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

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

Who can help prepare an FDA 510(k) submission like BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer 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.

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

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

Becton, Dickinson and Company filed the 510(k) submission for BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978).

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

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

K210978 · Becton, Dickinson and Company · BSP · Dec 22, 2021 · Anesthesiology

Device Facts

Record ID	K210978
Device Name	BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
Applicant	Becton, Dickinson and Company
Product Code	BSP · Anesthesiology
Decision Date	Dec 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures. This device is intended for adult and pediatric patients. The BD™ Spinal Introducer Needle is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients.

Device Story

BD Spinal Needles (Quincke and Whitacre points) and Spinal Introducer Needles are sterile, single-use devices used to access the spinal cavity. The needles consist of a stainless steel cannula bonded to a polypropylene hub; the stylet features a color-coded polypropylene handle. The introducer acts as a guide for spinal needle insertion. Used in clinical settings by healthcare professionals for diagnostic lumbar puncture, myelography, or regional anesthesia delivery. The device facilitates fluid withdrawal or anesthetic injection, directly impacting clinical management of anesthesia or diagnostic procedures. Benefits include reliable spinal access and compatibility with standard ISO 594 connectors.

Clinical Evidence

Bench testing only. No clinical data was required. Performance was verified through mechanical testing (ISO 594, ISO 7864) and biocompatibility testing (ISO 10993-1:2018), including cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemolysis, and neurotoxicity assessment.

Technological Characteristics

Materials: Stainless steel cannula, polypropylene hub/shield, epoxy/insert molded adhesive. Design: ISO 594-1/2 compliant connectors. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Configurations: Various gauges (18G-27G) and lengths (1.25"-7").

Indications for Use

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

BD Spinal Needle (K091758)

Reference Devices

BD® Quincke Spinal NRFit™ Needle (K193131)
BD® Whitacre Spinal NRFit™ Needle (K193131)
BD® Spinal Introducer NRFit™ Needle (K193131)

Related Devices

K193131 — BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle · Becton, Dickinson and Company · Sep 29, 2020
K160294 — SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles · PAJUNK GmbH Medizintechnologie · Oct 21, 2016
K170112 — IMD's Lumbar Puncture Needle · International Medical Development, Inc.(Imd) · Feb 2, 2018
K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle · Global Medikit Limited · Jul 29, 2022
K091758 — BD SPINAL NEEDLE 27G · Becton Dickson & Co. · Oct 9, 2009

