K Number
K193131
Device Name
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Date Cleared
2020-09-29

(322 days)

Product Code
Regulation Number
868.5150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures. These devices are intended for adult and pediatric patients. The BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients.
Device Description
The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle are single use, sterile needles which incorporate an ISO 80369-6 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use). Each type of needle consists of a hollow, stainless steel cannula, a translucent, polypropylene hub and a polypropylene shield. The cannula is bonded to the hub at one end and there is a specific needle point (Quincke or Whitacre) at the other end. The BD® Spinal Introducer NRFit™ Needle is only available with a Quincke needle point. The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle also contain a stylet and are available in various needle lengths. The stylet consists of a solid, stainless steel wire bonded to a polypropylene handle. All three needles are available in various gauges. The needle hubs for all three needles are ISO 80369-6 compliant connectors. The needle shields are yellow to indicate that the device is intended to only connect to ISO 80369-6 compatible devices. The stylet handle for the BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle and the needle hub of the BD® Spinal Introducer NRFit™ Needles are color coded and correlate to the gauge size per ISO 6009:2016.
More Information

Not Found

No
The device description and performance studies focus on the physical characteristics and mechanical performance of the needles, with no mention of AI or ML.

No
The device is described as an instrument intended for diagnostic procedures (diagnostic lumbar puncture and myelography) and fluid exchange (injection/withdrawal), not for treating a condition or disease.

Yes

The "Intended Use / Indications for Use" section explicitly states that the needles are for "purposes of diagnostic lumbar puncture and myelography procedures," which are diagnostic in nature.

No

The device description clearly details physical components made of stainless steel and polypropylene, and the performance studies involve physical testing of these components. There is no mention of software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the devices are for gaining entry into or puncturing the spinal cavity for injection/withdrawal of fluids for diagnostic lumbar puncture and myelography procedures. While these procedures can be part of a diagnostic process, the needles themselves are tools for accessing the site and collecting or delivering substances. They are not used in vitro (outside the body) to examine specimens for diagnostic purposes.
  • Device Description: The description details the physical components of needles and introducers, which are instruments used in vivo (within the body).
  • Lack of IVD Characteristics: There is no mention of reagents, assays, or any process that involves testing biological samples in vitro to diagnose a condition.

The devices are instruments used in medical procedures, not diagnostic tests performed on samples.

N/A

Intended Use / Indications for Use

The BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients.

The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures. These devices are intended for adult and pediatric patients.

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

BSP

Device Description

The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle are single use, sterile needles which incorporate an ISO 80369-6 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).

Each type of needle consists of a hollow, stainless steel cannula, a translucent, polypropylene hub and a polypropylene shield. The cannula is bonded to the hub at one end and there is a specific needle point (Quincke or Whitacre) at the other end. The BD® Spinal Introducer NRFit™ Needle is only available with a Quincke needle point. The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle also contain a stylet and are available in various needle lengths. The stylet consists of a solid, stainless steel wire bonded to a polypropylene handle. All three needles are available in various gauges.

The needle hubs for all three needles are ISO 80369-6 compliant connectors. The needle shields are yellow to indicate that the device is intended to only connect to ISO 80369-6 compatible devices. The stylet handle for the BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle and the needle hub of the BD® Spinal Introducer NRFit™ Needles are color coded and correlate to the gauge size per ISO 6009:2016.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

spinal cavity

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

Prescription Use

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)

Performance Tests:
BD has performed the following non-clinical/design verification testing/analysis and the results of these tests/analysis demonstrate that the BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle performed in an equivalent manner to the predicate device.
Per ISO 80369-6:
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:
Stylet Pull Force
Handle/Hub Separation Force
Needle Shield/Hub Separation Force

Per ISO 7864:
Cannula Pull Force (Bond between hub and needle)

Per ISO 9626:
Cannula Deflection/Stiffness
Cannula Breakage

A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018. Based on the evaluation, the following biological tests were conducted:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Material-Mediated Pyrogenicity
Chemical Characterization

Additionally, the following tests were performed:
Hemolysis
LAL Endotoxin
Particulate Matter
Neurotoxicity Assessment

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.

