(118 days)
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites.
Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.
Here's an analysis of the provided text regarding the Ace Medical Autofuser System (K060258), broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria for the device's performance (e.g., "flow rate must be within X% of target"). Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Risk Control Measures | Verified and/or validated as appropriate. |
| Design Verification (General) | Results demonstrate that the predetermined acceptance criteria were met. |
| Design Validation (General) | Results demonstrate that the predetermined acceptance criteria were met. |
| Substantial Equivalence (Overall) | The modified device is substantially equivalent to the cleared original device (K041585). |
| Safety and Efficacy Concerns | The modified Autofuser system does not raise any new safety and efficacy concerns when compared to the original Autofuser device. |
| Kit Components | Legally marketed (pre-amendment, exempt, or substantially equivalent through PN process). Substantially equivalent to components in predicate pain management kits. |
From the text, "The design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met," implies that internal criteria were established and achieved, but the specific metrics are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on modifications to an existing device and demonstrating substantial equivalence through design verification and validation, rather than a clinical study with a patient-based test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation appears to be based on engineering verification and validation of the device's performance against internal specifications and comparison to predicate devices, not on expert consensus regarding clinical outcomes.
4. Adjudication Method for the Test Set
As no test set involving human assessment or expert review is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. This submission is for modifications to an elastomeric infusion pump, which typically does not involve this type of study design. The focus is on the device's mechanical and functional performance, not on human interpretive tasks that would benefit from MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an elastomeric infusion pump. There is no "algorithm only" or "standalone" performance described in the context of AI or software. The performance assessed would be the physical pumping mechanism and its ability to deliver fluids at specific rates.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is implicit in its design specifications and functional requirements. For example, a target flow rate, reservoir size, and bolus delivery mechanism. The document states that "design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met." This implies the ground truth was based on engineering specifications and established performance benchmarks for infusion pumps, not on pathology, outcomes data, or expert consensus in a clinical sense.
8. Sample Size for the Training Set
As this is a submission for a medical device (an elastomeric infusion pump) and not an AI/ML algorithm that requires a training set, the concept of a "training set" does not apply to this document.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI/ML algorithm for this device, information on how its "ground truth" was established is not applicable.
§ 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).