(288 days)
The NMI Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults. Catheters greater than 40 cm are intended for femoral vein insertion.
The NMI Dialysis Catheter (NMI DC) is a Carbothane, double lumen catheter used to remove and return blood during hemodialysis and apheresis. The catheter lumens are 'D' shaped, open at the distal tip with a total of 4 side holes (two at venous tip, two at arterial tip). The distal venous tip extends beyond the arterial lumen to reduce recirculation. The distal tip is tapered and curved to facilitate insertion. The distal tip also includes a guidewire lumen to facilitate insertion by the optional guidewire placement technique. The proximal section of the device contains a fixed polyester cuff that allows for tissue ingrowth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with colorcoded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter. The catheters are intended to be inserted percutaneously and are primarily placed in the right internal jugular vein of an adult patient. This implantation procedure is recommended to be carried out under direct fluoroscopic guidance. The catheter shaft, bifurcation, and extension legs incorporate Endexo polymer for improved resistance to thrombus formation on the surfaces of the catheter.
Here's an analysis of the provided text regarding the NMI Dialysis Catheter, focused on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report. Therefore, many of the specific details requested, particularly for clinical trials (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, ground truth for training set), are not present in this type of document. The focus here is on demonstrating performance against established standards and internal specifications, and often leverages in vitro and in vivo animal or simulated studies.
However, I will extract what is available and explain where information is missing due to the nature of the document.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance." Instead, it lists the types of performance tests conducted and concludes that the device "successfully passed relevant testing per the above Guidance and standards." This implies the acceptance criteria for each test were met, even if the specific numerical thresholds aren't provided.
Here's an interpreted table based on the information given:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity | Successfully passed Tensile Testing (per EN ISO 10555-1, EN ISO 10555-3, FDA Guidance) |
| Flow Performance | Successfully passed Recirculation Testing (per FDA Guidance) |
| Biocompatibility | Successfully passed Mechanical Hemolysis (per ISO 10993-1) |
| Successfully passed Biocompatibility (per ISO 10993-1) | |
| Usability/Functionality | Successfully passed Priming Volume measurements (per Internal Product Specification) |
| Successfully passed Catheter Interface Compatibility (per Internal Product Specification) | |
| Thromboresistance | Successfully passed In-Vitro and In-Vivo Thromboresistance Testing (specific standards not explicitly listed but implied by "Endexo polymer for improved resistance to thrombus formation") |
| Overall Safety & Effectiveness | Successfully passed Internal Product Specification Requirements |
| "Successfully passed relevant testing per the above Guidance and standards" |
Additional Requested Information:
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 for Test Set: Not specified. This document focuses on bench testing and in vitro/animal in vivo studies, not human clinical trials. Sample sizes for these types of tests would be determined by the specific test protocols and standards (e.g., a certain number of catheters for tensile testing).
- Data Provenance: Not specified. Given it's a submission to the US FDA, the tests were likely conducted in the US or in labs compliant with US regulations, but no country of origin is explicitly stated.
- Retrospective or Prospective: Not applicable in the context of human data. The tests described are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert readers to establish ground truth for interpreted data (e.g., medical images). The ground truth in these types of studies is the objective measurement from the bench or in vitro test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human adjudication for diagnostic outcomes.
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:
- No. This is a medical device (catheter) and not an AI-powered diagnostic tool. MRMC studies are not relevant here.
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 performance evaluations (e.g., tensile strength, recirculation, hemolysis) would be the objective measurements derived from the standardized test methods themselves. For example, for tensile testing, the ground truth is the breaking force measured by the testing equipment. For thromboresistance, it would be the observed thrombus formation in vitro or in vivo (animal model), compared to a control or predicate.
8. The sample size for the training set:
- Not applicable. This 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 for the same reason as above.
Summary of Study:
The studies conducted for the NMI Dialysis Catheter were primarily benchtop performance tests ("in vitro") and some in vivo animal studies (for thromboresistance), as indicated by the mention of "In-Vitro and In-Vivo Thromboresistance Testing." These tests were designed to evaluate the catheter's physical properties, functional performance (e.g., recirculation), biocompatibility, and resistance to thrombus formation against recognized international standards (ISO, EN ISO) and FDA guidance documents.
The conclusion of the submission is that "Based on successful results of testing... the proposed device is determined to be substantially equivalent to the predicate devices." This means the device met the performance expectations set by the applicable standards and guidance, demonstrating it is as safe and effective as 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.