(265 days)
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.
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).
The document is a 510(k) summary for the BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Testing (All per ISO 594 unless specified) | |
| Fluid leakage by Pressure Decay | Met ISO 594 requirements |
| Subatmospheric pressure air leakage | Met ISO 594 requirements |
| Stress cracking | Met ISO 594 requirements |
| Resistance to separation from axial load | Met ISO 594 requirements |
| Resistance to separation from unscrewing | Met ISO 594 requirements |
| Resistance to overriding | Met ISO 594 requirements |
| Stylet Pull Force (per BD internal requirements) | |
| - Quincke Needle 18G | ≥ 8 lbf |
| - Quincke Needle 20G | ≥ 5 lbf |
| - Quincke Needle 22G | ≥ 5 lbf |
| - Quincke Needle 23G | ≥ 5 lbf |
| - Quincke Needle 25G | ≥ 3.5 lbf |
| - Quincke Needle 26G | ≥ 3.5 lbf |
| - Quincke Needle 27G | ≥ 3.5 lbf |
| - Whitacre Needle 22G | ≥ 5 lbf |
| - Whitacre Needle 24G | ≥ 5 lbf |
| - Whitacre Needle 25G | ≥ 5 lbf |
| - Whitacre Needle 27G | ≥ 5 lbf |
| Handle/Hub Separation Force (per BD internal requirements) | Handle must not disengage when held upside down (Met requirements) |
| Needle Shield/Hub Separation Force (per BD internal requirements) | Needle shield must not disengage from hub when held upside down (Met requirements) |
| Cannula Pull Force (Bond between hub and needle) | Met ISO 7864:2016 requirements |
| Biocompatibility Testing (All per ISO 10993-1:2018 unless specified) | |
| Cytotoxicity | Non-cytotoxic (Per ISO 10993-5:2009) |
| Sensitization | Non-sensitizer (Per ISO 10993-10:2010) |
| Intracutaneous Reactivity | Non-irritant (Per ISO 10993-10:2010) |
| Acute Systemic Toxicity | Non-toxic (Per ISO 10993-11:2017) |
| Material-Mediated Pyrogenicity | Non-pyrogenic (Per ISO 10993-11:2017 and USP<151>) |
| Chemical Characterization | Acceptable extractables/leachables profile (Per ISO 10993-18:2005) |
| Additional Testing | |
| Hemolysis | Non-hemolytic (Per ISO 10993-4:2017) |
| LAL Endotoxin | 2.15 EU/device (Per USP<85>, met limits) |
| Particulate Matter | Met limits (Per USP <788>) |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the functional and biocompatibility tests. It indicates that the tests were performed according to specified ISO standards and internal requirements. Data provenance is not specified beyond the fact that these are non-clinical/design verification tests performed by BD. There is no indication of country of origin for any data or whether it is retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The tests performed are engineering and biocompatibility evaluations of physical device properties, not assessments requiring expert interpretation of clinical data in the same way an AI/ML device would.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for conventional medical devices (needles), not an AI-assisted device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria in this submission is based on established engineering standards (e.g., ISO 594, ISO 7864, ISO 10993, USP) and internal company requirements for device functionality and safety. The performance is measured against these objective, predefined criteria rather than a subjective "ground truth" established by experts or clinical outcomes in the context of diagnostic accuracy.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device, therefore, there is no training set.
9. How Ground Truth for Training Set Was Established
Not applicable. There is no training set.
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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
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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
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Indications for Use
510(k) Number (if known)
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.
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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:
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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."
