(413 days)
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.
The subject BD Epilor™ (Loss of Resistance Syringe) is used in various types of epidural anesthesia procedures. The purpose of this syringe is to help the anesthesiologist locate the epidural space prior to administering either single shot or continuous epidural anesthesia. The syringe assembly consists of a lubricated polypropylene barrel imprinted with a graduated scale, a polypropylene plunger rod, and a silicone rubber stopper which is a double-ribbed to prevent leakage. BD Epilor ™ is used in conjunction with an epidural needle for the purpose of identifying the epidural space. BD Epilor™ syringes are available in 7ml sizes and supplied in plastic configurations and as sterile or Bulk Non-Sterile.
The provided document is a 510(k) Premarket Notification for the BD Epilor™ Syringe, and it is primarily a comparison to a predicate device to demonstrate substantial equivalence. It does not describe the acceptance criteria and a study proving a device meets these criteria in the context of an AI/machine learning-enabled device.
The BD Epilor™ Syringe is a physical medical device (Loss of Resistance Syringe), not an AI-enabled device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance) are not applicable to this document.
However, I can extract the acceptance criteria and the (non-AI) studies performed to show equivalence to the predicate device.
Acceptance Criteria and Reported Device Performance (BD Epilor™ Syringe)
The submission focuses on demonstrating substantial equivalence to a predicate device (B-D Loss of Resistance Syringe, K925902) through various performance and material characteristic comparisons, rather than establishing acceptance criteria for a novel AI-driven outcome. The "acceptance criteria" are implied by meeting established ISO standards, internal BD requirements, and biocompatibility standards, and the "reported device performance" is that the device met these requirements.
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Functional Tests (per ISO 594-1 and 594-2) | |
| Luer-Lok Separation Force | Meets ISO 594-2 requirement |
| Luer Slip Separation Force | Meets ISO 594-1 requirement |
| Unscrewing Torque (Luer-Lok) | Meets ISO 594-2 requirement |
| Resistance to Overriding (Luer-Lok) | Meets ISO 594-2 requirement |
| Luer Leakage (Positive Pressure Decay) (Luer-Lok & Luer-Slip) | Meets ISO 594-1 and 594-2 requirement |
| Sub-Atmospheric Pressure Air Leakage (Luer-Lok & Luer-Slip) | Meets ISO 594-1 and 594-2 requirement |
| Stress Cracking | Meets ISO 594-1 and 594-2 requirement |
| Functional Tests (per BD internal requirements) | |
| Ink Permanency | Meets BD internal requirements |
| Fit Test | Meets BD internal requirements |
| Stopper Leakage | Meets BD internal requirements |
| Biocompatibility Tests (per ISO 10993 Series and USP) | |
| Cytotoxicity | Non-cytotoxic (Per ISO 10993-5, ISO 10993-12, & USP <87>) |
| Sensitization | Non-sensitizer (Per ISO 10993-10) |
| Intracutaneous Reactivity | Non-irritant (Per AAMI ISO 10993-10 & USP <88>) |
| Acute Systemic Toxicity | Non-toxic (Per ISO 10993-11 & USP <88>) |
| Material-mediated Pyrogenicity | Non-pyrogenic (Per ISO 10993-11:2017 & USP <151>) |
| Extractables/Leachables | Acceptable (Per ISO 10993-18); Heavy metal tests: Pass |
| Hemolysis | Non-hemolytic (Per ISO 10993-4, ASTM Guideline F619-14, ASTM Guideline F756-17) |
| Additional Tests | |
| Particulate Matter | Particulate number is under the limit (Per USP 788) |
| Sterilization Validation | Validated per ISO 11135 |
Since this is not an AI/ML device, the following points regarding AI studies are not applicable and thus cannot be provided from this document:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
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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
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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) |
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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 ofPreparation: | April 15, 2022 | |
| Subject Device | Trade Name: | BD Epilor™ Syringe |
| Common Name: | Loss of Resistance Syringe | |
| RegulationNumber: | 21 CFR §868.5140 | |
| Regulation Name: | Anesthesia Conduction Kit | |
| Regulatory Class: | Class II device | |
| Product Code: | CAZ (Anesthesia Conduction Kit) | |
| Classification Panel: | Anesthesiology | |
| PredicateDevice | Trade Name: | B-D Loss of Resistance Syringe |
| 510(k) Reference: | K925902 | |
| Common Name: | Loss of Resistance Syringe | |
| RegulationNumber: | 21 CFR §868.5140 | |
| Regulation Name: | Anesthesia Conduction Kit | |
| Regulatory Class: | Class II device | |
| Product Code: | CAZ (Anesthesia Conduction Kit) | |
| Classification Panel: | Anesthesiology | |
| Reason ForChange | The purpose of the submission is to re-baseline the Predicatedevice B-D Loss of Resistance Syringe. | |
| DeviceDescription | The subject BD Epilor™ (Loss of Resistance Syringe) is used invarious types of epidural anesthesia procedures. The purpose ofthis syringe is to help the anesthesiologist locate the epiduralspace prior to administering either single shot or continuousepidural anesthesia. The syringe assembly consists of alubricated polypropylene barrel imprinted with a graduatedscale, a polypropylene plunger rod, and a silicone rubberstopper which is a double-ribbed to prevent leakage. BD |
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Premarket Notification - Traditional Section 7 – 510K Summary
| Epilor ™ is used in conjunction with an epidural needle for thepurpose of identifying the epidural space. BD Epilor™ syringesare available in 7ml sizes and supplied in plastic configurationsand as sterile or Bulk Non-Sterile. | |
