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Hospira infusion sets are intended for use in parenteral, enteral and epidural therapies and the administration of fluids, medications, nutritional fluids, blood and blood products. Safety features on these devices aid in prevention of needle-stick injuries.

Indications for use may include hospital and other medical settings, ambulatory and home use,

The Hospira infusion sets, previously cleared in K052052 (Hospira Plum A+,A+3) and K060806 (Gemstar infusion sets) are intended for use with dedicated Hospira Infusion Pumps. Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components which may be shared across Hospira set families.

These administration set families include primary sets, secondary sets, extension sets, piggyback sets, gravity sets, microbore sets, macrobore sets, and sets which allow concurrent delivery. These sets provide a range of physical characteristics such as priming volume, length, diameter, materials etc.

This submission describes modifications to existing Hospira Infusion Sets (K052052 and K060806), primarily involving a change in the bonding process and the conversion of tubing material from DEHP to Non-DEHP PVC. The study presented focuses on demonstrating that the modified devices maintain the same safety and effectiveness as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample size for each test. However, it indicates that "Hospira Infusion sets with laser welded access device" and "Hospira Infusion sets with Non-DEHP PVC yellow striped tubing" were tested. This implies that representative samples of the modified devices were used for testing.

The data provenance is not specified in terms of country of origin, but it is retrospective in the sense that it relies on bench testing and comparisons to existing predicate devices, rather than a prospective clinical trial.

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

This type of study does not involve "ground truth" established by human experts in the way an imaging diagnostic device might. The "ground truth" for these tests are the established and recognized international standards (e.g., ISO standards) and the specifications derived from the design inputs for an infusion set. Compliance with these standards is objectively measured through defined test methods rather than expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the evaluation is based on objective conformance to established standards and physical/functional specifications, not on subjective expert interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where human interpretation plays a significant role. The current submission pertains to physical and chemical modifications of a medical device, which are assessed through bench testing.

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

Not applicable. This device is not an AI algorithm. The performance evaluation is for the physical medical device itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of established engineering design requirements, compliance with international ISO standards (e.g., for biocompatibility, sterility, dimensional conformance), and the functional claims and intended use of an infusion set. These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This study does not involve machine learning or AI, so there is no "training set."

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

Not applicable.

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The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite software is intended for use in intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids and blood/blood products.

The indications for use include hospital, ambulatory and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.

GemStar™ SP Infusion System is a family of single channel electromechanical infusion pumps (7-therapy, 6-therapy and Pain Management Pumps). It operates on a volumetric, piston driven, fluid displacement principle. An in-line cassette is used to meter IV fluids through sterile dedicated administration sets designed to be used exclusively with GemStar® infusers. The pumps display provides visible indication of several functions, including active pump operations, alarms, program status and the parameters of fluid flow. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. Power options include AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The infusers function as both pole mounted and ambulatory infusion pumps.

The subject device is based on modifications of the predicate infusion pumps. The modifications to the Hospira GemStar® Infusion System are made to allow for download of the Infusion Suite to the pump from the PC –based software (GemStar™ SP Infusion Suite) in order to facilitate the programming of the pump and to provide the ability to enforce dosing limits for applicable therapies. GemStar™ SP Infusion Suite software will be distributed separately as an accessory to the pump. No changes are made to the pump performance specifications or to the administration sets used with the pump.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GemStar™ SP Infusion System.

Important Note: The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be required for a PMA (Premarket Approval). Therefore, the document primarily highlights the similarities to existing devices and the absence of new safety/effectiveness concerns, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission focused on substantial equivalence and modifications to an existing device, explicit numerical acceptance criteria and a detailed "reported device performance" table are not present in the provided document. The acceptance criteria are implicitly met by demonstrating that the modified device performs "as safe and effective" as the predicate device and that "no changes are made to the pump performance specifications."

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

The document does not describe a specific "test set" in the context of an independent performance study. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices already on the market and cleared by the FDA. The "testing" in such a submission typically involves verification and validation of the modified components (e.g., software functionality, electrical safety, EMC compatibility) against established standards and internal requirements, rather than a clinical performance study with a distinct test set of patients or medical scenarios.

Therefore, information on:

• Sample size used for the test set: Not applicable/not provided in this type of submission.
• Data provenance (country of origin, retrospective/prospective): Not applicable/not provided.

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

This information is not applicable/not provided because the document does not describe a study involving human expert adjudication to establish ground truth for a test set. This is a premarket notification for a Class II medical device (infusion pump), where the primary focus is on engineering and performance specifications, and substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Not applicable/not provided. There is no described study requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided document. This type of study is more common for diagnostic imaging devices where human interpretation directly impacts clinical outcomes, and the goal is to show the AI's impact on reader performance or diagnostic accuracy. For an infusion pump, the effectiveness is primarily mechanical and software-driven, verified through engineering tests and comparison to predicate device performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The document does not describe a standalone algorithm-only performance study. The device is an infusion pump system with associated software. The "performance" is a holistic function of the hardware and software working together to deliver fluids, with the software facilitating programming and safety features (dose limits). The safety and effectiveness are established through the entire system's functionality, not just an isolated algorithm. The software component, "GemStar™ SP Infusion Suite," is an accessory to the pump facilitating programming, and its performance is implicitly validated by demonstrating "similar concept of the protocol download" to a predicate device's software.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" is established by:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate devices (Hospira GemStar® Infusion Pump System K060806 and LifeCare PCA® Infusion System with Hospira MedNet™ Software K042800). The current device demonstrates that it is "as safe and effective" as these.
• Engineering Standards and Specifications: Implicitly, the pump's mechanical and electrical performance (e.g., flow accuracy, alarm functionality, dose limit enforcement) is verified against established engineering standards and the device's own design specifications, which are themselves benchmarked against predicate devices and regulatory requirements.

There is no mention of pathology, expert consensus on patient data, or extensive clinical outcomes data specific to this submission.

8. The Sample Size for the Training Set

The document does not mention a "training set" as described in the context of machine learning. This device, an infusion pump with programming software, would likely have its software developed and verified through standard software engineering practices (e.g., unit testing, integration testing, system testing, regression testing) rather than through training on a dataset in the AI/ML sense.

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

Since a "training set" (in the AI/ML sense) is not mentioned or implied by the nature of this device and submission, the method for establishing its ground truth is not applicable/not provided. The ground truth for the product's design and verification is based on established engineering principles, regulatory compliance, and the performance characteristics of its predicate devices.

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