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.

K160294

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

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

September 29, 2020

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

Re: K193131

Trade/Device Name: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: September 1, 2020 Received: September 2, 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.

1

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 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.

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193131

Device Name BD® Spinal Introducer NRFit™ Needle

Indications for Use (Describe)

The BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles.

This device is intended for adult and pediatric patients.

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

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

Indications for Use

510(k) Number (if known) K193131

Device Name

BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle

Indications for Use (Describe)

The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.

These devices are intended for adult and pediatric patients.

Type of Use (Select one or both, as applicable)
☑ 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."

4

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510(k) Summary (21 CFR §807.92)

BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle

and BD® Spinal Introducer NRFit™ Needle
-------------------------------------------

| 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
September 22, 2020 | |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD® Quincke Spinal NRFit™ Needle,
BD® Whitacre Spinal NRFit™ Needle,
BD® Spinal Introducer NRFit™ Needle
Anesthesia Conduction Needle
21 CFR §868.5150
Anesthesia Conduction Needle
Class II device
BSP (Needle, Conduction, anesthetic
(W/Wo Introducer))
Anesthesiology | |
| Predicate Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | SPROTTE® NRFit™ and Quincke NRFit™
Lumbar Puncture needles
K160294
Anesthesia Conduction Needle
21 CFR §868.5150
Anesthesia Conduction Needle
Class II device
BSP (Needle, Conduction, anesthetic
(W/Wo Introducer))
Anesthesiology | |
| Reason for
Submission | The purpose of this submission is to introduce an array of
spinal and spinal introducer needles which comply with the
ISO 80369-6:2016 standard entitled Small-bore connectors for
liquids and gases in healthcare applications - Part 6:
Connectors for neuraxial applications. The connectors
specified in ISO 80369-6 are referred to as NRFit™ connectors.
The BD spinal and spinal introducer needles with NRFit™
connectors will be referred to as BD® Quincke Spinal NRFit™
Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal
Introducer NRFit™ Needle. | | |
| Device Description | The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal
NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle are
single use, sterile needles which incorporate an ISO 80369-6
compliant connector. The needles are also available in bulk,
non-sterile configurations (to be sterilized prior to use). | | |
| | Each type of needle consists of a hollow, stainless steel
cannula, a translucent, polypropylene hub and a polypropylene
shield. The cannula is bonded to the hub at one end and there
is a specific needle point (Quincke or Whitacre) at the other
end. The BD® Spinal Introducer NRFit™ Needle is only
available with a Quincke needle point. The BD® Quincke
Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™
Needle also contain a stylet and are available in various needle
lengths. The stylet consists of a solid, stainless steel wire
bonded to a polypropylene handle. All three needles are
available in various gauges. | | |
| | The needle hubs for all three needles are ISO 80369-6
compliant connectors. The needle shields are yellow to
indicate that the device is intended to only connect to ISO
80369-6 compatible devices. The stylet handle for the BD®
Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal
NRFit™ Needle and the needle hub of the BD® Spinal
Introducer NRFit™ Needles are color coded and correlate to
the gauge size per ISO 6009:2016. | | |
| Indications for Use | The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre
Spinal NRFit™ Needle are intended to gain entry into or
puncture the spinal cavity permitting injection (including
anesthesia) / withdrawal of fluids for purposes of diagnostic
lumbar puncture and myelography procedures.
These devices are intended for adult and pediatric patients. | | |
| | The BD® Spinal Introducer NRFit™ Needle is intended for
placement or introduction of spinal needles.
This device is intended for adult and pediatric patients. | | |
| Element of
Comparison | Subject Device | Predicate Device | |
| Indications for Use | The BD® Quincke
Spinal NRFit™ Needle
and BD® Whitacre
Spinal NRFit™ Needle
are intended to gain
entry into or
puncture the spinal
cavity permitting
injection (including
anesthesia) /
withdrawal of fluids
for purposes of
diagnostic lumbar
puncture and
myelography
procedures.
These devices are
intended for adult
and pediatric
patients.

