BD Syringe NRFit Lok and BD Syringe NRFit Slip

K192538 · Becton, Dickinson and Company · QEH · Sep 4, 2020 · General Hospital

Device Facts

• Record ID: K192538
• Device Name: BD Syringe NRFit Lok and BD Syringe NRFit Slip
• Applicant: Becton, Dickinson and Company
• Product Code: QEH · General Hospital
• Decision Date: Sep 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.

Device Story

Sterile, single-use piston syringes designed for neuraxial applications; features ISO 80369-6 (NRFit) compliant connectors to prevent misconnections with non-neuraxial devices. Assembly includes lubricated polypropylene barrel, synthetic rubber stopper, and yellow-colored polypropylene plunger rod. Operated manually by healthcare professionals to aspirate or inject fluids. Yellow plunger rod provides visual designation for neuraxial compatibility. Device reduces risk of misconnection compared to traditional Luer-based syringes. Used in clinical settings for spinal or epidural procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional performance (leakage, stress cracking, separation forces, volumetric accuracy, plunger forces), packaging integrity (bubble leak, seal strength, microbial barrier), and biocompatibility (cytotoxicity, hemolysis, systemic toxicity, sensitization, pyrogenicity, genotoxicity, neurotoxicity).

Technological Characteristics

Materials: Polypropylene barrel/plunger, polyisoprene rubber stopper, silicone lubricant. ISO 80369-6 (NRFit) connector. Sterilization: Gamma or E-beam irradiation (SAL 10^-6). Dimensions: 3mL, 5mL, 10mL, 20mL, 50mL. Manual operation; no software or electronics.

Indications for Use

Indicated for neuraxial use by healthcare professionals for aspiration/injection of fluids.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

September 4, 2020

Becton, Dickinson and Company Murtaza Rana Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K192538

Trade/Device Name: BD Syringe NRFit Lok and BD Syringe NRFit Slip Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: August 6, 2020 Received: August 7, 2020

### Dear Murtaza Rana:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K192538

Device Name

BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip

Indications for Use (Describe)

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.

| 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 BD logo. The logo consists of an orange circle with a white design inside, and the letters "BD" in blue. The circle is on the left, and the letters are on the right.

## 510(k) Summary (21 CFR §807.92)

# BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip

| 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>Murtaza Rana<br>Staff Regulatory Affairs Specialist<br>[e-mail]<br>[phone]<br>[phone]<br>August 6, 2020 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | BD® Syringe NRFit™ Lok and BD®<br>Syringe NRFit™ Slip<br>Piston Syringe<br>21 CFR §880.5860<br>Piston Syringe<br>Class II device<br>QEH (Piston Syringe With Neuraxial<br>Connector - Epidural, Peripheral and/or<br>indirect CSF contact)<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 |
| Reason for<br>Submission | The purpose of this submission is to modify the tip of the<br>current BD Single Use, Hypodermic Syringe (previously cleared<br>under K980987) from the current Luer connections per ISO<br>594-1 and ISO 594-2 to the new ISO 80369-6 connectors<br>referred to as NRFit™. The new BD syringes with NRFit™<br>connectors will be referred to as BD® Syringe NRFit™ Lok and<br>BD® Syringe NRFit™ Slip. BD will continue to market the<br>current BD Single Use, Hypodermic Syringes with Luer<br>connections for general purpose use, while the new BD®<br>Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip will be for<br>neuraxial use per ISO 80369-6. | |
| Device Description | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip<br>are sterile, single use syringes with ISO 80369-6 (NRFit™) | |
| | compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. | |
| Indications for Use | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids. | |
| Technological Characteristics | The subject BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are equivalent to that of the predicate BD Single Use, Hypodermic Syringe in intended use, materials and performance characteristics. | |

