STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150

• K Number: K082772
• Device Name: STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
• Manufacturer: LIFE-TECH, INC.
• Date Cleared: 2009-02-09 ( 140 days)
• Product Code: BSP
• Regulation Number: 868.5150
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The StimPro is used to administer peripheral nerve blocks.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the StimPro Anesthesia Conduction Needle. This type of document does not contain the detailed technical study information required to answer the prompt.

FDA 510(k) clearance letters are primarily administrative documents that confirm a device's substantial equivalence to a legally marketed predicate device. They do not typically include:

• Detailed acceptance criteria for performance.
• Results of specific performance studies (like sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies).
• Information about training sets for algorithms.

Therefore, I cannot extract the requested information from the provided text. The document confirms market clearance based on substantial equivalence, but not the specific performance metrics or study details.

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).