The BD® Spinal
Introducer NRFit™
Needle is intended
for placement or
introduction of spinal
needles.
This device is
intended for adult
and pediatric
patients. | The SPROTTE®
NRFit™, Quincke
NRFit™ lumbar
puncture needles are
intended to gain
entry into or
puncture the spinal
cavity permitting
injection (including
anesthesia) /
withdrawal of fluids
for purposes of
diagnostic lumbar
puncture,
myelography/
discography
procedures.
The device is
intended for adult
and pediatric
patients. | |
| Needle
materials | Cannula | Stainless Steel | Stainless Steel |
| | Hub | Polypropylene or
Polypropylene +
Colorant (Introducer
Needle only) | Polycarbonate |
| | Adhesive | N/A | Epoxy resin |
| Stylet
materials | Wire | Stainless Steel | Stainless Steel |
| | Handle | Polypropylene + | Polycarbonate |
| (Spinal
Needles
only) | | Colorant | |
| Shield
Material | Shield | Polypropylene +
Colorant | Not specified |
| Hub Design | | Female
ISO 80369-6
connector | Female
ISO 80369-6
connector |
| Sterilization Method | | For Sterile products:
Ethylene Oxide (EO).
Validated according
to Overkill approach
per ISO 11135-
1:2014/Amd. 1:2018 | For Sterile products:
Ethylene Oxide (EO).
Validated according
to Overkill approach
per ISO 11135-1
(version not
specified) |
| SAL | | 10-6 | 10-6 |
| Shelf Life | | 5 Years | 5 Years |
| Needle Point | | BD® Quincke Spinal
NRFit™ Needle:
Quincke | Quincke NRFit
Lumbar Puncture
Needles:
Quincke |
| | | BD® Whitacre Spinal
NRFit™ Needle:
Whitacre | SPROTTE NRFit
Lumbar Puncture
Needles:
Sprotte |
| | | BD® Spinal
Introducer NRFit™
Needle:
Quincke | Introducer Needles:
Not specified |
| Needle Gauge | | BD® Quincke Spinal
NRFit™ Needle:
18G – 27G | Quincke NRFit
Lumbar Puncture
Needles:
20G – 27G |
| | | BD® Whitacre Spinal
NRFit™ Needle:
22G - 27G | SPROTTE NRFit
Lumbar Puncture
Needles:
18G - 29G |
| | | BD® Spinal
Introducer NRFit™
Needle:
18G - 20G | Introducer Needles:
Not specified |
| Needle Length | | BD® Quincke Spinal
NRFit™ Needle:
1.5" - 7" | Quincke NRFit
Lumbar Puncture
Needles:
50mm – 120mm
(1.97" - 4.72") |
| | BD® Whitacre Spinal
NRFit™ Needle:
3.5" – 5" | SPROTTE NRFit
Lumbar Puncture
Needles:
50mm – 150mm
(1.97″ – 5.91") | |
| | BD® Spinal
Introducer NRFit™
Needle:
1.25" | Introducer Needles:
Not specified | |
| Functional Testing: | | | |
| Fluid leakage by
Pressure Decay | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Subatmospheric
pressure air leakage | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Stress cracking | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Resistance to
separation from axial
load | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Resistance to
separation from
unscrewing | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Resistance to
overriding | Per ISO 80369-
6:2016 | Per ISO 80369-
6:2016 | |
| Stylet Pull Force | Per internal
requirements | Not specified | |
| Handle/Hub
Separation Force | Per internal
requirements | Not specified | |
| Needle Shield/Hub
Separation Force | Per internal
requirements | Not specified | |
| Cannula Pull Force
(Bond between hub
and needle) | Per ISO 7864:2016 | Per ISO 7864:2016 | |
| Cannula
Deflection/Stiffness | ISO 9626:2001 | ISO 9626:2016 | |
| Cannula Breakage | ISO 9626:2001 | ISO 9626:2016 | |
| Biocompatibility Testing:
Testing per ISO 10993-1:2018: | | | |
| Cytotoxicity | Per ISO 10993-
5:2009, Non- | Per ISO 10993-5,
Non-cytotoxic | |
| | | | |
| | cytotoxic | | |
| Sensitization | Per ISO 10993-
10:2010, Non-
sensitizer | Per ISO 10993-10,
Non-sensitizer | |
| | | | |
| | | | |
| Intracutaneous
Reactivity | Per ISO 10993-
10:2010, Non-irritant | Per ISO 10993-10,
Non-irritant | |
| | | | |
| | | | |
| Acute Systemic
Toxicity | Per ISO 10993-
11:2017, Non-toxic | Per ISO 10993-11,
Non-toxic | |
| | | | |
| | | | |
| Material-Mediated
Pyrogenicity | Per ISO 10993-
11:2017 and
USP, Non-
pyrogenic | Not specified | |
| | | | |
| | | | |
| | | | |
| Chemical
Characterization | Per ISO 10993-
18:2005, acceptable
extractables/leachabl
es profile | Not specified | |
| | | | |
| | | | |
| | | | |
| Additional Testing : | | | |
| Hemolysis | Per ISO 10993-
4:2017, Non-
hemolytic | Per ISO 10993-4,
Non-hemolytic | |
| | | | |
| | | | |
| LAL Endotoxin | Per USP,
2.15 EU/device | Not specified | |
| | | | |
| | | | |
| Particulate Matter | Per USP , Met
limits | Not specified | |
| | | | |
| | | | |
| Neurotoxicity
Assessment | No signs of systemic
toxicity or
neurological
impairment from
exposure of leachable
compounds from the
test article | Not specified | |

