BD Epilor Syringe

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May 19, 2022 Becton Dickinson and Company Huwien Yang Senior Regulatory Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K210983 Trade/Device Name: BD Epilor Syringe Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia conduction kit Regulatory Class: Class II Product Code: CAZ Dated: April 15, 2022 Received: April 18, 2022 Dear Huwien Yang: 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. 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 {1}------------------------------------------------ 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 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) K210983 Device Name BD Epilor™ Syringe #### Indications for Use (Describe) BD Epilor™ syringes are intended for use with either air or liquid in conjunction with an epidural needle for identifying the epidural space. These types of syringes facilitate the "loss of resistance" technique for identifying the epidural space by reducing subjectivity when locating this space and the potential for complications when administering epidural anesthesia to patients. Not for spinal applications. These devices are intended for adult and pediatric patients. | Type of Use (Select one or both, as applicable) | | | | |-------------------------------------------------|---------------------------------------------|--|--| | > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K210983 Image /page/3/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of an orange circular symbol with radiating lines, resembling a sun or starburst, followed by the letters "BD" in blue. The letters are bold and capitalized, with a sans-serif font, and are positioned to the right of the circular symbol. Submitter Information Premarket Notification - Traditional Section 7 – 510K Summary # 510(k) Summary (21 CFR §807.92) BD Epilor™ Syringe | Submitter Name: | Becton, Dickinson and Company | |--------------------|--------------------------------------| | Submitter Address: | 1 Becton Drive | | | Franklin Lakes, NJ 07417 | | Contact Person: | Huiwen Yang | | | Senior Regulatory Affairs Specialist | | Email Address: | Huiwen.yang@bd.com | | Phone Number: | Phone: (201) 847-4408 | | | Fax: (201) 847-5397 | | | Email Address: | Huiwen.yang@bd.com | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | | Phone Number: | Phone: (201) 847-4408 | | | Fax Number: | Fax: (201) 847-5307 | | | Date of<br>Preparation: | April 15, 2022 | | Subject Device | Trade Name: | BD Epilor™ Syringe | | | Common Name: | Loss of Resistance Syringe | | | Regulation<br>Number: | 21 CFR §868.5140 | | | Regulation Name: | Anesthesia Conduction Kit | | | Regulatory Class: | Class II device | | | Product Code: | CAZ (Anesthesia Conduction Kit) | | | Classification Panel: | Anesthesiology | | Predicate<br>Device | Trade Name: | B-D Loss of Resistance Syringe | | | 510(k) Reference: | K925902 | | | Common Name: | Loss of Resistance Syringe | | | Regulation<br>Number: | 21 CFR §868.5140 | | | Regulation Name: | Anesthesia Conduction Kit | | | Regulatory Class: | Class II device | | | Product Code: | CAZ (Anesthesia Conduction Kit) | | | Classification Panel: | Anesthesiology | | Reason For<br>Change | The purpose of the submission is to re-baseline the Predicate<br>device B-D Loss of Resistance Syringe. | | | Device<br>Description | The subject BD Epilor™ (Loss of Resistance Syringe) is used in<br>various types of epidural anesthesia procedures. The purpose of<br>this syringe is to help the anesthesiologist locate the epidural<br>space prior to administering either single shot or continuous<br>epidural anesthesia. The syringe assembly consists of a<br>lubricated polypropylene barrel imprinted with a graduated<br>scale, a polypropylene plunger rod, and a silicone rubber<br>stopper which is a double-ribbed to prevent leakage. BD | | {4}------------------------------------------------ Premarket Notification - Traditional Section 7 – 510K Summary | | Epilor ™ is used in conjunction with an epidural needle for the<br>purpose of identifying the epidural space. BD Epilor™ syringes<br>are available in 7ml sizes and supplied in plastic configurations<br>and as sterile or Bulk Non-Sterile. | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Indications for Use</b> | BD Epilor™ syringes are intended for use with either air or<br>liquid in conjunction with an epidural needle for identifying the<br>epidural space. These types of syringes facilitate the “loss of<br>resistance” technique for identifying the epidural space by<br>reducing subjectivity when locating this space and the potential<br>for complications when administering epidural anesthesia to<br>patients. These devices are intended for adult and pediatric<br>patients. | ## Technological Characteristics The subject devices are equivalent to the predicate devices in intended use, materials and performance characteristics: | Element of<br>Comparison | Subject Device | Predicate Device | Comparison | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | 510K # | K210983 | K925902 | Not applicable | | Indications for<br>Use/Intended<br>Use | BD Epilor™ syringes<br>are intended for use<br>with either air or liquid<br>in conjunction with an<br>epidural needle for<br>identifying the epidural<br>space. These types of<br>syringes facilitate the<br>"loss of resistance"<br>technique for<br>identifying the epidural<br>space by reducing<br>subjectivity when<br>locating this space and<br>the potential for<br>complications when<br>administering epidural<br>anesthesia to patients.