|---|---|
| Indications for Use | BD Epilor™ syringes are intended for use with either air orliquid in conjunction with an epidural needle for identifying theepidural space. These types of syringes facilitate the “loss ofresistance” technique for identifying the epidural space byreducing subjectivity when locating this space and the potentialfor complications when administering epidural anesthesia topatients. These devices are intended for adult and pediatricpatients. |
Technological Characteristics
The subject devices are equivalent to the predicate devices in intended use, materials and performance characteristics:
| Element ofComparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510K # | K210983 | K925902 | Not applicable |
| Indications forUse/IntendedUse | BD Epilor™ syringesare intended for usewith either air or liquidin conjunction with anepidural needle foridentifying the epiduralspace. These types ofsyringes facilitate the"loss of resistance"technique foridentifying the epiduralspace by reducingsubjectivity whenlocating this space andthe potential forcomplications whenadministering epiduralanesthesia to patients.Not for spinalapplication, | B-D Loss of ResistanceSyringe is used incombination with anEpidural Needle in thefirst phase of theEpidural AnesthesiaProcedure. The "loss ofresistance" technique inepidural anesthesia isused for identifying theepidural space prior toadministration ofmedication orplacement of anEpidural Catheter. Byattaching a LORSyringe filled with air orsaline to the epiduralneedle the clinician canidentify arrival of theneedle tip in theepidural space by adramatic Loss ofResistance to syringeplunger movement. | Equivalent,theindications foruse/intendeduse has beenmodified toprovide betterclarity. |
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Premarket Notification - Traditional
| Barrel | Polypropylene | Polypropylene | same | |
|---|---|---|---|---|
| Syringe materials | BarrelLubricant | Silicone | Silicone | same |
| PlungerRod | Polypropylene+Colorant(Blue) | Polypropylene+Colorant(Blue) | same | |
| Stopper | Self- lubricated silicone | Self-lubricated silicone | same | |
| StopperLubricant | Silicone | Silicone | same | |
| Barrel ink | Black Ink | Black Ink | same | |
| Syringe Type | 3 Pieces (barrel,stopper and plunger) | 3 Pieces (barrel,stopper and plunger) | same | |
| Tip type | Luer-Lok™ or Luer Slipper ISO 594-1: 1986and ISO 594-2:19987mL | Luer-Lok™ or Luer Slipper ISO 594-1: 1986and ISO 594-2:19983mL, 5mL, 10mL ,20mL | Equivalent;Only 7mL BDEpilor™syringes areoffered | |
| DoseSetting/Volumes | ||||
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | same | |
| SAL | 10-6 | 10-6 | same | |
| Shelf Life | 5 Years | 5 Years | same | |
| Functional Tests | ||||
| Ink Permanency | Per BD internalrequirements | Per BD internalrequirements | same | |
| Luer-LokSeparationForce | Meets ISO 594-2requirement; | Meets ISO 594-2requirement; | same | |
| Luer SlipSeparation force | Meets ISO 594-1requirement | Meets ISO 594-1requirement | same | |
| UnscrewingTorque(Luer-Lok) | Meets ISO 594-2requirement | Meets ISO 594-2requirement | same | |
| Resistance toOverriding(Luer-Lok) | Meets ISO 594-2requirement | Meets ISO 594-2requirement | same | |
| Luer Leakage -PositivePressure Decay(Luer-Lok and | Meets ISO 594-1 and594-2 requirement | Meets ISO 594-1 and594-2 requirement | same | |
| Luer-Slip ) | ||||
| Sub-AtmosphericPressure AirLeakage (Luer-Lok and Luer-Slip ) | Meets ISO 594-1 and594-2 requirement | Meets ISO 594-1 and594-2 requirement | same | |
| Stress Cracking | Meets ISO 594-1 and594-2 requirement | Meets ISO 594-1 and594-2 requirement | same | |
| Fit Test | Meet BD internalrequirements | Meet BD internalrequirements | same | |
| StopperLeakage | Meet BD internalrequirements | Meet BD internalrequirements | Same | |
| Biocompatibility tests | ||||
| Cytotoxicity | Per ISO 10993-5, ISO10993-12, & USP<87>:Non-cytotoxic | Non-cytotoxic | Equivalent | |
| Sensitization | Per ISO 10993-10:Non-sensitizer | Non-sensitizer | Equivalent | |
| IntracutaneousReactivity | Per AAMI ISO 10993-10& USP<88>:Non-irritant | Non-irritant | Equivalent | |
| Acute SystemicToxicity | Per ISO 10993-11 &USP<88> :Non-toxic | Non-toxic | Equivalent | |
| Material-mediatedPyrogenicity | Per ISO 10993-11:2017 & USP<151>:Non-pyrogenic | Non-pyrogenic | Equivalent | |
| Extractables/Leachables | Per ISO 10993-18:Acceptable | Heavy metal tests;Pass | Equivalent | |
| Hemolysis | Per ISO 10993-4, ASTMGuideline F619-14,ASTM Guideline F756-17:Non-hemolytic | Non-hemolytic | Equivalent | |
| Additional Tests:ParticulateMatter | Per USP 788:Particulate number isunder the limit. | Below the limit | Equivalent | |
| PerformanceTests | BD has performed the following non-clinical/design verificationtesting based on the risk analysis conducted and the results ofthese tests demonstrate that the BD EpilorTM performed in an |
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Premarket Notification - Traditional
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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.
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Premarket Notification - Traditional
| Summary ofSubstantialEquivalence | Based on the intended use, technological characteristics andperformance testing, the subject device meets therequirements that is considered sufficient for its intended use.Therefore, BD EpilorTM syringe is substantially equivalent to thepredicate device in principles of operation, technology, design,materials and performance. The indications for use/intendeduse has been modified to provide better clarity. |
|---|---|
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).