(445 days)
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.
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.
The provided text is a 510(k) summary for the BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle. It describes the subject device, its indications for use, and compares it to a predicate device to demonstrate substantial equivalence.
Based on the information provided, this document deals with the regulatory clearance of a medical device (epidural needles) and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and effect sizes, are not applicable to this submission.
The acceptance criteria and performance data provided are for physical and biological characteristics of the medical device, not for an AI algorithm's diagnostic or predictive performance.
Here's an attempt to answer the questions based only on the provided document, highlighting when the information is not applicable or not present for AI/ML-specific inquiries:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the subject device and the predicate device across various aspects, including functional testing and biocompatibility testing. The "Substantially Equivalent" column indicates that the subject device met the acceptance criteria by demonstrating equivalence or acceptable performance based on established standards or internal requirements.
| Acceptance Criteria (Test/Measure) | Reported Device Performance (Subject Device) | Predicate Device Performance (Reference/Standard) | Substantial Equivalence Finding |
|---|---|---|---|
| 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 stretch with no separation at stylet/handle junction) | Not specified | Substantially equivalent* (Additional testing performed to address risks) |
| Handle/Hub Separation Force | Per internal requirements (Handle must not disengage when held upside down) | Not specified | Substantially equivalent* (Additional testing performed to address risks) |
| Needle Shield/Hub Separation Force | Per internal requirements (Needle shield must not disengage from hub when held upside down) | Not specified | Substantially equivalent* (Additional testing performed to address risks) |
| 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 (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 (Subject device performed this test, predicate did not specify) |
| Chemical Characterization | Per ISO 10993-18:2005, acceptable extractables/leachables | Not specified | N/A (Subject device performed this test, predicate did not specify) |
| Additional Testing | |||
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Per ISO 10993-4, Non-hemolytic | N/A (Subject device performed this test, predicate did not specify) |
| LAL Endotoxin | Per USP<85>, ≤ 2.15 EU/device | Not Specified | N/A (Subject device performed this test, predicate did not specify) |
| Particulate Matter | Per USP <788>, Met limits | Not Specified | N/A (Subject device performed this test, predicate did not specify) |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. | N/A | N/A (Performed on subject device materials, leveraging data from K193131) |
Notes:
- The asterisks (*) indicate that for "Stylet Pull Force," "Handle/Hub Separation Force," and "Needle Shield/Hub Separation Force," the subject device had internal requirements and performed additional testing because the predicate device did not specify these tests, and there were design differences that necessitated these tests to ensure safety and effectiveness.
- "N/A" in the "Substantial Equivalence" column for some biocompatibility and additional tests indicates that these specific tests were performed by the subject device's manufacturer but were not explicitly specified for the predicate device in the comparison table. This implies the subject device met these criteria, contributing to substantial equivalence based on a broader assessment including materials equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML-enabled device. The testing described focuses on physical and biological performance of the device itself (e.g., fluid leakage, material strength, biocompatibility), not on data-driven performance. The sample sizes for the functional and biocompatibility tests are not explicitly stated in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not an AI/ML-enabled device and no ground truth from expert readers/reviewers was established for its performance. The "ground truth" for this device's performance is based on established engineering standards (ISO standards, USP standards) and internal testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML-enabled device and no human adjudication process for performance was involved.
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
Not applicable. This is not an AI/ML-enabled device. No MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-enabled device. There is no algorithm to test in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from:
- International Standards: ISO (International Organization for Standardization) standards (e.g., ISO 594, ISO 9626, ISO 10993, ISO 7864) for functional, mechanical, and biocompatibility properties.
- United States Pharmacopeia (USP) Standards: (e.g., USP<151>, USP<85>, USP<788>) for specific biological and purity tests.
- Internal Requirements: For tests not explicitly covered by external standards but deemed critical by the manufacturer (e.g., Stylet Pull Force, Handle/Hub Separation Force, Needle Shield/Hub Separation Force). The rationale for these internal tests is provided, linking them to specific risks (e.g., user inconvenience, inability to use product, needle-stick injury).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
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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.
