(100 days)
The Palindrome P Hemodialysis Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.
The Palindrome P Catheter Repair Kit is indicated to repair the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s) of the Palindrome P Hemodialysis Catheter
The Palindrome Reverse Tunneled Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion.
The Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm
The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The Catheter will be supplied with a detached connector assembly allowing for the catheter tip to be positioned in the vein and tunneled retrograde to the exit site. The hub and back end of the catheter is then assembled with a snap lock connector with compression ring.
A Palindrome™ Reverse Tunneled catheter repair kit will be offered to replace damaged extensions and / or extension adaptors.
The provided text describes the 510(k) Premarket Notification for the PalindromeTM P Hemodialysis Catheter. It outlines the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Here's a breakdown of why and what information is missing:
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Acceptance Criteria and Reported Device Performance: While the document states "Testing was performed to compare the proposed Palindrome™ P Reverse Tunneled Catheter to predicate device. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices," it does not provide a table of specific acceptance criteria (e.g., flow rates, material biocompatibility thresholds, tensile strength limits) or the quantitative results from these tests. It only makes a general claim of substantial equivalence.
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Sample Size and Data Provenance for Test Set: This information is completely absent. The document mentions "testing was performed" but provides no details on the number of catheters tested, the source of any data (e.g., in-vitro, in-vivo, animal studies, human clinical data), or whether this data was retrospective or prospective.
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Number and Qualifications of Experts for Ground Truth: Since no specific clinical or image-based studies are detailed, there is no mention of experts, their qualifications, or their role in establishing ground truth. This type of information would typically be relevant for diagnostic devices that rely on expert interpretation.
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Adjudication Method: Similar to the above, without specific clinical or diagnostic study details, an adjudication method is not mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This document pertains to a medical device (hemodialysis catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not applicable or mentioned. There's no AI component in this device.
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Standalone (Algorithm Only) Performance: As this is a physical medical device and not an algorithm, the concept of "standalone performance" for an algorithm is not applicable.
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Type of Ground Truth Used: The document implies that the "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices. However, the specific metrics and how they were established for either the predicate or the new device are not detailed.
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Sample Size for Training Set: Since this is a physical device and not an AI model, there is no concept of a "training set" in the machine learning sense.
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How Ground Truth for Training Set was Established: Not applicable for the same reason as above.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence through a general statement of "verification/validation" against predicate devices. It does not offer the granular detail concerning acceptance criteria, study methodologies, expert involvement, or data characteristics that your questions are looking for, particularly those questions relevant to AI/ML or diagnostic devices.
To answer your questions accurately, a much more detailed technical report or study protocol usually submitted to the FDA (beyond the public 510(k) summary) would be required. This summary is intended to provide an overview to justify commercialization based on equivalence, not to fully detail all underlying testing.
§ 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.