(445 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the needles, with no mention of AI or ML.
No
The device is a needle used for administering anesthesia or analgesia, which are therapeutic agents, but the needle itself does not provide therapy. It is a delivery device.
No
Explanation: The device, an epidural needle, is used for the administration of anesthesia or to introduce a catheter. Its function is to deliver substances or facilitate procedures, not to diagnose conditions.
No
The device description clearly outlines physical components like needles, cannulas, hubs, and shields, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of anesthesia or analgesia into the epidural space, or to introduce a catheter or spinal needle. This is a direct medical intervention on a patient's body.
- Device Description: The device is a needle designed for physical insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for therapeutic and procedural purposes.
N/A
Intended Use / Indications for Use
BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are single use, sterile needles which incorporate an ISO 594-1/-2 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 over the needle. The cannula is bonded to the hub at one end. The BD Perisafe™ Epidural needles also contain a plastic stylet handle and are available in various needle lengths. The needle hubs are ISO 594-1 and ISO 594-2 compliant connectors. The stylet handle for the BD Perisafe™ Epidural needles is color coded and correlate to the gauge size per ISO 6009:2016.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space, spinal and epidural spaces
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)
The following non-clinical/design verification testing/analysis were performed:
- Fluid leakage by Pressure Decay (Per ISO 594-1 and 594-2)
- Subatmospheric pressure air leakage (Per ISO 594-1 and 594-2)
- Stress cracking (Per ISO 594-1 and 594-2)
- Resistance to separation from axial load (Per ISO 594-1 and 594-2)
- Resistance to separation from unscrewing (Per ISO 594-2)
- Resistance to overriding (Per ISO 594-2)
- Stylet Pull Force (Per internal requirements - Must exhibit material stretch with no separation at stylet/handle junction)
- Handle/Hub Separation Force (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)
- Cannula Pull Force (Bond between hub and needle) (Per ISO 7864:2016)
- Cannula deflection/ Stiffness (Per ISO 9626:2001)
- Cannula breakage (Per ISO 9626:2001)
Biocompatibility Testing (Per ISO 10993-1:2018):
- Cytotoxicity (Per ISO 10993-5:2009, Non-cytotoxic)
- Sensitization (Per ISO 10993-10:2010, Non-sensitizer)
- Intracutaneous Reactivity (Per ISO 10993-10:2010, Non-irritant)
- Acute Systemic Toxicity (Per ISO 10993-11:2017, Non-toxic)
- Material-Mediated Pyrogenicity (Per ISO 10993-11:2017 and USP, Non-pyrogenic)
- Chemical Characterization (Per ISO 10993-18:2005, acceptable extractables/leachables)
Additional Testing:
- Hemolysis (Per ISO 10993-4:2017, Non-hemolytic)
- LAL Endotoxin (Per USP, 2.15 EU/device)
- Particulate Matter (Per USP , Met limits)
- Neurotoxicity Assessment (No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article.)
Results: The results of these tests demonstrate that the BD Perisafe™ Epidural Needles performed in an equivalent manner to the predicate devices and continue to meet all the predetermined acceptance criteria, demonstrating substantial equivalence.
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
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July 1, 2022
Becton, Dickinson and Company Murtaza Rana Sr. Manager, Regulatory Affairs 1 Becton Drive Mc 237 Franklin Lakes, New Jersey 07417
Re: K211085
Trade/Device Name: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 27, 2022 Received: May 31, 2022
Dear Murtaza Rana:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 medical devices and radiation-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) K211085
Device Name
BD Perisafe™ Tuohy Epidural Needle BD Perisafe™ Weiss Epidural Needle
Indications for Use (Describe)
BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.
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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
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510(k) Summary (21 CFR §807.92)
BD Perisafe™ Tuohy Epidural Needle BD Perisafe™ Weiss Epidural Needle
| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Date of Preparation: | Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Murtaza Rana
Senior Regulatory Affairs Manager
murtaza.rana@bd.com
(201) 847-6980
May 27, 2022 | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Perisafe™ Tuohy Epidural Needle
BD Perisafe™ Weiss Epidural Needle
Anesthesia Epidural Needle
21 CFR 868.5150
Anesthesia Conduction Needle
Class II device
BSP (Needle, Conduction, Anesthetic
(W/Wo Introducer))
Anesthesiology | |
| Predicate Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | Epidural Anesthesia Needles, Spinal
Anesthesia Needles, Combined
Anesthesia Needles
K171518
Epidural Anesthesia Needles, Spinal
Anesthesia Needles, Combined
Anesthesia Needles
21 CFR 868.5150
Anesthesia Conduction Needle
Class II Device
BSP (Needle, Conduction, Anesthetic
(W/Wo Introducer))
Anesthesiology | |
| Reason for
Submission | The intent of this 510(k) submission is to establish a new 510(k)
baseline for the BD Perisafe™ Tuohy Epidural Needle and
BD Perisafe™ Weiss Epidural Needle. | | |
| Device Description | BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss
Epidural Needle are single use, sterile needles which incorporate
an ISO 594-1/-2 compliant connector. The needles are also
available in bulk, non-sterile configurations (to be sterilized prior
to use). | | |
4
| | Each type of needle consists of a hollow, stainless steel cannula,
a translucent, polypropylene hub and a polypropylene shield
over the needle. The cannula is bonded to the hub at one end.
