(322 days)
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 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.
The provided text describes the 510(k) Premarket Notification for the "BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle". This document outlines the device specifications and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
It's important to note that this 510(k) summary focuses on medical devices (needles), not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria (such as test set provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document. The study described is a series of non-clinical, laboratory-based performance tests and biocompatibility evaluations.
Here's the information extracted from the document that is applicable to the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests and indicates that the subject device "met all predetermined acceptance criteria for the above-listed performance tests." Specific quantitative acceptance criteria or detailed results (e.g., exact measured values) are not provided in this summary; rather, it states that the device successfully met the criteria as per various ISO standards and internal requirements.
| Test Type | Acceptance Criteria (as per standard/requirement) | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Fluid leakage by Pressure Decrease | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Subatmospheric pressure air leakage | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Stress cracking | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to separation from axial load | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to separation from unscrewing | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to overriding | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Stylet Pull Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Handle/Hub Separation Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Needle Shield/Hub Separation Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Pull Force (Bond between hub and needle) | Per ISO 7864:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Deflection/Stiffness | ISO 9626:2001 (for subject device), ISO 9626:2016 (for predicate) | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Breakage | ISO 9626:2001 (for subject device), ISO 9626:2016 (for predicate) | Met criteria (performed in an equivalent manner to predicate device) |
| Biocompatibility Testing | ||
| Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | Non-cytotoxic |
| Sensitization | Per ISO 10993-10:2010, Non-sensitizer | Non-sensitizer |
| Intracutaneous Reactivity | Per ISO 10993-10:2010, Non-irritant | Non-irritant |
| Acute Systemic Toxicity | Per ISO 10993-11:2017, Non-toxic | Non-toxic |
| Material-Mediated Pyrogenicity | Per ISO 10993-11:2017 and USP<151>, Non-pyrogenic | Non-pyrogenic |
| Chemical Characterization | Per ISO 10993-18:2005, acceptable extractables/leachables profile | Acceptable extractables/leachables profile |
| Additional Testing | ||
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Non-hemolytic |
| LAL Endotoxin | Per USP<85>, 2.15 EU/device | Met limits (2.15 EU/device) |
| Particulate Matter | Per USP <788>, Met limits | Met limits |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article | No signs of systemic toxicity or neurological impairment |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in terms of exact numbers of devices tested for each criterion. The document refers to testing "Per ISO" standards, which would define the sample sizes required for compliance.
- Data Provenance: The testing was non-clinical (laboratory testing) and conducted by Becton, Dickinson and Company. No geographic origin or retrospective/prospective nature is specified as it's not applicable to materials and performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to the testing for these medical devices. Ground truth, in this context, is established by adherence to recognized international standards (ISO, USP) for physical and biocompatibility properties, not by expert human interpretation of data like in AI/ML studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept is not applicable. The testing involves objective physical and chemical measurements against predetermined pass/fail criteria established by international standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This document is for physical medical devices (needles), not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document is for physical medical devices (needles), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests relies on established international standards (ISO, USP) for physical properties (e.g., fluid leakage, tensile strength) and biological responses (e.g., cytotoxicity, hemocompatibility). For example, "Non-cytotoxic" per ISO 10993-5 is the ground truth.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.
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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.
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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
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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."
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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."
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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 | |
|---|---|
| ----------------------------------------- | -- |
| SubmitterInformation | Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Fax Number:Date of Preparation: | Becton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Murtaza RanaStaff Regulatory Affairs SpecialistMurtaza.rana@bd.com(201) 847-6980(201) 847-5307September 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™ NeedleAnesthesia Conduction Needle21 CFR §868.5150Anesthesia Conduction NeedleClass II deviceBSP (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 needlesK160294Anesthesia Conduction Needle21 CFR §868.5150Anesthesia Conduction NeedleClass II deviceBSP (Needle, Conduction, anesthetic(W/Wo Introducer))Anesthesiology | |
| Reason forSubmission | The purpose of this submission is to introduce an array ofspinal and spinal introducer needles which comply with theISO 80369-6:2016 standard entitled Small-bore connectors forliquids and gases in healthcare applications - Part 6:Connectors for neuraxial applications. The connectorsspecified 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® SpinalIntroducer NRFit™ Needle. | ||
