(78 days)
Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets.
For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration
Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.
Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Prepare™ Cartridge:
This 510(k) summary describes a device that is an accessory to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert review are not applicable. The device is a physical cartridge that holds medication, and its evaluation focuses on physical characteristics, biocompatibility, and sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Physical/Technical | ||
| Comparable to Predicate | "Physical and technical characteristics, including materials used in construction, size, intended use, and ability to interface with specified CADD® pumps are comparable." | This is a qualitative statement of comparability to the predicate device, CADD® 1 Medication Cassette Reservoir. No specific quantitative acceptance criteria or performance metrics are provided for general physical/technical aspects beyond the more specific items below. |
| Cartridge Capacity | "Prepare™ Cartridge capacity... are substantially equivalent to the CADD® Administration Set." | Specific capacity value not given, but stated to be substantially equivalent to the predicate. |
| Accuracy of Delivery | "Accuracy of delivery... are substantially equivalent to the CADD® Administration Set." | Specific accuracy metric not given, but stated to be substantially equivalent to the predicate. |
| Volume Delivered per Pump Cycle | "Volume delivered per pump cycle... are substantially equivalent to the CADD® Administration Set." | Specific volume metric not given, but stated to be substantially equivalent to the predicate. |
| Fit to Pump | "Fit to pump are substantially equivalent to the CADD® Administration Set." | Qualitative and comparative. |
| Biocompatibility | ||
| Non-irritating | "Certified as non-irritating" | Meets ISO-10993-1 recommendations. |
| Non-cytotoxic | "Certified as non-cytotoxic" | Meets ISO-10993-1 recommendations. |
| Non-toxic | "Certified as non-toxic" | Meets ISO-10993-1 recommendations. |
| Non-hemolytic | "Certified as non-hemolytic" | Meets ISO-10993-1 recommendations. |
| Non-sensitizing | "Certified as non-sensitizing" | Meets ISO-10993-1 recommendations. |
| Sterility | ||
| Sterilized by Ethylene Oxide Gas | "Sterilized by ethylene oxide gas in a validated sterilization process." | Indicates method and validation. No specific sterility assurance level (SAL) is explicitly stated, but "validated process" implies meeting regulatory requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text for the bench tests. The description only states "The device and the predicate were subjected to various bench tests."
- Data Provenance: Not explicitly stated beyond being "bench tests." It can be inferred that these were laboratory tests conducted by the manufacturer, APPRO Healthcare, Inc. There is no mention of country of origin of data in a clinical sense, nor is it a retrospective or prospective clinical study. These are engineering and laboratory tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is hardware for drug delivery, not an interpretative medical device (like imaging or diagnostics). Therefore, "ground truth" established by human experts in the context of diagnostic accuracy is not relevant here. The "truth" for physical/technical performance, biocompatibility, and sterility is determined by validated test methods and established scientific principles, not expert consensus interpretation of data.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for bench testing of a physical medical device accessory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a physical device accessory, not an AI/ML diagnostic or interpretive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Not applicable. This is a physical non-AI device. There is no "algorithm only" performance to evaluate. The performance described is of the physical cartridge itself in conjunction with the specified infusion pumps.
7. The Type of Ground Truth Used
- Engineering/Laboratory Test Standards and Specifications: The "ground truth" for the performance criteria (capacity, accuracy of delivery, volume, fit) would be derived from the design specifications of the device and established test methods, likely involving measurements against a standard for the predicate device. For biocompatibility, the ground truth is the absence of adverse biological responses as defined by ISO-10993 standards and validated assays. For sterility, it's the successful completion of a validated sterilization process to achieve a specific Sterility Assurance Level (SAL), typically 10^-6.
8. The Sample Size for the Training Set
- Not applicable. This is a physical non-AI device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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).