(28 days)
The Niagara®, Niagara® Slim-Cath®, and Brevia® Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis therapy via the jugular, subclavian or femoral vein.
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The provided text is a 510(k) summary for Bard Access Systems' Niagara®, Niagara® Slim-Cath®, and Brevia® Dual Lumen Catheters. This document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a de novo study with specific acceptance criteria and detailed performance data against them.
Therefore, many of the requested elements for a study proving device meets acceptance criteria cannot be extracted directly from this document. The submission asserts equivalence based on unchanged indications for use, technological characteristics, and "safety and performance testing," but does not detail that testing or specific acceptance criteria.
Here's an attempt to address your request based on the provided text, with explicit notes where information is not available or not applicable to this type of regulatory submission:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)
This 510(k) submission argues for substantial equivalence to predicate devices, rather than establishing new acceptance criteria and proving performance against them in a de novo study. The core "acceptance criteria" for a 510(k) is that the new device is as safe and effective as a legally marketed predicate device.
The document states:
"Based on the indications for use, technological characteristics, and safety and performance testing, the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."
Since specific performance metrics and acceptance criteria for this device are not defined in the context of a new study, a table cannot be constructed. Instead, the "performance" shown is that it is equivalent to the predicate devices.
Supplementary Information:
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document does not describe a clinical "test set" in the context of a de novo study with human subjects. The evaluation is based on demonstrating equivalence to existing predicate devices.
- Data Provenance: Not applicable. No new clinical data from a prospective or retrospective study is presented. The assessment relies on a comparison of design, materials, and intended use to previously approved devices.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No new clinical test set or ground truth establishment by experts is described in this regulatory submission. The comparison is to established predicate devices.
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Adjudication Method for the Test Set:
- Not applicable. No new clinical test set requiring adjudication is described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not a study involving human readers or AI assistance. It's a submission for a physical medical device (catheter) based on substantial equivalence.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This is not an AI algorithm.
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Type of Ground Truth Used:
- Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) is established by the safety and effectiveness profile of the predicate devices (Niagara® Short Term Dialysis Catheters K965178, Niagara® Slim-Cath® Short Term Dialysis Catheters K010778, Brevia® Short Term Dialysis Catheters K881743). The new devices are deemed substantially equivalent to these.
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Sample Size for the Training Set:
- Not applicable. This is not a machine learning model or AI device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. (See #7)
Summary of the Document's Nature:
This 510(k) pertains to a Special 510(k) submission, which typically indicates a change to an existing device that does not alter its fundamental scientific technology or intended use. The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed in the U.S. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness.
The document explicitly states:
- "The intended use has not changed from the predicate catheters."
- "The indications for use has not changed from the predicate catheters."
- "Technological similarities between the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters and the predicate devices remain identical. There are no new questions raised regarding safety or efficacy of the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters."
Therefore, the "proof" that the device meets "acceptance criteria" is the FDA's concurrence that it is substantially equivalent to existing, approved devices based on the submission's arguments about design, materials, sterilization, principles of operation, and indications for use, supported by general "safety and performance testing" which is not detailed here.
§ 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.