BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

Q: Who is the manufacturer of BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle?

Becton, Dickinson and Company filed the 510(k) submission for BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle (K193131).

Q: What is the FDA product code for BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle?

BSP. It is classified under 21 CFR 868.5150 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K193131 · Becton, Dickinson and Company · BSP · Sep 29, 2020 · Anesthesiology

Device Facts

Record ID	K193131
Device Name	BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Applicant	Becton, Dickinson and Company
Product Code	BSP · Anesthesiology
Decision Date	Sep 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Pediatric

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 Story

Single-use, sterile spinal needles and introducer needles; stainless steel cannula bonded to polypropylene hub; includes stylet with polypropylene handle; features ISO 80369-6 compliant NRFit™ connectors to prevent misconnections; yellow needle shields indicate NRFit™ compatibility; color-coded per ISO 6009:2016. Used by clinicians to access spinal cavity for diagnostic or anesthetic procedures. Device provides physical conduit for fluid withdrawal or injection. Benefits include standardized, secure neuraxial connections reducing risk of misconnection errors.

Clinical Evidence

Bench testing only. No clinical data required. Performance verified via ISO 80369-6 (leakage, stress cracking, separation forces), ISO 7864 (cannula pull force), and ISO 9626 (stiffness/breakage). Biocompatibility confirmed per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, neurotoxicity).

Technological Characteristics

Stainless steel cannula; polypropylene hub and shield; solid stainless steel stylet wire with polypropylene handle. ISO 80369-6 compliant neuraxial connectors. Color-coded per ISO 6009:2016. Sterilized via Ethylene Oxide (EO) per ISO 11135-1:2014. Single-use, sterile or non-sterile (to be sterilized).

Indications for Use

Indicated for adult and pediatric patients requiring spinal cavity access for diagnostic lumbar puncture, myelography, or fluid withdrawal/injection (including anesthesia). The introducer needle is indicated for the placement or introduction of spinal needles.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

SPROTTE® NRFit™ and Quincke NRFit™ Lumbar Puncture needles (K160294)

Related Devices

K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors · Smiths Medical Asd, Inc. · Jun 14, 2018
K172823 — Portex NRFit Epidural Needles · Smiths Medical Asd, Inc. · Jun 12, 2018
K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles · Myco Medical Supplies, Inc. · Sep 29, 2021
K160294 — SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles · PAJUNK GmbH Medizintechnologie · Oct 21, 2016
K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle · Becton, Dickinson and Company · Dec 22, 2021

Submission Summary (Full Text)

{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) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with a stylized sunburst design inside, followed by the letters "BD" in blue. The sunburst design has a central circle with rays emanating outwards, and the letters "BD" are in a bold, sans-serif font. ## 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 | | | |…