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The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.

The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.

The provided text describes a medical device, the Kendall Argyle® 1.9 Fr Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter, and its 510(k) submission to the FDA. It does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or information on reader studies, training sets, or ground truth establishment.

The document primarily focuses on:

• Device Identification: Proprietary name, common name, classification, and predicate devices.
• Description: Physical characteristics of the catheter.
• Intended Use: For venous catheterization or long-term IV administration in neonates/pediatric patients, with details on placement and types of fluids/medications administered.
• Technological Characteristics: Stating equivalence to predicate devices in materials, function, indications for use, and design.
• Nonclinical Testing: Biocompatibility testing performed according to ISO-10993, confirming material biocompatibility.
• FDA Communication: The 510(k) clearance letter confirming substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the given text. This information would typically be found in a more detailed clinical study report or performance evaluation document, which is not part of this 510(k) summary.

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The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.

This document is a 510(k) summary for the Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter, submitted to the FDA. It does not describe an AI device or specific performance criteria for such a device. Instead, it outlines the substantial equivalence of this catheter to a predicate device and details nonclinical testing related to biocompatibility.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them in the context of AI device performance. The document does not contain any of the following:

1. A table of acceptance criteria and the reported device performance: There are no performance metrics or acceptance criteria for an AI device in this document.
2. Sample size used for the test set and the data provenance: Not applicable as no AI device performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Description: A sterile, single-patient use, urinary drainage catheter made from 100% vulcanized silicone material, coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
• Intended Use: Drainage, collection, and/or measurement of urine, typically via urethral insertion, but also suprapubic or nephrostomy tract placement.
• Substantial Equivalence: Claimed to be substantially equivalent to the Kendall DOVER Foley Catheter predicate device.
• Nonclinical Testing: Biocompatibility testing demonstrated compliance with ISO 10993-1 and FDA modified matrix (memorandum G95-1).
• FDA's Determination: The FDA determined substantial equivalence, but specifically stated that no claims regarding the effectiveness of the inorganic silver ion releasing polymer to reduce microbial adherence or urinary tract infections could be made due to a lack of microbial adherence data.

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MAHURKAR® QPLUS® Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The MAHURKAR® QPLUS® Catheter has a 13.5Fr radiopaque polyurethane catheter shaft with two large lumens (arterial and venous) running longitudinally along the length of the catheter shaft. The catheter version with a straight shaft either has curved extensions or straight extensions. The catheter version with a pre-curved shaft has straight extensions.

MAHURKAR® QPLUS® Catheter is available in kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.

The provided text is a 510(k) Premarket Notification for the MAHURKAR® QPLUS® Catheter. This document is for a medical device and therefore does not contain information about software, algorithms, or AI. Consequently, I cannot address your request for specific details regarding an AI device's acceptance criteria and study information, as these are not relevant to the provided text.

The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (MAHURKAR® Triple Lumen Catheter and MAHURKAR® Dual Lumen Catheter) based on design, materials, physical characteristics, and performance characteristics.

Therefore, for each of your points, the information is not applicable or cannot be extracted from the provided text.

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MAHURKAR® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The MAHURKAR® Triple Lumen Catheter features three lumens. The catheter has a 12 Fr radiopaque polyurethane catheter shaft with two large lumens and one smaller medial lumen running longitudinally along the length of the catheter shaft. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions. The two large lumens have curved extensions, and the smaller medial lumen has straight extension tubing. The catheter is available in various implantable lengths.

MAHURKAR® Triple Lumen Catheter is available in singles, kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies the predicate device's infection rate is the benchmark for acceptability.

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

• Sample Size (Evaluable Patients): 393 patients
• Total Patients in Study: 485 patients
• Data Provenance: Multi-centered, prospective, randomized clinical study. The country of origin is not explicitly stated, but the FDA approval letter suggests it's within the US regulatory framework.

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

This information is not provided in the document. The study assessed "catheter related blood stream infection" as the primary outcome, which would typically be diagnosed by clinicians, but the specific number or qualifications of these diagnosticians are not mentioned.

4. Adjudication Method for the Test Set

This information is not explicitly stated in the document. The study design mentions "evaluable patients" and a "comparison" between two catheters, but doesn't detail how the primary outcome (infection) was adjudicated if there were discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This study is a clinical comparison of two medical devices (catheters) based on infection rates.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This study is a clinical trial comparing the performance of a new catheter with a predicate catheter.

7. Type of Ground Truth Used

The ground truth used was clinical outcome data, specifically "catheter related blood stream infection for each patient at the time of catheter removal." This implies a definitive clinical diagnosis based on established medical criteria for infection.

8. Sample Size for the Training Set

The document describes a clinical study to evaluate the device's performance, not a study to train an algorithm. Therefore, there is no training set in the context of this document.

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

Since there was no training set for an algorithm, this question is not applicable. The ground truth for the clinical study was established through the diagnosis of catheter-related blood stream infections in patients.

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Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.

The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.

This document is a 510(k) summary for the Kendall Excilon® A.M.D. Antimicrobial Sponges. It focuses on demonstrating substantial equivalence to previously marketed devices and does not contain information about specific acceptance criteria, device performance, or human subject studies as typically described for software or AI-based devices.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Reported Device Performance: This submission is for a physical wound dressing, not a software or AI device. The document states that "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This is the extent of performance "criteria" discussed, and it's for biocompatibility, not for a functional or diagnostic performance as would be expected for a device where a table of acceptance criteria and reported performance would be relevant.
• No Study Data for Software/AI Performance: The submission does not describe a study that proves device performance in the context of AI or software. There are no mentions of test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This is not applicable to a non-digital, physical medical device like an antimicrobial sponge.
• No AI or Software Component: The device described is an antimicrobial wound dressing. It does not incorporate any AI, machine learning, or software components that would require the types of studies and criteria outlined in your request.

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KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.

The provided text is a 510(k) summary for a medical device (Kendall Kerlix MD Antimicrobial Gauze Dressing) and the FDA's clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain any information regarding clinical studies, acceptance criteria for device performance, or human-in-the-loop performance evaluation.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance through substantial equivalence, which primarily relies on comparison to existing legally marketed devices, rather than a clinical performance study with specific acceptance criteria.

To elaborate on why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) or acceptance criteria are mentioned. The document states "Biocompatibility testing... has demonstrated that it meets the requirements of quidelines presented in the 10993 ISO Standard, Part 1," but these are safety/biocompatibility guidelines, not performance criteria for a diagnostic or therapeutic effect.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts related to clinical performance studies, which are not detailed in this 510(k) submission. The document relies on "nonclinical testing" (biocompatibility) and comparison to predicate devices' intended use and composition.

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