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 22, 2021 Becton, Dickinson and Company Nikita Mahendra Kumar Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K210978 Trade/Device Name: BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: November 18, 2021 Received: November 19, 2021 Dear Nikita Mahendra Kumar: We have reviewed vour 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 {1}------------------------------------------------ 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 Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210978 Device Name BD™ Quincke Spinal Needle and BD™ Whitacre Spinal Needle Indications for Use (Describe) The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures. 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) Device Name BD™ Spinal Introducer Needle #### Indications for Use (Describe) The BD™ Spinal Introducer 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized orange sunburst symbol on the left and the letters "BD" in blue on the right. The sunburst symbol is a circle with several triangular rays emanating from the center. The letters "BD" are in a bold, sans-serif font. ## 510(k) Summary (21 CFR §868.5150) # BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal | Submitter Information | Submitter Name: | Becton, Dickinson and Company | |--------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------| | | Submitter Address: | 1 Becton Drive Franklin Lakes, NJ 07417 | | | Contact Person: | Nikita Abirami Mahendra Kumar Senior Regulatory Affairs Specialist | | | Email Address: | Nikita.Abirami.Mahendra.Kumar@bd.com | | | Phone Number: | (201) 847-5641 | | | Date of Preparation: | November 11, 2020 | | Subject Device | Trade Name: | BD™ Quincke Spinal Needle BD™ Whitacre Spinal Needle BD™ Spinal Introducer Needle | | | Common Name: | Anesthesia Conduction Needle | | | Regulation Number: | 21 CFR 868.5150 | | | Regulation Name: | Anesthesia Conduction Needle | | | Regulatory Class: | Class II device | | | Product Code: | BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) | | | Classification Panel: | Anesthesiology | | Predicate Device | Trade Name: | BD Spinal Needle | | | 510(k) Reference: | K091758 | | | Common Name: | Spinal Needle | | | Regulation Number: | 21 CFR 868.5150 | | | Regulation Name: | Anesthesia Conduction Needle | | | Regulatory Class: | Class II Device | | | Product Code: | BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) | | | Classification Panel: | Anesthesiology | | Reference Device | Trade Name: | BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle, BD® Spinal Introducer NRFit™ Needle | | | 510(k) Reference: | K193131 | | | Common Name: | Anesthesia Conduction Needle | | | Regulation Number: | 21 CFR 868.5150 | | | Regulation Name: | Anesthesia Conduction Needle | | | Regulatory Class: | Class II Device | | | Product Code: | BSP (Needle, Conduction, anesthetic (w/wo Introducer)) | | | Classification Panel: | Anesthesiology | ## Introducer Needle {5}------------------------------------------------ | Reason for Submission | BD received 510(k) premarket notification clearance for the 27G BD Spinal Needle with Quincke Type-point in 2009 per K091758. | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | This 510(k) submission also includes the BDTM Whitacre Spinal Needle and the BDTM Spinal Introducer Needle. The intent of this 510(k) submission is to establish a new 510(k) baseline for these two devices. | | Device Description | The BD Quincke Spinal Needle, BD Whitacre Spinal Needle are available in various gauges and needle lengths. The needle consists of a hollow needle (cannula) bonded to a clear hub at one end and a specific needle-point type (Quincke or Whitacre) at the other end. The stylet has a handle, which is color-coded and correlates to the gauge size. | | | The BD Spinal Needle Introducer consists of a needle, needle hub and needle shield and is available in various gauges. The needle consists of a hollow needle (cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle-point type at the other end. The introducer needle is optional aid through which a spinal needle can be inserted. | | | The BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer devices are single use, sterile needles which, incorporate the ISO 594-1 and ISO 594-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use). | | Indications for Use | The BDTM Spinal 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 and myelography procedures. These devices are intended for adult and pediatric patients. | | | The BDTM Spinal Introducer Needle is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients | | Technological Characteristics | The subject devices are equivalent to the predicate devices in materials, principles of operation, design and performance characteristics. The subject devices are similar to the predicate devices in their intended use. | {6}------------------------------------------------ | Element of Comparison | Subject Devices (K210978) | Predicate Devices: BD Spinal Needles (K091758) | | | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------| | Indications for Use | The BD™ Quincke Spinal Needles and BD Whitacre