(63 days)
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.
| Acceptance Criteria (Inferred from Predicate's Testing Areas) | Reported Device Performance (For K161866 - assumed equivalent to predicate K150407) |
|---|---|
| Power Injection Flow Rate (specific mL/sec values per size) | * 3F Single Lumen/20 cm: 2 mL/sec |
- 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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).