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510(k) Data Aggregation
(88 days)
The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.
The Bolus Accessory may connect to any positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed.
The provided document describes the I-Flow Bolus Accessory Set, a mechanical device intended to deliver fixed boluses of medication. The primary focus of the document is on the specifications and equivalence to previously marketed devices (510(k) submission).
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified refill times. | All models performed within the specified accuracy when tested at nominal conditions. (This is the reported performance for the Bolus Accessory based on testing at standard operating conditions). |
| Priming/Residual Volume: <= 0.75 ml | Not explicitly stated as an "acceptance criterion" in a pass/fail format, but listed as a "Standard Operating Condition" with a value of "≤ 0.75 ml". The document does not explicitly state that the device "met" this, but lists it as a specification. |
| Operating Temperature: 88 ± 2°F (skin temperature) | Not explicitly stated as an "acceptance criterion" or "met" performance, but listed as a "Standard Operating Condition." |
| Test Solution: Normal saline (0.9% NaCl) | Used for testing (implied by "Test Solution: normal saline (0.9% NaCl )"). |
| Operating Pressure: 8 to 17 psi pressure source | Tested within this range (implied by "Operating Pressure: 8 to 17 psi pressure source"). |
| Head Height: 0" | Tested at this condition (implied by "Head Height: 0""). |
| Biocompatibility: Conformance with ISO 10993 Part 1 for all fluid path components. | Biological testing is in conformance with ISO 10993 Part 1 for all fluid path components. |
| Sterilization: Suitable for gamma radiation (cobalt 60) or ETO sterilization. | The method of sterilization is gamma radiation (cobalt 60). Packaging is suitable for radiation or ETO sterilization. (The document states the method used and the packaging suitability). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only states "All models performed within the specified accuracy when tested at nominal conditions." It does not provide the number of devices tested or the number of boluses delivered during testing.
- Data Provenance: The document does not explicitly state the country of origin. Given the submission to the US FDA, it's highly likely the testing was conducted to US standards, but the specific lab location is not provided. The data is retrospective as it's part of a 510(k) submission for a device already developed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of device and study. The "ground truth" for a mechanical infusion device like the Bolus Accessory is typically established by direct physical measurement (e.g., precise liquid volume measurement for bolus accuracy) using calibrated laboratory equipment, not by human expert consensus or clinical assessment of images/outcomes.
4. Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is established by direct measurement with equipment, there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret and classify medical cases. The Bolus Accessory is a mechanical infusion device, and its performance is assessed by mechanical and accuracy tests, not by human interpretation of its output in a clinical diagnosis context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence, a standalone performance study was done. The described "Performance Data" and "Accuracy" testing are essentially standalone algorithm/device performance evaluations. The device's ability to deliver accurate bolus volumes is measured directly without human intervention in the delivery mechanism or interpretation of its output. The device itself is a mechanical system, not an algorithm in the traditional AI sense, but its performance is evaluated in a standalone manner against its specifications.
7. Type of Ground Truth Used:
- The ground truth used for accuracy and performance testing would be based on direct, calibrated laboratory measurements of physical properties. For example:
- Bolus Volume: Measured using highly accurate volumetric measuring equipment.
- Priming/Residual Volume: Measured volumetrically.
- Biocompatibility: Assessed through laboratory tests following ISO 10993 Part 1 standards.
8. Sample Size for the Training Set:
- Not applicable. This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and engineering are based on principles of fluid dynamics and mechanics, not data-driven training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a mechanical device, there is no ground truth to establish for it.
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