MERCURY MEDICAL CPR BAG EXHALATION FILTER

• K Number: K954490
• Device Name: MERCURY MEDICAL CPR BAG EXHALATION FILTER
• Manufacturer: MERCURY MEDICAL
• Date Cleared: 1996-10-03 ( 372 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K883693 , K951484 , K953687 , K911622 , K851070
• Predicate For: N/A

Intended Use

Not Found

Device Description

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.

AI/ML Overview

I am sorry, but the provided text is a summary of the 510(k) safety and effectiveness information for a medical device called "Mercury CPR Bag with Filter." It describes the device, its components, and mentions that it's a combination of previously cleared devices with independent laboratory data for BFE and VFE.

However, the text does not contain any information about a study that reports acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, ground truth establishment, or any details about AI/ML models or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. The document is a regulatory summary, not a study report.

Summary

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Image /page/0/Picture/0 description: This image shows a Mercury Medical document. The document includes the Mercury Medical logo, the date "OCT-03-1996", and the time "09:19". There is also a number "9*13014804204" and what appears to be a tracking number "K954490".

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 Ward

P.02

October 2, 1996 Date

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).