(238 days)
The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.
The Vas-Cath Niagara™ catheter is a polyurethane catheter which allows for dialysis, hemoperfusion or apheresis. The Niagara™ catheter contains two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic nylon clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. Both a fixed and a removable suture wing are provided for securing the catheter after initial placement.
The cross-section of the oval shaft contains two round arterial and venous lumens. The arterial lumen exit is bevelled and is perforated with two holes. The venous lumen extends beyond the arterial lumen and ends with a soft atraumatic black tip. The Niagara™ catheters are available in a straight configuration with 15cm, 20cm, and 24cm insertion lengths; as well as in a pre-curved configuration with 12.5 cm, 15 cm and 20 cm insertion lengths.
This document describes a 510(k) submission for the Niagara™ Dual Lumen Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the Vas-Cath Soft-Cell™ Catheter (K871488). Therefore, the study presented focuses on justifying this equivalence rather than establishing acceptance criteria against a clinical benchmark.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in a quantitative, pass/fail sense as one might find for a new device claiming superiority or meeting a specific performance threshold. Instead, it aims to demonstrate substantial equivalence by comparing the Niagara™ catheter to the predicate device across various characteristics and in vitro performance data.
The table implicitly defines the performance characteristics being compared, and the "reported device performance" are the values listed for the Niagara™ Catheter. The "acceptance criteria" can be inferred as "being comparable to or better than the predicate device."
| Characteristic | Predicate Device Performance (Vas-Cath Soft-Cell™ Catheter K871488) | Niagara™ Catheter Performance (Reported Device Performance) | Inference of "Acceptance Criteria" |
|---|---|---|---|
| Shaft Diameter | 12.5 French | 13.5 French | Comparable |
| Materials | Polyurethane body and extensions, PVC connectors | Polyurethane body and extensions, PVC connectors | Equivalent |
| Priming Volume (arterial lumen) | 12cm: 1.3cc, 19cm: 1.5cc, 23cm: 1.7cc | 15cm: 1.3cc, 20cm: 1.5cc, 24cm: 1.6cc | Comparable |
| Priming Volume (venous lumen) | 12cm: 1.4cc, 19cm: 1.6cc, 23cm: 1.8cc | 15cm: 1.4cc, 20cm: 1.6cc, 24cm: 1.7cc | Comparable |
| Shape of arterial/venous lumens | "Double-D" lumens | two round lumens | Comparable (functionally similar) |
| Indications | hemodialysis, hemoperfusion, apheresis | hemodialysis, hemoperfusion, apheresis | Equivalent |
| Catheter Insertion lengths | 12 cm, 19 cm, 23 cm | 15cm, 20cm, and 24cm | Comparable |
| Tip Characteristic | 45° bevelled tip | soft black tip | Comparable (design variation) |
| Manufacturing Process | Injection Molded bifurcation onto Body and Extensions. Catheter is one piece | Injection Molded bifurcation onto Body and Extensions. Catheter is one piece | Equivalent |
| Elongation | (Not explicitly stated for predicate, but implied as "substantially equivalent") | Demonstrated to be "substantially equivalent" | Comparable |
| Tensile strength of molded joints | (Not explicitly stated for predicate, but implied as "substantially equivalent") | Demonstrated to be "substantially equivalent" | Comparable |
| Leakage | (Not explicitly stated for predicate, but implied as "substantially equivalent") | Demonstrated to be "substantially equivalent" | Comparable |
| Recirculation | (Not explicitly stated for predicate, but implied as "substantially equivalent") | Demonstrated to be "substantially equivalent" | Comparable |
| Maximum pressure and vacuum | (Not explicitly stated for predicate, but implied as "substantially equivalent") | Demonstrated to be "substantially equivalent" | Comparable |
| Flow rate | (Implied to be lower than Niagara™) | Greater than the Soft-Cell™ catheter | Superior (beneficial difference) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for the "in vitro performance data." It refers to "bench testing" but doesn't provide the number of units tested for elongation, tensile strength, leakage, recirculation, maximum pressure, vacuum, or flow rate.
- Data Provenance: The studies were in vitro (bench testing). The submitter, Vas-Cath Incorporated, is located in Mississauga, Ontario, Canada. Therefore, the testing likely occurred in Canada or a facility contracted by them. The data is prospective as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the presented data. The studies are in vitro performance tests of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" for these tests would be the measurement results obtained from validated testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, these are objective in vitro measurements, not subjective evaluations requiring adjudication by experts.
5. 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 submission concerns a physical medical device (catheter), not an AI-based system or diagnostic imaging. Therefore, no MRMC study was performed, nor is there any AI involvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the in vitro performance tests would be the measured physical and mechanical properties of the catheters, derived from standard engineering and materials testing methods. For example, a flow meter would provide the ground truth for flow rate, and a pressure gauge for maximum pressure. These are objective measurements rather than expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set was used.
§ 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.