MERCURY MEDICAL CPR BAG EXHALATION FILTER

K954490 · Mercury Medical · CAH · Oct 3, 1996 · Anesthesiology

Device Facts

• Record ID: K954490
• Device Name: MERCURY MEDICAL CPR BAG EXHALATION FILTER
• Applicant: Mercury Medical
• Product Code: CAH · Anesthesiology
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Device Story

Mercury CPR Bag with Filter; combination of Mercury Medical CPR Resuscitator (K911622) and Medicomp Filter (K851070). Device functions as a bacterial filter for breathing circuits. Used in clinical resuscitation settings to provide ventilation while filtering exhaled/inhaled gases. Output is filtered air delivery to patient. Benefits include reduction of cross-contamination risk during manual ventilation.

Clinical Evidence

Bench testing only; independent laboratory data provided for BFE and VFE.

Technological Characteristics

Resuscitation bag with integrated bacterial/viral filter. Mechanical filtration principle. No software or electronic components.

Regulatory Classification

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.

Predicate Devices

• Mercury Medical CPR Resuscitator (K911622)
• Medicomp Filter (K851070)
• Intertech/Inspiron Resuscitation Bag Filter (K883693)
• Westmed (K951484)
• Westmed (K953687)

Submission Summary (Full Text)

{0}

OCT-03-1996 09:19 FROM MERCURY MEDICAL
TJ 9*13014804204 P.02

# MERCURY MEDICAL®
K954490
OCT - 3 1996

REVISED
ENCLOSURE E
SMDA SUMMARY
K954490

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR 897.92. This device is the combination of two previously cleared devices: the Mercury Medical CPR Resuscitator (K911622) with Filter manufactured by Medicomp (K851070), which has been subsequently tested and supported with independent laboratory data for BFE and VFE. This would be consistent with the application of the Intertech/Inspiron Resuscitation Bag Filter (K883693) and Westmed (K951484) and (K953687).

- Product Name - Mercury CPR Bag with Filter
- Common Name - Resuscitation Bag Filter
- Classification Name - Filter, Bacterial, Breathing Circuits

Arthur J. Ward

October 2, 1996
Date

11300A-49th Street North • Clearwater, Florida 34622-4800 • 813-573-0088