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The Oral Enteral Syringe is intended for the delivery of liquid medication, formula and breast milk.

The Oral Enteral Syringe is intended as a single use, sterile, device for the delivery of liquid medication, formula and breast milk. The Oral Enteral Syringe comes in multiple volume sizes ranging from 1cc to 60cc [e.g., 1cc, 3cc, 10cc, 20cc, 30cc and 60cc]. The VR Medical Oral Enteral Syringe, as well as the predicate device [Phillips Children's Medical Venture Oral/ Enteral Syringe (K100099)] has 'labeling' on the device itself, i.e., highly visible labeling on side of barrel marked ORAL/ENTERAL ONLY, and the utilization of bright orange colorant for the plunger and cap that easily distinguishes the syringe for feeding and not other uses.

The Oral Enteral Syringe incorporates safety connectors which eliminate the risk of IV administration through the feeding tube, i.e., the safety connectors will not mate with Luer Lock or Leur slip fittings.

The VR Medical Oral Enteral Syringe design incorporates various components, e.g., barrels, plungers, caps and end caps, which are comprised of commercially available materials with demonstrated acceptable biocompatibility, as listed below:
Barrel Material: Polypropylene 370Y
Piston Material: Thermoplastic Elastomer IR307
Plunger Material: Polypropylene 370Y
Plunger Colorant: Orange Pigment*
Cap Material: Polypropylene 370Y
Cap Colorant: Orange Pigment (P21024)
Barrel Gradation Ink: PPE Ink Series (on outside of barrel)
Nozzle Material: Polypropylene 370Y (molded with barrel)

The Oral Enteral Syringe does not contain natural rubber latex, DEHP, or BPA.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: VR Medical Oral Enteral Syringe
Premarket Notification (510(k)) Number: K110853
Date of Submission: May 12, 2011
Date of Clearance: May 13, 2011

The document describes a 510(k) submission for the VR Medical Oral Enteral Syringe, asserting its substantial equivalence to predicate devices (Phillips Children's Medical Venture Oral/Enteral Syringe (K100099) and Wei Gao Group Medical Syringe (K072739)). The primary focus for substantial equivalence is on the device's design, materials, function, and safety, especially concerning its enteral-only design to prevent misconnections with IV lines.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a separate, quantified section with matching "reported device performance" values for all tests. Instead, it details various tests conducted, with the implicit acceptance criterion being that the VR Medical Syringe performs equivalently to the predicate or meets established standards. The summary below interprets the "Justification" column as the implied acceptance goal or comparison.

• VR Medical and Phillips Children's device tips are substantially equivalent.
• VR Medical device tip is not substantially equivalent to the Wei Gao Group Syringe tip (this is okay as the primary predicate is Phillips).
• VR Medical device tip is not compliant with ISO 594 standard's tip requirements.
• VR Medical device tip is not compliant with other small-bore connectors listed in ISO 80369-1 except Enteral feeding tips.
• The width of the VR Medical syringe tip (OD) is larger than the ISO 594 Female Luer Connector IV connector ID dimensions (4.27-4.31 mm), thus cannot physically fit an ISO 594 rigid female Luer connector.
• The VR Medical Oral Enteral Syringe's tip dimensions fit well within the female connector of three different commercially available feeding tubes (MPS Acacia, AMERITUS, NeoMed). |

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

The document does not specify the exact sample sizes for each test performed on the VR Medical Oral Enteral Syringe. It generally refers to "VR Medical Syringe tested" without providing the number of units.

The data provenance is primarily from in-vitro testing conducted by VR Medical Technology Co. (the applicant), based in China ("90 Gao Xin Road, ZhouZhuang Kunshan 215325, China"). The substantial equivalence also relies on retrospective data from predicate devices and referenced standards or regulations (e.g., K100099, K072739, ISO standards, 21 CFR sections). The testing described appears to be prospective for the VR Medical Syringe itself, conducted specifically for this 510(k) submission.

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

The document does not describe the use of medical experts to establish "ground truth" in the traditional sense for these engineering and performance tests. The "ground truth" for these tests is based on:

• Established engineering standards: ISO 7886-1, ISO 7886-2, ISO 80369-1.
• Regulatory precedents: 21 CFR sections for material safety (biocompatibility).
• Performance of predicate devices: K100099 serves as a benchmark for substantial equivalence.
• Analytical engineering evaluations: These would typically be performed by engineers with expertise in medical device design and testing. No specific number or qualifications are provided for these engineers.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) is described, as the testing involves objective engineering measurements and comparisons against standards and predicate device performance rather than subjective interpretations by human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices (e.g., imaging devices where human readers interpret results) to assess reader performance with and without AI assistance. The VR Medical Oral Enteral Syringe is a mechanical device, not an interpretative one, so an MRMC study is not applicable.

6. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study

No standalone performance study of an algorithm was conducted. This device is a physical product, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for these tests is:

• Technical Specifications/Standards: ISO standards for syringe performance (e.g., volume accuracy, general requirements), ISO 80369-1 for small-bore connectors.
• Predicate Device Performance: The performance characteristics of the Phillips Children's Medical Venture Oral/Enteral Syringe (K100099) served as a benchmark for many tests, establishing a baseline of "safe and effective" performance.
• Regulatory Compliance: Specifically, 21 CFR for material biocompatibility and FDA's previous conclusions on colorants.
• Compatibility with Commercially Available Products: The ability of the syringe's tip to fit into existing enteral feeding tubes on the market.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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