(90 days)
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.
The Z-800 Infusion System consists of the infusion pumps and approved external IV administration sets. The major modifications are as following: 1. Added a counter in software for cumulative volume of fluid infused in order to monitor pump utilization. The odometer feature enables pump display a reminder for user to service the pump once a preset volume limit is reached. 2. Implemented optional set based free flow protection. Modified set based free flow protection mechanism consists of a proprietary pinch clamp on the standard IV set tubing and an optional spring loaded clamp holder module on the pump. The pinch clamp can be manually opened for priming. The clamp holder is designed such that the pinch clamp is automatically closed once it is loaded into the clamp holder. Upon pump door close, the pump door activates the pinch clamp loaded in the clamp holder to open to allow flow go through. Upon pump door open, the spring in the clamp holder forces the pinch clamp to close. When the IV set is removed from the pump, the pinch clamp remains at closed position to avoid unintended free flow. A sensor on the clamp holder detects presence of the pinch clamp. "No Clamp" status can be displayed on pump screen to inform user that the clamp is absent. 3. Implemented optional Wi-Fi communication module for serial port to enable bidirectional communication through RF signal. A self-contained serial Wi-Fi convertor module is embedded into the Z-800 infusion pump to enable wireless communication. The Z-800 infusion pump sends serial command to the Wi-Fi convertor module. The Wi- Fi convertor module translates the serial communication command from the Z-800 infusion pump to RF signals and responsible for handling communication protocol with external devices. The serial Wi-Fi convertor enables the user to initiate a query on the pump for external information by entering partial patient identifier information as search criteria. External information returned from the query may include patient information, such as name, date of birth, and IV medication order. The patient and order information are presented to the healthcare professional during infusion programming process to be confirmed for association with the infusion. The Wi-Fi convertor also enables Z-800 infusion pump to publish infusion status data, with the associated patient and order identifiers, which can be utilized by external systems such as EMR. 4. Added an ESD/EMI shielding cap for serial port to enhance pump survivability under injection of Electromagnetic noise and Electrostatic Discharge. 5. Optimized pressure sensor zero point value determination process for better accuracy. 6. Optimized peristaltic plate to maximize durability of peristaltic module. 7. Optimized peristaltic cams in peristaltic module to maximize its durability. 8. Optimized rubber feet for increased durability.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for a Special 510(k) Device Modification for the Z-800 Infusion System. It focuses on device changes and comparison to a predicate device, rather than a clinical study with detailed performance metrics and ground truth establishment.
However, I can extract the general performance parameter for flow rate accuracy, which serves as an implicit acceptance criterion based on its comparison to the predicate device.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
Based on the "Equivalency Matrix," the primary performance parameter stated is Flow Rate Accuracy.
| Acceptance Criteria (Stated Performance of Predicate Device) | Reported Device Performance (Z-800 Infusion System with Odometer) |
|---|---|
| $±5%$ Flow Rate Accuracy | $±5%$ Flow Rate Accuracy |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes engineering modifications and an equivalency comparison, not a detailed clinical study with a test set.
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)
This information is not provided in the document. The type of device (infusion pump) typically relies on engineering and laboratory testing for performance validation, not expert-based ground truth for a test set in the way a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is an infusion pump, which does not involve "human readers" or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document in the context of a "standalone" performance study for an AI algorithm. The device itself is a standalone infusion pump, and its performance (e.g., flow rate accuracy) would have been evaluated independently in engineering tests, but these details are not given here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For flow rate accuracy, the ground truth would be established through metrology and calibrated reference standards in a laboratory setting. This is implied by the nature of the device and the performance metric, but not explicitly stated as "ground truth" using those terms within the document.
8. The sample size for the training set
This information is not provided in the document. The document describes modifications to an existing medical device, not the development and training of a new AI algorithm where a "training set" would be relevant. The "optimization" mentioned (e.g., pressure sensor, peristaltic plate/cams) would typically involve engineering design iterations and testing, not machine learning training.
9. How the ground truth for the training set was established
This information is not provided in the document, as there is no mention of a "training set" in the context of AI or machine learning.
§ 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).