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For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.

The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.

The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.

Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.

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

This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.

7. The Type of Ground Truth Used

The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician), to clinicians to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.

An enteral syringe consists of a syringe barrel with integral tip (ENFit), plunger, gasket, barrel lubricant and can be supplied with or without a syringe tip cap. Only the 5mL single use syringe can be connected with compatible enteral syringe-driver pumps; the other syringes are for manual use.

The provided document is a 510(k) Premarket Notification for ENFit enteral syringes, which are medical devices used for delivering enteral fluids. It outlines the regulatory process for clearance, not a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing and conformance to established standards, rather than clinical studies with human participants.

Therefore, I cannot provide the information requested in the prompt's structured format (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types, training set details) because this document does not describe such a study for an AI/ML powered device.

The document details the following about the device's testing and intended performance:

• Device Type: ENFit enteral syringes (NUTRIFIT™)
• Intended Use: Delivering enteral fluids to the gastrointestinal system of patients unable to eat and swallow. Intended for use in clinical or home care settings by laypersons (under supervision) and clinicians, for pediatric and adult use.
• Regulatory Class: Class II (Product Code: PNR, Regulation Number: 21 CFR 876.5980 - Gastrointestinal tube and accessories).
• Predicate Device: ENFit enteral pump syringes PENTA™/ENFit enteral pump syringes NUTRIFIT™ (K161141).
• Testing and Evaluation:
  • Performance test: According to ISO 7886-1/-2 & ISO 80369-3/-20, including testing after simulated clinical use and cleaning.
  • Biocompatibility tests: According to ISO 10993 series requirements.
  • Sterility validation and tests: According to ISO 11135.
  • Packaging validation and tests: According to ISO 11607-1/-2.
  • Labeling requirements: According to ISO 15223-1 and FDA Guidance "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications."
• Conclusion: The tests demonstrated that the ENFit enteral syringes NUTRIFIT™ are safe and effective, meet their intended use, and are similar to the predicate device in terms of intended use, indications for use, and medical technique.

The document emphasizes compliance with international standards (ISO) and FDA guidance for medical devices, specifically for physical characteristics, sterility, biocompatibility, and packaging, rather than performance metrics related to diagnostic accuracy, image interpretation, or other tasks that would involve AI/ML algorithms and require the types of studies outlined in your request.

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ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.

ENFit enteral pump syringes consists of disposable enteral feeding syringes that deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes are designed so that, while administering enteral solutes and medication, any accidental risk of connection to a parenteral system is prevented, through the female ENFit connector for connection to an enteral access device, designed according to the AAMI/CN3:2014 (PS) Part 3 requirements, allowing only enteral use. They have plungers, made of synthetic rubber which does not contain natural latex, in order to prevent any allergies.

The provided document for the PENTA ENFit™ and NUTRIFIT™ ENFit enteral pump syringes (K161141) outlines the acceptance criteria through compliance with various international standards and the study that proves the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance standards, and for each, it implicitly states that the device met the acceptance criteria as demonstrated by in vitro bench testing. Specific numerical performance values are not provided in this summary.

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

The document refers to "in vitro bench tests" and "performance evaluations" performed at the PENTAFERTE ITALIA S.r.l. site, Loc. Nocella SP 262, I-64012 Campli (TE) – Italy. This indicates the country of origin of the data is Italy.

The description "in vitro bench tests" implies a prospective test setup where specific tests are conducted under controlled laboratory conditions to evaluate the device against predefined standards.

The document does not specify the sample size used for the test sets in any of the performance evaluations.

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)

This information is not applicable as the evaluation involved in vitro bench testing against published international standards for medical devices and not an expert-based clinical assessment of patient data. Therefore, there was no "ground truth" derived from expert consensus on a test set of cases in the traditional sense of diagnostic or clinical performance studies.

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

This information is not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases, and a discrepancy resolution process is needed to establish a consensus ground truth.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for an ENTERAL PUMP SYRINGE, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This information is not applicable as this submission is for a physical medical device (enteral pump syringes), not an algorithm or AI system.

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

As indicated in point 3, the concept of "ground truth" as it applies to clinical or diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The performance of the device was assessed against predefined technical and safety specifications outlined in international and national standards (e.g., ISO, AAMI, EN, ASTM, EP). Compliance with these standards serves as the "truth" for device functionality and safety.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device. The concept of a "training set" typically applies to machine learning or AI models, which are not involved in this device's evaluation.

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

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

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