study with the requested details.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The document is a 510(k) submission from Baxa Corporation in Englewood, CO, USA. The testing listed (Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification, Packaging validation) are general categories of testing typically performed to demonstrate device safety and performance according to U.S. FDA requirements. It is a prospective submission about the device, but the testing itself would be conducted prospectively on manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a device performance verification document, not a diagnostic algorithm. The "ground truth" here would relate to whether the device meets its engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device performance verification.
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 applicable. This device is an IV fluid transfer set, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm separate from its mechanical function. Its performance is inherent to its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be established by engineering and quality standards, such as:
- Precisely measured fluid volumes using calibrated equipment.
- Sterility testing according to established protocols (e.g., absence of microbial growth).
- Biocompatibility testing against recognized standards (e.g., ISO 10993-1).
- Physical strength and leak testing.
- The "ground truth" is adherence to these measurable, objective criteria.
8. The sample size for the training set
- Not applicable. This device does not use an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable as there is no training set for an AI model.
Summary of what the document confirms:
- Device: Repeater Pump II Tube Sets (IV fluid transfer set, Class II device).
- Intended Use: Fluid transfer in hospital pharmacies for repeatable drug dosage distribution and reconstitution.
- Comparison: Substantially equivalent to the Repeater™ Pump Tube Sets (predicate device).
- Key Performance Improvements over Predicate:
- Piston pump methodology (vs. peristaltic) eliminates need for recalibration with different viscosities/flow rates.
- Improved volume accuracy (+/- 0.02mL for 0.2-2mL, +/- 1% for >2mL, compared to +/- 10% for 0.2mL, +/- 5% for 0.5mL, +/- 3% for 1.0mL for predicate).
- Higher max flow rate (over 21mL/sec vs. over 14mL/sec).
- Longer pumping life (200L vs. 150L).
- Sterilized by Gamma Radiation (vs. ETO for predicate).
- Planned Testing: Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation, Disposable Design Verification, Microbial Ingress Validation, System Design Verification, Packaging validation.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.