(205 days)
The MedComp® Duo-Coat Catheter is indicated for use in attaining short term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion sites are the subclavian or femoral vein.
The MedComp® DUO-COAT Catheter Double Lumen combines the MEDCOMP Duo-Flow Catheter with a dual purpose surface coating. Bound heparin reduces thrombus formation on the catheter outer surface and at arterial and venous ports, in 4-hour invitro-studies'. The round catheter design and lubricious surface may aid in catheter insertion by reducing friction on the outer surface. The fixed circular tube within a tube allows for a 360 arterial uptake and provides consistent flows from 350 to 400 ml/min. The catheter lumen is fabricated from a soft, thermo-sensitive, polyurethane material that is rigid upon insertion, but which becomes soft upon reaching body temperature to reduce vessel trauma. The external lumen surface incorporates heparin to reduce the risk of thrombus. The catheter hub is molded from soft pliable polyurethane to increase patient comfort. The soft radiopaque tip reduces vessel trauma and aids in confirmation of tip placement. Extensions are color coded with a red luer and clamp for the arterial lumen and a blue luer and clamp for the venous lumen for easy identification.
Here's a breakdown of the acceptance criteria and study information for the MedComp® DUO-COAT Catheter Double Lumen, based on the provided text:
Important Note: This submission is a 510(k) Pre-market Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" described are often comparisons to the predicate and performance tests to ensure safety and effectiveness, rather than extensive clinical trials with human subjects as might be seen for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Predicate Equivalence | Substantially equivalent to Duo-Flow Double Lumen Catheter (K974236). |
| Thrombus Formation Reduction (Outer Surface & Ports) | Bound heparin reduces thrombus formation on the catheter outer surface and at arterial and venous ports, in 4-hour in-vitro-studies. Hemodynamic testing under strenuous simulation testing demonstrated that the surface modification reduced the risk of thrombosis. (Results from comparative evaluation against uncoated control catheters after simulated dialysis testing with heparinized bovine blood.) |
| Insertion Aid / Reduced Friction | The round catheter design and lubricious surface may aid in catheter insertion by reducing friction on the outer surface. Comparison of treated and untreated surfaces showed a marked reduction in drag on the surface after application of the lubricious heparin. |
| Consistent Flow Rates (Arterial Uptake) | The fixed circular tube within a tube allows for a 360° arterial uptake and provides consistent flows from 350 to 400 ml/min. |
| Material Properties (Thermo-sensitive) | Fabricated from a soft, thermo-sensitive, polyurethane material that is rigid upon insertion, but which becomes soft upon reaching body temperature to reduce vessel trauma. |
| Biocompatibility | Testing conducted on the uncoated catheter, similar to that conducted on the predicate device, confirmed that the presence of the lubricious heparin did not affect the safety of the catheter. |
| Mechanical Integrity | Testing conducted on the uncoated catheter, similar to that conducted on the predicate device, confirmed that the presence of the lubricious heparin did not affect the safety of the catheter. |
| Patient Comfort | The catheter hub is molded from soft pliable polyurethane to increase patient comfort. (This is a design feature, not directly a tested performance metric in the provided text). |
| Tip Placement Confirmation / Vessel Trauma | The soft radiopaque tip reduces vessel trauma and aids in confirmation of tip placement. (Design features). |
| Safety (General) | Confirmed that the presence of the lubricious heparin did not affect the safety of the catheter (via biocompatibility screens and mechanical integrity tests). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or subjects in the provided text. The testing mentioned refers to "comparative evaluation against uncoated control catheters" and "hemodynamic testing under strenuous simulation testing." It implies in vitro testing, not human trials.
- Data Provenance:
- Country of Origin: Not specified, but generally assumed to be within the US or compliant with US regulatory standards for a US FDA submission.
- Retrospective or Prospective: The reported tests ("4-hour in-vitro-studies", "hemodynamic testing under strenuous simulation testing," "comparative evaluation") are presented as prospective in vitro bench tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The evaluation method described is primarily in vitro laboratory testing and comparison to an uncoated control, not an expert-driven ground truth assessment for a diagnostic or imaging device.
4. Adjudication Method for the Test Set
None. The testing described is in vitro laboratory performance evaluation (e.g., thrombus formation, drag reduction, consistent flow rates, biocompatibility, mechanical integrity) against a control, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically performed for diagnostic imaging or AI devices where human readers interpret cases. This device is a medical catheter, and its evaluation focuses on physical and biological performance characteristics, not diagnostic interpretation. Therefore, there is no mention of human readers or effect size of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This is a physical medical device (catheter), not an AI algorithm. Its performance is inherent to its design and materials, not learned from data.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims appears to be established through:
- Quantitative In Vitro Measurements: Direct measurement of parameters like flow rates (350-400 ml/min), thrombus formation (reduction in 4-hour studies), and drag reduction (marked reduction).
- Comparative Assessment: Performance compared against "uncoated control catheters" for thrombus formation and drag.
- Predicate Device Performance: Substantial equivalence claims often benchmark against the known safety and effectiveness of the predicate.
- Biocompatibility Standard Tests: Implied adherence to established biocompatibility screens.
- Mechanical Integrity Tests: Implied adherence to established tests for device durability and function.
8. The Sample Size for the Training Set
Not Applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As this is not an AI/ML device, there is no training set and therefore no ground truth established for it.
§ 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.