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The Pajunk EpiLong Sets Pediatric are intended for delivery of continuous conduction of epidural anesthesia. The catheter has to be removed or replaced after 72 hours. They are to be used with pediatric patient population.

The Pajunk EpiLong Sets Pediatric acc. Marhover are intended for delivery of continuous conduction of epidural anesthesia. The Marhover-Set contains a NanoLine coated cannula. The catheter has to be removed or replaced after 72 hours. They are to be used with pediatric patient population.

The Pajunk pediatric epidural catheter is placed in the epidural space to facilitate a longer anesthetic effect. It is intended for use with pediatric patients. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

Pajunks pediatric epidural needles are anesthesia conduction needles employed to identify and to access epidural space. It is intended for use with pediatric patients. After epidural space is accessed and the catheter is inserted the anesthesia conduction needle has to be withdrawn from the patient.

Pajunk's EpiLong Anesthesia Sets Pediatric are single use, sterile, non-pyrogenic and latex free medical device kits for use with pediatric patients. They are intended for continuous epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. The set is equipped with an epidural needle, for example the Tuohy. The Tuohy needle is a proven and established needle variant used in epidural anaesthesia. PAJUNK® offers the catheters for pediatric use in different lenghts and diameters. The catheter itself is equipped with ascending depth graduations. With these depth graduations the position of the catheter can be exactly determined at any time. A marker at the end of the catheter indicates how deep the catheter can be introduced. Optionally the catheter can be employed with a stylet, an integrated spiral (called Epilong Soft Pediatric) or open tip.

The Pediatric epidural Anesthesia Set provides a standard epidural needle. Variant: The EpiLong Marhofer Kit. Within this Kit the needle is (NanoLine or lacqueur) coated. The catheter comes with a catheter container introductory aid for better handling and shape security, a LOR syringe, a flat filter and a Tuohy Borst adaptor. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylet. There is no change in components compared to the EpiLong sets already cleared for market. All components are available seperately.

The provided document K062902 is a 510(k) Premarket Notification for Pajunk's EpiLong Sets Pediatric and related components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study to establish performance against acceptance criteria. Therefore, the document does not contain information about explicit acceptance criteria or a dedicated study proving the device meets particular performance metrics.

Instead, the submission states:

• Pajunks EpiLong Anesthesia Sets Pediatric are substantially equivalent to Pajunks EpiLong Set (K060311), BBraun's Perifix Pediatric epidural kit (K962696), Portex's Pediatric Epidural and Peripheral Block Anesthesia Catheter (K033080), and MEDDEVICE's Bio-mate pediatric epidural catheter (K901129).
• The indication for use of the previously cleared EpiLong Sets for an unspecified patient population is enhanced for pediatric patients.
• There is no change in technology or material compared to the predicate devices.
• The reliance for demonstrating safety and effectiveness is primarily on a clinical literature review (Section 10 of the submission, which is not provided in the excerpt) and the established safety/effectiveness of the predicate devices.

Given this, I cannot extract a table of acceptance criteria, reported device performance, sample sizes for test or training sets, details on expert ground truth, adjudication methods, or MRMC study results because the provided text does not describe a study to prove performance against specific acceptance criteria.

The information provided focuses on:

• Device Description: Single-use, sterile, non-pyrogenic, latex-free medical device kits for continuous epidural anesthesia delivery in pediatric patients, using a Polyamide indwelling catheter (to be removed/replaced after 72 hours). Includes an epidural needle (e.g., Tuohy).
• Predicate Devices: Several previously cleared pediatric epidural kits and catheters.
• Sterilization: EtO method, identical to other Pajunk devices, with annual validation and quarterly verification.
• Technology Characteristics: Standard epidural needle (variants include NanoLine or lacquer coated), catheter with depth graduations, closed tip with three lateral holes (optional open tip, integrated spiral, stylet). No change in components from already cleared EpiLong sets.
• Conclusion: The comparison to predicate devices demonstrates the proposed devices are "at least as safe and effective as, and substantially equivalent to the predicate devices."

Therefore, the questions cannot be answered from the provided text as the application relies on substantial equivalence rather than a de novo performance study against new acceptance criteria.

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