BD Plastipak Syringe

K182589 · Becton, Dickinson and Company · FMF · Mar 14, 2019 · General Hospital

Device Facts

• Record ID: K182589
• Device Name: BD Plastipak Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: FMF · General Hospital
• Decision Date: Mar 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BD Plastipak™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection.

Device Story

BD Plastipak™ Syringe is a three-piece, single-use, sterile or bulk non-sterile hypodermic syringe; available in 3mL and 20mL sizes. Device consists of a lubricated polypropylene barrel with graduated scale, a lubricated thermoplastic elastomer (TPE) stopper, and a polypropylene plunger rod. Operates via manual aspiration (pulling plunger) or injection/expulsion (depressing plunger). Connects to compatible female 6% (Luer) connectors via Luer Slip or male 6% (Luer Lock) connection. Used by healthcare professionals in clinical settings for general fluid management. Output is the delivery or aspiration of fluids; healthcare providers use the graduated scale for volume measurement. Benefits include precise fluid handling and delivery. Device is provided sterile (Irradiation or EtO) or bulk non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical design verification and biocompatibility testing. Bench testing included volumetric accuracy, leakage, plunger force, and sterility/biocompatibility (cytotoxicity, hemolysis, systemic toxicity, sensitization, pyrogenicity) per ISO 10993 and USP standards.

Technological Characteristics

Materials: Polypropylene barrel/plunger, TPE stopper, silicone lubricant. Dimensions: 3mL and 20mL. Connectivity: Luer Slip or Luer Lock. Sterilization: Irradiation or EtO (SAL 10^-6). Standards: ISO 7886-1, ISO 7886-2, ISO 10993, USP <87>, <88>, <381>, <788>, <85>.

Indications for Use

Indicated for 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

• Becton Dickinson Single Use Hypodermic Syringes (K980987)

Submission Summary (Full Text)

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March 14, 2019

Becton, Dickinson and Company % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313

Re: K182589

Trade/Device Name: BD Plastipak Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: February 14, 2019 Received: February 15, 2019

Dear Mark Job:

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

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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 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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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

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| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Expiration Date: 06/30/2020 | Food and Drug Administration |
| See PRA Statement below. | <b>Indications for Use</b> |
| 510(k) Number (if known) | K182589 |
| Device Name | BD Plastipak ^TM Syringe |
| Indications for Use (Describe) | The BD Plastipak ^TM Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection. |

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="float:left">☒</span> <span style="float:left">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="float:left">☐</span> <span style="float:left">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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bd.com

Image /page/3/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with a white starburst-like design inside it. To the right of the circle are the letters "BD" in blue. The letters are in a bold, sans-serif font.

# 510(k) Summary (21 CFR §807.92) BD Plastipak™ Syringe

| Submitter: | Leslie Robinson-Frye<br>Staff Regulatory Affairs Specialist<br>Becton, Dickinson and Company<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Phone: [phone]<br>Fax: [phone] | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Date Prepared: | Leslie Robinson-Frye<br>March 13, 2019 | |
| Subject Devices: | Name of Device:<br>Common Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code: | BD Plastipak™ Syringe<br>Piston Syringe<br>Piston Syringe, (21 CFR §880.5860)<br>II<br>FMF |
| Predicate Devices: | Name of Device:<br>510(k) Reference:<br>Common Name:<br>Classification:<br>Product Code: | Becton Dickinson Single Use Hypodermic Syringes<br>K980987<br>Piston Syringe<br>Piston Syringe, (21 CFR §880.5860, Class II device)<br>FMF |

This predicate has not been subject to a design-related recall.

#### Reason for Submission

The purpose of this submission is to modify the stopper material, barrel/stopper lubricant, stopper dimensions, stopper manufacturing location, product name, and label statements (pump claim and do not re-sterilize) of the predicate Becton Dickinson Single Use Hypodermic Syringes.

### Device Description

The 3mL and 20mL BD Plastipak™ Syringe is a three-piece, single use, sterile or bulk non-sterile (BNS) hypodermic syringe with Luer Slip or male 6% (Luer Lock) connection, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies consist of a lubricated polypropylene barrel with a graduated scale, a lubricated thermoplastic elastomer stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD Plastipak™ Syringe incorporates a scale graduated in units of milliliters.

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Image /page/4/Picture/2 description: The image contains the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sun-like symbol in orange on the left and the letters "BD" in blue on the right. The sun-like symbol has a central circle with radiating lines, and the letters "BD" are in a bold, sans-serif font.

The BD Plastipak™ Syringe is provided sterile by Irradiation or Ethylene Oxide Gas (EtO) sterilization methods in a syringe only configuration or with a BD Hypodermic Needle, BD SafetyGlide™ Hypodermic Needle or BD Eclipse™ Hypodermic Needle. The BD Plastipak™ Syringe is also provided in a bulk nonsterile, syringe only configuration.

