(265 days)
No
The device description and performance studies focus on the physical characteristics and material biocompatibility of the needles, with no mention of AI or ML.
No
This device is intended for diagnostic and procedural use (injection/withdrawal of fluids), not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic lumbar puncture and myelography procedures."
No
The device description clearly outlines physical components like needles, hubs, and stylets, and the performance studies focus on physical properties and material biocompatibility, indicating it is a hardware device.
Based on the provided text, the BD™ Spinal Needles and BD™ Spinal Introducer Needle are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states the devices are for gaining entry into the spinal cavity for injection or withdrawal of fluids for diagnostic lumbar puncture and myelography procedures. This involves interacting directly with the patient's body to access fluids, not for testing samples in vitro (outside the body).
- Device Description: The description details needles and introducers, which are instruments used for accessing the body, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples, reagents, or diagnostic assays, which are typical characteristics of IVD devices.
- Performance Studies: The performance studies focus on the physical and material properties of the needles (fluid leakage, strength, biocompatibility), not on the accuracy or performance of a diagnostic test.
Therefore, these devices are considered medical devices used for procedures that may facilitate diagnostic testing (by obtaining samples), but they are not IVD devices themselves.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BSP
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal cavity
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
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 was not required for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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)
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
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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, Non- | ||||
pyrogenic | Per ISO 10993-11:2017 | |||
and USP, Non- | ||||
pyrogenic | ||||
Chemical Characterization | Per ISO 10993- | |||
18:2005, acceptable | ||||
extractables/leachables | Per ISO 10993-18:2005, | |||
acceptable | ||||
extractables/leachables |
7
Confidential & Proprietary
8
9
profile | profile | |
---|---|---|
Additional Testing: | ||
Hemolysis | Per ISO 10993-4:2017, | |
Non-hemolytic | Per ISO 10993-4, Non- | |
hemolytic | ||
LAL Endotoxin | Per USP, | |
2.15 EU/device | Not specified | |
Particulate Matter | Per USP , Met | |
limits | Not specified | |
Neurotoxicity | ||
Assessment | No signs of systemic | |
toxicity or neurological | ||
impairment from | ||
exposure of leachable | ||
compounds from the | ||
test article. | Not specified |
| 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. |