(49 days)
Indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.
The Modified NexSite HD Hemodialysis Catheter for long term use is intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane catheter has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to assist with the direction of the catheter. The catheter is provided in three catheter lengths (32cm, 36cm and 40cm). The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement.
The Modified NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The Modified NexSite HD Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Marvao Modified NexSite™ HD Hemodialysis Catheter:
Important Note: The provided text describes a Special 510(k) Premarket Notification. This type of submission is used when a manufacturer is making a modification to their own legally marketed device and the modification does not affect the device's fundamental scientific technology or principles of operation. As such, the testing approach is different from a de novo submission or a traditional 510(k) for a truly novel device. The focus here is on demonstrating that the modifications do not negatively impact performance compared to the predicate, and that the modified device remains substantially equivalent. Therefore, a "study" in the sense of a clinical trial or a deep algorithmic performance evaluation (like for AI/ML) is not present.
Acceptance Criteria and Reported Device Performance
Given the nature of the Special 510(k) for a modified hemodialysis catheter, the "acceptance criteria" are implied by the comparison testing to the predicate device and the adherence to relevant standards. The "study" largely consists of direct comparison testing of predefined characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Modified NexSite HD performs equivalently to the predicate (K121933) in pre-defined characteristics. | "Comparison testing was performed on pre-defined characteristics using proposed finished NexSite™ HD devices and commercial predicate devices (K121933). The test results support the substantial equivalence of the Modified NexSite™ HD device to the predicate devices." |
| Adherence to ISO 10555-1: Catheter design and performance are reliable according to the standard. | "Performance testing was performed on the predicate NexSite HD, Hemodialysis Catheter for long term use to assure reliable design and performance in accordance with ISO 10555-1. The materials and manufacturing processes used in the manufacture of the Modified NexSite HD catheters are identical to those used in the manufacture of cleared NexSite HD devices (K121933). Therefore most of the performance testing completed for the cleared NexSite HD catheters was applicable to the Modified NexSite HD catheters, and as such the testing was not repeated." |
| Visual and Dimensional Analysis: Modified catheters meet specified visual and dimensional requirements. | "The testing performed specifically on the proposed Modified NexSite HD catheters includes visual and dimensional analysis..." |
| Pressure vs. Flow Testing: Modified catheters maintain specified pressure and flow characteristics. | "...and pressure vs. flow testing. The test results demonstrate that the Modified NexSite™ HD, Catheter for long term use meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate devices." |
| Material and Manufacturing Process Identity: Materials and manufacturing processes are identical to the cleared predicate device (K121933). | "The materials and manufacturing processes used in the manufacture of the Modified NexSite HD catheters are identical to those used in the manufacture of cleared NexSite HD devices (K121933)." |
| Sterilization: Device is sterile. | "The Modified NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process." |
| Biocompatibility: Suitable for blood contact duration > 30 days. | "The Modified NexSite HD Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure." (Implied acceptance by using identical materials to predicate). |
Further Information (Based on provided text):
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "proposed finished NexSite™ HD devices and commercial predicate devices (K121933)" were used for comparison testing. However, the number of units tested for visual, dimensional, and pressure/flow analysis is not provided.
- Data Provenance: Not explicitly stated, but assumed to be from Marvao Medical Devices, Ltd. in Galway, Ireland, where the devices are manufactured. The testing is laboratory-based performance testing of the physical device. The data is prospective for this submission as the testing was done on the "proposed finished" modified devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the type of device and submission. "Ground truth" in this context refers to engineering specifications and performance standards (like ISO 10555-1), not expert interpretation of medical images or outcomes.
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Adjudication method for the test set:
- Not applicable. Performance testing against engineering specifications does not typically involve expert adjudication in the same way clinical or image-based studies do.
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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 a physical medical device (catheter), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance testing is its engineering specifications and international performance standards (e.g., ISO 10555-1) and the performance characteristics of the legally marketed predicate device (K121933).
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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. The "design" and "materials" from the predicate device serve as the foundational "knowledge base," but this isn't a training set in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. See point 7. The underlying principles for hemodialysis catheters, materials science, and manufacturing processes, which were established for the predicate device, form the basis for the modified device.
§ 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.