CLEAR-THERM MICRO HME, MODEL 1441

• K Number: K032322
• Device Name: CLEAR-THERM MICRO HME, MODEL 1441
• Manufacturer: INTERSURGICAL, INC.
• Date Cleared: 2004-05-13 ( 290 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the patient and equipment and is designed to reduce bacterial/viral contamination between patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Clear-Therm Micro HME, Model 1441" and mostly discusses regulatory compliance and the device's indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or a more detailed technical submission.

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).