DR. JAPAN FACIL POINT SPINAL NEEDLE

• K Number: K020934
• Device Name: DR. JAPAN FACIL POINT SPINAL NEEDLE
• Manufacturer: MYCO MEDICAL, INC.
• Date Cleared: 2002-10-25 ( 217 days)
• Product Code: BSP
• Regulation Number: 868.5150
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For spinal administration of anesthetic agents to provide regional anesthesia.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text ({0}, {1}, {2}, {3}) does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification response from the FDA regarding a spinal needle, confirming its substantial equivalence to a legally marketed predicate device. It briefly mentions the "Indication For Use" of the device, but there are no details about specific performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide the requested table or answer the specific questions about a device study.

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).