5

6

Technological

Characteristics

7

8

9

The indications for use for the subject BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are the same as that of the predicate devices, with the exception of additional discography use which is included for the predicate device. This difference does not impact the determination of substantial equivalence as the subject device's indications for use still fall within in the indications for use for the predicate device.

The indications for use for the subject BD® Spinal Introducer NRFit™ Needle has been specified above as intended for placement or introduction of spinal needles. While the predicate device does not specify this specific indications for use, the usage spinal needles as an introducer is a well-established clinical practice, and is typically associated with the needle gauge size. Both the subject and predicate device are available in the same size ranges. Furthermore, the introducer is still being used to enter the spinal cavity utilizing a mode of action that is identical to the predicate device. As such, all

10

performance testing conducted for these products remained the same. Given this, the difference does not impact the determination of substantial equivalence since the BD® Spinal Introducer NRFit™ Needle.

The differences in some of the component materials mentioned above do not impact the determination of substantial equivalence since biocompatibility testing was conducted on the entire device and individual components as applicable per ISO 10993-1:2018.

The differences in some of the technological characteristics mentioned above do not impact the determination of substantial equivalence since the same performance tests were conducted as the predicate device.

| Performance Tests | BD has performed the following non-clinical/design verification
testing/analysis and the results of these tests/analysis
demonstrate that the BD® Quincke Spinal NRFit™ Needle,
BD® Whitacre Spinal NRFit™ Needle and BD® Spinal
Introducer NRFit™ Needle performed in an equivalent manner
to the predicate device. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Per ISO 80369-6:
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:
Stylet Pull Force

Handle/Hub Separation Force

Needle Shield/Hub Separation Force
● |
| | Per ISO 7864:
Cannula Pull Force (Bond between hub and needle) |
| | Per ISO 9626:
Cannula Deflection/Stiffness

Cannula Breakage
● |
| | A biocompatibility evaluation was conducted on the subject
device per ISO 10993-1:2018. Based on the evaluation, the
following biological tests were conducted: |
| | Cytotoxicity

Sensitization

Intracutaneous Reactivity

Acute Systemic Toxicity

Material-Mediated Pyrogenicity
● |
| | • Chemical Characterization |
| | Additionally, the following tests were performed:
• Hemolysis
• LAL Endotoxin
• Particulate Matter
• Neurotoxicity Assessment |
| | 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® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal
NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle are
substantially equivalent to the predicate devices in intended
use, principles of operation, technology, design, materials and
performance. |

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