(184 days)
Niagara 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.
Flexxicon II Dual Lumen Catheters are "Indicated for use in attaining temporary vascular access for hemodialysis, hemoperfusion and apheresis treatments. They are intended to be inserted in the subclavian, jugular or femoral vein, as required."
Short-Term Dialysis Catheters as currently distributed by BAS are dual lumen catheters, available in straight and precurved configurations with multiple insertion lengths. Catheters are made from soft polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the access to the catheter. A fixed, rotatable suture wing is located at the bifurcation.
The provided document is a 510(k) summary for a change in luer connectors for short-term dialysis catheters. It describes non-clinical performance data and does not contain information about studies involving human subjects, AI, or expert adjudication. Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on compliance with several recognized standards and FDA guidances. The document states that "All test results confirm the modified devices to be substantially equivalent to the predicate devices."
| Test Category | Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Luer Connection Tests | ISO 594-1:1986 (General Requirements for Conical fittings with 6% taper) | |
| ISO 594-2:1986 (Lock Fittings for Conical fittings with 6% taper) | ||
| FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, for: |
- Dimensions
- Tensile strength of catheter body to hub attachment (extension leg to hub attachment)
- Leakage at hub
- Catheter burst pressure (positive internal pressure) | "The test results met the requirements."
"The Short-Term Dialysis Catheters with new luer connectors met all the performance criteria of the tests performed." |
| General Catheter Requirements | ISO 10555-1:1997 (Sterile, single-use intravascular catheters, Part 1: General requirements) | Addressed implicitly by the overall claim of meeting performance criteria, though specific results for this standard are not detailed beyond the luer connection. |
| Central Venous Catheter Requirements | ISO 10555-3:1997 (Sterile, single-use intravascular catheters, Part 3: Central venous catheters) | Addressed implicitly by the overall claim of meeting performance criteria, though specific results for this standard are not detailed beyond the luer connection. |
| Biocompatibility | AAMI/ANSI/ISO-10993-1:1997 (Biological evaluation of medical devices – Part 1: Evaluation and testing)
FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long-term devices (worst-case for these short-term devices) | "Biocompatibility testing results met the requirements of ISO-10993, 'Biological Evaluation of Medical Devices Part-1: Evaluation and Testing' and the FDA Modified ISO 10993 Test Profile..." |
| Sterilization | AAMI/ANSI/ISO 11135:1994 (Medical devices Validation and routine control of ethylene oxide sterilization) | The device uses ethylene oxide sterilization, implying compliance, as the document refers to this standard when discussing conformance to recognized standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the document. The testing was "bench testing" of the luer connectors.
- Data Provenance: The studies were non-clinical, bench tests, not involving human subjects or patient data. Therefore, country of origin or retrospective/prospective does not apply.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The ground truth was established through adherence to recognized international standards and FDA guidances for non-clinical device performance. No experts were described as establishing a "ground truth" in the context of interpretation or diagnosis as would be relevant for software or imaging studies.
4. Adjudication Method
This information is not applicable as there was no human interpretation or decision-making process described that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study is a non-clinical device engineering evaluation, not a clinical study involving human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
No, a standalone algorithm performance study was not done. This study is related to the physical performance of a medical device component.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established by recognized international standards and FDA guidances for medical device safety and performance (e.g., ISO 594-1, ISO 594-2, ISO 10555 series, ISO 10993, AAMI/ANSI/ISO 11135, and FDA's specific guidance for intravascular catheters). This is a technical ground truth based on engineering and biocompatibility criteria.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this was a physical device modification, not an AI/machine learning study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no 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.