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The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs. The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.

The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Gravity Flow Control Sets will be available in both primar I.V. sets and extension sets. It incorporates a standard bag spike, flexible drip chamber, PVC tubing, Clamp and ending with a standard male luer lock. Various flow rates are established by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet. Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Gravity Flow Control Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided text, it appears this is a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "MPS Gravity Flow Control Set," is essentially an IV set accessory designed to control fluid flow rates via a mechanical rotary device. Therefore, many of the typical questions for AI/ML device studies, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable.

The core of this submission is demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and material biocompatibility testing.

Here's a breakdown of the requested information, adjusted to reflect the nature of the device:

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

Since this is a non-AI/ML device submission focusing on substantial equivalence, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC). Instead, they revolve around demonstrating that the device is safe and performs comparably to the predicate.

Study that proves the device meets the acceptance criteria:

The primary "study" is a combination of:

• Nonclinical Test Summary: This specifically addresses the biocompatibility and safety of materials.
• Technological Comparison Analysis: This is an argumentative comparison establishing that the device's design and mechanism for flow control are identical to the predicate device, K871753 and K852254, marketed by ConMed Corporation (originally Master Medical Corporation).

Additional Information (where applicable for this non-AI/ML device):

• 2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the sense of clinical data or images. The "testing" involved material testing per ISO 10993, for which sample sizes are not specified in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML is not relevant here. The "ground truth" for material safety relies on established ISO standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. This is not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is established by the standards outlined in ISO 10993. For functional performance, the "ground truth" is the established function of the predicate device.
• 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
• 9. How the ground truth for the training set was established: Not applicable.

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For use as a needleless alternative to IV set injection ports. The NIMATM adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection.
For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV.
For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.
For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.
For use with standard luer taper connections.
For single patient use.

The NIMATM adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMATM adapter valve is opened by inserting a standard male luer taper, such as on an extension set, IV tubing or syringe to the female end of the NIMATM adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMATM adapter is packaged individually and as attached as part of extension sets

The provided text is a 510(k) summary for a medical device called the "NIMA™ Needleless Injection Site Master Adapter with PosiFlow™ Positive Displacement Feature." This document describes the device, its intended use, and its comparison to a predicate device.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about sample sizes, ground truth establishment, expert involvement, or AI/human reader studies.

The summary states:

• "The new design meets all performance specifications established for the originally approved device."
• "Tripartite biocompatibility testing indicates that the new materials are safe and biocompatible."
• "The NIMA™ adapter with PosiFlow™ Positive Displacement Feature modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device."

These are generalized statements of compliance and equivalence, but they do not provide the detailed information requested in the prompt about specific acceptance criteria and the methods used to demonstrate that the criteria were met.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or any of the other study-specific details, as that information is not present in the provided text.

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• For aspiration or iniection of medical from inverted multidose vials and bags
• For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood bome pathogens such as HIV and HBV.
• For use up to 24 hours, or in accordance with current guidelines of IV therapy.
• For use with standard luer taper connections.
• For singe patient use.

The CDC Vial and Bag Access Pin are adapters which pierce a rubber stoppered drug vial and/or bag and allows access to the contents. The CDC Vial and Bag Access Pins will be available with and without a 2-way luer activated check valve or with an extension line. The luer activated check valve or extension line is used to prevent loss of medication during aspiration or injection from inverted vials or bags. The 0.45 micron air vent is used to eliminate air and particulates in the vial or bag contents during aspiration. The CDC Vial and Bag Access Pin are provided sterile and non-pyrogenic in sealed single unit pouches.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that employs AI or machine learning.

The document describes a medical device called "CDC Vial and Bag Access Pins," its features, intended use, and a nonclinical test summary concerning biocompatibility. It concludes by stating the device's safety, effectiveness, and substantial equivalence to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets them, especially with components related to AI, machine learning, expert reviews, or comparative effectiveness studies.

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a. For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection.
b. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV.
C. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.
d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.
e. For use with standard luer taper connections.
f. For single patient use.

The NIMA™ adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMA™ adapter valve is opened by inserting a standard male luer taper, such as on an extension set. IV tubing or syringe to the female end of the NIMA™ adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMA™ adapter is packaged individually and as attached as part of extension sets

This document is a 510(k) summary for a medical device called the "NIMA™ Needleless Injectionsite Master Adapter and IV Sets." This document does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device. It describes:

• Submitter and Contact Information: Critical Device Corporation.
• Device Trade Name: NIMA™ Needleless Injectionsite Master Adapter and IV Sets.
• Common Name: Intravenous (IV) Medication Connector and IV Sets.
• Predicate Device: NIMA™ Needleless Injectionsite Master Adapter and IV Sets (the previous version of the same device).
• Description: A two-way valve for needleless intermittent and continuous IV access, preventing needle stick injuries.
• Intended Use: As a needleless alternative to IV set injection ports, to reduce needle stick injuries, as a replacement for injection caps, for injection/gravity flow/fluid withdrawal, with standard luer taper connections, and for single patient use.
• Technological Comparison: States that the technological characteristics are equivalent to the currently approved predicate device. The key changes are alternate materials and an extended use duration (from 24 to 96 hours).
• Nonclinical Test Summary: New materials meet all performance specifications established for the original device. Tripartite biocompatibility testing shows the new materials are safe and biocompatible.
• Conclusion: The modifications have demonstrated safety and effectiveness and are substantially equivalent to the legally marketed predicate device.

To answer your specific questions, this document does not provide the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory submission demonstrating substantial equivalence based on material changes and extended use duration, primarily relying on nonclinical testing (biocompatibility and performance specification adherence) rather than a clinical trial with acceptance criteria for device performance.

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Ask a specific question about this device