(218 days)
None
No
The document describes humidifier chambers, which are passive components, and there is no mention of AI or ML in the text.
No
The device is a humidifier chamber used to humidify air delivered to patients. It supports a therapeutic process (humidification during air delivery) but is not a therapeutic device itself, as it does not directly treat or diagnose a disease or condition. It is an accessory to a larger system.
No
Explanation: The device is a humidifier chamber used to humidify air delivered to patients and does not perform any diagnostic functions.
No
The device description clearly states it is a "humidifier chamber," which is a physical hardware component used with a humidifier unit. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to humidify air delivered to patients. This is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a humidifier chamber, designed to hold water for humidification. This aligns with the therapeutic function described in the intended use.
- Lack of IVD Characteristics: The document does not mention any activities related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the humidifier chambers for the SCT 3000 are medical devices used for patient care, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.
Product codes
73 BTT
Device Description
The humidifier chambers offered for use with the SCT 3000.
- Adult low flow humidifier chamber
- Adult extended run humidifier chamber
- Pediatric low compressible volume humidifier chamber
- Adult hi flow humidifier chamber
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
Adult and pediatric.
Intended User / Care Setting
Hospital, anesthesia, ICU, respiratory therapy
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)
Performance Testing
None applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K903138, K864173, K850647, K862923, K934140
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with the text "The New Marq of Excellence" underneath it. The logo is a stylized letter "Q" made up of three parallel lines. The text is in a serif font and is underlined. The image is in black and white.
K96225
Non-Confidential Summary of Safety and Effectiveness June 3, 1996
JAN 1 4 1997
page 1 of 3
| Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, CO 80112 | Tel - (303) 790-4835
Fax - (303) 799-0210 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Official contact: | Tom Dielmann, Director, Regulatory Affairs / Quality Assurance |
| Proprietary or Trade Name: | Accessories for Marquest SCT 3000 Heated Humidification
System |
| Common/Usual Name: | Accessories for heated humidifiers |
| Classification Name: | 73 BTT - Respiratory Gas Humidifier (direct patient interface)
Subsection 868.5450 |
| Intended device: | Humidifier chambers for use with SCT 3000 Heated Humidifier |
| Predicate devices: | Marquest SCT 3000 - K903138
HPD Medical - K864173
Fisher & Paykel - K850647, K862923, K934140 |
| Device description: | The humidifier chambers offered for use with the SCT 3000. |
-
- Adult low flow humidifier chamber
-
- Adult extended run humidifier chamber
-
- Pediatric low compressible volume humidifier chamber
-
- Adult hi flow humidifier chamber
Indicated use:
The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.
Targeted population:
Any patient utilizing the SCT 3000 heated humidifier. Adult and pediatric.
page 3 of 51
面
1
Non-Confidential Summary of Safety and Effectiveness
June 3, 1996
page 2 of 3
Environment of use:
(
1
Hospital, anesthesia, ICU, respiratory therapy
Comparison to predicate devices:
| Attribute | Marquest
humidifier chambers | HPD Medical / Fisher & Paykel
humidifier chambers |
|----------------------------------------------------------------------------|---------------------------------|------------------------------------------------------|
| Use
Intended for use in
anesthesia | Yes | Yes |
| Intended for use in
respiratory therapy | Yes | Yes |
| Indicated for use with
heated humidifiers | Yes | Yes |
| Indicated for use with only
specific manufacturers heated
humidifier | Yes | Yes |
| Indicated for single use | Yes | Yes |
| Indicated for use with
adult and pediatric cases | Yes | Yes |
| Design
Clear housing | Yes | Yes |
| 15 /22 mm fittings for
connection to circuit | Yes | Yes |
| Different sizes | Yes | Yes |
| Water inlet ports | Yes | Yes |
| Labeling delineating water
levels on chamber | Yes | Yes |
| Materials
Polystyrene /
polycarbonate housing | Yes | Yes |
page 4 of 51
2
Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996
page 3 of 3
Comparison to predicate devices: (continued)
| Attribute | Marquest
humidifier chambers | HPD Medical / Fisher & Paykel
humidifier chambers |
|-------------------------------|---------------------------------|------------------------------------------------------|
| Materials (continued) | | |
| Aluminum base / heating plate | Yes | Yes |
| Performance Testing | | |
| None applicable | Yes | Yes |
B. Differences
Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.