| Device Description | The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre SpinalNRFit™ Needle and BD® Spinal Introducer NRFit™ Needle aresingle use, sterile needles which incorporate an ISO 80369-6compliant 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 steelcannula, a translucent, polypropylene hub and a polypropyleneshield. The cannula is bonded to the hub at one end and thereis a specific needle point (Quincke or Whitacre) at the otherend. The BD® Spinal Introducer NRFit™ Needle is onlyavailable with a Quincke needle point. The BD® QuinckeSpinal NRFit™ Needle and BD® Whitacre Spinal NRFit™Needle also contain a stylet and are available in various needlelengths. The stylet consists of a solid, stainless steel wirebonded to a polypropylene handle. All three needles areavailable in various gauges. | |||
| The needle hubs for all three needles are ISO 80369-6compliant connectors. The needle shields are yellow toindicate that the device is intended to only connect to ISO80369-6 compatible devices. The stylet handle for the BD®Quincke Spinal NRFit™ Needle and BD® Whitacre SpinalNRFit™ Needle and the needle hub of the BD® SpinalIntroducer NRFit™ Needles are color coded and correlate tothe gauge size per ISO 6009:2016. | |||
| Indications for Use | The BD® Quincke Spinal NRFit™ Needle and BD® WhitacreSpinal NRFit™ Needle 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 devices are intended for adult and pediatric patients. | ||
| The BD® Spinal Introducer NRFit™ Needle is intended forplacement or introduction of spinal needles.This device is intended for adult and pediatric patients. | |||
| Element ofComparison | Subject Device | Predicate Device | |
| Indications for Use | The BD® QuinckeSpinal NRFit™ Needleand BD® WhitacreSpinal NRFit™ Needleare intended to gainentry into orpuncture the spinalcavity permittinginjection (includinganesthesia) /withdrawal of fluidsfor purposes ofdiagnostic lumbarpuncture andmyelographyprocedures.These devices areintended for adultand pediatricpatients.The BD® SpinalIntroducer NRFit™Needle is intendedfor placement orintroduction of spinalneedles.This device isintended for adultand pediatricpatients. | The SPROTTE®NRFit™, QuinckeNRFit™ lumbarpuncture needles areintended to gainentry into orpuncture the spinalcavity permittinginjection (includinganesthesia) /withdrawal of fluidsfor purposes ofdiagnostic lumbarpuncture,myelography/discographyprocedures.The device isintended for adultand pediatricpatients. | |
| Needlematerials | Cannula | Stainless Steel | Stainless Steel |
| Hub | Polypropylene orPolypropylene +Colorant (IntroducerNeedle only) | Polycarbonate | |
| Adhesive | N/A | Epoxy resin | |
| Styletmaterials | Wire | Stainless Steel | Stainless Steel |
| Handle | Polypropylene + | Polycarbonate | |
| (SpinalNeedlesonly) | Colorant | ||
| ShieldMaterial | Shield | Polypropylene +Colorant | Not specified |
| Hub Design | FemaleISO 80369-6connector | FemaleISO 80369-6connector | |
| Sterilization Method | For Sterile products:Ethylene Oxide (EO).Validated accordingto Overkill approachper ISO 11135-1:2014/Amd. 1:2018 | For Sterile products:Ethylene Oxide (EO).Validated accordingto Overkill approachper ISO 11135-1(version notspecified) | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years | |
| Needle Point | BD® Quincke SpinalNRFit™ Needle:Quincke | Quincke NRFitLumbar PunctureNeedles:Quincke | |
| BD® Whitacre SpinalNRFit™ Needle:Whitacre | SPROTTE NRFitLumbar PunctureNeedles:Sprotte | ||
| BD® SpinalIntroducer NRFit™Needle:Quincke | Introducer Needles:Not specified | ||
| Needle Gauge | BD® Quincke SpinalNRFit™ Needle:18G – 27G | Quincke NRFitLumbar PunctureNeedles:20G – 27G | |
| BD® Whitacre SpinalNRFit™ Needle:22G - 27G | SPROTTE NRFitLumbar PunctureNeedles:18G - 29G | ||
| BD® SpinalIntroducer NRFit™Needle:18G - 20G | Introducer Needles:Not specified | ||
| Needle Length | BD® Quincke SpinalNRFit™ Needle:1.5" - 7" | Quincke NRFitLumbar PunctureNeedles:50mm – 120mm(1.97" - 4.72") | |
| BD® Whitacre SpinalNRFit™ Needle:3.5" – 5" | SPROTTE NRFitLumbar PunctureNeedles:50mm – 150mm(1.97″ – 5.91") | ||
| BD® SpinalIntroducer NRFit™Needle:1.25" | Introducer Needles:Not specified | ||
| Functional Testing: | |||
| Fluid leakage byPressure Decay | Per ISO 80369-6:2016 | Per ISO 80369-6:2016 | |
| Subatmosphericpressure 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 toseparation from axialload | Per ISO 80369-6:2016 | Per ISO 80369-6:2016 | |
| Resistance toseparation fromunscrewing | Per ISO 80369-6:2016 | Per ISO 80369-6:2016 | |
| Resistance tooverriding | Per ISO 80369-6:2016 | Per ISO 80369-6:2016 | |
| Stylet Pull Force | Per internalrequirements | Not specified | |
| Handle/HubSeparation Force | Per internalrequirements | Not specified | |
| Needle Shield/HubSeparation Force | Per internalrequirements | Not specified | |
| Cannula Pull Force(Bond between huband needle) | Per ISO 7864:2016 | Per ISO 7864:2016 | |
| CannulaDeflection/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 | |
| IntracutaneousReactivity | Per ISO 10993-10:2010, Non-irritant | Per ISO 10993-10,Non-irritant | |
| Acute SystemicToxicity | Per ISO 10993-11:2017, Non-toxic | Per ISO 10993-11,Non-toxic | |
| Material-MediatedPyrogenicity | Per ISO 10993-11:2017 andUSP<151>, Non-pyrogenic | Not specified | |
| ChemicalCharacterization | Per ISO 10993-18:2005, acceptableextractables/leachables profile | Not specified | |
| 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 orneurologicalimpairment fromexposure of leachablecompounds from thetest article | Not specified |
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Technological
Characteristics
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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
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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 verificationtesting/analysis and the results of these tests/analysisdemonstrate that the BD® Quincke Spinal NRFit™ Needle,BD® Whitacre Spinal NRFit™ Needle and BD® SpinalIntroducer NRFit™ Needle performed in an equivalent mannerto the predicate device. |
|---|---|
| Per ISO 80369-6:Fluid leakage by Pressure Decay●Subatmospheric pressure air leakageStress 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 subjectdevice per ISO 10993-1:2018. Based on the evaluation, thefollowing 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 criteriafor the above-listed performance tests, demonstratingsubstantial equivalence to the predicate device. | |
| Clinical Testing | Clinical testing was not required for this submission |
| Summary ofSubstantialEquivalence | The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre SpinalNRFit™ Needle and BD® Spinal Introducer NRFit™ Needle aresubstantially equivalent to the predicate devices in intendeduse, principles of operation, technology, design, materials andperformance. |
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§ 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).