#### Intended Use

The BD Plastipak™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection.

### Comparison of Technological Characteristics

The subject BD Plastipak ™ Syringe is equivalent to that of the predicate BD Hypodermic Syringe in intended use, materials and performance characteristics.

The stopper material, lubricant and dimensions are different between the subject and predicate devices However, the above differences are not critical in the safety and effectiveness of the device when used as labeled as demonstrated through functional testing.

| Element of Comparison | Subject Device | Predicate Device | |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for Use/Intended Use | The BD Plastipak™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection. | These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. | |
| Syringe Materials | Plunger | Polypropylene | Polypropylene |
| | Barrel | Polypropylene | Polypropylene |
| | Barrel Silicone | Silicone | Silicone |
| | Stopper | Thermo Plastic Elastomer (TPE) Copolymer | Polyisoprene Rubber |
| | Stopper Silicone | Silicone | Silicone |
| Syringe Dimensions | Stopper | - Stopper Outer Diameter<br>-Stopper Inner Diameter | - Stopper Outer Diameter<br>-Stopper Inner Diameter |
| | | | |
| Sterilization Methods | EtO<br>Irradiation | EtO<br>Irradiation | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years | |
| Functional Testing: | | | |
| Startup Time | ISO7886-2 | ISO7886-2 | |
| Volumetric Accuracy<br>(Manual Use, tolerance on graduated capacity) | ISO7886-1 and ISO 7886-2 | ISO7886-1 and ISO 7886-2 | |
| Sterility Product<br>(N/A* for BNS) | ISO 11135 , ISO 11137 and<br>PH Eur. 5.0 | ISO 11135 , ISO 11137 and<br>PH Eur. 5.0 | |
| Not Manufactured with BPA | Manufacturing process does not<br>include BPA | Manufacturing process does<br>not include BPA | |
| Not made with natural rubber latex | Not made with natural rubber<br>latex | Not made with natural<br>rubber latex | |
| Stopper Separation from plunger | ISO7886-1 | ISO7886-1 | |
| Liquid leakage past stopper under<br>pressure (back rib) | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Liquid leakage past stopper under<br>pressure (front rib) | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Air Leakage past Stopper in<br>aspiration | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Dead space | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Maximum Usable Capacity | ISO7886-1 | ISO7886-1 | |
| Fiducial Line | ISO7886-1 | ISO7886-1 | |
| Hard Height | ISO7886-2 | ISO7886-2 | |
| Short-Term Flow Rate Accuracy<br>(incl Stiction) | ISO 7886-2 | ISO 7886-2 | |
| Overall Percentage Error | ISO7886-2 | ISO7886-2 | |
| Max Variation in Flow Rate | ISO7886-2 | ISO7886-2 | |
| Plunger Movement Forces (Pump) | ISO7886-2 | ISO7886-2 | |
| Syringe Compliance | ISO7886-2 | ISO7886-2 | |
| Uniform Stopper Appearance | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Scale -<br>Graduation Line Intervals | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Scale -<br>Unit of measure | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Scale Lines | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Scale Numbering | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| | | | |
| Scale Length | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Scale Position | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Marking - Syringe Barrel | ISO7886-1 and ISO7886-2 | ISO7886-1 and ISO7886-2 | |
| Air leakage past stopper in<br>aspiration (vacuum) | ISO7886-1 | ISO 7886-1 | |
| Stopper separation from plunger | ISO7886-1 | ISO 7886-1 | |
| | Biocompatibility Testing: | | |
| Cytotoxicity | ISO 10993-5, 10993-12 and<br>USP <87> | ISO 10993-5, 10993-12 and<br>USP <87> | |
| Hemolysis | Per ISO 10993-4 and 10993-12 | Per ISO 10993-4 and 10993-12 | |
| Acute Systemic Toxicity | Per ISO 10993-11 and 10993-12 | Per ISO 10993-11 and 10993-12 | |
| Intracutaneous Reactivity | Per ISO 10993-10, 10993-12 USP<br>and <88> | Per ISO 10993-10, 10993-12<br>USP and <88> | |
| Sensitization | Per ISO 10993-10 | Per ISO 10993-10 | |
| Pyrogenicity | Per ISO 10993-11, 10993-12 and<br>USP 151 | Per ISO 10993-11, 10993-12<br>and USP 151 | |
| Elastomeric Closures for Injections | USP <381> | USP <381> | |
| ISO 7886-1: Acidity/Alkalinity and<br>Extractable Metals | ISO 7886-1 | ISO 7886-1 | |
| Extractables/Leachables Assessment | ISO 10993-17 and ISO 10993-18 | ISO 10993-17 and<br>ISO 10993-18 | |
| Particulate Matter | USP <788> | USP <788> | |
| Endotoxin, LAL | USP <85> | USP <85> | |

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Image /page/5/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with white rays emanating from the center, next to the letters "BD" in blue. The letters are bold and sans-serif.

