DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

• K Number: K951928
• Device Name: DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
• Manufacturer: CSEN LTD.
• Date Cleared: 1997-05-30 ( 766 days)
• Product Code: BSP
• Regulation Number: 868.5150
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Double-Holed Pencil Point Spinal Needle (DHPP)

AI/ML Overview

This is an FDA premarket notification (510(k)) letter for a medical device. This type of document is a clearance letter, not a study report or a detailed description of device performance or clinical trials. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document.

This letter only states that the device, a "Double-Holed Pencil Point Spinal Needle (DHPP)," has been found "substantially equivalent" to legally marketed predicate devices. It does not contain details about specific acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

To answer your questions, one would need access to the 510(k) submission document itself, which would include the performance data and the comparison to the predicate device.

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).