The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.

Device Description

The BD Oral/Enteral Syringe with BD UniVia Connection is a standard piston, syringe which incorporates a safety connector that is incompatible with luer (6%) connectors and intravenous devices. The BD Oral/Enteral Syringe with BD UniVia Connection is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a synthetic rubber stopper. In addition, the plunger rod of the BD Oral/Enteral Syringe with BD UniVia Connection incorporates an orange colorant to further distinguish the device from a standard piston, syringe. The performance of the BD Oral/Enteral Syringe with BD UniVia Connection is equivalent to the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "BD Oral/Enteral Syringe with BD UniVia Connection." This submission focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML driven device, therefore many of the typical acceptance criteria and study design elements for AI/ML devices are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Item #	Performance Specification (Acceptance Criteria)	Reported Device Performance
1	Tip Cap Leakage	Equivalent performance to predicates
2	Connection w/ Mating Devices	Equivalent performance to predicates
3	Luer Incompatibility	Equivalent performance to predicates
N/A	Operating principle	Same as predicate device
N/A	Barrel, plunger rod, stopper materials	Same as Becton, Dickinson Single Use Hypodermic Syringe predicate device
N/A	Barrel, plunger rod, stopper design	Same as Becton, Dickinson Single Use Hypodermic Syringe predicate device (with exception of safety connector)
N/A	Non-luer connector	Similar to Children's Medical Ventures Oral/Enteral Syringe, with same design intent
N/A	ISO 7886-1 and ISO 7886-2 compliance	Meets requirements (with exception of safety connector feature)
N/A	ISO 10993 compliance	Meets requirements as applicable
N/A	Sterilization assurance level (SAL)	Same as predicate device

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

The document mentions "Design Verification tests were performed." However, it does not provide any specific sample sizes for these tests for each performance element. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) as this is a physical medical device and not an AI/ML model being trained on data.

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

This information is not applicable to this type of device submission. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on training or test data. For a physical device, performance is evaluated against engineering specifications and predicate device performance, not expert-established "ground truth" on data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers or labelers for AI/ML model ground truth establishment. For a physical device, performance is measured objectively against predefined engineering and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. MRMC studies are typically done for AI/ML-assisted diagnostic devices to assess the impact of AI on human reader performance. This device is a physical syringe, not an AI diagnostic tool.

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

This information is not applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, risk analysis, product requirements, and comparison to the performance of predicate devices. It is not expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML. The "equivalence" claimed is based on physical and functional properties, as well as adherence to relevant ISO standards.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML model, and therefore there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

Summary of the Study:

The study described is a Design Verification Test for a physical medical device (BD Oral/Enteral Syringe with BD UniVia Connection). The primary goal of the study was to demonstrate substantial equivalence to existing predicate devices (Children's Medical Ventures Oral/Enteral Syringe, Becton, Dickinson Single Use, Hypodermic Syringe, and BD Oral Syringe).

The study involved testing various performance elements of the new syringe, including:

Tip Cap Leakage
Connection with Mating Devices
Luer Incompatibility

The "acceptance criteria" were that the device's performance for these elements would be equivalent to the predicate devices. The results reported confirm that the BD Oral/Enteral Syringe with BD UniVia connection "performed in an equivalent manner to the predicate devices." Additionally, the device demonstrated compliance with various ISO standards (ISO 7886-1, ISO 7886-2, ISO 10993) and maintained the same materials, design principles, and sterilization levels as its predicates.

This type of submission largely relies on proving that the new device does not introduce new questions of safety or effectiveness compared to legally marketed devices, which is typical for 510(k) clearances of non-software or non-AI medical devices.

Summary

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K 112434
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510(K) Summary of Safety and Effectiveness

Date Prepared: 23 August 2011

SEP 2 9 2011

1. Submitted By:

John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 201 847 5473 Tel: Fax: 201 847 5307

2. Device Name:

Trade Name:	BD Oral/Enteral Syringe with BD UniVia Connection
Common Name:	Gastrointestinal tubes and accessories
Classification Name:	Tube, Feeding
Classification:	Class II, 21 CFR 880.5980

3. Predicate Device:

Trade Name:	Children's Medical Ventures Oral/Enteral Syringe
Manufacturer:	Children's Medical Ventures
510(k) Number:	K100099
Trade Name:	Becton Dickinson Single Use, Hypodermic Syringe
Manufacturer:	Becton, Dickinson and Comoany
510(k):	K980987
Trade Name:	BD Oral Syringe
Manufacturer:	Becton, Dickinson and Comoany
510(k):	Class I Exempt

4. Device Description:

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5. Intended Use:

The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.

Technological Characteristics: 6.

As compared to the predicate device, the principal device of this 510(k) premarket notification:

a) Operates under the same operating principle as the predicate device
b) Has the same barrel, plunger rod and stopper materials as the Becton, Dickinson Single Use Hypodermic Syringe predicate device.
c) Has the same barrel, plunger rod and stopper design used in the Becton, Dickinson Single Use Hypodermic Syringe predicate device with the exception of the safety connector
d) Has a similar non-luer connector as the Children's Medical Ventures Oral/Enteral Syringe, with the same design intent
e) Meets the requirements of ISO 7886-1 and ISO 7886-2 respectively with the exception of the safety connector feature
Meets the requirements of ISO 10993 as applicable to the intended use of the device f)
g) Is sterilized to the same sterilization assurance level (SAL) as the predicate device
h) Demonstrated equivalent performance to the predicate devices during design verification testing.

7. Performance:

Design Verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the BD Oral/Enteral Syringe with BD UniVia connection performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design Verification tests for unique BD Oral/Enteral Syringe with BD UniVia Connection performance elements include:

Item#	Performance Specification:	Status of BD Oral/Enteral Syringe:
1	Tip Cap Leakage	Equivalent performance to predicates
2	Connection w/ Mating Devices	Equivalent performance to predicates
3	Luer Incompatibility	Equivalent performance to predicates

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Feed and Drug admini usuanon 10903 New Hampshire Avenue Document Mail Cemer - WO66-G609 Silver Spring, MiD 20995-0002

Mr. John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical System 1 Becton Drive FRANKLIN LAKES NJ 07417

Q.E.P.D.

Re: K112434

Trade/Device Name: BD Oral/Enteral Syringe with BD UniVia Connection Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 23, 2011 Received: August 24, 2011

Dear Mr. Roberts:

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. 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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert Remer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

112434 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

BD Oral/Enteral Syringe with BD UniVia Connection

Indications for Use:

The BD Oral/Enteral Syringe with BD UniVia Connection are intended to be used by healthcare professionals to measure and administer oral medication and enteral nutrition.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.