(162 days)
Not Found
Not Found
No
The 510(k) summary describes a heat and moisture exchanger, a passive medical device, and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No.
The device is a heat and moisture exchanger, which is typically used for respiratory support and not considered a therapeutic device in itself.
No
Explanation: The device description states it is a "heat and moisture exchanger" and references 21 CFR 868.5375, which defines a "humidifier for medical gas." These types of devices are therapeutic or supportive, not diagnostic.
No
The device description clearly states it is a "heat and moisture exchanger" and describes physical characteristics like size, dead space, and weight, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions.
- Device Description: The description clearly states the device is a "heat and moisture exchanger" used in respiratory care. This function is related to patient support and therapy, not in vitro diagnostic testing of samples.
- Lack of IVD-related terms: The description does not mention any terms typically associated with IVDs, such as "sample," "analyte," "assay," "diagnosis," "screening," etc.
- Predicate Device: The predicate device is also described as a "heat and moisture exchanger," further confirming the device's function is not diagnostic.
Therefore, the information provided strongly suggests this device is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K964382
April 15, 1997
Subject: 510(k) Summary of Safety and Effect veness
Product: Gibeck Humid-Vent® Filter Compact Angled/Humid-Vent® Filter Compact Straight
Summary:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.
The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.
The principal difference between the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight and the Humid-Vent Filter is the size of the device. This change is not considered to be critical to the intended therapeutic. diagnostic, prosthetic or surgical use of the device nor should this change significantly affect the safety or effectiveness of the device when used as labeled.
Submitter/Contact Person
12-14 - 1-2
10/29/96
Date
Gibeck. Inc. 10640 East 59th Street . P.O. Box 36430 . Indianapolis, IN 46236 Telephone: (317) 823-6866 · Telefax: (317) 823-1662 A Member of the Gibeck Group