(125 days)
The Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia.
The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
The Pajunk Loss of Resistance (LOR)-Syringe is 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. These syringes are not intended for injection or aspiration.
The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device.
Pajunk's EpiLong set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a epidural anesthesia kit consisting of a needle for insertion into the epidural space (a special Tuohy Cannula), a catheter for anesthesia administration to the epidural space, a flat filter as well as an adapter. After administration of immediate epidural anesthesia, the epidural catheter may be placed via the cannula into the epidural space. The cannula is then withdrawn, leaving the Epidural Catheter tip in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
The provided document is a 510(k) Premarket Notification Submission for the EpiLong Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics.
Instead, the submission states:
- Conclusion: "The comparison between the predicate device and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices." (Page 1)
- FDA's finding: "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..." (Page 2)
In summary, there is no study described in this document that proves acceptance criteria are met, as the regulatory pathway chosen (510(k)) relies on substantial equivalence to a predicate device, not on meeting specific, pre-defined performance acceptance criteria through the types of studies typically associated with AI/software devices.
The document primarily focuses on:
- Device description and indications for use.
- Identification of predicate devices (BBrauns Perifix K813186).
- Mention of sterilization processes.
- A "detailed discussion of substantial equivalence" in a section (Section 12) that is not included in the provided text.
Without Section 12 or other detailed performance testing reports, it's impossible to extract the requested information.
§ 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).