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The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction of physician or other certified health care professional.

The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids. blood and blood products to a human patient under the direction of physician or other certified health care professional.

The Z-800 Infusion System consists of the Z-800 Infusion Pump and approved external IV administration sets. The scope of this 510K is to qualify CareFusion's blood administration sets (K882302) for use with the currently marketed Z-800 infusion pump system so as to extend the intended use of the Z-800 Volumetric Infusion Pumps to include intravenous administration of blood and blood products. The infusion pump remains the same as currently marketed Z-800 infusion pump, as in the predicated device Z-800 infusion system (K0717545).

The Z-800 infusion system contains the following components:

• The infusion delivery mechanism: Volumetric linear peristaltic pumping mechanism assembly.
• Approved IV administration sets include External IV sets for intravenous parenteral fluid delivery . and for intravenous blood and blood product delivery.
• . User Interface consists of a 128 X 64 dot matrix LCD display; a 14 key membrane keypad; a LED flow rate display; two device status indicator LEDs; power status indicator LEDs (AC & Battery); an audio speaker; an external alarm light accessory; an software alarm handler.
• The embedded software on the main CPU execute an infusion pump state machine, which monitors . the execution of currently programmed infusion as well as a collection of safety related alarm conditions.
• A watchdog timer is set at 50ms interval. Fail to satisfy the watchdog timer will cause both main . CPU and motor control CPU reset, pump device parks at a fail safe state, and an audible alarm to sound.
• Power supply consists of AC/DC power. Z-800 infusion pump is intended to be used as a pole . mounted pump. It contains a medical device grade switch power supply (input 100-240V 50-60Hz, 0-1.4A. output 15vdc) and a rechargeable 4700mA. 8X1.2 volt Nickel Metal Hydride battery pack. A fully charged new battery will power at least 8hr of continuous infusion (at 125mL/hr). A full battery charging time on a new battery is around 5hr. The battery charging circuitry has a dedicated controlling CPU, which manages the charging current as well as the battery safety monitoring. Redundant temperature sensor is embedded in the battery pack capable of shut off the charging current if battery pack temperature is above the safety threshold.
• . There is 128K flash EPROM memory which stores the embedded software along with 8K NVRAM for user specified configuration as well as preserving infusion parameters between power cycles.
• . Z-800 infusion pump uses linear peristaltic pumping mechanism driven by a step motor through driving belt. The ID/OD, wall thickness and the durometer of the IV set are specified by Zyno to the IV set manufacturers to ensure the accuracy specification of flow rate.
• . The user interface design requirement of the Z-800 pump is focused on simplicity and intuitiveness. The keypad contains 3 groups of keys: the navigation key group; the data entry key group; and the action key group. There is no numeric data entry keypad. All data entry kevs are scroll key. This design is to focus user's attention to the data entry results on the display while entering the infusion parameters, so as to mitigate data entry error caused by key bounce or user hitting the wrong keys,
• . The Z-800 infusion pump has an all metal casing to improve the durability of the pump and the integrity of the pumping/free flow protection mechanism. The pump door and the mating pump front panel are made in milled aluminum. The tubing guide cavity is designed to mitigate tubing loading error. If the tubing is not loaded correctly, the door can not be closed. Even user jam close the door, the mating pump door and the front panel will shut off the tubing to prevent free flow, and the drip sensor accessory will report no flow to alert user of misloaded tubine.
• . There is no known contraindication.

Here's an analysis of the provided text regarding the Z-800 Infusion System, focusing on acceptance criteria and the supporting study:

The provided document, K100705, is a 510(k) summary for the Z-800 Infusion System. This particular submission concerns qualifying CareFusion's blood administration sets for use with the already marketed Z-800 infusion pump to extend its intended use to include intravenous administration of blood and blood products.

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria and reported performance specifically for the new intended use (blood administration) are related to hemolysis testing.

