Search Results

The Power Injectable Infusion Set with Huber Needle is indicated for:

• Use with implanted infusion ports for continuous or intermittent infusion therapy. .
• Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
• Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
• Power injection of contrast media up to 325 PSI. .

The Power Injectable Infusion Set with male luer lock is indicated for:

• Use with central venous catheters for continuous or intermittent infusion therapy. .
• Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
• Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
• . Power injection of contrast media up to 325 PSI.

The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters.

The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.

The MPS Acacia Power Injectable Infusion Set is a Class II device (product code FPA) intended for general infusion therapy and power injection of contrast media.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria with numerical targets or thresholds. Instead, it refers to general "necessary verification and validation testing" to assure "substantial equivalence" to predicate devices.

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

The document does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generically states that "All necessary verification and validation testing has been performed."

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

This information is not applicable to this type of device submission. The device is a medical accessory (infusion set) and its performance evaluation does not typically involve expert review or establishment of "ground truth" in the way a diagnostic AI algorithm would. Its performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. The Power Injectable Infusion Set is a physical medical device, not a diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

No, a standalone study (in the context of an algorithm) was not done. This device is a physical product and does not involve an algorithm.

7. The Type of Ground Truth Used:

This information is not applicable in the traditional sense of a diagnostic device. The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science standards, and performance testing against predetermined physical and functional parameters. For example, pressure ratings, flow rates, and material integrity are tested in a controlled environment. The document implies compliance with these via "all necessary verification and validation testing."

8. The Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this device.

Ask a specific question about this device

The MPS Acacia Enteral Feeding Tube is intended to be placed into the stomach, nasogastrically or orogastrically, for the introduction of fluids and/or oral medication. The Enteral Feeding Tube is disposable and single use only. Not intended for intravascular or intravenous use.

The MPS Acacia Enteral Feeding Tube is a polyurethane or polyvinyl chloride (PVC) tube of various French sizes and lengths. A rigid female oral connector is attached to the proximal end of the Enteral Feeding Tube and accepts all male oral connectors such as those found on oral syringes.

The provided 510(k) summary for the MPS Acacia Enteral Feeding Tube (K080328) indicates that the device's acceptance criteria are met through non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No specific "test set" of patient data was used in a clinical study for this 510(k). The evaluation relied on non-clinical assessment of the design and comparison to predicate devices.
• Data Provenance: Not applicable. No clinical data was collected or analyzed for this 510(k).

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

• Not applicable. No ground truth was established by experts for a test set in the context of this 510(k), as no clinical study was performed. The evaluation was based on the manufacturer's engineering assessment and regulatory comparison.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical study or test set requiring expert adjudication was conducted, there was no adjudication method.

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

• No, an MRMC comparative effectiveness study was not done. This 510(k) is for an enteral feeding tube, which is a physical medical device, not an AI software or imaging interpretation tool that would typically undergo such a study.

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

• No, a standalone performance study was not done. This device is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For this 510(k), the "ground truth" essentially refers to the established safety and effectiveness of the legally marketed predicate devices (Kendall's Argyle Indwell Polyurethane Feeding Tube K820442 and Argyle PVC Feeding Tube K820441). The MPS Acacia Enteral Feeding Tube's performance is deemed acceptable because it is substantially equivalent in design, materials, and intended use to these already-approved devices, with a minor modification (the connector) that does not alter its fundamental function or safety profile.

8. The Sample Size for the Training Set

• Not applicable. As no artificial intelligence or machine learning component is involved, there is no "training set."

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

• Not applicable. As no artificial intelligence or machine learning component is involved, there is no "training set" or ground truth establishment relevant to one.

Ask a specific question about this device

1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.
2. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.
3. Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

The MPS Acacia Nerve Block Needle consists of a stainless steel cannula with various tip types (Blunt, Housted, Touhy, Crawford, Quincke, Chiba, Sprotte, Freeman) and a molded plastic hub. A stylet is also provided consisting of a stainless steel shaft and a molded plastic hub.

The MPS Acacia Nerve Block Stimulating Needle version is electrically conductive at the distal end of the device.

