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510(k) Data Aggregation
(82 days)
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery.
The Accufuser and Accufuser Plus systems are also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an 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 Accufuser/Accufuser Plus pump and administration set are intended for single patient use.
The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.
The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.
This is a 510(k) premarket notification for an elastomeric infusion pump. There is no information in this document about a study that used a test set, human readers or ground truth as this is not applicable for this kind of device. The document mostly focuses on the substantial equivalence to predicate devices and the device's specifications.
Here's the relevant information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (from device specifications) | Reported Device Performance (from device specifications) |
|---|---|---|
| Accuracy | ||
| 60 ml Reservoir | +/- 10% of nominal flow rate at 95% confidence interval | +/- 10% of nominal flow rate at 95% confidence interval |
| 100 ml Reservoir | +/- 10% of nominal flow rate at 95% confidence interval | +/- 10% of nominal flow rate at 95% confidence interval |
| 275 ml Reservoir | +/- 15% of nominal flow rate at 95% confidence interval | +/- 15% of nominal flow rate at 95% confidence interval |
| 550 ml Reservoir | +/- 15% of nominal flow rate at 95% confidence interval | +/- 15% of nominal flow rate at 95% confidence interval |
| Operating Pressure | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 5 to 6 psi |
| System Residual Volume | < an explicitly stated value (implied "as low as possible") | < 3 ml (includes tubing and reservoir) |
| Operating Temperature | Calibrated to deliver at 32°C / 89.6°F. (Effect: Flow rate increases approximately 1% per 1°F / 0.56°C increase in temperature.) | The Accufuser and Accufuser Plus systems are calibrated to deliver solution at the labeled nominal flow rate when the temperature of the infusate in the flow restrictor (distal end) is 32° C / 89.6°F (normal skin temperature). Flow rate increases approximately 1% per 1°F / 0.56°C increase in temperature. |
| Fluid Viscosity | Calibrated using 5% Dextrose in Water (D5W). (Effect: Flow rate increases as fluid viscosity decreases.) | The Accufuser and Accufuser Plus systems are calibrated using 5% Dextrose in Water (D5W) as the infusate. Flow rate increases as fluid viscosity decreases. (E.g., Using sterile water as diluent will increase the flow rate by approximately 10%.) |
| Head Height | Calibrated with zero head height. (Effect: Increased head height will cause increased flow rate.) | The Accufuser and Accufuser Plus systems are calibrated with zero head height. Increased head height will cause increased flow rate. (E.g., +43 cm / +17" of head height will increase flow rate by approximately 12%.) |
| Material Conformance | Conformance with ISO 10993 Part 1 for fluid path materials. | All fluid path materials of the Accufuser/Accufuser Plus system are in conformance with ISO 10993 Part 1. |
| Sterilization | ETO sterilization (packaging suitable for it, and it's a validated method). | Packaging is suitable for ETO sterilization. ETO is the validated sterilization method. |
| Reservoir Volume Range | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 60 ml to 550 ml |
| Flow Rate Range | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 0.5 ml/hr to 10.0 ml/hr |
| Bolus Levels | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 0.5 ml, 1.0 ml and 2.0 ml |
| Lockout Times | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 6 minutes to 60 minutes and include increments of 6, 8, 15, 30 and 60 minutes. |
2. Sample size used for the test set and the data provenance:
- This device is an elastomeric infusion pump. The provided document is a 510(k) summary for a submission in 2002. It does not describe a clinical study involving a "test set" of patient data in the context of AI/software performance.
- The performance criteria are related to the physical and functional characteristics of the pump (e.g., flow rate accuracy, residual volume). The "study" referenced would involve laboratory testing and engineering verification, not clinical data sets.
- Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) as it relates to AI/software is not applicable and not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study assessing AI performance or diagnostic accuracy based on expert interpretation of data. The ground truth for device performance (e.g., flow rate) would be established by validated measurement equipment and engineering standards.
4. Adjudication method for the test set:
- Not applicable, as this is not a study involving human adjudication of results from a test set.
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. This document pertains to an elastomeric infusion pump, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, an infusion pump, and does not involve standalone algorithm performance in the context of AI.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by validated engineering measurements and testing. For example, flow rate accuracy would be determined by precisely measuring the volume of fluid delivered over a specific time under controlled conditions, comparing it to the nominal (labeled) flow rate. Similarly, residual volume would be measured post-infusion. Calibration standards and metrology provide the "ground truth" for these physical properties.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a "training set." Device design and validation are based on engineering principles and testing.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
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