Other general device performance specifications for the Z-800 Infusion Pump are found in the "Equivalency Matrix" (Table 1), establishing equivalence to predicate devices. These performance metrics include:

• Volume and Rate Accuracy: +/- 5%
• Occlusion Pressure Accuracy: Low: 4 psi, Medium: 16 psi, High: 30 psi (adjustable)
• Rate Range: 1 ml/hr to 999 ml/hr in 1 ml/hr increment
• Battery Life: 8 hours at 125 ml/hr

The document states that these general performance specifications of the Z-800 infusion pump remain the same as the currently marketed device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of blood samples or test runs performed for the hemolysis study. It mentions "production units" of the Z-800 infusion pump were used.
• Data Provenance: The hemolysis test was conducted by a "certified lab" according to "recognized Good Laboratory Practices" following an "FDA recognized ASTM standard." The blood used was "human blood." The document does not explicitly state the country of origin but implies a US context given the FDA submission. The study appears to be prospective as it was performed specifically to address the incremental risk of hemolysis identified during the risk analysis for the extended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is a laboratory test (hemolysis testing) and not a clinical study involving experts establishing ground truth for diagnostic or clinical outcomes. The "ground truth" for the hemolysis test is objectively measured plasma free hemoglobin levels and statistical correlation, not expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies when multiple reviewers assess cases and discrepancies need to be resolved. The hemolysis test results are quantitative measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This is a medical device (infusion pump) and the study focuses on its physical performance and biological interaction (hemolysis), not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study was performed regarding the functional aspects of the physical device. The hemolysis test evaluates the device's interaction with blood without human intervention in the hemolysis measurement process itself. The broader device validation summarized in "Z-800 Validation Summary Report TR800-2010-02" (mentioned as Appendix E) would further demonstrate the standalone performance of the infusion pump (e.g., flow rate accuracy, occlusion detection) without considering human-in-the-loop aspects.

7. Type of Ground Truth Used

For the hemolysis testing, the ground truth was objective laboratory measurements of "plasma free hemoglobin level" and "correlation coefficient for the hemoglobin standard curve." These are quantitative, biologically derived measurements based on established ASTM standards and Good Laboratory Practices.

8. Sample Size for the Training Set

This information is not applicable. The Z-800 Infusion System is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are validated through engineering tests and quality control, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

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A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand.

The provided document is a 510(k) summary for a medical device (Blood Hand Pump Set) and is not a study. Therefore, it does not contain detailed information about acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment typically found in a scientific study.

The document indicates that the device's substantial equivalence was determined based on its "technological characteristics" and "performance data" indicating it "meets specified requirements." However, it does not specify what those requirements are or how the performance data was generated beyond a general statement.

Here's an analysis based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The flow rate for hand pump compression administration "may be as much as twice that of gravity flow." (This is a characteristic, not a performance metric against a specific criterion). |

Missing Information:

• Specific quantitative acceptance criteria (e.g., minimum flow rate, pressure limits, material biocompatibility, sterility) are not provided.
• Actual measured performance values against these criteria are not given.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information:

• Sample Size: Not reported. The document does not describe any specific "test set" of data or how it was generated.
• Data Provenance: Not reported. It's unclear if any testing involved human subjects or was entirely bench testing, and if so, where it took place (country of origin). The document refers to "performance data" generally.
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Missing Information:

• Not applicable. This type of device (blood administration set) does not typically involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI diagnostic device would. Its performance is assessed through engineering and biocompatibility testing. The "ground truth" for a device like this would be engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Missing Information:

• Not applicable for this type of device and submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information:

• Not applicable. This is a medical device for fluid administration, not an AI-assisted diagnostic tool for human readers. No human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Missing Information:

• Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical design and materials.

7. Type of Ground Truth Used

Missing Information:

• The document implies that the ground truth/basis for evaluation was adherence to engineering specifications, safety standards, and equivalence to predicate devices. It does not mention pathology, outcomes data, or expert consensus in a clinical sense for performance evaluation.

8. Sample Size for the Training Set

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

In summary: The provided 510(k) summary is a regulatory document demonstrating substantial equivalence, not a detailed scientific study. It focuses on comparing the new device's technological characteristics and overall performance to already cleared predicate devices rather than presenting detailed raw data, specific acceptance criteria values, sample sizes, or methodologies of internal validation tests. For medical devices like this, performance data typically refers to results from bench testing (e.g., flow rate tests, pressure resistance, sterility testing, material compatibility) and not clinical trial data involving "ground truth" from experts for diagnostic purposes.

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