(307 days)
The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.
The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.
Here's a breakdown of the acceptance criteria and study information for the Acute Dual Lumen Hemodialysis Catheter, based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document lists various performance characteristics that were tested. While specific numerical acceptance criteria (e.g., "flow rate must be > X mL/min") are not explicitly detailed in the summary, the general statement indicates the device "met the minimum requirements that are considered adequate for its intended use." This implies that for each test, there was an established benchmark or range that the device successfully achieved.
| Performance Attribute | Reported Device Performance |
|---|---|
| Air Leakage | Met minimum requirements (implies no unacceptable leaks) |
| Liquid Leakage | Met minimum requirements (implies no unacceptable leaks) |
| Tensile Strength | Met minimum requirements (implies adequate strength) |
| Catheter Flow Rate | Met minimum requirements (implies adequate flow) |
| Priming Volume | Met minimum requirements (implies acceptable volume) |
| Kinking | Met minimum requirements (implies resistance to kinking) |
| Repeated Clamping | Met minimum requirements (implies durability with clamping) |
| Conical Luer Lock Fittings | Met minimum requirements (implies proper fit and function) |
| Surface Appearance | Met minimum requirements (implies acceptable appearance) |
| Chemical Tolerance | Met minimum requirements (implies acceptable tolerance) |
| Recirculation Rate | Met minimum requirements (implies acceptable rate) |
| Pressure vs Flow Rate | Met minimum requirements (implies acceptable relationship) |
| Sterilization | Meets ISO 11135 standards |
| Shelf Life | Meets ISO 11607-1 standards |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogen, Bacterial Endotoxin Testing, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, Intramuscular Implantation, Hemocompatibility (Hemolysis Direct Contact, Hemolysis Indirect Contact, Thrombogenicity In Vitro Blood Loop Assay, Complement Activation, Mechanically Induced Hemolysis), Chronic Toxicity, Carcinogenicity) | Meets ISO 10993-1 standards (implies acceptable biocompatibility profile) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flow rate or tensile strength). It only states that "Bench testing was conducted."
Regarding data provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The testing described is prospective, as it involves the evaluation of the subject device's performance before market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The document describes bench testing and biocompatibility testing against established standards (FDA recognized standards, ISO standards), rather than studies involving human experts establishing "ground truth" on clinical cases. The "ground truth" here is the adherence to these engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
This is not applicable as the described testing does not involve human expert adjudication of clinical cases. The "adjudication" is essentially the determination by a testing facility or qualified personnel that the device either passed or failed the specified test criteria based on the relevant standard.
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 MRMC comparative effectiveness study was mentioned. The device is a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of this medical device is based on established engineering standards, international standards (ISO), and regulatory requirements for the safety and performance of such devices. For example:
- Bench Testing: Engineering specifications and performance limits for properties like flow rate, tensile strength, leakage, etc.
- Biocompatibility Testing: Standards outlined in ISO 10993-1, which define acceptable levels of biological response to medical devices.
- Sterilization and Shelf Life: Standards like ISO 11135 and ISO 11607-1.
8. The Sample Size for the Training Set:
Not applicable. This document describes the evaluation of a physical medical device, not a machine learning algorithm that would have a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, no training set is relevant for this type of device submission.
§ 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.