The modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypodermic syringe with a 6% (Luer) connector in 1ml Luer Slip, 3ml and 5ml Luer Lok and Luer Slip syringe sizes. The syringe assembly consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod. The changes to the modified device from the predicate include a new synthetic stopper material and a new silicone based stopper lubricant formulation. The syringe performance characteristics are equivalent to the predicate device. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The modified BD Single Use, Hypodermic Syringe are provided sterile, by either EO or an Irradiation sterilization method, in a syringe only configuration or with a pre-attached or side-by-side hypodermic needle.

AI/ML Overview

The provided text describes a 510(k) summary for a BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device and its performance characteristics. This is a medical device submission, and the "study" referred to is the design verification testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Performance Characteristic	Test Performed	Acceptance Criteria	Reported Device Performance
Functional Testing
Sustaining Force	Determination of forces required to operate plunger (ISO 7886-1 - Annex G)	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Break-Out Force	Determination of forces required to operate plunger (ISO 7886-1 - Annex G)	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Pump Sticktion / Force	Determination of forces required to move the piston (ISO 7886-2 - Annex C)	Per ISO 7886-2	Performed in an equivalent manner to the predicate device
Stopper Seal	Water Leakage Test (ISO 7886-1 - Annex D)	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Autoclavability	Water Leakage Test (ISO 7886-1 - Annex D) After Syringe autoclave for 15mins at 270°F	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Chemical Testing (Extractables)
Zinc	ISO 7886-1	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Lead, Tin, Iron	ISO 7886-1	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Cadmium	ISO 7886-1	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
pH shift	ISO 7886-1	Per ISO 7886-1	Performed in an equivalent manner to the predicate device
Biocompatibility Testing
Cytotoxicity	ISO10993-5:1999	Non-Toxic	Non-Toxic
Hemolysis	ISO10993-4:2002/A:2006	Non-Toxic	Non-Toxic
Acute Systemic Toxicity	ISO10993-11:2006	Non-Toxic	Non-Toxic
Intracutaneous Reactivity	ISO10993-10:2002/A1:2006	Non-Irritant	Non-Irritant
Murine Local Lymph Node Assay	ISO10993-10:2002/A1:2006	Non-Sensitizer	Non-Sensitizer
Pyrogenicity	ISO10993-11:2006	Non-Pyrogenic	Non-Pyrogenic

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in the provided text for each specific test. The document generally refers to "Design Verification tests" that were performed.
Data Provenance: The tests were conducted as part of the "Design Verification testing" for the modified BD Single Use, Hypodermic Syringe. This is a prospective testing approach conducted by the manufacturer, Becton, Dickinson and Company, for a 510(k) submission in the USA (Franklin Lakes, NJ).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of device submission or the nature of the testing performed. The "ground truth" here is defined by meeting the specified ISO standards and biocompatibility criteria through objective physical and chemical testing, not by expert interpretation of complex data (like in image diagnosis).

4. Adjudication method for the test set

This is not applicable. The outcome of these tests are objective measurements and biological responses against defined standards, not subjective interpretations requiring adjudication.

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

This is not applicable. This submission is for a medical device (hypodermic syringe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effectiveness are irrelevant here.

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

This is not applicable. As stated above, this is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance characteristics relies on:

International Standards: Meeting the requirements and specifications defined by ISO 7886-1 and ISO 7886-2 for functional and chemical properties.
Biocompatibility Standards: Meeting the criteria defined by various parts of ISO 10993 for biological safety.
Predicate Device Equivalence: The tests also aimed to demonstrate equivalent performance to the predicate device (K980987).

8. The sample size for the training set

This is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. No training set was used.

Summary

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510(K) Summary of Safety and Effectiveness

MAY 13 2011

KU0771

Date Prepared: 16 March 2011

Submitted By: 1.

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

2. Device Name:

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

Predicate Device: 3.

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

4. Device Description:

న్. Intended Use:

The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

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Technological Characteristics: 6.

The principal device of this 510(k) premarket notification is the result of a design change to the predicate device (K980987) conducted in accordance with Quality System Regulations, 21 CFR 820. The BD Single Use, Hypodermic Syringe is Substantially Equivalent to the predicate device, given that:

a) The BD Single Use, Hypodermic Syringe has the same intended use as the predicate device
b) The BD Single Use, Hypodermic Syringe operates under the same operating principle as the predicate device
c) The BD Single Use, Hypodermic Syringe barrel and plunger rod use an identical design and identical materials as the predicate device
d) The BD Single Use, Hypodermic Syringe and the predicate device meet the requirements for manual use and use with power-driven pumps as defined by ISO 7886-1 and ISO 7886-2 respectively.
e) The BD Single Use, Hypodermic Syringe and the predicate device component materials comply with ISO 10993 as applicable to the intended use of the device
The BD Single Use, Hypodermic Syringe and the predicate device are sterilized to an f) SAL of 10-6 via an EtO or Irradiation sterilization process
g) The BD Single Use, Hypodermic Syringe are assembled and packaged at the same manufacturing location utilizing the same equipment as the predicate device
h) The BD Single Use, Hypodermic Syringe demonstrated equivalent performance to the predicate device during design verification testing.

6. Performance:

Design Verification tests were performed based on the risk analysis performed, and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.

Design Verification testing included the following:

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Performance Characteristic	Test Performed	Acceptance Criteria
Functional Testing
Sustaining Force	Determination of forces requiredto operate plungerISO 7886-1 - Annex G	Per ISO 7886-1
Break-Out Force	Determination of forces requiredto operate plungerISO 7886-1 - Annex G	Per ISO 7886-1
Pump Sticktion / Force	Determination of forces requiredto move the pistonISO 7886-2 - Annex C	Per ISO 7886-2
Stopper Seal	Water Leakage TestISO 7886-1 - Annex D	Per ISO 7886-1
Autoclavability	Water Leakage TestISO 7886-1 - Annex DAfter Syringe autoclave for15mins at 270°F	Per ISO 7886-1
Chemical Testing (Extractables)
Zinc	ISO 7886-1	Per ISO 7886-1
Lead, Tin, Iron	ISO 7886-1	Per ISO 7886-1
Cadmium	ISO 7886-1	Per ISO 7886-1
pH shift	ISO 7886-1	Per ISO 7886-1

Biocompatibility Testing

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Cytotoxicity	ISO10993-5:1999	Non-Toxic
Hemolysis	ISO10993-4:2002/A:2006	Non-Toxic
Acute Systemic Toxicity	ISO10993-11:2006	Non-Toxic
Intracutaneous Reactivity	ISO10993-10:2002/A1:2006	Non-Irritant
Murine Local Lymph NodeAssay	ISO10993-10:2002/A1:2006	Non-Sensitizer
Pyrogenicity	ISO10993-11:2006	Non-Pyrogenic

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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

Mr. John Roberts Regulatory Affairs Specialist Becton, Dickinson and Company BD Medicalsurgical 1 Becton Drive MC237 Franklin Lakes, New Jersey 07417

MAY 1 3 2011

Re: K110771

Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 19, 2011 Received: April 21, 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.

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Page 2- Mr. Roberts

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

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): 长儿1077 |

BD Single Use, Hypodermic Syringe Device Name:

Indications for Use:

The BD Single Use, Hypodermic Syringe is intended for use by health care professionls for general purpose fluid aspiration/injection.

Prescription Use X Over-The-Counter Use 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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Rilis C. Chapman 5/12/11
(Division Sign-Off)

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:.0(k) Number: K110771

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).