Who is the manufacturer of BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle?

Becton, Dickinson and Company filed the 510(k) submission for BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085).

What is the FDA product code for BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle?

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

What is the regulatory pathway for BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle?

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

What are the predicate devices for BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle?

Epidural Anesthesia Needles, Spinal (K171518).

Who can help prepare an FDA 510(k) submission like BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle

K211085 · Becton, Dickinson and Company · BSP · Jul 1, 2022 · Anesthesiology

Device Facts

Record ID	K211085
Device Name	BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Applicant	Becton, Dickinson and Company
Product Code	BSP · Anesthesiology
Decision Date	Jul 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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. These devices are intended for adult and pediatric patients.

Device Story

Single-use, sterile epidural needles (Tuohy or Weiss tip) used by clinicians to access the epidural space. Device consists of a stainless steel cannula bonded to a polypropylene hub, with a color-coded polypropylene stylet handle and protective shield. Clinician inserts needle into patient's epidural space; needle serves as conduit for anesthetic/analgesic delivery or catheter placement. Weiss tip includes wings on hub for improved manual grip. Device facilitates regional anesthesia administration, potentially benefiting patients by enabling pain management or surgical anesthesia. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data required. Performance verified via ISO 594-1/-2 (fluid leakage, pressure decay, stress cracking, axial load, unscrewing, overriding), ISO 9626 (stiffness, breakage), ISO 7864 (cannula pull force), and internal testing (stylet/handle/shield separation). Biocompatibility confirmed per ISO 10993-1:2018 (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, chemical characterization) and additional testing (hemolysis, LAL endotoxin, particulate matter, neurotoxicity).

Technological Characteristics

Materials: stainless steel cannula, polypropylene hub/shield. Dimensions: 16G-20G, lengths 50.8mm-127mm. Tip geometries: Tuohy, Weiss. Connectivity: None. Energy: None. Sterilization: EO (10^-6 SAL). Standards: ISO 594-1/-2 (connectors), ISO 6009:2016 (color coding), ISO 7864:2016 (cannula pull), ISO 9626:2001 (cannula stiffness/breakage).

Indications for Use

Indicated for adult and pediatric patients requiring administration of anesthesia or analgesia into the epidural space, placement of epidural catheters, or introduction of spinal needles for combined spinal-epidural procedures.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

Epidural Anesthesia Needles, Spinal (K171518)

Reference Devices

BD® Whitacre Spinal NRFit™ Needle (K193131)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. 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) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> </svg> 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white design inside, and the letters "BD" in blue. The design inside the circle looks like a stylized sun or flower. # 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<151>, 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<85>, 2.15 EU/device | Not Specified | N/A | | Particulate Matter | Per USP <788>, 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 |

BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle

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BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

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