Search Results

The MananTM Nephrostomy Drainage Catheter is for percutaneous nephrostomy.

Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail-loop and non-locking pigtail. Also included with the catheters are stiffening cannulas.

The provided text describes a 510(k) submission for the Manan™ Nephrostomy Drainage Catheter. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a study describing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document is a 510(k) summary and FDA letter, which do not detail specific acceptance criteria or performance data from a new study. The submission relies on "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Available. No new test set or study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Available. No new test set requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Available. No new test set described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable/Not Available. The device is a physical drainage catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable/Not Available. As above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable/Not Available. No new study is presented requiring a "ground truth." The submission relies on substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable/Not Available. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable/Not Available. As above, no training set is relevant or described.

Summary of available information from the document:

• Device Name: Manan™ Nephrostomy Drainage Catheter
• Applicant: Medical Device Technologies, Inc.
• Common Name: Nephrostomy drainage catheter
• Classification Name: §878.4200-Introduction Drainage Catheter and Accessories
• Indications for Use: The Manan™ Nephrostomy Drainage Catheter is for percutaneous nephrostomy.
• Predicate Device: Manan Medical Products, Nephrostomy Drainage Catheter (510(k) No. K953547)
• Device Description: Made from biocompatible implantable urethane (Tecoflex) that softens at body temperature. Comes in various end configurations (locking pigtail-loop, non-locking pigtail) and includes stiffening cannulas.
• Regulatory Determination: The FDA determined the device is substantially equivalent to the predicate device.

Ask a specific question about this device