The BD Perisafe™ Epidural needles also contain a plastic stylet
handle and are available in various needle lengths.
The needle hubs are ISO 594-1 and ISO 594-2 compliant
connectors. The stylet handle for the BD Perisafe™ Epidural
needles is color coded and correlate to the gauge size per ISO
6009:2016. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™
Weiss Epidural Needle are indicated for the administration of
anesthesia or analgesia into the epidural space, or to introduce
a dedicated catheter for continuous administration of anesthesia
or analgesia into the epidural space. They can also be used to
introduce a spinal needle to perform a combined spinal and
epidural procedure.
These devices are intended for adult and pediatric patients. |
| Technological
Characteristics | The subject devices are equivalent to the predicate devices in
intended use, materials and performance characteristics. |
5
| Element of
Comparison | Subject Device
(BD Perisafe™
Tuohy
Epidural Needle
BD Perisafe™ Weiss
Epidural Needle) | Predicate
Device
(Epidural
Anesthesia
Needles,
Zhejiang kindly
Medical
Devices,
K171518) | Substantial Equivalence |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BD Perisafe™
Tuohy Epidural
Needle and BD
Perisafe™ Weiss
Epidural Needle are
indicated for the
administration of
anesthesia or
analgesia into the
epidural space, or to
introduce a dedicated
catheter for
continuous
administration of
anesthesia or
analgesia into the
epidural space. They
can also be used to
introduce a spinal
needle to perform a
combined spinal and
epidural procedure.
These devices are
intended for adult and
pediatric patients. | The Epidural
Anesthesia
Needles are
intended to be
used for injection
into the epidural
space/or placing
the epidural
catheter into the
epidural space.
The Combined
Anesthesia
Needles are
intended for
injection of local
anesthetics into
the spinal and
epidural spaces of
a patient to
provide regional
anesthesia. The
administration of
the spinal
anesthesia allows
rapid anesthesia
onset and the
placement of an
epidural catheter
allows for bolus
injections or
continuous
infusion of local
anesthetics or
other drugs into
the epidural
space. | Substantially equivalent to
predicate device as both are
intended for administration of
anesthesia in epidural space
and for combined spinal and
epidural procedures. |
| Technological Characteristics | | | |
| Components | Stylet Handle
Stylet
Needle Tube
(Cannula)
Needle Hub
Protective Cap of
Needle (Shield) | Stylet Hub
Stylet
Needle Tube
Needle Hub
Needle Hub
Insert
Protective Cap of
Needle | Substantially equivalent. The
only difference is the absence of
a needle hub insert. This is
because the needle tube
(cannula) is insert molded to the
needle hub for the subject
device. |
| Needle Gauge | 16G - 20G | 14G - 22G | The proposed devices have |
| Needle Length | 50.8mm, 80mm,
88.9mm, 127mm | 65mm, 70mm,
80mm, 90mm,
100mm, 110mm,
120mm, 150mm | different combination of needle
gauge and needle length
compared with the predicate
device. However, the different
device configurations will be
selected by the physician per
patient's condition. Therefore,
this difference is not considered
to affect substantial
equivalence. |
| Needle Tip | Tuohy, Weiss | Tuohy | The Weiss needle tip geometry
is same as the Tuohy needle tip
geometry with the only
difference being the addition of
"wings" to the needle hub to
make it easier to grasp the
needle with both hands for
placement. This difference is
not considered to affect
substantial equivalence. |
| Sterile | EO Sterilized, 10-6 | EO Sterilized, 10-6 | Substantially equivalent. |
| Single Use | Single Use | Single Use | Substantially equivalent. |
| Labeling | Conform with 21 CFR
801 | Conform with 21
CFR 801 | Substantially equivalent. |
6
| Functional Testing: | |||
|---|---|---|---|
| Fluid leakage by Pressure | |||
| Decay | Per ISO 594-1 and 594-2 | Per ISO 594-1 | |
| and 594-2 | Substantially | ||
| equivalent. | |||
| Subatmospheric pressure air | |||
| leakage | Per ISO 594-1 and 594-2 | Per ISO 594-1 | |
| and 594-2 | Substantially | ||
| equivalent. | |||
| Stress cracking | Per ISO 594-1 and 594-2 | Per ISO 594-1 | |
| and 594-2 | Substantially | ||
| equivalent. | |||
| Resistance to separation | |||
| from axial load | Per ISO 594-1 and 594-2 | Per ISO 594-1 | |
| and 594-2 | Substantially | ||
| equivalent. | |||
| Resistance to separation | |||
| from unscrewing | Per ISO 594-2 | Per ISO 594-2 | Substantially |
