(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 ) |
| Sensitization | Non-sensitizer (Per ISO 10993-10) |
| Intracutaneous Reactivity | Non-irritant (Per AAMI ISO 10993-10 & USP ) |
| Acute Systemic Toxicity | Non-toxic (Per ISO 10993-11 & USP ) |
| Material-mediated Pyrogenicity | Non-pyrogenic (Per ISO 10993-11:2017 & USP ) |
| 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.
§ 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).