(145 days)
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.
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.