(372 days)
No
The device description explicitly states it is a combination of two previously cleared, non-AI/ML devices and mentions testing for BFE and VFE, which are standard filtration performance metrics, not indicative of AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is described as a CPR Resuscitator with a filter, which is designed to assist with breathing and provide protection during resuscitation, but it does not actively treat a disease or condition. It is a support device.
No
The description states the device is composed of a CPR Resuscitator and a filter, both previously cleared devices. There is no information to suggest it performs any diagnostic function, and the "Intended Use / Indications for Use" section is blank.
No
The device description explicitly states it is a "combination of two previously cleared devices," which are physical medical devices (a CPR Resuscitator and a Filter). There is no mention of software as the primary or sole component.
Based on the provided text, there is no indication that this device is an IVD (In Vitro Diagnostic).
Here's why:
- No mention of IVD: The text does not use the term "IVD" or describe any function related to testing samples from the human body outside of the body.
- Device Description: The description clearly states it's a combination of a CPR Resuscitator and a Filter. These are devices used for respiratory support, not for in vitro diagnostic testing.
- Lack of IVD-related information: The sections that would typically contain information relevant to an IVD (like intended use for diagnostic purposes, sample types, analytical performance, etc.) are either "Not Found" or describe a different type of device.
Therefore, based solely on the provided text, this device is not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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