(334 days)
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.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 80369-3:2016 (Small-bore connectors for enteral applications) | Compliance stated through in vitro bench testing. Designed to reduce accidental connection to parenteral systems. |
| AAMI/ANSI/ISO 80369-1:2010 (General requirements for small-bore connectors) | Compliance stated through in vitro bench testing. |
| AAMI/CN3:2014 (PS) (Small-bore connectors for enteral applications) | Compliance stated through in vitro bench testing. Device designed according to AAMI/CN3:2014 (PS) Part 3 requirements for female ENFit connector. |
| EN ISO 7886-1:1997 (Manual hypodermic syringes) | Compliance stated through in vitro bench testing (specifically mentioned for pump compatibility). |
| EN ISO 7886-2:1997 (Hypodermic syringes for power-driven pumps) | Compliance stated through in vitro bench testing (specifically mentioned for pump compatibility). |
| ANSI/AAMI/ISO 80369-20:2015 (Common test methods for small-bore connectors) | Compliance stated through in vitro bench testing. |
| EP § 3.2.8 (European Pharmacopoeia standard) | Compliance stated through in vitro bench testing. |
| ASTM D790-15e2 (Flexural Properties of Plastics) | Compliance stated through in vitro bench testing. |
| EN 1615:2000 (Enteral Feeding Catheters and Giving Sets) | Compliance stated through in vitro bench testing. |
| AAMI ANSI ID54:1996/(R)2012 (Enteral Feeding Set Adapters And Connectors) | Compliance stated through in vitro bench testing. |
| Bioburden tests | Met acceptance criteria. |
| Sterility tests | Met acceptance criteria. |
| Validation of EtO Sterilization process | Met acceptance criteria. |
| Packaging evaluation | Met acceptance criteria. |
| Labeling evaluation | Met acceptance criteria. |
| EtO Residual (according to EN ISO 10993-7) | Met acceptance criteria. |
| Biocompatibility (according to ISO 10993 series) | Met acceptance criteria. |
| Usability tests (according to AAMI/IEC 62366-1:2015) | Met acceptance criteria. |
| Mechanical performance (e.g., integrity, leak resistance) | Implied through compliance with ISO 80369 series, typically covers these aspects. Device is "designed and tested to assure conformance to the requirements for its intended use." |
| Pump Compatibility (with enteral infusion pump) | Demonstrated by in vitro bench tests showing compliance with EN ISO 7886-1 and EN ISO 7886-2. |
| Dimensional compliance (ENFit connector) | Compliance to AAMI/CN3:2014 (PS) Part 3 Table B.2 Female Enteral Small-Bore Connector. |
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.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.