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The MaxGuard Advanced Luer Activated Device with Antimicrobial Technology is a sterile single use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxGuard Connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The MaxGuard with Antimicrobial Technology may inhibit the growth of microorganisms on the surfaces of the MaxGuard device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms:

Staphylococcus aureus, ATCC 6558 Staphylococcus epidermidis. ATCC 12228 Escherichia coli, ATCC 8739 Enterococcus faecalis, ATCC 51299 Pseudomonas aeruginosa, ATCC 9027 Klebsiella pneumonia. ATCC 4352 Candida albicans, ATCC 10231

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This document is a 510(k) premarket notification for a medical device called "MaxGuard Advanced Luer Activated Device with Antimicrobial Technology." It's an FDA clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics in the context of an AI/ML device.

This document describes a medical device designed to reduce microbial contamination in IV lines. The "acceptance criteria" presented are related to its antimicrobial efficacy, specifically its ability to achieve a "4+ log reduction" of certain microorganisms. This is not a study about an AI/ML device, so most of the questions are not applicable.

Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the claimed performance standard for its antimicrobial properties:

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

Specific organisms for which a 4+ log reduction was demonstrated:

• Staphylococcus aureus, ATCC 6558
• Staphylococcus epidermidis, ATCC 12228
• Escherichia coli, ATCC 8739
• Enterococcus faecalis, ATCC 51299
• Pseudomonas aeruginosa, ATCC 9027
• Klebsiella pneumonia, ATCC 4352
• Candida albicans, ATCC 10231

The following information cannot be found in the provided document, as it pertains to an AI/ML device study, which is not the subject of this 510(k) clearance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Tru-Swab™ Stopcock is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Tru-Swab™ Stopcock." This document primarily addresses the substantial equivalence of the device to a legally marketed predicate device and grants permission for the manufacturer to market it.

It does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or comparative effectiveness studies (MRMC studies).

The letter is a regulatory approval document and does not delve into the detailed technical or clinical studies that would typically provide the information requested in your prompt. Therefore, I cannot generate the requested table and study details based on the provided text.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed device description that includes performance data and study methodologies.

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The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle.

On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress.

The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.

Here's a breakdown of the acceptance criteria and study information for the Medegen Medical Manufacturing Services Drug Access Spike, based on the provided 510(k) summary:

This device (Drug Access Spike) is a relatively simple medical accessory, and as such, the "acceptance criteria" and "study" are not presented in the same highly quantitative, performance-metric-driven way you might see for a diagnostic AI device. Instead, the submission focuses on substantial equivalence to legally marketed predicate devices, and the "proof" is demonstrating that the new device shares the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, for aspects related to "device performance" in the context of an AI-driven system, the information is largely absent or inferred, as it's not a diagnostic or decision-support tool.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a drug access spike), the acceptance criteria are not in the form of specific performance metrics like sensitivity, specificity, or AUC, as would be common for AI-based diagnostic devices. Instead, they revolve around safety, functionality, and equivalence to existing devices.

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

• Sample Size for Test Set: Not applicable. This device is a physical medical accessory, not an AI model that processes data or images. Performance is demonstrated through compliance with standards (biocompatibility) and functional description/comparison to predicates, rather than a data-driven "test set."
• Data Provenance: Not applicable for an AI test set. The "provenance" here relates to the predicate devices themselves, which are legally marketed in the US.

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

• Number of Experts & Qualifications: Not applicable. The "ground truth" for this device's safety and effectiveness is established by its compliance with recognized standards (ISO 10993), functional design, and comparison to existing, cleared devices. It does not involve expert review of data/images to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no diagnostic test set requiring adjudication in this context.

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

• MRMC Study: No. This is not an imaging or diagnostic device that involves human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's approval is based on:
  • Regulatory Standards Compliance: Demonstrated adherence to ISO 10993 for biocompatibility.
  • Functional Equivalence: The described mechanism of action and intended use are directly comparable to those of the predicate devices.
  • Predicate Device History: The predicate devices themselves have an established history of safety and effectiveness on the market.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI model with a training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI model.

Summary of the "Study" (Rationale for Acceptance):

The "study" or basis for acceptance described in this 510(k) is a substantial equivalence demonstration. This process involves:

• Identification of Predicate Devices: Three equivalent devices (from ICU Medical and Baxter Healthcare Corp) with established 510(k) clearances were identified.
• Comparison of Intended Use: The applicant demonstrated that the Drug Access Spike shares the same intended use as the predicate devices.
• Comparison of Technological Characteristics: The applicant detailed the physical design and function of the device, showing it operates similarly to the predicates. Specific mention of the previously cleared NAC component further supports this.
• Biocompatibility Testing: The device's materials were tested to meet the ISO 10993 standard for biocompatibility, addressing a key safety aspect.
• Conclusion of No New Questions of Safety or Effectiveness: By successfully demonstrating the above, the FDA concluded that the device is substantially equivalent to the predicates and raises no new questions of safety or effectiveness.

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The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.

The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.

Components will be assembled into standard configurations specified by the customer and packaged.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, clinical study design, or expert involvement as described in your request. The document appears to be a 510(k) summary for an "Intravascular Administration Set and Extension Set," primarily focusing on regulatory information, device description, intended use, and biocompatibility, but not on clinical performance evaluation details.

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The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device called "The NAC™ PLUS Needleless Access Connector". It discusses the device's regulatory classification, substantial equivalence to predicate devices, and general regulatory requirements.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Mention of ground truth types, training set sample sizes, or how training set ground truth was established.

This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

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