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The Palindrome™ RT Chronic Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome™ RT Chronic Catheter is supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vasculature before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde manner. The fully assembled Palindrome™ RT Chronic Catheter has a 15.0 Fr. radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which includes suture wings. The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

The provided document (K111817) describes a 510(k) submission for the Palindrome™ RT Chronic Catheter. This is a medical device, and the document focuses on demonstrating its substantial equivalence to predicate devices, rather than an AI/ML software. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," etc., are not applicable in this context.

However, I can extract the relevant information regarding acceptance criteria and the study performed for this device.

Acceptance Criteria and Reported Device Performance

Study Details

• Sample size used for the test set and data provenance: Not specified in the document. The testing was "bench top functional testing."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was bench testing of a physical medical device.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical medical device, not an AI/ML software for image interpretation.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used: For the bench testing, the "ground truth" would be the engineering specifications for Catheter to Tunneler Attachment Strength and Retention Strength.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which training data is used.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study performed was "Bench top functional testing." The objective was to support substantial equivalence between the modified Palindrome™ RT Chronic Catheter and a predicate device. The test protocol specifically evaluated:

• Catheter to Tunneler Attachment Strength
• Catheter to Tunneler Retention Strength

The results of this performance testing showed that "the modified device continues to meet the relevant product specifications," thereby supporting the determination of substantial equivalence. This implies that the 'acceptance criteria' were the pre-defined "relevant product specifications" for these two functional aspects.

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