(26 days)
The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-tern vascular access for hemodialysis and apheresis. It may be insected percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.
The Centros and CentrosFLO Long-Term Hemodialysis Catheters are dual lumen, 15FR catheters available in a straight configuration with multiple lengths. The catheter comes with a stiffening stylet that can be used for over-the-wire placement. The stiffening stylet has a female Luer which is over-molded on a nylon shaft with a tapered distal tip. Distal to the female Luer is a rotating male locking collar which can be used to attach the stylet to the catheter. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length pre-formed split-tip, with (CentrosFLO) or without (Centros) side-holes. The distal venous lumen extends past the arterial lumen, and includes a quide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixed polyester cuff, an integrated bifurcation, suture wing, and extension legs with color coded occlusion clamps and Luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on ID tags within the occlusion clamps. The trade name and cuff-to-tip length are printed on the catheter bifurcation. The procedure kits include the necessary accessories to correctly insert the catheter.
The provided document is a 510(k) Premarket Notification for the Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to a predicate device through conformity to recognized performance standards and bench testing.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance data. Instead, it states that a "battery of tests was performed based on the requirements of the below recognized performance standards and draft guidance, as well as biocompatibility, sterilization, and labeling standards and guidance."
The document generally states that the device "met the predetermined acceptance criteria applicable to the safety and efficacy of the device." No specific numerical values for acceptance criteria or performance are presented.
Here's an inferred list of the performance tests conducted, with the understanding that the acceptance criteria are implicitly derived from the referenced standards and guidance documents:
| Test Performed | Implied Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Conformance to design specifications | Met |
| Stylet removal from catheter | Smooth removal without damage or excessive force | Met |
| Guidewire slit liquid leakage | No leakage or leakage within acceptable limits | Met |
| Stylet insertion in catheter | Smooth insertion without damage or excessive force | Met |
| Visual inspection | Absence of defects, conformance to visual standards | Met |
| Guidewire passage through stylet | Smooth passage without obstruction or damage | Met |
| Stylet Protrusion | Protrusion within specified limits | Met |
| Force at break stylet hub to shaft | Meets minimum strength requirements | Met |
| Stylet Luer gauging | Conformance to Luer taper standards (ISO 594-1/2) | Met |
| Stylet Luer separation force | Meets specified separation force requirements | Met |
| Stylet Luer unscrewing torque | Meets specified unscrewing torque requirements | Met |
| Stylet Luer ease of assembly | Easy and secure assembly | Met |
| Stylet Luer resistance to overriding | Resists overriding during assembly | Met |
| Stylet Luer stress cracking | No stress cracking observed | Met |
| Biocompatibility | Meets ISO 10993-1 requirements | Met |
| Sterilization | Meets ISO 11135-1 requirements | Met |
| Labeling | Conformance to FDA guidance | Met |
| General Requirements for Intravascular Catheters (ISO 10555-1) | Conformance to all applicable sections | Met |
| Central Venous Catheters Specific Requirements (ISO 10555-3) | Conformance to all applicable sections | Met |
| Intravascular Catheter Introducers (ISO 11070) | Conformance to all applicable sections | Met |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device premarket notifications that rely on bench testing, it is generally assumed that these tests are conducted internally by the manufacturer (Merit Medical Systems, Inc., located in South Jordan, UT, USA) and are prospective experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The document describes bench testing against engineering standards and guidance documents, not a clinical study involving human assessment or expert consensus for "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability, which is not the case for the described bench tests.
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
This information is not applicable and not provided in the document. The filing describes a physical medical device (catheter) and its bench testing, not an AI or imaging diagnostic device. Therefore, no MRMC study, AI assistance, or effect size is discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. As stated above, this is not an AI or algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the described bench tests, the "ground truth" is defined by the acceptance criteria established by the referenced international standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135-1, ISO 10993-1, ISO 11070) and FDA guidance documents. The device's performance is compared against these predetermined, objective, and quantitative or qualitative benchmarks.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.
§ 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.