The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.

Device Description

The BD Emerald™ Single Use, Hypodermic Syringe is a three-piece sterile, single use, hypodermic syringe with a 6% Luer taper tip that is provided in the following syringe sizes: 2ml, 3ml, 3ml, and 10ml. All sizes will be available with either a Luer Slip or Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination.

The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a resin stopper, and a polypropylene plunger rod. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of a lubricated stainless steel needle attached to a polypropylene hub with epoxy.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract details relevant to acceptance criteria and the study proving device performance:

Device: BD Emerald™ Single Use Hypodermic Syringe

The provided document is a 510(k) summary for a BD Emerald™ Single Use Hypodermic Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study demonstrating new performance criteria for a novel device. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like sample size for test sets, ground truth establishment for AI/imaging devices, MRMC studies, standalone algorithm performance) are not applicable in this context.

The "acceptance criteria" here are primarily based on meeting established international standards for medical devices of this type and demonstrating equivalent performance to predicate devices through design verification testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO Standards / Predicate Equivalence)	Reported Device Performance (as stated in the 510(k) summary)
Intended Use Equivalence: Same intended use as predicate devices.	The BD Emerald™ Single Use Hypodermic Syringe has the same intended use (general purpose aspiration and injection of fluids by healthcare professionals) as the predicate devices.
Operating Principle Equivalence: Operates under the same operating principle as predicate devices.	The BD Emerald™ Single Use Hypodermic Syringe operates under the same operating principle as the predicate devices.
Manual Use Requirements (ISO 7886-1): Meets requirements for manual use.	The BD Emerald™ Single Use Hypodermic Syringe meets the requirements for manual use as defined by ISO 7886-1. Performance Testing specifically states the device was "designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1. Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use."
Material Biocompatibility (ISO 10993): Materials comply with ISO 10993 as applicable.	The device's materials comply with ISO 10993 as applicable to the intended use. Biocompatibility Testing states "The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a Risk Management Process."
Sterility Assurance Level (SAL) of 10^-6.	The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6. Sterilization and Shelf-life Testing states "The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 11135-1, Sterilization of Healthcare Products - Ethylene Oxide Sterilization Process for Medical Devices."
Equivalent Performance (Design Verification Testing): Demonstrates equivalent performance to predicate devices.	"The results of Design Verification tests demonstrate that the BD Emerald™ Single Use. Hypodermic Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended." The document also states the device has "similarities...in intended use, function and basic composition" and "testing to voluntary standards provides additional evidence that the BD Emerald™ Single Use Hypodermic Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy and performance."
Needle Requirements (if included) (ISO 7864 & ISO 9626): Meets applicable requirements for hypodermic needles and tubing.	"The needles that may be included with the syringe meet the applicable requirements outlined in ISO 7864, Sterile Hypodermic Needles for Single Use and ISO 9626, Stainless Steel Needle Tubing for the Manufacture of Medical Devices."

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

Sample Size for Test Set: The document does not specify a numerical sample size for "design verification tests." These tests typically involve a defined number of units or batches tested per established protocol for each specific characteristic (e.g., force to activate plunger, leak tests, sterility tests). The 510(k) summary summarizes the conclusion of these tests rather than the details of the testing protocols.
Data Provenance: Not explicitly stated as country of origin. This would be internal testing conducted by Becton, Dickinson and Company. The nature of the testing (design verification, performance, biocompatibility, sterilization) implies these are prospective tests performed on newly manufactured devices or prototypes.