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

| Element of<br>Comparison | Subject Device | Predicate Device | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Indications for Use | The BD® Syringe NRFit™ Lok<br>and BD® Syringe NRFit™ Slip<br>are intended for neuraxial use<br>by healthcare professionals<br>for aspiration/injection of<br>fluids. | The BD Single Use,<br>Hypodermic Syringe is<br>intended for use by health<br>care professionals for general<br>purpose fluid<br>aspiration/injection. | |
| Syringe materials | Barrel | Polypropylene | Polypropylene |
| | Barrel<br>Lubricant | Silicone | Silicone |
| | Plunger Rod | Polypropylene with yellow<br>colorant | Polypropylene |
| | Stopper | Polyisoprene Rubber | Polyisoprene Rubber |
| | Stopper<br>Lubricant | Silicone | Silicone |
| | Tip type | NRFit™ lock or slip per ISO<br>80369-6:2016 | Luer-Lok™ or Luer Slip per<br>ISO 594-1: 1986 and ISO<br>594-2: 1998 |
| Sterilization Method | Gamma Irradiation/<br>E-beam Irradiation | Gamma Irradiation/<br>E-beam Irradiation | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years | |
| Functional Testing: | | | |
| | | | |
| Fluid leakage by<br>Pressure Decay | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-1:1986 and<br>ISO 594-2:1998 | |
| Subatmospheric<br>pressure air leakage | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-1:1986 and<br>ISO 594-2:1998 | |
| Stress cracking | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-1:1986 and<br>ISO 594-2:1998 | |
| Resistance to<br>separation from axial<br>load | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-1:1986 and<br>ISO 594-2:1998 | |
| Resistance to<br>separation from<br>unscrewing | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-2:1998 | |
| Resistance to<br>overriding | Per ISO 80369-6:2016 and<br>ISO 80369-20:2015 | Per ISO 594-2:1998 | |
| Needle hub<br>connectivity | Per BD internal requirements | Per BD internal requirements | |
| Tip integrity | Per BD internal requirements | Per BD internal requirements | |
| Dead space | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Volumetric accuracy | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Maximum usable<br>capacity | Per ISO 7886-1:2017 | Per ISO 7886-1:1993 | |
| Plunger Retention<br>Force * | Per ISO 7886-1:2017 | Per ISO 7886-1:2017 | |
| Sticktion* | Per ISO 7886-2:1996 | Per ISO 7886-2:1996 | |
| Plunger Movement<br>Force | Per ISO 7886-2:2020 | N/A. Not required previously<br>for predicate device. | |
| Syringe Compliance | Per ISO 7886-2:2020 | N/A. Not required previously<br>for predicate device. | |
| Break Out Force | Size<br>3ml<br>5ml<br>10ml<br>20ml<br>50ml | Max (lb) @ 500mm/min<br>≤ 4<br>≤ 4<br>≤ 4.5<br>≤ 7.5<br>≤ 9.0 | |
| Sustaining force | Size<br>3ml<br>5ml<br>10ml<br>20ml<br>50ml | Max (lb) @ 500mm/min<br>≤ 1.5<br>≤ 2.0<br>≤ 2.0<br>≤ 2.5<br>≤ 5.0 | |
| Scale Permanency | No Heavy Removal under<br>solvent rub | No Heavy Removal under<br>solvent rub | |
| Packaging Testing | | | |
| Bubble Leak<br>Testing* | Per ASTM F2096:2011 | Per ASTM F2096:2011 | |
| Seal Strength | Per ASTM F88/F88M:2015 | Per ASTM F88/F88M:2015 | |
| Testing* | | | |
| Microbial Barrier<br>Testing* | Per ASTM F1608: 2009 | Per ASTM F1608: 2009 | |
| Biocompatibility Testing: | | | |
| Testing per ISO 10993-1:2018: | | | |
| Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | Per ISO 10993-5:2009, Non-cytotoxic | |
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Per ISO 10993-4:2002/A1:2006, Non-hemolytic | |
| Acute Systemic<br>Toxicity | Per ISO 10993-11:2006, Non-toxic | Per ISO 10993-11:2006, Non-toxic | |
| Intracutaneous<br>Reactivity | Per ISO 10993-10:2010, Non-irritant | Per ISO 10993-10:2010, Non-irritant | |
| Sensitization | Per ISO 10993-10:2010, Non-sensitizer | Per ISO 10993-10:2010, Non-sensitizer | |
| Material-mediated<br>Pyrogenicity | Per ISO 10993-11:2006 and<br>USP<151>, Non-pyrogenic | Per ISO 10993-11:2006 and<br>USP 151, Non-pyrogenic | |
| LAL Endotoxin | Per USP<85>,<br>2.15 EU/device | Per USP<85>,<br>< 0.2 EU/device | |
| Chemical<br>Characterization | Per ISO 10993-18:2005,<br>acceptable<br>extractables/leachables<br>profile | Per ISO 10993-18:2005,<br>acceptable<br>extractables/leachables<br>profile | |
| Subacute/Subchronic | Per ISO 10993-11; No<br>treatment related adverse<br>effects | N/A. Not Required previously<br>for predicate device | |
| Genotoxicity | Per ISO 10993-3:2014, Non-<br>mutagentic and non-<br>clastogenic | N/A. Not required previously<br>for predicate device. | |
| Additional Testing : | | | |
| Acidity/Alkalinity and<br>Extractable Metals | Per ISO 7886-1:2017, Met<br>limits | Per ISO 7886-1:1993, Met<br>limits | |
| Particulate Matter | Per USP <788>, Met limits | N/A. Not required previously<br>for predicate device. | |
| Neurotoxicity<br>Assessment | No signs of systemic toxicity<br>or neurological impairment<br>from exposure of leachable<br>compounds from the test<br>article | N/A. Not required previously<br>for predicate device. | |

