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510(k) Data Aggregation
(268 days)
Hospira Extension Set, Hospira Primary Set
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets and the Hospira Primary Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
The provided document (K161036) is a 510(k) summary for medical devices (Hospira Extension Set and Hospira Primary Set), which are intravenous administration sets. It describes the device, its intended use, and the technological characteristics compared to predicate devices. The primary change addressed in this submission is the replacement of the current Dial-A-Flo flow control device with a new one from a different manufacturer.
The document does not contain information about acceptance criteria or performance from a study in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The acceptance criteria and performance data presented here are for a traditional medical device (IV administration sets) undergoing a change in a component.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device meeting them as if it were an AI/ML device.
However, I can extract the acceptance criteria and reported device performance for the Hospira Extension Set and Hospira Primary Set as described in the document, which are related to non-clinical and performance testing of the physical medical device.
Acceptance Criteria and Reported Device Performance (as related to the physical medical device):
The acceptance criteria are generally implied by meeting applicable standards.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials of construction meet applicable material test requirements for ISO 10993. | New data generated showing all materials of construction meet applicable material test requirements for ISO 10993. Tested ISO 10993-4 (Hemocompatibility), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-11 (Intracutaneous Irritation), Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Pyrogenicity. |
| Performance Testing | Device performs as intended in accordance with applicable standards, specifically ISO 8536-4. Compliance with ISO 594-1 and ISO 594-2 (covered by predicate). All testing is acceptable. | New performance data generated ensuring the device performs as intended in accordance with ISO 8536-4. Tested sections: 6.1 Particulate Contamination, 6.2 Leakage, 6.3 Tensile Strength, 6.6 Tubing, 6.7 Fluid Filter, 6.9 Flow Regulator, 6.10 Flow Rate, 6.11 Injection Site, 6.12 Male Conical Fitting, 6.13 Protective Caps. All testing reported as acceptable. |
| Sterility | Product Sterility Assurance Level (SAL) is 10-6. | The product Sterility Assurance Level is 10-6. |
| Functional Equivalence | Meet the functional claims and intended use as described in the product labeling. Substantially equivalent to predicate devices. | Hospira Extension Sets and Hospira Primary Sets meet the functional claims and intended use. Found substantially equivalent to K142974 and K143015. |
Information Not Applicable to this Document (as it's not an AI/ML device study):
- Sample sized used for the test set and the data provenance: Not applicable for this type of device submission. Performance testing is typically done on physical samples, and the number of samples is not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on objective measurements against engineering specifications and standards.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, ground truth is based on established ISO standards, engineering specifications, and validated test methods (e.g., flow rate measurement, leak detection, material compatibility assays).
- The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
- How the ground truth for the training set was established: Not applicable.
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(187 days)
Hospira Extension Sets
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.
The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.
| Acceptance Criteria (Standard & Section) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-4 Hemocompatibility | Acceptable |
| ISO 10993-5 Cytotoxicity | Acceptable |
| ISO 10993-10 Sensitization | Acceptable |
| ISO 10993-11 Intracutaneous Reactivity | Acceptable |
| Systemic Toxicity | Acceptable |
| Acute Toxicity | Acceptable |
| Subchronic Toxicity | Acceptable |
| Pyrogenicity | Acceptable |
| Mechanical/Functional Performance: | |
| ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment): | |
| 4.1 Gauging | Acceptable |
| 4.2 Liquid Leakage | Acceptable |
| 4.3 Air Leakage | Acceptable |
| 4.4 Separation Force | Acceptable |
| 4.5 Stress Cracking | Acceptable |
| ISO 594-2 (Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings): | |
| 4.1 Gauging | Acceptable |
| 4.2 Liquid Leakage | Acceptable |
| 4.3 Separation Force | Acceptable |
| 4.4 Unscrewing Torque | Acceptable |
| 4.5 Ease of Assembly | Acceptable |
| 4.6 Resistance to Overriding | Acceptable |
| 4.7 Stress Cracking | Acceptable |
| ISO 8536-4 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed): | |
| 6.1 Particulate Contamination | Acceptable |
| 6.2 Leakage | Acceptable |
| 6.3 Tensile Strength | Acceptable |
| 6.6 Tubing | Acceptable |
| 6.7 Fluid Filter | Acceptable |
| 6.9 Flow Regulator | Acceptable |
| 6.10 Flow Rate | Acceptable |
| 6.11 Injection Site | Acceptable |
| 6.12 Male Conical Fitting | Acceptable |
| 6.13 Protective Caps | Acceptable |
| Sterilization: | |
| Sterility Assurance Level (ANSI/AAMI/ISO 11137-1 and 11737-1) | 10^-6 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."
The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.
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 and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.
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
No MRMC comparative effectiveness study was done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.
8. The Sample Size for the Training Set
This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(101 days)
Hospira Extension Set
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira infusion sets are disposable devices for single patient use.
The provided text is related to a 510(k) premarket notification for a medical device called "Hospira Extension Set." This is an IV administration set. The document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the specific information requested in the prompt concerning acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a software algorithm or AI device.
The document discusses:
- Device Name: Hospira Extension Set
- Regulation Number: 21 CFR 880.5440
- Regulation Name: IV Administration Sets
- Regulatory Class: II
- Product Code: FPA
- Indications for Use: "Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system."
- Predicate Devices: LifeShield Vision Infusion Sets - K113683, Hospira Infusion Blood Sets - K101677, LifeShield Latex Free Microbore Set - K052722
- Reason for 510(k) submission: Modification to Secure Lock Male Luer
- Summary of non-clinical tests: Stated that "All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993."
- Summary of Performance Testing: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable. The product Sterility Assurance Level is $10^{-6}$."
The information requested in the prompt (acceptance criteria table, sample sizes for test/training, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, etc.) is typically associated with studies for AI/ML-enabled devices involving diagnostic or predictive tasks. The Hospira Extension Set is a physical medical device (IV administration set), and its 510(k) submission primarily relies on demonstrating substantial equivalence to predicates through material compatibility, physical performance testing, and sterility, rather than clinical studies with human readers or AI algorithms as described in your request.
Therefore, I cannot extract the requested information from the provided document as it is not relevant to this type of device and submission.
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