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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 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
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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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510(k) Summary (21 CFR §807.92)
BD Perisafe™ Tuohy Epidural Needle BD Perisafe™ Weiss Epidural Needle
| SubmitterInformation | Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Date of Preparation: | Becton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Murtaza RanaSenior Regulatory Affairs Managermurtaza.rana@bd.com(201) 847-6980May 27, 2022 | |
|---|---|---|---|
| Subject Device | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Perisafe™ Tuohy Epidural NeedleBD Perisafe™ Weiss Epidural NeedleAnesthesia Epidural 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: | Epidural Anesthesia Needles, SpinalAnesthesia Needles, CombinedAnesthesia NeedlesK171518Epidural Anesthesia Needles, SpinalAnesthesia Needles, CombinedAnesthesia Needles21 CFR 868.5150Anesthesia Conduction NeedleClass II DeviceBSP (Needle, Conduction, Anesthetic(W/Wo Introducer))Anesthesiology | |
| Reason forSubmission | The intent of this 510(k) submission is to establish a new 510(k)baseline for the BD Perisafe™ Tuohy Epidural Needle andBD Perisafe™ Weiss Epidural Needle. | ||
| Device Description | BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ WeissEpidural Needle are single use, sterile needles which incorporatean ISO 594-1/-2 compliant connector. The needles are alsoavailable in bulk, non-sterile configurations (to be sterilized priorto use). |
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| Each type of needle consists of a hollow, stainless steel cannula,a translucent, polypropylene hub and a polypropylene shieldover the needle. The cannula is bonded to the hub at one end.The BD Perisafe™ Epidural needles also contain a plastic stylethandle and are available in various needle lengths.The needle hubs are ISO 594-1 and ISO 594-2 compliantconnectors. The stylet handle for the BD Perisafe™ Epiduralneedles is color coded and correlate to the gauge size per ISO6009:2016. | |
|---|---|
| Indications for Use | The BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™Weiss Epidural Needle are indicated for the administration ofanesthesia or analgesia into the epidural space, or to introducea dedicated catheter for continuous administration of anesthesiaor analgesia into the epidural space. They can also be used tointroduce a spinal needle to perform a combined spinal andepidural procedure.These devices are intended for adult and pediatric patients. |
| TechnologicalCharacteristics | The subject devices are equivalent to the predicate devices inintended use, materials and performance characteristics. |
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| Element ofComparison | Subject Device(BD Perisafe™TuohyEpidural NeedleBD Perisafe™ WeissEpidural Needle) | PredicateDevice(EpiduralAnesthesiaNeedles,Zhejiang kindlyMedicalDevices,K171518) | Substantial Equivalence |
|---|---|---|---|
| Indications for Use | The BD Perisafe™Tuohy EpiduralNeedle and BDPerisafe™ WeissEpidural Needle areindicated for theadministration ofanesthesia oranalgesia into theepidural space, or tointroduce a dedicatedcatheter forcontinuousadministration ofanesthesia oranalgesia into theepidural space. Theycan also be used tointroduce a spinalneedle to perform acombined spinal andepidural procedure.These devices areintended for adult andpediatric patients. | The EpiduralAnesthesiaNeedles areintended to beused for injectioninto the epiduralspace/or placingthe epiduralcatheter into theepidural space.The CombinedAnesthesiaNeedles areintended forinjection of localanesthetics intothe spinal andepidural spaces ofa patient toprovide regionalanesthesia. Theadministration ofthe spinalanesthesia allowsrapid anesthesiaonset and theplacement of anepidural catheterallows for bolusinjections orcontinuousinfusion of localanesthetics orother drugs intothe epiduralspace. | Substantially equivalent topredicate device as both areintended for administration ofanesthesia in epidural spaceand for combined spinal andepidural procedures. |
| Technological Characteristics | |||
| Components | Stylet HandleStyletNeedle Tube(Cannula)Needle HubProtective Cap ofNeedle (Shield) | Stylet HubStyletNeedle TubeNeedle HubNeedle HubInsertProtective Cap ofNeedle | Substantially equivalent. Theonly difference is the absence ofa needle hub insert. This isbecause the needle tube(cannula) is insert molded to theneedle hub for the subjectdevice. |
