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The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Ross Embrace Enteral Pump". This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and does not contain the detailed study information requested in your prompt.

Therefore, I cannot extract the following information from the provided text:

• Acceptance Criteria and Reported Device Performance: This document does not specify performance acceptance criteria or report device performance against them.
• Sample size used for the test set and data provenance: No information about a test set or its data provenance is present.
• Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
• Adjudication method for the test set: No adjudication method is mentioned.
• Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: This is not relevant for an enteral pump.
• Type of ground truth_ used: No ground truth is discussed.
• Sample size for the training set: No training set is mentioned as this device is not an AI/ML product.
• How the ground truth for the training set was established: Not relevant as no training set is discussed.

In summary, the provided FDA clearance letter focuses on regulatory approval based on substantial equivalence and does not include the detailed technical study information that would be found in a clinical trial report or a more comprehensive technical submission.

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The Flexiflo/ROSS Enteral Feeding Tube is intended for nasoenteric placement into the stomach or small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. This device is also indicated for small bowel feeding of patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.

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The provided text is a 510(k) clearance letter from the FDA for the Flexiflo/ROSS Enteral Feeding Tube. This document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The letter primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar indications for use and technological characteristics to a device already on the market.
• Regulatory Classification: The device is classified as Class II, under 21 CFR §876.5980, with Procode: 78 KNT.
• Conditions for Marketing: It outlines the general controls provisions of the Act that the manufacturer must adhere to.
• Indications for Use (from the enclosure): The tube is intended for nasoenteric placement into the stomach or small bowel for enteral feeding in pediatric, adult, or elderly patients, and for gastric decompression or evacuation of gastric contents.

Therefore, I cannot provide the requested information as it is not present in the given document.

To answer your request, I would need a document that describes the specific performance study conducted for the Flexiflo/ROSS Enteral Feeding Tube, including its methodology, results, and the pre-defined acceptance criteria it aimed to meet.

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The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.

Modification to FlexiFlo PolyG® Gastrostomy Tube

The provided text is a Food and Drug Administration (FDA) letter regarding a 510(k) premarket notification for a medical device. This type of document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The document states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices, which is a regulatory classification, not a performance validation based on specific acceptance criteria and a study.

To answer your request, I would need a document detailing the device's technical specifications, performance goals, and results from a clinical or non-clinical study.

Ask a specific question about this device