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510(k) Data Aggregation
(145 days)
14F Duo-Flow**®** Side X Side Double Lumen Catheter
The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion.
The Duo-Flow® Side X Side double lumen catheter is a radiopaque, polyurethane tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luers:
- Red Adaptor = proximal lumen
- Blue Adaptor = distal lumen
The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.
The catheter comes in a variety of sizes and is offered with curved or straight extensions.
The Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. All sizes of the Duo-Flow® Side x Side Catheter are available in a Basic Set intended to be used in an Interventional Radiology or Operating Suite. The Set includes primary insertion componentry for the Modified Seldinger Insertion Technique.
The provided FDA 510(k) clearance letter describes the 14F Duo-Flow® Side X Side Double Lumen Catheter and its substantial equivalence to a predicate device. However, this document does not detail an AI/algorithm-based medical device performance study.
The submission is for a physical medical device (a catheter) and focuses on demonstrating substantial equivalence through non-clinical (bench) testing and comparison of technical specifications with a previously cleared predicate device. Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this particular FDA clearance.
Here's an analysis based on the information provided, highlighting the acceptance criteria and how the device meets them within the context of a physical device submission and not an AI/algorithm study:
Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Device)
The acceptance criteria for this physical medical device are derived from establishing substantial equivalence to a predicate device (Duo-Flow® Side x Side Double Lumen Catheter, K192807) through a combination of identical intended use, similar technological characteristics, and satisfactory non-clinical performance testing. The "performance" here refers to physical and mechanical attributes, not diagnostic or predictive accuracy.
Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Bench Testing):
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for Substantial Equivalence) | Reported Device Performance (Subject Device - 14F Duo-Flow) | Supporting Information/Evidence |
|---|---|---|---|
| Intended Use | Identical to predicate device | "The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion." (Identical to predicate) | Form 4, Page 6. Confirmed identical to predicate in Table 1. |
| Technological Characteristics | Similar to predicate device; no changes affecting safety or effectiveness | Radiopaque, polyurethane tube with two D-shaped lumina (red/blue adaptors for proximal/distal). Both arterial and venous lumens contain side-holes. Incorporates Barium Sulphate. Available in various sizes and with curved/straight extensions. | Page 6 ("Summary of Technological Characteristics") and Page 7 (Table 1). The key difference is the larger French size (14F) compared to predicate (9F, 11F, 12F), necessitating verification of performance for this new size. Other aspects like material (polyurethane, Barium Sulphate), lumen design, and side-holes are similar. |
| Biocompatibility | Device materials are biocompatible | Evaluated in accordance with FDA Guidance 'Use of International Standard ISO 10993-1'. Leveraged from the predicate device. | Page 8 ("Summary of Non-Clinical Testing: Biocompatibility"). No new testing performed as it relied on predicate data. |
| Physical/Mechanical Performance | Meets established performance standards for catheters (e.g., leakage, flow rates, durability) | Passed a suite of bench tests: Dimensional Analysis, Air Leakage, Liquid Leakage, % Lumen Elongation, ISO 80369-7 Stress Cracking, ISO 80369-7 Luer Testing, Kink Resistance, Gravity Flow Rate, Flow vs Pressure, Priming Volume, Clamp Cycle, Simulated Use, Electrical Conductivity, Force at Break, Packaging Validation. | Page 9 ("Summary of Non-Clinical Testing: Performance Testing"). Specific values for flow rate and priming volume are provided (Pages 7-8) for various lengths, demonstrating performance for the 14F size. |
| Sterilization Method | Identical to predicate device | 1x and/or 2x EO Sterilized (Identical to predicate) | Page 6, Table 1. |
| Target Population | Identical to predicate device | Adult (Identical to predicate) | Page 6, Table 1. |
| Duration of Use | Identical to predicate device | Short-Term (Identical to predicate) | Page 6, Table 1. |
| Principles of Operation | Similar to predicate device | Insertion Site: Jugular, femoral or subclavian vein (Identical to predicate) | Page 8, Table. |
Details Not Applicable to this Submission (as it's not an AI/Algorithm Device):
The following information requested in the prompt is not applicable to this 510(k) submission, as it pertains to AI/algorithm-based medical devices or clinical studies that were explicitly stated as "not required nor performed":
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device clearance based on bench testing. No "test set" in the context of diagnostic data was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No diagnostic test set or adjudication was involved.
- 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 is not an AI-assisted device. The document explicitly states "Clinical testing was not required nor performed to support the substantial equivalence of these devices."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" concept does not apply to the physical and mechanical performance testing of a catheter.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI model.
In summary, the FDA 510(k) K250836 clearance for the 14F Duo-Flow® Side X Side Double Lumen Catheter is for a physical medical device. The "acceptance criteria" and "study" described in the document are focused on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and comprehensive non-clinical (bench) performance testing. There is no information regarding AI/algorithm performance or clinical studies in this submission.
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