(90 days)
THE MEDCOMP HEMO-FLOW™ DOUBLE LUMEN CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
The Medcomp Hemo-Flow™ Double Lumen Catheter is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long-term placement. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medcomp Hemo-Flow™ Double Lumen Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| In Vitro Performance | Recirculation (for hemodialysis catheters) | Tested | The submission states "In Vitro performance data... include: Recirculation". No specific numerical acceptance criteria (e.g., maximum recirculation percentage) or corresponding numerical performance values are provided in this summary. |
| In Vitro Performance | Flow Performance (for hemodialysis catheters) | Tested | The submission states "In Vitro performance data... include: Flow Performance". No specific numerical acceptance criteria (e.g., minimum flow rates at specific pressure drops) or corresponding numerical performance values are provided in this summary. |
| Substantial Equivalence | Intended Use | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Insertion Method | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Design | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Materials | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Performance | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Labeling | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Manufacturing Process | Substantially Equivalent | Compared to predicate devices. |
| Substantial Equivalence | Method of Sterilization | Substantially Equivalent | Compared to predicate devices. |
| New Features Comparison | 55cm length | Accepted as modified | This modification, along with femoral insertion instructions, was noted as a change from the predicate and was accepted. |
| New Features Comparison | Femoral insertion instructions for use | Accepted as modified | This modification, along with the 55cm length, was noted as a change from the predicate and was accepted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "In Vitro performance data" for Recirculation and Flow Performance. There is no information regarding the number of catheters tested or the conditions of the test.
- Data Provenance: Not specified. The testing is in vitro, so it does not involve human subjects or geographic locations. The submission does not indicate if the testing was performed internally by Medcomp or by an external laboratory.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This submission does not involve a clinical study requiring human interpretation or ground truth establishment by experts in the context of diagnostic accuracy. The performance data is based on in vitro (bench) testing.
4. Adjudication Method for the Test Set
- Not Applicable. As the performance data is from in vitro testing, there is no adjudication method for a test set in the sense of clinical interpretation or expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. The document explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices." Therefore, no MRMC study was conducted, and no effect size for human readers with/without AI assistance is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical device (catheter), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The type of ground truth used
- In Vitro Measurement Standards. For the recirculation and flow performance testing, the "ground truth" would be the direct measurement of relevant physical parameters (e.g., flow rates, pressure differentials, concentration changes to assess recirculation) against pre-defined engineering or performance standards for hemodialysis catheters. These standards are not explicitly detailed in the provided summary but would typically be established based on industry best practices and regulatory guidance for blood access devices.
8. The sample size for the training set
- Not Applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
Summary of Device Acceptance:
The Medcomp Hemo-Flow™ Double Lumen Catheter was accepted based on its substantial equivalence to existing predicate devices (K994105 and K012562). The manufacturer demonstrated this equivalence through design, materials, manufacturing process, and intended use comparison.
The primary performance data provided was in vitro testing for "Recirculation" and "Flow Performance." The submission asserted that because the design and materials remained largely unchanged from the predicates (except for a 55cm length and femoral insertion instructions), no further clinical studies were necessary. The FDA's 510(k) clearance indicates that these in vitro tests and the comparison to predicates were deemed sufficient to demonstrate the device's safety and effectiveness for its stated intended use. Specific acceptance values for recirculation and flow performance are not detailed in this summary.
§ 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.