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

Not applicable. This phrase typically refers to human expert adjudication in studies involving assessment of images or clinical data (e.g., radiologist review). For a mechanical device like a syringe, "ground truth" is established by direct physical measurements against predefined specifications or performance standards by qualified engineers and technicians, not clinical "experts" in the same sense.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Testing involves objective measurements and comparisons to engineering specifications and ISO standards, not subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not done. MRMC studies are specific to evaluating diagnostic devices (e.g., imaging AI) where multiple human readers assess cases, and their performance with and without AI assistance is compared. This is a general-purpose medical device (syringe) and does not involve such a study design.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and International Standards: For this type of device, "ground truth" is established by:
- Predefined engineering and design specifications for the syringe components and their performance characteristics (e.g., Luer taper dimensions, barrel volume accuracy, plunger force).
- The requirements and test methods outlined in international standards such as ISO 7886-1 (Sterile Hypodermic Syringes for Single Use), ISO 7864 (Sterile Hypodermic Needles for Single Use), ISO 9626 (Stainless Steel Needle Tubing), ISO 10993-1 (Biocompatibility), and ISO 11135-1 (Ethylene Oxide Sterilization). Performance against these quantifiable standards constitutes the "ground truth" for compliance.

8. The Sample Size for the Training Set

Not applicable. This device does not utilize a training set in the context of machine learning or AI. Design and manufacturing processes are based on engineering principles and established quality control, not data-driven training in this manner.

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

Not applicable. See point 8.

Summary

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510(K) Summary of Safety and Effectiveness

· NOV 2 8 201

2113741

Submitted By:

Kara McKee. Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 3247 Fax: 201 847 5307

Device Name:

Trade Name:	BD Emerald™ Single Use Hypodermic Syringe
Common Name:	Piston Syringe
Classification Name:	Syringe, Piston
Classification:	Class II, 21 CFR 880.5860.

Predicate Device:

Trade Name(s):	Becton Dickinson Single Use Hypodermic Syringe
Manufacturer:	Becton, Dickinson and Company
510(k) Number(s):	K980987 and K110771

Device Description:

Intended Use:

The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.

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K113241

page 2 of 3

Technological Characteristics:

The principle device of this 510(k) premarket notification is the result of material; design, and labeling changes to the predicate devices (K980987 and K110771) which were conducted in accordance with Ouality System Regulations, 21 CFR 820.

The BD Emerald™ Single Use Hypodermic Syringe is Substantially Equivalent to the predicate devices, given that both the principle and predicate devices:

have the same intended use
operate under the same operating principle
meet the requirements for manual use as defined by ISO 7886-1
have materials that comply with ISO 10993 as applicable to the intended use of the device
are sterilized to a Sterility Assurance Level (SAL) of 10-6
demonstrate equivalent performance during design verification testing.

Testing:

The results of Design Verification tests demonstrate that the BD Emerald™ Single Use. Hypodermic Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended.

Performance Testing:

The BD Emerald™ Single Use Hypodermic Syringe have been designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1. Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use. The needles that may be included with the syringe meet the applicable requirements outlined in ISO 7864, Sterile Hypodermic Needles for Single Use and ISO 9626, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.

Biocompatibility Testing:

The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a Risk Management Process.

Sterilization and Shelf-life Testing:

The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 11135-1, Sterilization of Healthcare Products - Ethylene Oxide Sterilization Process for Medical Devices.

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8.

The vast similarities of the BD Emerald™ Single Use Hypodermic Syringe to the predicate devices support the substantial equivalence in intended use, function and basic composition. The testing to voluntary standards provides additional evidence that the BD Emerald™ Single Use Hypodermic Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.

111324

The differences between the BD Emerald™ Single Use Hypodermic Syringe and the predicate devices do not raise new issues of safety or effectiveness. . . . . . .

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Kara McKee Regulatory Affairs Specialist Becton Dickinson 1 Beckton Drive Franklin Lakes, New Jersey 07417

NOV 2 8 2011

Re: K113241

Trade/Device Name: BD Emerald™ Single Use Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 1, 2011 Received: November 2, 2011

Dear Ms. McKee:

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.

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Page 2 - Ms. McKee

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 (reporting of medical device-related 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.htm 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 /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 vours.

Anthony V. Walker

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K | 3241

BD Emerald™, Single Use, Hypodermic Syringe Device Name:

Indications for Use:

The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (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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Robert Chayra 11/30/4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

`510(k) Number:

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).