BD Single Use, Hypodermic Syringe

K172670 · Becton, Dickinson and Company · FMF · Oct 23, 2018 · General Hospital

Device Facts

• Record ID: K172670
• Device Name: BD Single Use, Hypodermic Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: FMF · General Hospital
• Decision Date: Oct 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

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

Device Story

Three-piece, sterile, single-use hypodermic syringe; 3ml, 5ml, and 10ml Luer-Lok sizes. Components: lubricated polypropylene barrel with graduated scale, lubricated synthetic rubber stopper, polypropylene plunger rod. Operation: manual aspiration of fluids by pulling plunger rod; manual injection/expulsion by depressing plunger rod. Male 6% (Luer) connector interfaces with compatible female 6% (Luer) connectors. Used by healthcare professionals in clinical settings for general fluid management. Subject device incorporates new resin material in barrel; performance equivalent to predicate.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: break out force, sustaining force, flange bend force, dimensional stability, scale permanency, barrel impact, and ISO 7886/594 leakage testing. Biocompatibility testing per ISO 10993 included cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization, pyrogenicity, and chemical extractables analysis.

Technological Characteristics

Materials: polypropylene barrel (new resin), synthetic rubber stopper, silicone lubricant. 6% (Luer) male connector. Sizes: 3ml, 5ml, 10ml. Sterilization: Gamma irradiation or E-beam (SAL 10^-6). Complies with ISO 7886, ISO 594, ISO 10993, and ISO 11137-2:2013.

Indications for Use

Indicated for use by health care professionals for general purpose fluid aspiration and injection.

Regulatory Classification

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.

Predicate Devices

• BD Single Use, Hypodermic Syringe (K980987)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2018

Becton, Dickinson and Company Victoria Morrow Sr. Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K172670

Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 2, 2018 Received: February 5, 2018

Dear Victoria Morrow:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Alan M.
Stevens -S

Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K172670

Device Name BD Single Use, Hypodermic Syringe

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular orange symbol on the left and the letters "BD" in blue on the right. The orange symbol features a stylized sun-like design with rays emanating from a central point, while the letters "BD" are bold and slightly rounded.

## 510(k) Summary (21 CFR §807.92)

## BD Single Use, Hypodermic Syringe

| Submitter<br>Information | Submitter Name:<br>Submitter Address:<br>Contact Person:<br>Email Address:<br>Phone Number:<br>Fax Number:<br>Date of Preparation: | Becton, Dickinson and Company<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Victoria Morrow<br>Sr. Regulatory Affairs Specialist<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone]<br>October 23, 2018 | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject Device | Trade Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | BD Single Use, Hypodermic Syringe<br>Piston Syringe<br>21 CFR §880.5860<br>Piston Syringe<br>Class II device<br>FMF (Syringe, Piston)<br>General Hospital | |
| Predicate Device | Trade Name:<br>510(k) Reference:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | BD Single Use, Hypodermic Syringe<br>K980987<br>Piston Syringe<br>21 CFR §880.5860<br>Piston Syringe<br>Class II device<br>FMF (Syringe, Piston)<br>General Hospital | |
| Device<br>Description | The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use<br>hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Lok<br>syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by<br>health care professionals for general purpose fluid aspiration/injection. The syringe<br>assembly consists of a lubricated polypropylene barrel with a graduated scale, a<br>lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger<br>rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The<br>syringe barrel incorporates a male 6% (Luer) connector which is connectable to a<br>compatible female 6% (Luer) connector. The modified BD Single Use, Hypodermic<br>Syringe includes a new resin material in the barrel of the syringe. The syringe<br>performance characteristics are equivalent to the predicate device. | | |
| Indications for<br>Use | | The BD Single Use, Hypodermic Syringe is intended for use by health care<br>professionals for general purpose fluid aspiration/injection. | |
| Technological<br>Characteristics | | The subject BD Single Use, Hypodermic Syringe, which uses a new polyproplyene<br>barrel resin is equivalent to that of the predicate BD Single Use, Hypodermic<br>Syringe in intended use, materials and performance characteristics. | |

{4}------------------------------------------------

| Element of Comparison | Subject Device | Predicate Device | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indications for Use/Intended Use | The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | |
| Syringe materials | Barrel | Polypropylene | Polypropylene |
| | Barrel | Silicone | Silicone |
| | Lubricant | | |
| | Plunger Rod | Polypropylene | Polypropylene |
| | Stopper | Polyisoprene Rubber | Polyisoprene Rubber |
| | Stopper | Silicone | Silicone |
| | Lubricant | | |
| Sterilization Method | Gamma Irradiation<br>E-beam | Gamma Irradiation<br>E-beam | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years | |

#### Performance Tests

BD has performed the following non-clinical/design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device.

- Break Out Force ●
- Sustaining Force ●
- Flange Bend Force ●
- Dimensional Stability of Barrel ID (inner diameter) ●
- . Barrel Scale Permanency
- Barrel Impact Test
- ISO 7886 and ISO 594 Leakage Testing ●

The device is sterilized using a gamma irradiation process and was validated per ISO 11137-2:2013.

In addition, a biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted:

- Cytotoxicity (Per ISO 10993-5, Non-cytotoxic) ●
- Hemolysis (Per ISO 10993-4, Non-hemolytic
- Acute Systemic Toxicity (Per ISO 10993-11, Non-toxic) ●
- Intracutaneous Reactivity (Per ISO 10993-10, Non-Irritant) ●
- Sensitization (Per ISO 10993-10, Non-Sensitizer) ●
- Pyrogenicity (Per ISO 10993-11 and USP <151>, Non-Pyrogenic) ●
- Acidity/Alkalinity/ Extractable Metals (Per ISO 7886-1, met acceptance ● criteria)
- . Chemical Extractables Analysis (Per ISO 10993-18, no toxicologically significant differences in extractables profiles.)

Per the design control requirements specified in 21 CFR 820.30. the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.

{5}------------------------------------------------

| Clinical Testing | Clinical testing was not required for this submission |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | The BD Single Use, Hypodermic Syringe is substantially equivalent to the predicate<br>device in intended use, principles of operation, technology, design, materials and<br>performance. |