ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000

• K Number: K992796
• Device Name: ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
• Manufacturer: IMAGE-GUIDED NEUROLOGICS, INC.
• Date Cleared: 1999-10-25 ( 67 days)
• Product Code: HCA
• Regulation Number: 882.4100
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

For the Aspiration or Irrigation of fluids during Intracranial procedures. This device is not intended for implant

Device Description

Aspiration/Irrigation Catheter

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an "Aspiration/Irrigation Catheter." This type of document does not contain details about acceptance criteria or a study proving the device meets them.

The 510(k) process is primarily a premarket notification demonstrating that a device is "substantially equivalent" to a legally marketed predicate device. It typically relies on comparisons to existing devices and performance data that may or may not include rigorous clinical studies with specific acceptance criteria as you've described.

Therefore, I cannot provide the requested information based on the given text. The document refers to the device being substantially equivalent to prior predicate devices, which means its safety and effectiveness are deemed similar to those already on the market. It doesn't detail performance metrics or studies in the way you've outlined.

Regulation Number and Section

§ 882.4100 Ventricular catheter.

(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).