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If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

This device consists of the following components:
a. 1-Flex-Neck™ Catheter, Infant, made of long-term, implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate.
b. 1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter.
c. 1-Surgical grade marking pen
d. 1-Catheter connector, plastic
e. 1-Catheter cap, plastic
f. 1-Tube (20 cc) of water-soluble lubricating gel

This document describes a 510(k) submission for the Flex-Neck™ PD Catheter, Infant. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for device performance. Therefore, many of the requested elements (like MRMC study, separate training/test sets, expert qualifications, etc.) are not applicable to the information provided.

However, based on the available text, here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Functional testing has been performed," but does not specify the sample size used for these tests.
The data provenance is not explicitly stated, but given this is a 510(k) submission for a medical device in the US, the testing would generally be conducted by the manufacturer, MEDIGROUP, Inc. It is implicitly internal company testing rather than external clinical data. It is retrospective in the sense that the testing was completed prior to the submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The submission relies on functional testing for mechanical integrity and retention, not on expert-adjudicated ground truth like in image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No. This type of study is not mentioned as it's not relevant for demonstrating substantial equivalence of a physical medical device based on mechanical properties. The focus is on the device's physical and functional attributes.

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 or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the functional testing would be the physical measurement and observation of the device's mechanical integrity and retention properties under defined test conditions, evaluated against engineering specifications. This is not "expert consensus" or "pathology" in the typical sense, but rather objective physical testing results.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. See point 8.

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