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The Palindrome™ H H Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The Palindrome™ SI Chronic Catheter is indicated 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 performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

The Palindrome™ HSI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

The Palindrome™ H Chronic Catheter with Heparin coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface from the tip of the catheter to the cuff on the external surface and throughout the entire length on the internal surface (tip to luer adapters). The heparin coating serves to reduce platelet adhesion.

The Palindrome™ SI Chronic Catheter with Silver Impregnated sleeve has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

The Palindrome™ HSI Chronic Catheter with Heparin coating and Silver Impregnated sleeve has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface from the tip of the catheter to the cuff on the external surface and throughout the entire length on the internal surface (tip to luer adapters). The heparin coating serves to reduce platelet adhesion. The catheter also contains a silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

This document describes the premarket notification (510(k)) for the Palindrome™ H Chronic Catheter, Palindrome™ SI Chronic Catheter, and Palindrome™ HSI Chronic Catheter by Covidien. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to maintaining the relevant product specifications and biocompatibility, as demonstrated by the predicate devices. The study performed aims to show that the modifications do not negatively impact these established performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual functional or biocompatibility test. It mentions "bench top functional testing" and "biocompatibility testing," which are typically done on a representative sample of devices.

• Data Provenance: The testing mentioned is benchtop and likely conducted by the manufacturer (Covidien). The document also mentions "animal testing" supports the performance of the heparin coating and silver-impregnated sleeve in the "Indications for Use" section, but the details of this animal testing are not provided in the "Performance Data" section. It's retrospective in the sense that the testing was performed to support a pre-market submission, not as part of an ongoing clinical trial. There is no information regarding the country of origin of the data beyond the manufacturer being based in Mansfield, MA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a medical device seeking substantial equivalence based on in vitro (benchtop) and in vivo (animal) performance data, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The "ground truth" here is adherence to established engineering specifications and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring human expert adjudication of a test set in the traditional sense of diagnostic accuracy. The results of the functional and biocompatibility tests are assessed against pre-defined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images. This device is a catheter, and the performance data presented is based on physical and biological testing, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The described performance testing (benchtop functional and biocompatibility) represents the "standalone" performance of the device without human intervention or interpretation during the performance assessment itself. The device's physical and material properties are tested directly.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Engineering Specifications/Product Specifications: For functional performance, the device is evaluated against pre-defined requirements for resistance to kink, leak, burst, collapse, fatigue, tensile strength, heparin activity/concentration/durability, and sleeve adhesion.
• International Standards: For biocompatibility, adherence to ISO 10993 (Biological Evaluation of Medical Devices) is the ground truth.
• Material Equivalence: The ground truth for material characterization is the equivalence to the materials used in the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in this context. The study is evaluating the physical and biological performance of a medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device clearance.

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The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Acceptance Criteria and Reported Device Performance:

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