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

{6}------------------------------------------------

The intended uses of the subject and predicate devices are the same in that both are intended for use by healthcare professionals for aspiration/injection of fluids. However, due to the ISO 80369-6 connector, the BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are limited to neuraxial applications. As such, the neuraxial indication, is a subset of the predicate indications for use, which is for general purpose. Therefore, the above difference in indications for use is not critical to the intended use as the intended

{7}------------------------------------------------

use remains the same: for use by healthcare professionals for aspiration/injection of fluids. It further does not affect the safety and effectiveness of the device when used as labeled as demonstrated through functional testing. Biocompatibility testing per ISO 10993 and ISO 80369 testing were conducted to address the changes in indications for neuraxial use and tip design, respectively.

BD has performed the following non-clinical/design verification Performance Tests testing/analysis and the results of these tests/analysis demonstrate that the BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip performed in an equivalent manner to the predicate device. Per ISO 80369-6 and ISO 80369-20: . Fluid leakage by Pressure Decay Subatmospheric pressure air leakage . Stress cracking . ● Resistance to separation from axial load ● Resistance to separation from unscrewing Resistance to overriding . Per BD internal requirements: Needle hub connectivity . . Tip integrity Per ISO 7886-1: Dead space . . Volumetric accuracy Maximum usable capacity . Per ISO 7886-2:2020: . Plunger Movement Force Svringe Compliance ● A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018. The contact classification is external communicating, indirect contact with blood and tissue with a prolonged use. Based on the evaluation, the following biological tests were conducted: . Cytotoxicity . Hemolysis Acute Systemic Toxicity ● Intracutaneous Reactivity ● . Sensitization . Subacute/Subchronic

{8}------------------------------------------------

- Genotoxicity .
- Material-mediated Pyrogenicity .
- LAL Endotoxin
- . Chemical Characterization

Additionally, the following tests were performed:

- Acidity/Alkalinity and Extractable Metals per ISO 7886-. 1:2017
- Particulate Matter per USP <788> .
- . Neurotoxicity Assessment

| | Functional:<br>Per ISO 7886-1:2017:<br>• Plunger Retention Force<br>Per ISO 7886-2:1996:<br>• Sticktion<br>Per BD internal requirements:<br>• Break Out Force<br>• Sustaining force<br>• Scale Permanency |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Packaging:<br>Per ASTM F2096: 2011<br>• Bubble Leak Testing<br>Per ASTM F88/F88M: 2015<br>• Seal Strength Testing<br>Per ASTM F1608:2009<br>• Microbial Barrier Testing |
| | The subject device met all predetermined acceptance criteria<br>for the above-listed performance tests, demonstrating<br>substantial equivalence to the predicate device. |
| Clinical Testing | Clinical testing was not required for this submission |
| Summary of<br>Substantial<br>Equivalence | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip<br>are substantially equivalent to the predicate device in intended<br>use, principles of operation, technology, design, materials and<br>performance. |