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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
· Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.

The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

This document describes the FDA clearance for the SMARTeZ™ Elastomeric Infusion Pump (K242152), which identifies it as substantially equivalent to a previously cleared device (K151650). This submission is a "Special 510(k)" for the addition of new models with different nominal volumes, flow rates, and infusion times, along with a change to a detachable administration tube.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards. The document doesn't provide a direct "table" of acceptance criteria values alongside specific performance metrics for each, but rather states that tests were performed in conformance with these standards.

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

The document does not explicitly state the numerical sample size for each specific test in the "test set". It mentions "bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650)". The provenance of the data is not specified in terms of country of origin. The studies are described as "bench performance verifications and validations," indicating controlled laboratory testing, and would be considered prospective for the specific tests performed on the Subject device to support this 510(k).

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

This information is not provided in the document. The document describes bench testing and compliance with standards for a medical device. Ground truth, in the context of expert review, is not applicable here as these are performance tests and biocompatibility assessments, not diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes objective performance testing and compliance with standards, not a case-based review where expert adjudication would be needed.

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 applicable. The device is an elastomeric infusion pump, a hardware device for fluid delivery, not a software device or an AI application that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical device, an elastomeric infusion pump, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The ground truth for this device's performance is objective measurements against established engineering and biocompatibility standards (e.g., flow rate accuracy within specifications, confirmation of sterility, absence of cytotoxicity).

8. The Sample Size for the Training Set

This information is not applicable. This document describes the clearance of a physical medical device (an elastomeric infusion pump) based on engineering performance and biocompatibility testing, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device.

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The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.

The SMARTeZ Pump, is a single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line (see Figure 5-1). The constriction of elastomeric fluid reservoir drives the medication through the tubing and eventually through a flow restrictor out into the patient connection. Drug products should be stored in their approved containers and closures.

The SMARTeZ Pump, an elastomeric infusion pump, underwent a series of bench tests to demonstrate its performance and safety, aligning with ISO 28620:2010 standards. The study aimed to prove that the device consistently delivers medication within specified flow rate tolerances under various conditions, including nominal operation, changes in ambient temperature and solution viscosity, and after exposure to physical stresses like pressure, traction, and drops, as well as refrigeration. It also verified leak-proof integrity and the absence of retrograde flow.

Here is a summary of the acceptance criteria and the reported device performance:

1. Table of acceptance criteria and the reported device performance:

• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis confirmed flow accuracy within +/- 15% at 99% confidence (lower- and upper-bounds of -0.400% to +0.151%) when filled with nominal volume and delivering normal saline at 31°C with the pump 40cm below the catheter site. |
  | Flow Rate Test (Change of Ambient Temperature) | Mean flow rates should be no more than 15% slower when compared to those tested at 31°C. | Passed. Mean flow rate was 14.07% slower, confirming the IFU claimed temperature effect. |
  | Flow Rate Test (Change of Solution Viscosity) | Mean flow rates should be no more than 10% slower when compared to those tested with 0.9% NaCl as control solution. | Passed. Mean flow rate was 9.81% slower, confirming the IFU claimed fluid viscosity effect. |
  | Flow Rate Test after Resistance to Pressure Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Pressure Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Leak-Proof Test after Drop Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Resistance to Traction Test | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Resistance to Traction Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Flow Rate Test after Refrigeration | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both flow rate and leak integrity criteria. Statistical analysis showed flow rate accuracy was not affected. |
  | Leak-Proof Test after Refrigeration | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
  | Retrograde Flow of Infusate Test | Retrograde flow should not be observed when back pressure applied ≤ 0.34bar (5 psi). | Passed. Retrograde flow was observed at 0.8 bar (11.6 psi), which is double the acceptance criteria. |
  | Flow Rate Test under Non-Ambient Pressure (Influence of Routes of Administration) | - Mean flow rate: ±15% compared to nominal.
• At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal, independent of IV, intra-arterial, and subcutaneous routes. | Passed. Flow accuracy of +/- 15% was maintained, independent of the 3 routes of infusion administered. |
  | Performance/Functionality Testing for Chemotherapy Articles | - Flow accuracies (nominal, after pressure/traction/refrigeration, non-ambient pressure): Mean flow rate ±15% of nominal, 80% nominal volume within ±50% instantaneous.
• Watertight after pressure, traction, drop, and refrigeration.
• No retrograde flow at back pressure ≤ 0.34bar (5 psi). | Passed. All samples met all acceptance criteria. |

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample size (number of devices) used for each individual bench test. However, it consistently refers to "All test samples" passing the criteria. It also mentions "The samples were tested."
The data provenance is from bench testing, which implies a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these types of studies are typically not applicable to physical bench tests of device functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study described is a series of bench tests for device performance against predefined engineering and regulatory standards (ISO 28620:2010), not a study involving expert assessment or clinical ground truth.

4. Adjudication method for the test set:

This is not applicable as the study involves objective physical measurements and functional checks against quantitative acceptance criteria, not subjective human evaluations requiring adjudication.

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 is not applicable as the device is a physical infusion pump, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical infusion pump, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical and fluid dynamic performance.

7. The type of ground truth used:

The ground truth for the performance tests was established by objective measurements against quantitative engineering and regulatory standards (ISO 28620:2010), specifically defined numerical tolerances for flow rate, and observable physical properties like leak-proof integrity and retrograde flow.

8. The sample size for the training set:

This is not applicable as the device does not employ machine learning or AI models that require a training set.

9. How the ground truth for the training set was established:

This is not applicable as the device does not employ machine learning or AI models.

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