(50 days)
The Lockbox is intended to hold a Medfusion™ 3000 Series Syringe Pump and provide reasonably secure access to the medication syringe contained within.
The Lockbox is an accessory to the Medfusion™ 3000 Series Syringe Pump. It is a lockable, plastic enclosure for the pump when the pump is loaded with a commercially available syringe containing medication. The Lockbox may be attached to an IV pole with the Pole Mount Bracket or with modification to a horizontal square rail.
The provided text describes a 510(k) submission for a medical device called "Lockbox for Medfusion™ 3000 Series Pumps". This device is a lockable plastic enclosure for an infusion pump and is primarily evaluated based on its physical properties and biocompatibility, not on AI or diagnostic performance metrics. Therefore, many of the requested categories for AI-based device evaluation are not applicable.
Here's an analysis of the available information:
Acceptance Criteria and Study Details for "Lockbox for Medfusion™ 3000 Series Pumps"
Given the nature of the device (a physical lockbox accessory for an infusion pump), the acceptance criteria and study methods differ significantly from those typically used for AI/diagnostic devices. The focus is on physical suitability, safety (biocompatibility), and achieving its stated intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Physical Suitability | Ability to securely hold the Medfusion™ 3000 Series Syringe Pump. | Confirmed through bench testing. |
| Ability to provide reasonably secure access to the medication syringe. | Confirmed through bench testing. | |
| Compatibility with various mounting options (IV pole, horizontal square rail). | Demonstrated (implicitly through design description and intended use). | |
| Biocompatibility | Materials of construction are biocompatible; no adverse biological reactions expected. | Assessed. Device is biocompatible based on similarity to other marketed devices from Smiths Medical MD, Inc. |
| Usability | Ergonomics and ease of use in its intended environment. | Evaluated through Usability Studies. |
| Structural Integrity | Durability and robustness under normal conditions of use. | Evaluated through Bench Testing. |
| Dimensional Conformance | Correct fit with the Medfusion™ 3000 Series Syringe Pump. | Evaluated through Bench Testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of a specific number of units for bench testing or usability studies.
- Data Provenance: The testing was "non-clinical" and involved "Bench Testing" and "Usability Studies." This suggests in-house testing performed by Smiths Medical MD, Inc. No information regarding country of origin for data or whether it was retrospective/prospective is provided, as it's not relevant for this type of device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable in the context of this device. The "ground truth" for a physical lockbox relates to its mechanical function, security, and material science, which are typically assessed by engineers and materials scientists rather than medical experts in a diagnostic "ground truth" sense.
4. Adjudication Method for the Test Set
- Not applicable. The evaluation of physical properties and usability does not involve an adjudication method like those used for diagnostic decisions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. The Lockbox is a physical accessory, not a diagnostic tool or something that directly influences human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm or AI component in the Lockbox device. Its "performance" is entirely physical and mechanical.
7. The Type of Ground Truth Used
- The "ground truth" was established based on engineering specifications, material science principles, and functional requirements for a secure enclosure. For biocompatibility, it was based on similarity to established biocompatible materials used in other Smiths Medical products.
8. The Sample Size for the Training Set
- Not applicable. There is no AI model or algorithm that required a "training set" for this device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).