(78 days)
The AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.
The AutoDose Infusion System is a general use infusion system that is intended to infuse intravenous solutions of predetermined volumes in an order based on the AutoDose Bag configuration. It is intended that this system will infuse multiple intravenous solutions of predetermined volumes without user interaction. The system is comprised of the AutoDose, a mechanical roller device design in conjunction with the AutoDose Bag, a multiple chambered IV container, and the AutoDose Bag Administration Set. The single use multiple chambered IV container is designed to fit within the reusable AutoDose device with the end user pushing a start button once the AutoDose Bag Administration Set has been connected to the patient's indwelling access device. The AutoDose Bag Administration Set size will determine the system flow rate and will be offered in rates of 50 ml/hr, 100 ml/hr, and 200 ml/hr.
It is intended that the AutoDose Bag be provided empty and sterile to the end user. The AutoDose Bag can then be appropriately filled on the order of a physician by a pharmacy. The filling of the AutoDose Bag is performed using standard procedures, equipment and the AutoDose Filling Fixture. The AutoDose Filling Fixture is a tool developed to hold the AutoDose Bag for the pharmacist during the filling process. A clamp is automatically activated by the AutoDose Filling Fixture to securely close the bag after it has been filled.
The AutoDose Infusion System has been designed to simplify user interaction in the administration of multiple solutions safely with a reduction of a number of steps and a number of supplies typically used by healthcare providers.
The AutoDose Bag and the AutoDose Bag Administration Set will be sterilized per AAMI guidelines to a 10 6 sterility assurance level (SAL). Pyrogenicity will be LAL assessed per production lot in accordance with USP guidelines.
The provided text describes the AutoDose Infusion System and its premarket notification, but it does not contain the detailed acceptance criteria or the full study report that would enable a comprehensive description of how the device meets all acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the AutoDose Infusion System was evaluated to verify it met product specifications. It lists key performance characteristics that were tested.
| Acceptance Criteria (Product Specifications) | Reported Device Performance |
|---|---|
| Average Flow Rate | Performed to requirements |
| Flow Rate Accuracy | Performed to requirements |
| Maximum Infusion Pressure | Performed to requirements |
| Residual Volumes | Performed to requirements |
Missing Information: The specific quantitative acceptance criteria (e.g., "Flow Rate Accuracy ±5%") and the exact measured performance values are not provided in this summary. The document only states that the device "performed to the requirements in the specifications."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that "The AutoDose, AutoDose Bag and AutoDose Administration Set was tested". However, it does not specify the sample size used for this testing (e.g., number of units, number of tests performed).
Data Provenance: The study was conducted at the "Final Design Phase" by the manufacturer, Tandem Medical, Inc. This indicates it was an internal validation study and likely prospective, as it was done to verify product specifications before market release. The country of origin is Tandem Medical, Inc.'s location: San Diego, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is an infusion system, and its performance is evaluated against engineering specifications (e.g., flow rate, pressure) rather than subjective human assessment requiring expert consensus on a 'ground truth'. The "ground truth" here is the objective measurement of device output against predefined engineering and performance standards.
4. Adjudication Method for the Test Set
This is not applicable for a device that relies on objective physical measurements against engineering specifications. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device. MRMC studies are used to evaluate the impact of a new diagnostic technology on human reader performance, typically in fields like medical imaging. The AutoDose Infusion System is a therapeutic device with objective performance metrics.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The performance data discussed (Average Flow Rate, Flow Rate Accuracy, Maximum Infusion Pressure, Residual Volumes) refers to the standalone performance of the AutoDose Infusion System. The system's design is described as "simplifying user interaction" and infusing "without user interaction" once initiated, suggesting its performance is primarily intrinsic to the device's mechanics and design. The testing would therefore be focused on the device's ability to meet its specifications independently.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the AutoDose Infusion System is based on objective engineering and product specifications. This involves direct measurement of physical parameters like flow rate, pressure, and residual volumes using appropriate calibration and measurement equipment.
8. Sample Size for the Training Set
This information is not applicable in the context of the provided document. The AutoDose Infusion System is a mechanical device, not an AI/machine learning algorithm that requires a "training set" of data. The "design phase" would involve engineering and prototyping, possibly with iterative testing, but not in the sense of an ML training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this type of mechanical medical device.
§ 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).