(144 days)
The Epidrum is intended for use in epidural procedures between a luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space.
The Epidrum is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.
The Epidrum comprises a small chamber, featuring a female Luer inlet port and a male Luer exit port on opposing sides, with an expandable membrane as one of the sides between the ports. The Epidrum is a single use device, manufactured from medical grade polymers.
The provided text is a 510(k) summary for the Epidrum device and does not contain detailed information about a study proving its acceptance criteria, or the specific performance metrics typically found in such studies for AI/ML devices. The Epidrum is a medical device designed to visually signal when an epidural needle has entered the epidural space. The filing focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria.
Therefore, the requested information, particularly regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, cannot be extracted from this document as it pertains to AI/ML device evaluations.
The document primarily compares the Epidrum to a predicate device (Avid-Nit Loss of Resistance Syringe) based on intended use, indications for use, and technological principles (loss of resistance). It concludes that the Epidrum operates on the same principle despite using visual cues instead of tactile feedback, and therefore "raises no new questions of safety and effectiveness."
Summary of available information (as per the prompt's request, but acknowledging the limits of the document):
- Acceptance Criteria and Reported Device Performance: Not explicitly stated as the primary focus is on substantial equivalence to a predicate device.
- Sample Size for Test Set and Data Provenance: Not applicable as no performance study data is presented.
- Number of experts and qualifications to establish ground truth for the test set: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this type of study is not described.
- Standalone (algorithm only without human-in-the-loop performance) study: No, as this is a mechanical device, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, the document does contain the following relevant comparisons to a predicate device:
1. A table of acceptance criteria and the reported device performance
| Criteria/Aspect | Epidrum (Device Under Review) | Avid-Nit Loss of Resistance Syringe (Predicate Device) |
|---|---|---|
| Intended Use | Intended for use in epidural procedures between a Luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space. | Intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. |
| Indications for Use | Intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space. | Intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space. |
| Technological Differences | The design incorporates an expandable membrane which deflates when the needle tip enters the epidural space giving an instantaneous, clear, visual signal. | The loss of resistance to the plunger of the syringe, when the distal tip of the needle penetrates the epidural space, is sensed by touch via the user's thumb. |
| Conclusion of Equivalence | Although the Epidrum uses different senses of the user (visual:touch) from the Loss of Resistance Syringe mentioned above, it operates on precisely the same loss of resistance principle, has the same intended use and raises no new questions of safety and effectiveness. |
The study that "proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (Avid-Nit Loss of Resistance Syringe, K001731) based on comparison of intended use, indications for use, and operating principle. The "acceptance criteria" here are implicitly related to the requirements for substantial equivalence, which primarily involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. No specific clinical trial or performance study data comparing the Epidrum's visual signal performance against a predefined numerical acceptance threshold is provided.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).