(103 days)
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
The provided text describes a 510(k) summary for the MAHURKAR™ Triple Lumen Dialysis Catheter, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not contain information typically associated with acceptance criteria and study details for an AI/ML powered device, specifically due to the device being a physical medical product (catheter) rather than a software-as-a-medical-device (SaMD).
Therefore, a significant portion of your requested information (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth types) is not applicable to this physical device submission.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices through performance data related to physical and functional aspects of the catheter. The "acceptance criteria" are implied by the successful testing showing equivalence and mechanical integrity.
| Acceptance Criterion (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Catheter mechanical integrity maintained after power injections | "Tensile testing and leak and burst testing to ensure catheter mechanical integrity was not diminished after power injections." | Testing was performed to ensure the catheter's physical structure remains intact after high-pressure injections, a key safety and functionality aspect. The implication is that the device met these standards. |
| Accurate Central Venous Pressure (CVP) Monitoring | "Central Venous Pressure testing was conducted to verify that the catheter was capable of being used for accurate pressure monitoring as compared to the predicate device." | This confirms the device's ability to fulfill its CVP monitoring function. The implication is that the device performs accurately for CVP monitoring. |
| Substantial Equivalence to Predicate Devices | "Results of the verification / validation testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices." | The overall acceptance criterion is to prove substantial equivalence to existing, legally marketed devices (K020089 and K083675) for the expanded indications. The reported performance confirms this. |
| Adherence to maximum recommended infusion rate for power injection | Maximum recommended infusion rate is 5 mL/sec for power injection of contrast media. | This is an intended use specification, and the prior testing (mechanical integrity) supports the catheter's ability to safely handle this rate. |
Study Details for a Physical Medical Device (Catheter)
The following details are not relevant or available for this physical device as they typically apply to AI/ML software evaluations.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical catheters subjected to various engineering tests (tensile, leak, burst, CVP). Data provenance would be from materials testing and physical experiments, not country of origin of data in a clinical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical integrity is established by engineering standards and measurement equipment, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This method is used for resolving discrepancies in expert labeling or diagnoses, not for physical product testing.
- 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 for AI-assisted diagnostic tools, not a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, physical measurements from testing (e.g., pressure readings, force measurements during tensile tests, observation of leaks/bursts), and comparison to the established performance of predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is present:
The study described is a series of engineering verification and validation tests aimed at demonstrating the MAHURKAR™ Triple Lumen Dialysis Catheter's performance characteristics (mechanical integrity, pressure monitoring capability) and its substantial equivalence to predicate devices (Mahurkar™ Triple Lumen Dialysis Catheter K020089 and Bard Power-Trialysis Triple Lumen Dialysis Catheter K083675). The data provenance is from laboratory testing of the physical device. The "ground truth" for this context is the adherence to engineering standards and comparison against the known performance of the predicate devices.
§ 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.