Search Results

The BioFlo Midline catheter is indicated for short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

The BioFlo Midline Catheter is a short term peripheral venous access device between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.

This document is a 510(k) summary for the BioFlo Midline Catheter, which concerns a change in the Directions For Use (DFU) of an already cleared device. Therefore, the information typically found in acceptance criteria and detailed study reports for a device's initial clearance is not fully present or directly applicable.

Based on the provided text, the device itself (BioFlo Midline Catheter) was previously cleared, and this submission (K161866) focuses specifically on a change to its labeling (DFU). The core claim is that since only the DFU changed, and the physical device is identical to the predicate (K150407), no new performance testing was required.

Here's an attempt to answer your questions based on the available information, noting where data is implicitly accepted from the predicate or explicitly stated as not applicable for this particular submission:

1. A table of acceptance criteria and the reported device performance

For this specific 510(k) (K161866), no new acceptance criteria or reported performance data for the device itself are provided because the change is limited to the DFU. The performance of the device is considered substantially equivalent to the predicate device (K150407) based on its identical materials, design, and components.

However, the document lists the types of bench testing performed for the predicate BioFlo Midline Catheter (K150407), which would have had associated acceptance criteria at the time of its clearance.

• 4F Single Lumen/20 cm: 6 mL/sec
• 5F Single Lumen/20 cm: 6 mL/sec
• 5F Dual Lumen/20 cm: 6 mL/sec |
  | Static Burst Strength | Assumed to meet standard requirements (Detail not provided in this document) |
  | Multiple Power Injections | Assumed to meet standard requirements (Detail not provided in this document) |
  | Gravity Flow Rate | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Length (conforming to specified range) | "between 3 to 10 inches in length (8 to 25 cm)" |
  | Priming Volume | Assumed to meet standard requirements (Detail not provided in this document) |
  | Midline Identification | Assumed to meet standard requirements (Detail not provided in this document) |
  | Dimensional Verification (ID, OD, Length) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Kink/Flex Resistance (Elongation, Stiffness, Flex Life Strength) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Alcohol Compatibility | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Marking & Identification/Radiopacity Testing | Assumed to meet standard requirements (Detail not provided in this document) |
  | Tensile Testing (Catheter and Assembly) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Compatibility Testing | Assumed to meet standard requirements (Detail not provided in this document) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For K161866, no new performance testing was conducted, hence no test set sample size is applicable.

For the predicate device (K150407), which underwent the listed bench testing, the document does not specify the sample sizes used for each test or the data provenance. It only states that the tests were non-clinical bench testing conducted according to FDA guidance and international standards. This implies lab-based testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to an update based solely on a change to the Directions For Use (DFU), as no clinical ground truth assessment or expert review of performance data was conducted for this specific submission. The DFU change was aligned with updated Infusion Nurses Society (INS) Standards of Practice and compared to another cleared midline catheter's DFU.

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

Not applicable for this submission as no new testing was performed and no expert adjudication of performance data was required regarding the DFU change.

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

Not applicable. This device is an intravascular catheter, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

For K161866, the "ground truth" for the DFU change was the Infusion Nurses Society (INS) Standards of Practice, specifically noting changes made between the 2011 and 2016 versions, and comparison to the DFU of a similar predicate device (Bard PowerGlide Midline catheter K133856) to ensure consistent clinical interpretation and safety.

For the predicate device (K150407)'s original bench testing, the ground truth would have been established by the performance characteristics defined in the relevant international standards (e.g., EN ISO 10555-1, EN ISO 10555-3, ISO 594-2, EN ISO 10993-1) and FDA guidance documents.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

Ask a specific question about this device

The BioFlo Midline Catheter is indicated for short term access (

The BioFlo Midline Catheter is a short term (

The provided text describes a 510(k) premarket notification for the BioFlo Midline Catheter. It outlines the device's characteristics, intended use, and a comparison with predicate and reference devices, along with performance data from non-clinical bench testing. However, the document does not describe a clinical study in the format requested, nor does it provide the detailed acceptance criteria and study results for a device that relies on AI or machine learning.

The acceptance criteria mentioned are general performance aspects for a medical device (intravascular catheter), and the "study" referred to is a series of non-clinical bench tests. The concept of "AI performance," "human reader improvement with AI," "standalone algorithm performance," "ground truth," and "training set" are not applicable to this particular device and its regulatory submission as described.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to extract relevant information from the document, acknowledging the limitations:

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

The document lists various non-clinical bench tests performed. These tests implicitly define "acceptance criteria" through their successful completion, demonstrating that the device meets relevant standards for its intended use. Exact quantitative acceptance criteria are not explicitly stated in numerical form within this summary, but the successful completion of the tests implies meeting the required thresholds.

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

• Sample size: Not specified. The document only mentions "non-clinical bench testing." For bench tests, sample sizes can vary significantly depending on the specific test and standard requirements, but these are typically physical units, not patient data sets.
• Data provenance: Not applicable in the context of clinical or image-based data. The tests are non-clinical bench tests.

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

• Not applicable. This device is a physical medical device (catheter) undergoing bench testing, not a diagnostic or AI-driven device requiring expert-established ground truth from patient data.

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

• Not applicable. This concept is relevant for clinical studies or AI evaluations involving human readers and ground truth, not for the described bench tests.

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. This is not an AI-based device, and no MRMC study was performed or mentioned.

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

• No. This is not an AI-based device.

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

• Not applicable in the context of patient data ground truth. The "ground truth" for bench testing is defined by the technical specifications and performance requirements outlined in the referenced standards (e.g., ISO 10555-1, ISO 594-2).

8. The sample size for the training set:

• Not applicable. This device does not involve an AI algorithm that requires a training set.

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

• Not applicable. This device does not involve an AI algorithm.

Summary of the Study (Bench Testing) that Proves the Device Meets Acceptance Criteria:

The study proving the BioFlo Midline Catheter meets acceptance criteria consists of a series of non-clinical bench tests. These tests were conducted in accordance with several FDA Guidance Documents and international standards, including:

• FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters"
• EN ISO 10555-1:2013 - "Intravascular Catheters - Sterile and Single-Use Catheters - Part 1: General Requirements"
• EN ISO 10555-3:2013 - "Intravascular Catheters Sterile and Single-Use Catheters Part 3: Central Venous Catheters"
• ISO 594-2:1998 - "Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings"
• EN ISO 10993-1:2009 - "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"

The specific tests performed included: Power Injection Flow Rate, Static Burst Strength, Multiple Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Midline Identification, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radiopacity Testing, Tensile Testing, and Compatibility Testing with insertion accessories.

The submission concludes that "successful results of non-clinical bench testing" demonstrate that the proposed device is substantially equivalent to the predicate device. This implies that the device met all the required performance specifications and safety criteria as defined by the referenced standards and guidance documents.

Ask a specific question about this device