(148 days)
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.
The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.
When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:
The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.
The proposed device consists of a single-use disposable elastomeric infusion pump, designed to deliver medication/fluids at a constant flow rate, and a microcatheter for fluid delivery. The device is intended for use in tissue, and is not intended for use in intravascular, epidural or intrathecal modes of delivery. Delivery of medication is achieved via an elastomeric reservoir that maintains relatively constant pressure, forcing solution through a 0.2μ filter and into the associated microcatheter assembly. The device will be provided as a convenience kit.
The provided text describes the SEMPERFLO Infusion System and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It states that "functional performance testing (bench and animal testing) have been submitted" and "These results indicate that the proposed device meets or exceeds all functional requirements," but it does not provide the specifics of those tests, the acceptance criteria used, or the performance results in a quantifiable manner.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to answer as much as possible based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility: Acceptable per ISO 10993-1. | Material found to be acceptable for its intended use. |
| Functional Performance: Meets or exceeds all functional requirements. | Device meets or exceeds all functional requirements (details of requirements and specific performance values are not provided in this summary). |
| Flow Rate: Constant flow rate. | Designed to deliver medication/fluids at a constant flow rate. (Specific flow rate range or deviation from nominal is not provided). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document. The document mentions "bench and animal testing" but does not give sample sizes for these tests.
- Data Provenance: Not explicitly stated for specific test data, but the submission is from Ethicon, Inc., a Johnson & Johnson Company, based in Somerville, NJ, USA. The testing likely occurred in a controlled lab or animal setting. The nature of the testing implies prospective data collection for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. The document does not describe a study involving expert assessment of outcomes or image interpretation. The testing focuses on device function and material properties.
4. Adjudication method for the test set
- Adjudication method: Not applicable/Not specified. This typically applies to studies where human interpretation (e.g., of medical images) requires consensus. For functional device testing, "ground truth" is typically established by direct measurement against engineering 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
- MRMC Study: No, an MRMC study was not done. This device is an infusion system, not an AI-powered diagnostic tool requiring human reader interpretation. The document does mention "The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management," but it does not present a comparative effectiveness study with human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The SEMPERFLO Infusion System is a physical medical device, not an algorithm. Its performance is inherent to its design and function, not an AI algorithm.
7. The type of ground truth used
- Ground Truth: For material compatibility, it was "methods specified in ISO Standard 10993-1." For functional performance, it would be engineering specifications and pre-defined acceptance criteria for flow rates, material integrity, sterility, etc., as determined by the manufacturer's R&D and QA processes.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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).