(106 days)
The Syringe•Mate System is indicated for patients requiring slow, continuous intravenous, epidural, or subcutaneous administration of medications.
The new device consists of a line of Syringe•Mate System infusion pumps which will be manufactured with three different fixed, flow rates: *One Day Syringe•Mate System (4.2 mL/hr) *Five Day Syringe®Mate System (0.8 mL/hr) *Seven Day Syringe . Mate System (0.6 mL/hr)
The provided text describes a 510(k) premarket notification for the Syringe•Mate System. It focuses on demonstrating substantial equivalence to predicate devices based on material composition, overall design, and intended use. The document includes a summary of nonclinical tests but does not provide specific acceptance criteria or a detailed study report that proves the device meets those criteria in the format requested.
Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological and Chemical Reactivity | Biological methods specified in ISO 10993-1 and USP Physicochemical tests acceptable for intended use. | Materials found to be acceptable for their intended use. |
| Functional Performance (Flow Rate) | Not explicitly stated (e.g., within X% of target flow rate) | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
| Functional Performance (Residual Volume) | Not explicitly stated | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
| Functional Performance (Pressure Relief Valve) | Not explicitly stated | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified. It's likely internal testing by Baxter Healthcare Corporation, but a country of origin or retrospective/prospective nature is not mentioned.
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. This device is a medical pump, not an AI/diagnostic device that requires expert-established ground truth for image/data interpretation. The testing focuses on physical and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
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. This is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The performance testing is analogous to "standalone" in that it assesses the device's inherent function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biological/chemical tests: Compliance with ISO 10993-1 and USP Physicochemical tests serves as the "ground truth" or standard.
- For functional tests (flow rate, residual volume, pressure relief valve): Presumably, the engineering specifications and design requirements for these parameters serve as the "ground truth" against which performance is measured.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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).