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The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.

The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.

The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.

The provided text describes a 510(k) premarket notification for two medical devices: the Universa® Loop Drainage Catheter Set and the Universa® Malecot Drainage Catheter Set. It does not describe an AI/ML device or a study involving such a device. Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the information related to acceptance criteria and the studies performed for these physical medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in the provided document.
• Data provenance: Not applicable. These are physical device tests, not data-driven studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. Ground truth for these physical device tests is established through engineering and biological standards, not expert consensus on data interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Performance is measured against physical test standards.

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

• MRMC study: No. This is not an AI/ML device.

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

• Standalone study: No. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for these physical device tests is based on:
  • Engineering specifications and material properties (for tensile strength, flow rates).
  • Functional design requirements (for retention).
  • International standards (ISO 10993-1 for biocompatibility).
  • Instructions for use for simulated clinical performance.

8. The sample size for the training set

• Sample size: Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

• Ground truth establishment: Not applicable. No training set for an AI/ML context.

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Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.

The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex.

The provided 510(k) summary for the "Bard malecot and pezzer drains" (K070879) does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria through a rigorous scientific study with ground truth and expert adjudication.

Instead, this document is a regulatory submission demonstrating substantial equivalence to previously marketed predicate devices (K910197 and K910846).

Here's what the document does state regarding performance:

• G. Performance Data Summary: "The Bard malecot and pezzer drains referenced in this submission are held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted."

This statement implies that the device was tested to ensure it met internal company specifications, but it does not detail those specifications, provide quantitative acceptance criteria, or describe a study design that would involve a test set, ground truth, or expert review in the way typically expected for medical imaging AI devices or diagnostic tests.

Therefore, I cannot populate the requested table or sections with the information provided in this document. The information in the 510(k) pertains to design, manufacturing, and general performance equivalence, not a detailed clinical or technical performance study with specified metrics.

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The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.

Manan drainage catheters are made from a biocompatible 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 malecot end configuration. Also included with the catheters are flexible stiffening cannula.

The provided document is a 510(k) summary for a medical device called the Manan™ Malecot Basket Drainage Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

Here's why the requested information is absent:

• Acceptance Criteria and Device Performance Table: This document is a regulatory submission for substantial equivalence. It focuses on comparing the new device to a legally marketed predicate device (Manan Medical Products' Malecot Basket Drainage Catheter, K954147), not on demonstrating performance against pre-defined acceptance criteria through a clinical study.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: These are all elements typically found in a clinical study report or a detailed validation study, especially for AI/ML-based devices. The Manan™ Malecot Basket Drainage Catheter is a physical medical device (a catheter), and its 510(k) submission largely relies on material compatibility and design similarity to its predicate, rather than on performance metrics from a diagnostic or algorithmic standpoint.

Summary:

This 510(k) submission is for a physical medical device (a catheter) and aims to demonstrate substantial equivalence to a predicate device. It does not include information about clinical studies with specific acceptance criteria, test sets, expert ground truth, or AI/ML performance metrics.

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Ask a specific question about this device