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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
| SubmitterInformation | Submitter Name: | Becton, Dickinson and Company |
|---|---|---|
| Submitter Address: | 1 Becton DriveFranklin Lakes, NJ 07417 | |
| Contact Person: | Nikita Abirami Mahendra KumarSenior 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 NeedleBD™ Whitacre Spinal NeedleBD™ 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
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| Reason for Submission | BD received 510(k) premarket notification clearance for the 27GBD Spinal Needle with Quincke Type-point in 2009 per K091758. |
|---|---|
| This 510(k) submission also includes the BDTM Whitacre SpinalNeedle and the BDTM Spinal Introducer Needle. The intent of this510(k) submission is to establish a new 510(k) baseline forthese two devices. | |
| Device Description | The BD Quincke Spinal Needle, BD Whitacre Spinal Needle areavailable in various gauges and needle lengths. The needleconsists of a hollow needle (cannula) bonded to a clear hub atone end and a specific needle-point type (Quincke or Whitacre)at the other end. The stylet has a handle, which is color-codedand correlates to the gauge size. |
| The BD Spinal Needle Introducer consists of a needle, needlehub and needle shield and is available in various gauges. Theneedle consists of a hollow needle (cannula) bonded to atranslucent colored hub (per gauge) at one end and a specificneedle-point type at the other end. The introducer needle isoptional aid through which a spinal needle can be inserted. | |
| The BD Quincke Spinal Needle, BD Whitacre Spinal Needle andBD Spinal Needle Introducer devices are single use, sterileneedles which, incorporate the ISO 594-1 and ISO 594-2compliant 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 orpuncture the spinal cavity permitting injection (includinganesthesia) / withdrawal of fluids for purposes of diagnosticlumbar puncture and myelography procedures. These devicesare intended for adult and pediatric patients. |
| The BDTM Spinal Introducer Needle is intended for placementor introduction of spinal needles. This device is intended foradult and pediatric patients | |
| Technological Characteristics | The subject devices are equivalent to the predicate devices inmaterials, principles of operation, design and performancecharacteristics. The subject devices are similar to the predicatedevices in their intended use. |
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| 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 SteelPolypropylene | Stainless SteelPolypropylene | |
| 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 SpinalNeedle:Quincke | BD Spinal Needle:Quincke | ||
| BD Whitacre SpinalNeedle:Whitacre | N/A | |||
| BD Spinal IntroducerNeedle:Quincke | N/A | |||
| Needle Gauge | BD Quincke SpinalNeedle:18G, 20G, 22G, 23G,25G, 26G, 27G | BD Spinal Needle:27G | ||
| BD Whitacre SpinalNeedle:22G, 24G, 25G, 27G | N/A | |||
| BD Spinal NeedleIntroducer:20G | N/A | |||
| Needle Length | BD Quincke SpinalNeedle:1.5″ – 7″ | BD Spinal Needle:3.5″, 4-11/16″ | ||
| BD Whitacre SpinalNeedle:3.5″ – 5″ | N/A | |||
| BD Spinal IntroducerNRFit™ Needle:1.25" | N/A | |||
| Functional Testing: | ||||
| Fluid leakage by PressureDecay | Per ISO 594 | Per ISO 594 | ||
| Subatmospheric pressureair leakage | Per ISO 594 | Per ISO 594 | ||
| Stress cracking | Per ISO 594 | Per ISO 594 | ||
| Resistance to separationfrom axial load | Per ISO 594 | Per ISO 594 | ||
| Resistance to separationfrom unscrewing | Per ISO 594 | Per ISO 594 | ||
| Resistance to overriding | Per ISO 594 | Per ISO 594 | ||
| Stylet Pull Force | Per internalrequirementsQuincke Needle | Per internalrequirementsQuincke 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 SeparationForce | Per internalrequirements(Handle must notdisengage when heldupside down) | Per internalrequirements(Handle must notdisengage when heldupside down) | ||
| Needle Shield/HubSeparation Force | Per internalrequirements(Needle shield must notdisengage from hubwhen held upsidedown) | Per internalrequirements(Needle shield must notdisengage from hubwhen held upside down) | ||
| Cannula Pull Force (Bondbetween 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-MediatedPyrogenicity | Per ISO 10993-11:2017and USP<151>, Non-pyrogenic | Per ISO 10993-11:2017and USP<151>, Non-pyrogenic | ||
| Chemical Characterization | Per ISO 10993-18:2005, acceptableextractables/leachables | Per ISO 10993-18:2005,acceptableextractables/leachables |
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Confidential & Proprietary
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| 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>, Metlimits | Not specified |
| NeurotoxicityAssessment | No signs of systemictoxicity or neurologicalimpairment fromexposure of leachablecompounds from thetest article. | Not specified |
| Performance Tests | BD has performed the following non-clinical/design verificationtesting/analysis and the results of these tests/analysisdemonstrate that the BD Quincke Spinal Needle, BD WhitacreSpinal Needle and BD Spinal Needle Introducer performed in anequivalent 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 overridingPer BD internal requirements:• Stylet Pull Force• Handle/Hub Separation Force• Needle Shield/Hub Separation ForcePer ISO 7864:• Cannula Pull Force (Bond between hub and needle)BD has performed the following Material BiocompatibilityPerformance testing on the BD® Quincke Spinal NRFit™ Needle,BD® Whitacre Spinal NRFit™ Needle and BD® Spinal IntroducerNRFit™ Needle that was cleared under K193131. The sametesting is being leveraged for this submission, as the materialsof the subject device are identical to that of the BD® SpinalNRFit Needles.Per ISO 10993-1:2018: |
|---|---|
| ------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| 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. |
§ 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).