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Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices. May be placed on a sterile field. Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.

The PentaFlush saline 0.9% NaCl prefilled syringe is a single-use device intended only for flushing in-situ vascular access devices. It is a polypropylene syringe containing an isotonic solution of sterile and non-pyrogenic 0.9% sodium chloride solution. These are ready for use devices that can be placed on sterile field. The product is available in volumes of 3ml, 5ml and 10ml of saline solution in 10 ml syringes, which has a larger diameter in order to avoid that, with the same force applied on the shaft button, the higher pressure generated in the 3ml capacities may cause the vascular catheter to rupture. What differentiates the three versions is the graduated scale, whose maximum capacity coincides with the nominal capacity of each version (3ml, 5ml and 10ml). In all capacities Luer Lock connector of the barrel is closed with a cap. The barrel is filled with a 0.9% NaCl isotonic solution, sterile, pyrogen-free, up to the nominal capacity of the scale; an acitotoxic synthetic rubber piston is assembled to the polypropylene plunger, whose fiducial line is positioned at the nominal capacity of the syringe. The primary packaging of PentaFlush pre-filled syringes can be in: a blister of medical paper and PE/PE peel, or an aluminum pouch of PET/ALL/PE peel. PentaFlush saline 0.9% NaCl prefilled syringes are used only by healthcare professionals, is intended for single patient and single use only. Does not contain preservatives. Not made with natural rubber latex. Rx Only.

This document describes the non-clinical testing for the PentaFlush saline 0.9% NaCl prefilled syringe. This device is an "Intravascular catheter" (Product Code: NGT) used for flushing in-situ vascular access devices. The study conducted is a non-clinical study to demonstrate conformance to applicable standards.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing performed on the device itself and its components. It does not refer to a "test set" in the context of patient data or clinical samples. The tests mentioned are laboratory-based and generally involve a specified number of samples of the device and its materials as required by the referenced standards. The data provenance is Pentaferte Italia S.r.l., based in Italy. The tests are prospective in the sense that they are conducted on the manufactured device to verify its compliance with standards.

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

This point is not applicable to the provided document. The study described is a non-clinical, laboratory-based testing of a medical device's physical, chemical, and biological properties according to established international standards. The "ground truth" is determined by the specific criteria outlined in each standard for each test, not by expert consensus on clinical data.

4. Adjudication method for the test set

This point is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies involving multiple readers for interpreting medical images or data. The non-clinical tests described have predefined pass/fail criteria based on the relevant standards.

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

This point is not applicable. The device is a prefilled saline syringe, not an AI-powered diagnostic or assistive tool for human readers.

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

This point is not applicable. The device is a medical product (prefilled saline syringe), not an algorithm.

7. The type of ground truth used

The ground truth used for these non-clinical tests is based on established international and national standards and monographs. For example, USP monographs for chemical assays, ISO standards for biocompatibility and sterilization, and ASTM standards for mechanical testing. These standards define the acceptable limits and methodologies against which the device performance is measured.

8. The sample size for the training set

This point is not applicable. The study is a non-clinical performance verification, not a study involving machine learning or AI that would require a training set.

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

This point is not applicable for the reasons mentioned in 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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