| 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 needlegauge and needle lengthcompared with the predicatedevice. However, the differentdevice configurations will beselected by the physician perpatient's condition. Therefore,this difference is not consideredto affect substantialequivalence. |
| Needle Tip | Tuohy, Weiss | Tuohy | The Weiss needle tip geometryis same as the Tuohy needle tipgeometry with the onlydifference being the addition of"wings" to the needle hub tomake it easier to grasp theneedle with both hands forplacement. This difference isnot considered to affectsubstantial equivalence. |
| Sterile | EO Sterilized, 10-6 | EO Sterilized, 10-6 | Substantially equivalent. |
| Single Use | Single Use | Single Use | Substantially equivalent. |
| Labeling | Conform with 21 CFR801 | Conform with 21CFR 801 | Substantially equivalent. |
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| Functional Testing: | |||
|---|---|---|---|
| Fluid leakage by PressureDecay | Per ISO 594-1 and 594-2 | Per ISO 594-1and 594-2 | Substantiallyequivalent. |
| Subatmospheric pressure airleakage | Per ISO 594-1 and 594-2 | Per ISO 594-1and 594-2 | Substantiallyequivalent. |
| Stress cracking | Per ISO 594-1 and 594-2 | Per ISO 594-1and 594-2 | Substantiallyequivalent. |
| Resistance to separationfrom axial load | Per ISO 594-1 and 594-2 | Per ISO 594-1and 594-2 | Substantiallyequivalent. |
| Resistance to separationfrom unscrewing | Per ISO 594-2 | Per ISO 594-2 | Substantiallyequivalent. |
| Resistance to overriding | Per ISO 594-2 | Per ISO 594-2 | Substantiallyequivalent. |
| Stylet Pull Force | Per internal requirements(Must exhibit material | Not specified | Substantiallyequivalent* |
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| stretchwith no separation atstylet/handle junction) | |||
|---|---|---|---|
| Handle/Hub Separation Force | Per internal requirements(Handle must not disengagewhen held upside down) | Not specified | Substantiallyequivalent* |
| Needle Shield/HubSeparation Force | Per internal requirements(Needle shield must notdisengage from hub whenheld upside down) | Not specified | Substantiallyequivalent* |
| Cannula Pull Force (Bondbetween hub and needle) | Per ISO 7864:2016 | Per ISO 7864:2016 | Substantiallyequivalent. |
| Cannula deflection/ Stiffness | Per ISO 9626:2001 | Per ISO 9626:1991 | Substantiallyequivalent. |
| Cannula breakage | Per ISO 9626:2001 | Per ISO 9626:1991 | Substantiallyequivalent. |
| Biocompatibility Testing:Testing per ISO 10993-1:2018: | |||
| Cytotoxicity | Per ISO 10993-5:2009,Non-cytotoxic | Per ISO 10993-5,Non-cytotoxic | Substantiallyequivalent. |
| Sensitization | Per ISO 10993-10:2010,Non-sensitizer | Per ISO 10993-10, Non-sensitizer | Substantiallyequivalent. |
| Intracutaneous Reactivity | Per ISO 10993-10:2010,Non-irritant | Per ISO 10993-10, Non-irritant | Substantiallyequivalent. |
| Acute Systemic Toxicity | Per ISO 10993-11:2017,Non-toxic | Per ISO 10993-11, Non-toxic | Substantiallyequivalent. |
| Material-MediatedPyrogenicity | Per ISO 10993-11:2017 andUSP<151>, Non-pyrogenic | Not specified | N/A |
| Chemical Characterization | Per ISO 10993-18:2005,acceptableextractables/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 |
| NeurotoxicityAssessment | No signs of systemic toxicity orneurological impairment fromexposure of leachable compoundsfrom 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:
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- 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 verificationtesting/analysis and the results of these tests/analysisdemonstrate that the BD Perisafe™ Epidural Needles performedin 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 BiocompatibilityPerformance testing on the BD Perisafe™ Tuohy Epidural Needleand BD Perisafe™ Weiss Epidural Needle. |
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| Per ISO 10993-1:2018:• Cytotoxicity• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Material-Mediated Pyrogenicity• Chemical CharacterizationAdditionally, the following tests were performed:• Hemolysis• LAL Endotoxin• Particulate MatterBD has performed the following Material BiocompatibilityPerformance testing on the BD® Whitacre Spinal NRFit™ Needlethat was cleared under K193131. The same testing is beingleveraged for this submission, as the materials of the subjectdevice are the same as that of the BD® Spinal NRFit Needles.• Neurotoxicity AssessmentThe subject device continues to meet all the predeterminedacceptance 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 ofSubstantialEquivalence | BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ WeissEpidural Needle are substantially equivalent to the predicatedevices in its intended use, principles of operation, technology,design, materials and performance |
§ 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).