| equivalent. | |||
| Resistance to overriding | Per ISO 594-2 | Per ISO 594-2 | Substantially |
| equivalent. | |||
| Stylet Pull Force | Per internal requirements | ||
| (Must exhibit material | Not specified | Substantially | |
| equivalent* |
7
| | stretch
with no separation at
stylet/handle junction) | | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------|
| Handle/Hub Separation Force | Per internal requirements
(Handle must not disengage
when held upside down) | Not specified | Substantially
equivalent* |
| Needle Shield/Hub
Separation Force | Per internal requirements
(Needle shield must not
disengage from hub when
held upside down) | Not specified | Substantially
equivalent* |
| Cannula Pull Force (Bond
between hub and needle) | Per ISO 7864:2016 | Per ISO 7864:2016 | Substantially
equivalent. |
| Cannula deflection/ Stiffness | Per ISO 9626:2001 | Per ISO 9626:1991 | Substantially
equivalent. |
| Cannula breakage | Per ISO 9626:2001 | Per ISO 9626:1991 | Substantially
equivalent. |
| Biocompatibility Testing:
Testing per ISO 10993-1:2018: | | | |
| Cytotoxicity | Per ISO 10993-5:2009,
Non-cytotoxic | Per ISO 10993-5,
Non-cytotoxic | Substantially
equivalent. |
| Sensitization | Per ISO 10993-10:2010,
Non-sensitizer | Per ISO 10993-10, Non-
sensitizer | Substantially
equivalent. |
| Intracutaneous Reactivity | Per ISO 10993-10:2010,
Non-irritant | Per ISO 10993-10, Non-irritant | Substantially
equivalent. |
| Acute Systemic Toxicity | Per ISO 10993-11:2017,
Non-toxic | Per ISO 10993-11, Non-toxic | Substantially
equivalent. |
| Material-Mediated
Pyrogenicity | Per ISO 10993-11:2017 and
USP, Non-pyrogenic | Not specified | N/A |
| Chemical Characterization | Per ISO 10993-18:2005,
acceptable
extractables/leachables | Not specified | N/A |
Additional Testing:
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Per ISO 10993-4, Non-hemolytic | N/A |
|---|---|---|---|
| LAL Endotoxin | Per USP, | ||
| 2.15 EU/device | Not Specified | N/A | |
| Particulate Matter | Per USP , Met limits | Not Specified | N/A |
| Neurotoxicity | |||
| Assessment | No signs of systemic toxicity or | ||
| neurological impairment from | |||
| exposure of leachable compounds | |||
| from the test article. | N/A | N/A |
profile
- Although it is not clear if these tests were performed by the predicate device manufacturer and since there are differences in design and materials between the predicate and subject devices, BD performs additional testing as needed to address any potential risks identified. These internal tests help mitigate the following risks:
8
- Stylet Pull Force This test addresses the risk of the stylet wire potentially . separating from the stylet handle, resulting in user inconvenience and/or inability to use the product.
- . Handle/Hub Separation Force - This test addresses the potential of the stylet falling out from the needle hub, which can result in user inconvenience and/or inability to use the product.
- . Needle Shield / Hub Separation Force - This test addresses the potential of the shield coming off too easily from the needle hub which could result in user inconvenience or potential for needle-stick injury.
Therefore, BD believes that these additional tests are reguired to support the safety and effectiveness of the subject devices.
| Performance Tests | BD has performed the following non-clinical/design verification
testing/analysis and the results of these tests/analysis
demonstrate that the BD Perisafe™ Epidural Needles 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 |
| | • | Stylet Pull Force |
| | Per ISO 9626 | |
| | • | Cannula deflection/ Stiffness |
| | • | Cannula breakage |
| | 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 Perisafe™ Tuohy Epidural Needle
and BD Perisafe™ Weiss Epidural Needle. | |
9
| | 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
BD has performed the following Material Biocompatibility
Performance testing on the BD® Whitacre Spinal NRFit™ Needle
that was cleared under K193131. The same testing is being
leveraged for this submission, as the materials of the subject
device are the same as that of the BD® Spinal NRFit Needles.
• Neurotoxicity Assessment
The subject device continues 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 | BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss
Epidural Needle are substantially equivalent to the predicate
devices in its intended use, principles of operation, technology,
design, materials and performance |