<br>Not for spinal<br>application, | B-D Loss of Resistance<br>Syringe is used in<br>combination with an<br>Epidural Needle in the<br>first phase of the<br>Epidural Anesthesia<br>Procedure. The "loss of<br>resistance" technique in<br>epidural anesthesia is<br>used for identifying the<br>epidural space prior to<br>administration of<br>medication or<br>placement of an<br>Epidural Catheter. By<br>attaching a LOR<br>Syringe filled with air or<br>saline to the epidural<br>needle the clinician can<br>identify arrival of the<br>needle tip in the<br>epidural space by a<br>dramatic Loss of<br>Resistance to syringe<br>plunger movement. | Equivalent,<br>the<br>indications for<br>use/intended<br>use has been<br>modified to<br>provide better<br>clarity. | {5}------------------------------------------------ Premarket Notification - Traditional | | Barrel | Polypropylene | Polypropylene | same | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Syringe materials | Barrel<br>Lubricant | Silicone | Silicone | same | | | Plunger<br>Rod | Polypropylene+Colorant<br>(Blue) | Polypropylene+Colorant<br>(Blue) | same | | | Stopper | Self- lubricated silicone | Self-lubricated silicone | same | | | Stopper<br>Lubricant | Silicone | Silicone | same | | | Barrel ink | Black Ink | Black Ink | same | | | Syringe Type | 3 Pieces (barrel,<br>stopper and plunger) | 3 Pieces (barrel,<br>stopper and plunger) | same | | Tip type | | Luer-Lok™ or Luer Slip<br>per ISO 594-1: 1986<br>and ISO 594-2:1998<br>7mL | Luer-Lok™ or Luer Slip<br>per ISO 594-1: 1986<br>and ISO 594-2:1998<br>3mL, 5mL, 10mL ,<br>20mL | Equivalent;<br>Only 7mL BD<br>Epilor™<br>syringes are<br>offered | | Dose<br>Setting/Volumes | | | | | | | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | same | | | SAL | 10-6 | 10-6 | same | | Shelf Life | | 5 Years | 5 Years | same | | | | | | | | | Functional Tests | | | | | | Ink Permanency | Per BD internal<br>requirements | Per BD internal<br>requirements | same | | Luer-Lok<br>Separation<br>Force | | Meets ISO 594-2<br>requirement; | Meets ISO 594-2<br>requirement; | same | | Luer Slip<br>Separation force | | Meets ISO 594-1<br>requirement | Meets ISO 594-1<br>requirement | same | | | Unscrewing<br>Torque(Luer-<br>Lok) | Meets ISO 594-2<br>requirement | Meets ISO 594-2<br>requirement | same | | | Resistance to<br>Overriding<br>(Luer-Lok) | Meets ISO 594-2<br>requirement | Meets ISO 594-2<br>requirement | same | | Luer Leakage -<br>Positive<br>Pressure Decay<br>(Luer-Lok and | | Meets ISO 594-1 and<br>594-2 requirement | Meets ISO 594-1 and<br>594-2 requirement | same | | Luer-Slip ) | | | | | | Sub-<br>Atmospheric<br>Pressure Air<br>Leakage (Luer-<br>Lok and Luer-<br>Slip ) | Meets ISO 594-1 and<br>594-2 requirement | Meets ISO 594-1 and<br>594-2 requirement | same | | | Stress Cracking | Meets ISO 594-1 and<br>594-2 requirement | Meets ISO 594-1 and<br>594-2 requirement | same | | | Fit Test | Meet BD internal<br>requirements | Meet BD internal<br>requirements | same | | | Stopper<br>Leakage | Meet BD internal<br>requirements | Meet BD internal<br>requirements | Same | | | Biocompatibility tests | | | | | | Cytotoxicity | Per ISO 10993-5, ISO<br>10993-12, & USP<br><87>:<br>Non-cytotoxic | Non-cytotoxic | Equivalent | | | Sensitization | Per ISO 10993-10:<br>Non-sensitizer | Non-sensitizer | Equivalent | | | Intracutaneous<br>Reactivity | Per AAMI ISO 10993-10<br>& USP<88>:<br>Non-irritant | Non-irritant | Equivalent | | | Acute Systemic<br>Toxicity | Per ISO 10993-11 &<br>USP<88> :<br>Non-toxic | Non-toxic | Equivalent | | | Material-<br>mediated<br>Pyrogenicity | Per ISO 10993-<br>11:2017 & USP<151>:<br>Non-pyrogenic | Non-pyrogenic | Equivalent | | | Extractables/<br>Leachables | Per ISO 10993-18:<br>Acceptable | Heavy metal tests;<br>Pass | Equivalent | | | Hemolysis | Per ISO 10993-4, ASTM<br>Guideline F619-14,<br>ASTM Guideline F756-<br>17:Non-hemolytic | Non-hemolytic | Equivalent | | | Additional Tests:<br>Particulate<br>Matter | Per USP 788:<br>Particulate number is<br>under the limit. | Below the limit | Equivalent | | | Performance<br>Tests | BD has performed the following non-clinical/design verification<br>testing based on the risk analysis conducted and the results of<br>these tests demonstrate that the BD EpilorTM performed in an | | | | {6}------------------------------------------------ # Premarket Notification - Traditional {7}------------------------------------------------ Premarket Notification - Traditional Section 7 – 510K Summary ### equivalent manner to the predicate device. Per ISO 594-1 and 594-2: - LL Separation Force ● - Unscrewing Torque ● - Overriding Torque ● - Luer Leakage – Positive Pressure Decay - Sub-Atmospheric Pressure Air Leakage ● - Stress Cracking ● Per BD internal requirements: - Ink Permanency ● - Fit Test - Stopper Leakage ● A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted: - Cytotoxicity ● - Sensitization ● - Intracutaneous Reactivity ● - Acute Systemic Toxicity - Material- mediated pyrogenicity ● - Hemolysis - Chemical Extractables Analysis ● Additionally, the following tests were performed: - Particulate Matter per USP <788> . The device is sterilized using ethylene oxide process and was validated per ISO 11135. Per the design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device. ## Clinical Testing Clinical testing was not required for the subject device this submission. {8}------------------------------------------------ Premarket Notification - Traditional | Summary of<br>Substantial<br>Equivalence | Based on the intended use, technological characteristics and<br>performance testing, the subject device meets the<br>requirements that is considered sufficient for its intended use.<br>Therefore, BD EpilorTM syringe is substantially equivalent to the<br>predicate device in principles of operation, technology, design,<br>materials and performance. The indications for use/intended<br>use has been modified to provide better clarity. | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|