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.

Device Description

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.

AI/ML Overview

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.

Summary

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JUN 0 3 2014

Benlan™
MED-RX® Oral/Enteral Syringes

SECTION 5 - 510(K) SUMMARY

Date of Summary: April 25, 2013

()Benlan

2760 Brighton Road Oakville, ON L6H 5T4 Tel (905) 829-5004 Fax (905) 829-5006

Official Contact:

Cheryl Brown – QA / RA Manager

Proprietary Name: Common Name: Classification Name: Class: Product Code: Predicate Device:

MED-RX® Oral/Enteral Syringe Feeding tubes Gastrointestinal tubes and accessories Class II KNT BD Oral/Enteral Syringe with BD UniVia Connection (K112434)

Device Description

Indications for Use

Substantial Equivalence

The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX® Oral/Enteral Syringes are substantially equivalent to the predicate BD Oral/Enteral Sryinge with BD UniVia Connection (K112434). Both proposed and predicate devices have the same intended use to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. Both the proposed device and the predicate device are manufactured from equivalent materials and feature distinct enteral connectors that are not compatible with luer devices or other small bore non-luer devices. The MED-RX® Oral/Enteral Syringes and the BD Oral/Enteral Sryinge with BD UniVia Connection are single-use, sterile devices, packaged in peelable pouches and sterilized using gamma radiation. There are no significant differences between the

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Image /page/1/Picture/1 description: The image shows the logo for Benlan MED-RX Oral/Enteral Syringes. The logo features a stylized image of a drop to the left of the word "Benlan" in bold, black letters. Below the name is the text "MED-RX Oral/Enteral Syringes".

proposed MED-RX® Oral/Enteral Syringes and the predicate device, BD Oral/Enteral Srvinge with BD UniVia Connection (K112434). Therefore the proposed device can be considered substantially equivalent to a legally marketed device.

Non-Clinical Test Summary

Verification of functional performance of the MED-RX® Oral/Enteral Syringes has been performed. The MED-RX® Oral/Enteral Syringes were subject to numerous performance tests including device functionality, device compatibility with luer and other small bore non-luer devices, cap resistance to leakage, separation of the cap during typical storage conditions, and for natural rubber latex content. 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.

Summary of Sterilization

Each MED-RX® Patient Delivery Set is individually packaged using a medical grade film pouch and sterilized using gamma radiation to a sterility assurance level of 1 x 10°. The radiation dose has been validated as per ANSI/AAMI/ISO 11137-1: 2006.

Summary of Biocompatibility Tests

Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX® Oral/Enteral Syringes are classified as limited duration, mucosal membrane contacting devices. Both configurations of the MED-RX® Oral/Enteral Syringe were tested for biocompatibility. A summary of the testing completed and the relevant standards are listed in Table 1.

Table 1: Biocompatibility Test Summary

Standard	Test Description .	Results
ISO 10993-5: 2009	ISO MEM Elution with L-929 MouseFibroblast Cells (Cytotoxicity)	Device is considered non-cytotoxic.
ISO 10993-10: 2010	Guinea Pig Maximization SensitizationTest (Method of Biomaterial Extracts)	Device did not elicit asensitization response.
ISO 10993-10: 2010	Intracutaneous Reactivity Test	The requirements of the testhave been met by the testarticle.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a person embracing or supporting another person, with flowing lines representing movement or support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 3, 2014

Benlan, Inc. Cheryl Brown Director of Quality Assurance & Regulatory Affairs 2760 Brighton Road Oakville, Ontario L6H 5T4 Canada

Re: K131183

Trade/Device Name: MED-RX® Oral/Enteral Syringes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 30, 2014 Received: June 3, 2014

Dear Cheryl Brown,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Cheryl Brown

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Benjamin Fisher-S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 - INDICATIONS FOR USE

510(K) Number (If Known): K131183

Device Name: MED-RX® Oral/Enteral Syringes

Indications For Use:

Prescription Use:	✓
(Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
N/A

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2014.06.03 17:55:19 -04'00'

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Regulation Number and Section

§ 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.