Search Results

The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Device Description

The NeoMed Oral / Enteral Syringe is specifically designed for administration of enteral liquids to neonatal and small pediatric patients. The NeoMed Oral / Enteral Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Oral / Enteral Syringes are compatible with NeoMed enteral-only connectors, the NeoMed extension sets and NeoMed feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteral/feeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Oral / Enteral Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Oral / Enteral Syringes possess design features that prevent connectivity to luer type devices and hence prevents the chance that a feeding tube could be infused into the IV line.

The NeoMed Oral / Enteral Syringe device consists of the following components:

Syringe Barrel
Syringe Plunger
Syringe Gasket
Syringe Tip
Syringe Cap

AI/ML Overview

Here's an analysis of the provided text regarding the NeoMed Oral / Enteral Syringe, focusing on the acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from text)	Reported Device Performance
Compliance with ISO 7886-1	Design verification testing has demonstrated the NeoMed Oral / Enteral Syringes "meet the applicable requirements of ISO 7886-1."
Compliance with ISO 7886-2	Design verification testing has demonstrated the NeoMed Oral / Enteral Syringes "meet the applicable requirements of ISO 7886-2."
Compliance with ISO 10993-1 (biocompatibility)	"The NeoMed Oral / Enteral Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results." Also, "have the same materials which comply with ISO10993-1 as applicable to the intended use of the device."
Sterility Assurance Level (SAL) of 10^-6^	"are sterilized to Sterility Assurance Level (SAL) of 10-6."
Equivalent performance to predicate device	"demonstrate equivalent performance during design verification testing." Specifically, "Design Verification testing as a result of the risk analysis has demonstrated that the NeoMed Oral / Enteral Syringes ranging from 0.5mL to 100mL are functionally equivalent to predicate NeoMed Sterile Syringes."
Compliance with ISO 80369-1	"meet the applicable requirements of ISO 80369-1."
Extended size range does not affect safety or effectiveness	"the new range of sizes do not affect safety or effectiveness when compared to the predicate device." And "the extended size range from the predicate does not affect safety or effectiveness."
Perform as intended (dispenser, measuring, fluid transfer)	"Design verification test results demonstrate that the NeoMed Oral / Enteral Syringe performs as intended."

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

The document does not explicitly state the specific "sample size" for the test set in terms of a number of units tested. It refers broadly to "Design Verification testing" and "test results." The data provenance is implied to be from internal testing conducted by NeoMed, Inc. and is therefore prospective for the device being submitted. There is no information regarding country of origin of the data beyond the manufacturer's location in the USA.

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

This information is not provided in the document. The document refers to "Design Verification testing" and "risk analysis," which implies engineering and technical testing against established standards, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.

4. Adjudication Method for the Test Set

This information is not provided as the "test set" appears to refer to engineering and performance testing against standards, not a clinical study requiring expert adjudication of results.

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

An MRMC comparative effectiveness study was not conducted. This is a medical device (syringe) and the submission focuses on its physical and functional performance, biocompatibility, and sterility, not on diagnostic or AI-assisted clinical interpretation.

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

This is not applicable as the device is a physical syringe, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device is based on engineering and performance standards (e.g., ISO 7886-1, ISO 7886-2, ISO 10993-1, ISO 80369-1) and the established performance of the predicate device (K092908). The testing verifies that the physical properties, functionality, and biocompatibility meet these predefined benchmarks, rather than clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set

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

Ask a Question

Ask a specific question about this device

Page 1 of 1