Search Results

The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Insulated Strap:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (510(k) Summary for K130867) does not list specific numerical acceptance criteria or performance metrics for the enFlow IV Fluid Warmer Insulated Strap. Instead, it focuses on qualitative compliance and equivalence.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "User Validation Testing" and "Design & Performance Verification Testing" but does not quantify the number of units or tests involved.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission from a US company (GE Healthcare, Totowa, NJ), the testing was likely conducted in the US, but this is not confirmed. The testing appears to be retrospective in the sense that it's evaluating a developed accessory against established standards and a predicate device, rather than a prospective clinical trial.

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

• Number of Experts: Not explicitly stated. The section mentions "User Validation Testing" but does not specify how many users were involved or if they were considered "experts" for establishing ground truth, and if so, their qualifications. The other tests (biocompatibility, design/performance verification, risk analysis) would involve qualified engineers and scientists, but these are not referred to as "experts establishing ground truth" in the context of clinical or diagnostic performance.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For non-clinical tests like material biocompatibility, functional verification, and risk analysis, formal adjudication methods like 2+1 or 3+1 are typically not applied in the same way they would be for expert review of images in a diagnostic AI study. Decisions would be based on test results meeting predefined specifications or standards.

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

• MRMC Study Done? No. The document explicitly states: "The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence." This means no comparative effectiveness study with human readers was conducted, as the device is an IV fluid warmer accessory, not a diagnostic imaging device.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as there was no MRMC study or AI component in this device.

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

• Standalone Study Done? Not applicable. This device is an IV fluid warmer accessory and does not involve an algorithm or AI for diagnostic or predictive purposes. Its performance is related to warming fluids and material properties.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus for disease presence or absence) is not directly applicable here. For this device, the "ground truth" or reference for evaluating its performance comes from:

• Defined Specifications: For functional, packaging, and labeling evaluations.
• Voluntary Standards: For overall compliance.
• ISO 10993: For biocompatibility requirements.
• Intended Use: For user validation testing.
• Predicate Device Performance: For establishing substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a hardware accessory and does not involve a "training set" in the context of machine learning or AI models.
• How Ground Truth for Training Set was Established: Not applicable.

Ask a specific question about this device

The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit. The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Strap device:

Important Note: The provided document (K121775) is for a modification to an already cleared device (enFlow IV Fluid Warmer, K112902). The modification is specifically the addition of a Strap as an accessory. Therefore, the core performance of the fluid warmer itself is not being re-evaluated in this submission. The focus is on the impact of the strap.

Acceptance Criteria and Reported Device Performance

The submission states: "The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm." And "[t]here have been no changes to either the intended use of the device or the fundamental scientific technology of the device."

Given this, the acceptance criteria are implicitly that the addition of the strap does not negatively impact the safety and effectiveness of the previously cleared enFlow IV Fluid Warmer.

Study Details

Based on the provided K121775 submission:

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

   • No specific test set sample size is mentioned for the strap itself.
   • The document explicitly states: "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." This means there was no clinical test set in the traditional sense for the strap.
   • Non-clinical studies (Risk Analysis, Biocompatibility Testing, Performance Testing) were conducted, but details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests specific to the strap are not provided in this summary. These would typically be detailed in a more comprehensive testing report.

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

   • Not applicable. No clinical test set requiring expert ground truth was performed for this specific modification.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set was performed.

4. 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:

   • Not applicable. This device is a medical fluid warmer, not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This is not an algorithmic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical tests (Risk Analysis, Biocompatibility, Performance Testing), the ground truth would be based on engineering specifications, regulatory standards, and established laboratory testing methodologies. No human-derived ground truth (like expert consensus or pathology) is relevant here.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Summary of the Study for this Specific Submission (K121775):

The submission K121775 is a "Special 510(k) Premarket Notification" for a minor change (adding a strap) to an already cleared device. As such, the "study" is primarily a demonstration of substantial equivalence to the predicate device (K112902) despite the modification, based on non-clinical data.

The relevant non-clinical studies mentioned are:

• Risk Analysis: To ensure the strap does not introduce new unacceptable risks.
• Biocompatibility Testing: To ensure the strap material is safe for patient contact (if applicable, though its primary function is to secure the warmer to the arm, not direct patient contact, the material's interaction with the warmer itself or incidental human contact could be considered).
• Performance Testing: To ensure the strap functions as intended (securing the warmer) and does not impede the warmer's performance.

The key finding is that these non-clinical tests supported substantial equivalence and that clinical testing was not required due to the nature of the modification. This implies that the strap was assessed to be safe and effective and did not alter the fundamental characteristics or performance of the fluid warmer.

Ask a specific question about this device