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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 HOSPIRA ® Enteral Feeding Sets is intended to deliver, via gravity or a pamp, liquid nuttition formulas to an enteral access device (a feeding tube).

The HOSPIRA ® Enteral Feeding Sets will consist of variations of the following components: non-DETIP Enteral feeding bags, non-DEHP plasticized polyvinyl tubing, fluid shut off devices, non-DEHP sight chambers, cassette technology and adapters for enteral feeding catheters.

1. Acceptance Criteria and Reported Device Performance

This 510(k) summary does not contain specific, quantifiable acceptance criteria or detailed performance data for the Hospira® Enteral Feeding Sets. Instead, it relies on a claim of substantial equivalence to previously cleared predicate devices (K810996, K052052, K865059, K052059).

The device's "performance" is implicitly deemed acceptable because it meets the "functional claims and intended use" and is similar in function and operating principles to the predicate devices. The primary differences highlighted are material composition (non-DEHP, non-PVC) rather than functional performance metrics.

Therefore, a table of acceptance criteria and reported device performance as typically understood for new, innovative devices with novel performance claims cannot be created from this document. The "acceptance criteria" here are essentially "demonstrated substantial equivalence to legally marketed predicate devices."

2. Sample Size and Data Provenance

This document does not describe a study involving a "test set" of data or patient samples in the way that AI/ML medical devices often do. The evaluation is based on comparison to existing device designs and their established safety and effectiveness.

• Sample Size: Not applicable in the context of this 510(k) submission, as no new clinical or performance data from a specific "test set" is presented.
• Data Provenance: Not applicable. The "data" here refers to the design specifications and materials of the proposed device, compared to those of predicate devices already marketed. This is not a study involving patient data from a specific country or design (retrospective/prospective).

3. Number of Experts and Qualifications

Not applicable. This type of submission relies on engineering and material science evaluations, and comparison to existing regulatory clearances, rather than expert consensus on diagnostic or clinical outcomes from a test set. The review and approval are conducted by FDA staff (e.g., Office of Device Evaluation), who are experts in medical device regulation and relevant scientific fields.

4. Adjudication Method

Not applicable. There is no test set or ground truth requiring expert adjudication described in this document.

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

No. This document does not mention or present any MRMC study. The device is an enteral feeding set, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers interpreting cases.

6. Standalone Performance Study

No. This document does not describe a standalone performance study in the context of an algorithm's performance without human intervention. The "performance" assessment is based on design similarities and adherence to established regulatory requirements for similar devices. The core claim is substantial equivalence, not novel performance to be proven by a standalone study.

7. Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or predictive algorithm. For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly the established safety and performance profile of the predicate devices, which have already been deemed safe and effective for their intended use by the FDA. The new device's design and materials are compared against this established benchmark.

8. Sample Size for the Training Set

Not applicable. This submission does not involve a "training set" as it would for an AI/ML device. There is no algorithm being trained.

9. How Ground Truth for the Training Set Was Established

Not applicable. There is no training set mentioned or implied in this document.

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