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• The MPS Fixed Flow Rate Set is intended for single use in continuous or intermittent infusion therapy.
• For use for infusion of I.V. fluids, and drugs.

The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Fixed Flow Rate Set incorporates a standard bag spike, flexible drip chamber, microbore infusion tubing, and ending with a standard male luer connector with luer-lock. Flow rate control is established by the flow dynamics of the microbore infusion tubing. Each set is provided with a spike protector, luer cap, and tubing clamp. Various configurations may also include 0.2 micron IV filter.

Each MPS Fixed Flow Rate Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Fixed Flow Rate Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

The provided text is related to a 510(k) premarket notification for a medical device called the "MPS Fixed Flow Rate Set." This documentation focuses on establishing substantial equivalence to a predicate device, as opposed to proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document primarily focuses on:

• Device Description and Intended Use: The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver fluid at a specified rate, incorporating standard components and controlling flow via microbore tubing. It's intended for single use in continuous or intermittent infusion therapy for I.V. fluids and drugs.
• Technological Comparison to Predicate Device: The core of the submission is to demonstrate substantial equivalence to the I-Flow® Fixed Flow Rate Gravity Set. The submission explicitly states, "There are no technological differences between the I-Flow Fixed Rate Gravity Set and the MPS Fixed Flow Rate Set. Both devices control gravity flow rates by varying the length of fixed internal diameter microbore tubing."
• Nonclinical Test Summary: Mentions that plastic components and bonding agents were tested per ISO 10993 for biocompatibility and safety.

Given these points, here is a breakdown of what can and cannot be answered from the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., flow rate accuracy within X%, duration of flow within Y%). The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
• Reported Device Performance: No specific quantitative performance data is provided for the MPS Fixed Flow Rate Set beyond the statement that "Flow rate control is established by the flow dynamics of the microbore infusion tubing." The document relies on the equivalence to the predicate device, which presumably has its own established performance characteristics.

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

• Sample Size for Test Set: Not applicable/not provided. This was a substantial equivalence submission, not a performance study with a 'test set' in the traditional sense of evaluating an algorithm. Nonclinical tests (biocompatibility) are mentioned, but sample sizes for those are not given.
• Data Provenance: Not applicable/not provided. The nonclinical tests are internal to the manufacturer (Medical Product Specialists, Inc., Brea, CA).

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 applicable. There was no 'ground truth' established by experts for a test set in the context of this 510(k) for this device type.

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

• Not applicable. No such adjudication was performed for device performance.

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 device is an intravenous fluid delivery set, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable. No ground truth in this sense was used. The basis for approval is substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no 'training set' as this device does not involve machine learning or AI.

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

• Not applicable.

Summary of Device Acceptance/Proof:

The "acceptance criteria" for the MPS Fixed Flow Rate Set, in the context of this 510(k) submission, was demonstrating substantial equivalence to the predicate device, the I-Flow® Fixed Flow Rate Gravity Set.

The "study that proves the device meets the acceptance criteria" in this case is the 510(k) submission itself, which presents:

• A clear description of the device and its intended use.
• A direct comparison of technological characteristics to the predicate device, explicitly stating "There are no technological differences." Both devices utilize the same principle of controlling gravity flow rates by varying the length of fixed internal diameter microbore tubing.
• A summary of nonclinical biocompatibility testing (per ISO 10993).

The FDA's review of this submission led to the determination that the device is substantially equivalent to the legally marketed predicate device, thus allowing it to be marketed. This regulatory process acknowledges that if a new device is sufficiently similar to an already approved one, it does not need to undergo the same rigorous, full-scale clinical trials required for novel devices.

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The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII 1. pumps for continuous infusion therapy. For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use. For use up to 24 hours per CDC guidelines or per hospital protocol. For use with standard luer taper connections. For single patient use.

Each MPS Reservoir Bag is sterilized in sealed individual pouches. Full labeling information is provided with each MPS Reservoir Bag. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MPS Reservoir Bag." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria and proves the device meets them through performance data.

The document highlights:

• Technological comparison to a predicate device: The MPS Reservoir Bag is compared to the "Baxter Drug Bag" in terms of materials, design, and intended use, asserting substantial equivalence. Minor differences in color coding and slide clamp attachment are noted.
• Nonclinical test summary: Materials and bonding agents were tested per ISO 10993 for biocompatibility.

Therefore, the information required to answer your request (acceptance criteria, device performance table, study details, human reader studies, ground truth establishment, training set details) is not present in the provided 510(k) summary. This type of submission typically relies on equivalence to a legally marketed device rather than extensive new clinical performance studies with defined acceptance criteria and performance metrics against human experts or pathology.

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The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. For use for infusion of I.V. fluids, blood, blood products and drugs. Change per CDC guidelines or per hospital Protocol.

The MPS Huber Needle Extension Set is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to microbore infusion tubing ending with a standard female luer connector with luer-lock. Each set is provided with a needle tip protector, luer cap, and color coded stabilization wings. Various configurations may also include Y injection sites, and clamps typically associated with standard microbore tubing infusion sets. Each MPS Huber Needle Extension Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Huber Needle Extension Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. This document is a 510(k) summary for the MPS Huber Needle Extension Set, focusing on its substantial equivalence to a predicate device, GISH VASTACK®, rather than a study demonstrating performance against specific acceptance criteria.

The key points from the provided text are:

• Device Description and Intended Use: The MPS Huber Needle Extension Set is a sterile, non-pyrogenic device for transdermal infusion via subcutaneous access ports, intended for use with implanted infusion ports for continuous or intermittent infusion therapy of IV fluids, blood, blood products, and drugs.
• Predicate Device: Gish VASTACK®
• Technological Comparison: The MPS Huber Needle Extension Set is substantially equivalent in materials, design, and intended use to the predicate device. The only design variation is in the needle grip, which is not expected to affect safety or effectiveness.
• Nonclinical Testing: Plastic component materials and bonding agents were tested per ISO 10993 Biological Testing of Medical and Dental Materials, indicating they are safe and biocompatible. Component metals are stated to meet an ASTM standard where biocompatibility is indicated.
• Conclusion: The device is deemed substantially equivalent to the legally marketed predicate device.

Therefore, I cannot provide a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria based on this submission. The document explicitly focuses on substantial equivalence based on material testing and design comparison, not on performance against quantitative acceptance criteria in a clinical or non-clinical study for efficacy or performance metrics typically found in such studies.

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