(403 days)
The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only.
The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Benlan™ MED-RX® Oral/Enteral Syringes:
The provided text is a 510(k) Summary for a medical device and therefore describes a regulatory submission for substantial equivalence, not a clinical study proving device performance against specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.
The "acceptance criteria" and "device performance" in this document refer to various functional, material, and safety tests to demonstrate that the device is as safe and effective as a legally marketed predicate device. The document does not describe a study evaluating the device's clinical performance with human readers, AI, or diagnostic accuracy metrics.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of document.
Here's how the provided information maps to your request:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance / Result |
|---|---|---|
| Substantial Equivalence | Comparison to Predicate Device (BD Oral/Enteral Syringe K112434) | * Intended Use: Same (measure and administer oral medication and enteral nutrition by healthcare professional). |
| * Materials: Manufactured from equivalent materials. | ||
| * Connectors: Feature distinct enteral connectors, incompatible with luer devices or other small bore non-luer devices (same as predicate). | ||
| * Sterilization: Single-use, sterile, packaged in peelable pouches, sterilized using gamma radiation (same as predicate). | ||
| * Conclusion: No significant differences. Considered substantially equivalent. | ||
| Functional Performance | Device Functionality | Successfully completed. |
| Device Compatibility (luer and other small bore non-luer devices) | Successfully completed (implies incompatibility as intended). | |
| Cap Resistance to Leakage | Successfully completed. | |
| Separation of the Cap (during typical storage conditions) | Successfully completed. | |
| Natural Rubber Latex Content | Successfully completed (implies non-use or compliance). | |
| Sterilization Assurance | Sterility Assurance Level | 1 x 10⁻⁶ (validated as per ANSI/AAMI/ISO 11137-1: 2006). |
| Biocompatibility (ISO 10993-5) | ISO MEM Elution with L-929 Mouse Fibroblast Cells (Cytotoxicity) | Device is considered non-cytotoxic. |
| Biocompatibility (ISO 10993-10) | Guinea Pig Maximization Sensitization Test | Device did not elicit a sensitization response. |
| Biocompatibility (ISO 10993-10) | Intracutaneous Reactivity Test | The requirements of the test have been met by the test article. |
Study Details (As applicable to this type of regulatory submission)
2. Sample size used for the test set and the data provenance:
- Sample Size (for functional and biocompatibility tests): The document states "All bench testing was successfully completed on both configurations of the MED-RX® Oral/Enteral Syringe: the overmold enteral tip syringe and the enteral tip syringe." It also states "Both configurations of the MED-RX® Oral/Enteral Syringe were tested for biocompatibility." Specific numerical sample sizes for each test are not provided.
- Data Provenance: The tests were conducted by the manufacturer, Benlan™ (located in Oakville, ON, Canada, as per the submission contact information). These are laboratory/bench tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a syringe, and the testing involves functional, material, and biological safety evaluations, not diagnostic image interpretation or complex clinical decision-making requiring "experts" to establish ground truth in the traditional sense of a clinical study. The "ground truth" for these tests are objective measurements (e.g., cytotoxicity, leakage, material properties) as defined by the relevant ISO standards.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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:
- No. This is a physical medical device (syringe) and not an AI or diagnostic imaging device. An MRMC study is not relevant to its regulatory approval in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (syringe) and not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional performance tests, the ground truth is derived from whether the device met pre-defined engineering specifications and performed as expected (e.g., no leakage, proper functionality, incompatibility with luer devices). These are objective criteria.
- For biocompatibility tests, the ground truth is established by the accepted scientific standards and methodologies outlined in the ISO standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and intracutaneous reactivity). The "truth" is whether the biological response meets the criteria for non-toxicity, non-sensitization, etc., as per the standard.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary: The provided document is a 510(k) summary for a non-active, non-diagnostic medical device. The "acceptance criteria" and "study" refer to engineering, functional, and biological safety testing designed to demonstrate substantial equivalence to a predicate device, rather than a clinical trial evaluating diagnostic or treatment efficacy that would typically involve human readers, AI, or complex outcome measures.
§ 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.