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Image /page/6/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a stylized orange sun-like symbol on the left and the letters "BD" in blue on the right. The sun-like symbol is a circle with rays emanating from it, and the letters "BD" are in a bold, sans-serif font.

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Image /page/7/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with a white starburst inside, followed by the letters "BD" in blue. The starburst has 10 points, and the letters "BD" are in a bold, sans-serif font.

## Non-Clinical Performance Data

BD has performed the following non-clinical/design verification testing, including shelf life testing and the results of these tests demonstrate that the BD Plastipak™ Syringe performed in an equivalent manner to the predicate devices. As there are no packaging changes occurring as part of this submission, all packaging data was leveraged from predicate devices. Labeling requiremented for BNS sterilization instructions.

| | Startup Time | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Syringe Performance | Volumetric Accuracy<br>(Manual Use, tolerance on<br>graduated capacity) | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. |
| | Sterility Product<br>(N/A* for BNS) | Subject device met the pre-established acceptance criteria per<br>ISO 11135, ISO 11137 and PH Eur. 5.0 |
| | Stopper Separation from<br>plunger | Subject device met the pre-established acceptance criteria per<br>ISO7886-1. |
| | Liquid leakage past stopper<br>under pressure (back rib) | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. |
| | Liquid leakage past stopper<br>under pressure (front rib) | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. |
| | Air Leakage past Stopper in<br>aspiration | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. |
| | Dead space | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. |
| | Maximum Usable Capacity | Subject device met the pre-established acceptance criteria per<br>ISO7886-1. |
| | Fiducial Line | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 |
| | Hard Height | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. |
| Short-Term Flow Rate<br>Accuracy (incl Stiction) | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. | |
| Overall Percentage Error | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. | |
| Max Variation in Flow Rate | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. | |
| Plunger Movement<br>Forces (Pump) | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. | |
| Syringe Compliance | Subject device met the pre-established acceptance criteria per<br>ISO7886-2. | |
| Uniform<br>Stopper<br>Appearance | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale - Graduation<br>Line Intervals | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale - Unit of measure | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale Lines | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale Numbering | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale Length | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Scale Position | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Marking - Syringe Barrel | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 and ISO7886-2. | |
| Air leakage past stopper in<br>aspiration (vacuum) | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 | |
| Stopper separation<br>from plunger | Subject device met the pre-established acceptance criteria per<br>ISO7886-1 | |

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Image /page/8/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular orange symbol with white rays emanating from the center, and the letters "BD" in blue. The symbol is on the left, and the letters are on the right. The logo is simple and modern, and it is easily recognizable.

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Image /page/9/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol is orange and features a stylized sun-like design with rays emanating from a central point. The letters "BD" are in blue and have a rounded, sans-serif font.

| Sterilization Test | Irradiation | Subject device met the pre-established acceptance criteria<br>per ISO 11137-1 and ISO 11137-2 |
|-----------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------|
| | Ethylene Oxide (Eto) | Subject device met the pre-established acceptance criteria<br>per ISO 11135 and ISO 10993-7 |
| Biocompatibility Test | Cytotoxicity | Per ISO 10993-5 and 10993-12, USP <87><br>Non-cytotoxic |
| | Hemolysis | Per ISO 10993-4 and 10993-12,<br>Non-hemolytic |
| | Acute Systemic Toxicity | Per ISO 10993-11 and 10993-12,<br>Non-toxic |
| | Intracutaneous Reactivity | Per ISO 10993-10 and 10993-12, USP <88><br>Non-Irritant |
| | Sensitization | Per ISO 10993-10,<br>Non-Sensitizer |
| | Pyrogenicity | Per ISO 10993-11, 10993-12 and USP 151,<br>Non-Pyrogenic |
| | Elastomeric Closures for<br>Injections | USP <381><br>Met Type I and II closures |
| | ISO 7886-1: | ISO 7886-1 |
| | Acidity/Alkalinity and<br>Extractable Metals | Pass |
| | Extractables/Leachables<br>Assessment | ISO 10993-17 and 18<br>Pass |
| | Particulate Matter | USP <788> Pass |
| | Endotoxin LAL | USP <85> Pass |

### Clinical Testing

Clinical testing was not required for this submission.

### Substantial Equivalence

The BD Plastipak™ Syringe is substantially equivalent to the predicate devices in intended use, operating principle, technology, design, materials and performance.

### Conclusion

The BD Plastipak™ Syringe has been verified to meet the established performance criteria above. The results of the non-clinical/design verification testing demonstrate that the BD Plastipak™ Syringe perform as intended and perform as well as the legally marketed predicate devices for the same intended use. Therefore the devices are substantially equivalent.