Spinal 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 and myelography procedures. This device is intended for adult and pediatric patients. The BD™ Spinal Needle Introducer is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients. | An anesthesia conduction needle is a device used to inject local anesthetics into a patient population to provide regional anesthesia. | | | | Needle materials | Cannula Hub | Stainless Steel Polypropylene | Stainless Steel Polypropylene | | | | Adhesive (Spinal Needles only) | Epoxy/Insert Molded | Epoxy/Insert Molded | | | Stylet materials (Spinal Needles only) | Wire | Stainless Steel | Stainless Steel | | | | Handle | Polypropylene + Colorant | Polypropylene | | | Shield Material | Shield | Polypropylene | Polypropylene | | | Hub Design | | ISO 594 | ISO 594 | | | Sterilization Method | | For Sterile products: Ethylene Oxide (EO) | Ethylene Oxide (EO) | | | SAL | 10-6 | 10-6 | | | | Shelf Life | 5 Years | 5 Years | | | | Needle Point | BD Quincke Spinal Needle: Quincke | BD Spinal Needle: Quincke | | | | | BD Whitacre Spinal Needle: Whitacre | N/A | | | | | BD Spinal Introducer Needle: Quincke | N/A | | | | Needle Gauge | BD Quincke Spinal Needle: 18G, 20G, 22G, 23G, 25G, 26G, 27G | BD Spinal Needle: 27G | | | | | BD Whitacre Spinal Needle: 22G, 24G, 25G, 27G | N/A | | | | | BD Spinal Needle Introducer: 20G | N/A | | | | Needle Length | BD Quincke Spinal Needle: 1.5″ – 7″ | BD Spinal Needle: 3.5″, 4-11/16″ | | | | | BD Whitacre Spinal Needle: 3.5″ – 5″ | N/A | | | | | BD Spinal Introducer NRFit™ Needle: 1.25" | N/A | | | | Functional Testing: | | | | | | Fluid leakage by Pressure Decay | Per ISO 594 | Per ISO 594 | | | | Subatmospheric pressure air leakage | Per ISO 594 | Per ISO 594 | | | | Stress cracking | Per ISO 594 | Per ISO 594 | | | | Resistance to separation from axial load | Per ISO 594 | Per ISO 594 | | | | Resistance to separation from unscrewing | Per ISO 594 | Per ISO 594 | | | | Resistance to overriding | Per ISO 594 | Per ISO 594 | | | | Stylet Pull Force | Per internal requirements Quincke Needle | Per internal requirements Quincke Needle | | | | | Gauge | Force (lbf) | Gauge | Force (lbf) | | | 18G | ≥ 8 | 18G | ≥ 8 | | | 20G | ≥ 5 | 20G | ≥ 5 | | | 22G | ≥ 5 | 22G | ≥ 5 | | | 23G | ≥ 5 | 23G | ≥ 5 | | | 25G | ≥ 3.5 | 25G | ≥ 3.5 | | | 26G | ≥ 3.5 | 26G | ≥ 3.5 | | | 27G | ≥ 3.5 | 27G | ≥ 3.5 | | | Whitacre Needle | | Whitacre Needle | | | | Gauge | Force (lbf) | Gauge | Force (lbf) | | | 22G | ≥ 5 | 22G | ≥ 5 | | | 24G | ≥ 5 | 24G | ≥ 5 | | | 25G | ≥ 5 | 25G | ≥ 5 | | | 27G | ≥ 5 | 27G | ≥ 5 | | Handle/Hub Separation Force | Per internal requirements (Handle must not disengage when held upside down) | | Per internal requirements (Handle must not disengage when held upside down) | | | Needle Shield/Hub Separation Force | Per internal requirements (Needle shield must not disengage from hub when held upside down) | | Per internal requirements (Needle shield must not disengage from hub when held upside down) | | | Cannula Pull Force (Bond between hub and needle) | Per ISO 7864:2016 | | Per ISO 7864:2016 | | | Biocompatibility Testing: | | | | | | Testing per ISO 10993-1:2018: | | | | | | Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | | Per ISO 10993-5, Non- 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<151>, Non- pyrogenic | | Per ISO 10993-11:2017 and USP<151>, Non- pyrogenic | | | Chemical Characterization | Per ISO 10993- 18:2005, acceptable extractables/leachables | | Per ISO 10993-18:2005, acceptable extractables/leachables | | {7}------------------------------------------------ Confidential & Proprietary {8}------------------------------------------------ K210978 {9}------------------------------------------------ | | profile | profile | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | Additional Testing: | | | | Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Per ISO 10993-4, Non- hemolytic | | LAL Endotoxin | Per USP<85>, 2.15 EU/device | Not specified | | Particulate Matter | Per USP <788>, 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 | | 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 Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer performed in an equivalent manner to the predicate devices. Per ISO 594 • 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) BD has performed the following Material Biocompatibility Performance testing on the BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle that was cleared under K193131. The same testing is being leveraged for this submission, as the materials of the subject device are identical to that of the BD® Spinal NRFit Needles. Per ISO 10993-1:2018: | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {10}------------------------------------------------ | 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 continue to meet all the 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 BDTM Quincke Spinal Needle, BDTM Whitacre Spinal Needle and BDTM Spinal Introducer Needle are equivalent to the predicate devices in materials, principles of operation, design and performance characteristics. The subject devices are similar to the predicate devices in their intended use. |