Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of AI or ML.

Therapeutic

Yes

The device is intended for the injection and aspiration of fluids, which are therapeutic actions performed by healthcare professionals.

Diagnostic

No
The device is described as a sterile syringe intended for the aspiration/injection of fluids. Its function is to administer or withdraw substances, not to provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (barrel, stopper, plunger rod) and performance testing related to material properties and mechanical function, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "aspiration/injection of fluids" in a neuraxial setting. This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes (e.g., administering medication, withdrawing cerebrospinal fluid).
Device Description: The description focuses on the physical characteristics of the syringe for fluid handling and connection to other medical devices.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. IVDs typically involve reagents, calibrators, controls, or instruments used to analyze biological samples.

Therefore, this device falls under the category of a general medical device used for fluid management in a clinical setting, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

QEH

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neuraxial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
Syringe 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
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 .
Neurotoxicity Assessment

Functional Tests:
Per ISO 7886-1:2017:

Plunger Retention Force
Per ISO 7886-2:1996:
Sticktion
Per BD internal requirements:
Break Out Force
Sustaining force
Scale Permanency

Packaging Tests:
Per ASTM F2096: 2011:

Bubble Leak Testing
Per ASTM F88/F88M: 2015:
Seal Strength Testing
Per ASTM F1608:2009:
Microbial Barrier Testing

The subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.

Clinical testing was not required for this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K980987

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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510(k) Summary (21 CFR §807.92)

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

| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Fax Number:
Date of Preparation: | Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Murtaza Rana
Staff Regulatory Affairs Specialist
Murtaza.rana@bd.com
(201) 847-6980
(201) 847-5307
August 6, 2020 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD® Syringe NRFit™ Lok and BD®
Syringe NRFit™ Slip
Piston Syringe
21 CFR §880.5860
Piston Syringe
Class II device
QEH (Piston Syringe With Neuraxial
Connector - Epidural, Peripheral and/or
indirect CSF contact)
General Hospital |
| Predicate Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Single Use, Hypodermic Syringe
K980987
Piston Syringe
21 CFR §880.5860
Piston Syringe
Class II device
FMF (Syringe, Piston)
General Hospital |
| Reason for
Submission | The purpose of this submission is to modify the tip of the
current BD Single Use, Hypodermic Syringe (previously cleared
under K980987) from the current Luer connections per ISO
594-1 and ISO 594-2 to the new ISO 80369-6 connectors
referred to as NRFit™. The new BD syringes with NRFit™
connectors will be referred to as BD® Syringe NRFit™ Lok and
BD® Syringe NRFit™ Slip. BD will continue to market the
current BD Single Use, Hypodermic Syringes with Luer
connections for general purpose use, while the new BD®
Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip will be for
neuraxial use per ISO 80369-6. | |
| Device Description | The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip
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

Comparison	Subject Device	Predicate Device
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.	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
Lubricant	Silicone	Silicone
	Plunger Rod	Polypropylene with yellow
colorant	Polypropylene
	Stopper	Polyisoprene Rubber	Polyisoprene Rubber
	Stopper
Lubricant	Silicone	Silicone
	Tip type	NRFit™ lock or slip per ISO
80369-6:2016	Luer-Lok™ or Luer Slip per
ISO 594-1: 1986 and ISO
594-2: 1998
Sterilization Method	Gamma Irradiation/
E-beam Irradiation	Gamma Irradiation/
E-beam Irradiation
SAL	10-6	10-6
Shelf Life	5 Years	5 Years
Functional Testing:

Fluid leakage by
Pressure Decay	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-1:1986 and
ISO 594-2:1998
Subatmospheric
pressure air leakage	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-1:1986 and
ISO 594-2:1998
Stress cracking	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-1:1986 and
ISO 594-2:1998
Resistance to
separation from axial
load	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-1:1986 and
ISO 594-2:1998
Resistance to
separation from
unscrewing	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-2:1998
Resistance to
overriding	Per ISO 80369-6:2016 and
ISO 80369-20:2015	Per ISO 594-2:1998
Needle hub
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
capacity	Per ISO 7886-1:2017	Per ISO 7886-1:1993
Plunger Retention
Force *	Per ISO 7886-1:2017	Per ISO 7886-1:2017
Sticktion*	Per ISO 7886-2:1996	Per ISO 7886-2:1996
Plunger Movement
Force	Per ISO 7886-2:2020	N/A. Not required previously
for predicate device.
Syringe Compliance	Per ISO 7886-2:2020	N/A. Not required previously
for predicate device.
Break Out Force	Size
3ml
5ml
10ml
20ml
50ml	Max (lb) @ 500mm/min
≤ 4
≤ 4
≤ 4.5
≤ 7.5
≤ 9.0
Sustaining force	Size
3ml
5ml
10ml
20ml
50ml	Max (lb) @ 500mm/min
≤ 1.5
≤ 2.0
≤ 2.0
≤ 2.5
≤ 5.0
Scale Permanency	No Heavy Removal under
solvent rub	No Heavy Removal under
solvent rub
Packaging Testing
Bubble Leak
Testing*	Per ASTM F2096:2011	Per ASTM F2096:2011
Seal Strength	Per ASTM F88/F88M:2015	Per ASTM F88/F88M:2015
Testing*
Microbial Barrier
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
Toxicity	Per ISO 10993-11:2006, Non-toxic	Per ISO 10993-11:2006, Non-toxic
Intracutaneous
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
Pyrogenicity	Per ISO 10993-11:2006 and
USP, Non-pyrogenic	Per ISO 10993-11:2006 and
USP 151, Non-pyrogenic
LAL Endotoxin	Per USP,
2.15 EU/device	Per USP,
, Met limits	N/A. Not required previously
for predicate device.
Neurotoxicity
Assessment	No signs of systemic toxicity
or neurological impairment
from exposure of leachable
compounds from the test
article	N/A. Not required previously
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 .
. Neurotoxicity Assessment

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