(73 days)
The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, are indicated for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-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 AutoFuser pump (Continuous type Silicone Balloon) provides continuous fluid delivery with attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
The AutoFuser pump family includes models of the standard AutoFuser with the addition of a Patient Medication Control Module (PCM). The Patient Medication Control Module allows the patient to administer a bolus of fixed volume with a fixed lockout (re-fill) time.
The pump is a disposable device intended for single patient use. The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
The AutoFuser and the AutoFuser PCM pumps are substantially similar to the I-Flow Homepump (Eclipse) C-Series (included in the I-Flow PainBuster kit and the On-Q pain management kit), the Baxter Infuser and Intermate, the McKinley Accufuser, and the B Braun spring pump (used in the Sgarlato pain kit).
The AutoFuser and the AutoFuser PCM pumps have fill volumes and flow rates substantially similar to the pumps of the McKinley Medical Accufuser, the I-Flow PainBuster (Homepump Eclipse C-Series), the B Braun spring pump included in the Sgarlato PCIP, and the Baxter Infusor and Intermate pumps.
The AutoFuser and AutoFuser PCM pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.
The provided text is a 510(k) premarket notification for a medical device called the "AutoFuser Elastomeric Infusion Pump." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics, ground truth, or statistical analyses common in AI/ML device studies.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be directly extracted or inferred from this document.
However, I can provide the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for an elastomeric infusion pump, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and meeting general device requirements rather than specific performance metrics like sensitivity, specificity, or accuracy (which are common for diagnostic AI/ML devices). The document states the device is "substantially similar" to predicate devices in several aspects.
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: General infusion use, routes, and pain management. | The AutoFuser and AutoFuser PCM pumps have the same intended use as predicate devices like the I-Flow Homepump (Eclipse) C-Series, Baxter Infuser and Intermate, McKinley Accufuser, and B Braun spring pump. |
| Design/Functionality Equivalence: Continuous fluid delivery, fixed flow rates, silicone balloon reservoir, optional patient-controlled bolus (PCM). | The AutoFuser pump provides continuous fluid delivery with attached, fixed rate administration set. A silicone balloon is used as both the fluid reservoir... and the pressure (energy) source. The AutoFuser PCM allows patient to administer a bolus of fixed volume with a fixed lockout (re-fill) time. |
| Specifications Equivalence: Fill volumes and flow rates. | The AutoFuser and AutoFuser PCM pumps have fill volumes and flow rates substantially similar to pumps of the McKinley Accufuser, I-Flow PainBuster (Homepump Eclipse C-Series), B Braun spring pump, and Baxter Infusor and Intermate. |
| Flow Control Mechanism Equivalence: Use of glass orifice or PVC tubing. | The AutoFuser and AutoFuser PCM pumps use either a glass orifice or PVC tubing to control the flow rate, similar to identified predicate devices. |
| Biocompatibility: Fluid path materials conformance to ISO 10993 Part 1. | All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1. |
| Disposability: Single patient use. | The pump is a disposable device intended for single patient use. |
| Ambulatory Suitability: Use in various environments. | The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document does not describe a clinical study with a test set in the way an AI/ML device submission would. The submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparison of design, functionality, materials, and intended use. Performance testing related to flow accuracy and other physical parameters would have been conducted by the manufacturer, but the details (sample size, data provenance) are not part of this summary.
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 / Not Provided. This type of information is relevant for studies validating diagnostic algorithms against expert consensus or pathology. For an infusion pump, "ground truth" would relate to precise fluid delivery, which is typically measured mechanically or chemically, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are used in studies involving subjective expert review, typically in diagnostic or qualitative assessments. This is not relevant for the type of device and submission described.
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
- Not Applicable / Not Provided. MRMC studies are specific to evaluating diagnostic systems, particularly those that involve human interpretation assisted by AI. The AutoFuser is an infusion pump, a therapeutic device, and does not involve "human readers" or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This question is also focused on AI/ML algorithms. The AutoFuser is a mechanical/elastomeric device, not an algorithm. Its performance is inherent to its design and manufacturing, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided (for the document content). For an infusion pump, "ground truth" for performance would be established through engineering and bench testing. This would involve precise measurements of flow rate, fill volume, pressure, and material compatibility against established standards and specifications. The document states "All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1," indicating adherence to material safety standards. However, the details of flow rate accuracy testing are not described in this summary.
8. The sample size for the training set
- Not Applicable / Not Provided. This refers to AI/ML model training data. This device is not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This refers to AI/ML model training data. This device is not an AI/ML product.
§ 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).