(232 days)
The r4 Duraspan"10 long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.
The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan" kit includes a catheter and introduction components. The catheter is supplied sterile.
The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.
The Duraspan 10 is similar to the Bard HemoGlide Star Series and the tip stagger is similar to the Arrow Step-Tip with the addition of a Biomimetic Coating that is identical to the coating on the Zeus Catheter.
The provided text describes a 510(k) premarket notification for a medical device, the Duraspan™ Long-Term Hemodialysis Catheter. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI device typically would.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. This is a different type of evaluation.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document's purpose is to show the device is similar enough to already approved devices, not to establish novel performance metrics against a defined ground truth.
Here's an explanation of what the document does describe in relation to the prompt:
-
Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative metrics or a table of performance. The "acceptance criteria" for a 510(k) submission are that the device is "substantially equivalent" to predicate devices and raises "no new questions regarding safety or efficacy." The reported "performance" is that it "met the requirements for its intended use" through testing based on existing standards and test methods, demonstrating substantial equivalence.
-
Sample Size Used for the Test Set and Data Provenance: Not applicable. The document refers to "testing" and "performance testing" but does not detail a specific "test set" of patient data in the way an AI diagnostic study would. The testing would likely involve bench testing, biocompatibility, and perhaps animal studies, but not a human subject "test set" for a diagnostic algorithm.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. There is no concept of "ground truth" establishment by experts in this context, as it's not an AI diagnostic device being evaluated for its accuracy.
-
Adjudication Method for the Test Set: Not applicable.
-
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done: No. This type of study is for evaluating human performance with and without AI assistance for interpretation tasks, which is not relevant to a hemodialysis catheter.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm-based device.
-
The Type of Ground Truth Used: Not applicable. For this catheter, the "ground truth" would be successful function and safety in a physiological environment, assessed through various engineering tests, biocompatibility tests, and potentially animal studies.
-
The Sample Size for the Training Set: Not applicable. This is not an AI device that uses a "training set."
-
How the Ground Truth for the Training Set was Established: Not applicable.
Summary based on the provided text:
The document outlines the regulatory basis for the Duraspan™ Long-Term Hemodialysis Catheter. It claims that the device:
- Met the requirements for its intended use.
- Is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to current commercially available catheters/cited predicates.
- Was thoroughly tested with tests based on existing standards and test methods.
- Raises no new questions regarding safety or efficacy.
The "study" or evaluation performed was a series of engineering and biocompatibility tests designed to demonstrate substantial equivalence to legally marketed predicate devices (HemoGlide Star Series, Zeus CT PICC, Arrow Step-Tip). The basis of approval is this demonstrated equivalence, not a direct measurement of diagnostic accuracy against a "ground truth" in human patients as would be expected for an AI diagnostic 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.