The Nerve Block Needle will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and gauges.

The Nerve Block Needle may be packaged individually or as part of a kit consisting of a catheter, various syringe sizes, introducer, extension set, gauze sponge, sponge applicator, drape, absorbent towel, hospital wrap, sterile gloves, and other commonly used FDA approved accessories dependent on the application as determined by the clinician.

The provided text is a 510(k) summary for the MPS Acacia Nerve Block Needle. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of submission, particularly for devices like needles, typically focuses on demonstrating equivalent physical and technical characteristics, and intended use as already approved devices, rather than conducting new clinical studies with acceptance criteria and performance metrics as might be seen for more complex or novel devices.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of 510(k) submission. The core of this document is a comparison to predicate devices, which implies that the acceptance criteria for "safety and effectiveness" are implicitly met by demonstrating similarity to already approved devices.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable / Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices based on physical and technical characteristics and intended use, not on a new test set of data.

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

• Not applicable / Not provided. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication method for the test set:

• Not applicable / Not provided.

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 a physical medical instrument (needle), not an AI or software-as-a-medical-device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used:

• Predicate device equivalence. The "ground truth" in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness through their own approval processes. The new device demonstrates "substantial equivalence" to this established "truth."

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device.

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

• Not applicable / Not provided.

Ask a specific question about this device

1. The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Ysite at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion.
2. The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous.
3. The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
4. The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.

The MPS Acacia MedFlo Elastomeric Pump consists of a non-latex elastomeric bladder that is secured onto a plastic mandrel. Secured to the inside of the mandrel is the non-DEHP administration tubing. Secured to the opposite end of the administration tubing is a male luer lock. Standard IV set accessories are integrated in the administration set of the elastomeric pump and may include (dependant on application as determined by the clinician) an air eliminating filter, pinch clamp, flow restrictor (fixed or variable), Y-site, checkvalve, and bolus mechanism. At the inlet port of the mandrel is a one-way checkvalve to allow for the filling of the device while not allowing fluid backup. Encasing the bladder, mandrel and part of the administration tubing is a clear, protective body. The elastomeric pump does not have an alarm function, is non-DEHP and does not contain latex.

The MPS Acacia MedFlo Elastomeric Pump will be available in configurations consisting of 50 to 500ml fill volume, and 0.5 to 10ml per hour flow rates.

A procedure kit may consist of an introducer, tear-away sheath, multi-port catheter, syringe, sterile tape, wound dressing, and sterile gloves (dependent on application as determined by the clinician), and may be included with each MedFlo Elastomeric Pump or sold separately dependent on the clinician's requirements.

I'm sorry, but this document does not contain the information required to fulfill your request. The provided text is a 510(k) summary for a medical device (MedFlo Elastomeric Pump) and primarily focuses on its description, intended use, and comparison to predicate devices for substantial equivalence. It does not include details about device performance acceptance criteria, specific studies with sample sizes, ground truth establishment, or expert reviews as typically found in clinical validation studies for AI/algorithm-based devices.

This document is from 2005, and the concept of AI/algorithm-based medical devices and their specific validation requirements (like MRMC studies) was not as prevalent or defined then as it is today.

Ask a specific question about this device

The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.

The MPS Safeguard Huber Device 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 infusion tubing ending with a standard female luer lock connector. Each set is provided with a needle tip protector, and luer cap. Various configurations may also include Y-injections sites, needleless injection sites, and clamps associated with standard tubing infusion sets. The MPS Acacia Safeguard Huber Device is designed to allow the clinician to activate a trigger on the device that will deploy a protective sheath to cover the entire needle once the device is removed from the patient. The device is designed to help minimize accidental needlestick injuries.

The provided submission focuses on establishing substantial equivalence for a medical device (MPS Acacia Safeguard Huber Device) to existing predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, such as MRMC studies, effect size, standalone performance, and ground truth methodologies for training data, are not applicable here.

The document describes non-clinical testing to demonstrate safety and performance for a medical device with a sharps injury prevention feature.

1. Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device