(159 days)
Not Found
No
The description details a servo-controlled mechanism using a feedback loop and a microprocessor to regulate temperature based on thermistor input. There is no mention of AI or ML algorithms for learning or decision-making beyond this basic control system.
Yes
The device is designed to provide heated, humidified gas to patients whose own humidification system is compromised, primarily during anesthesia or prolonged respiratory therapy, to prevent damage to the airways and maintain body temperature. This direct physiological benefit qualifies it as a therapeutic device.
No
The device description indicates its purpose is to provide heated, humidified gas for therapeutic use, not to diagnose medical conditions.
No
The device description clearly outlines hardware components such as heating elements, thermistors, and a microprocessor (Intel P80C32), indicating it is a physical device with integrated software for control.
Based on the provided information, the SCT 3000 Heated Humidifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide heated and humidified gas to patients during breathing support. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanism of heating and humidifying gas and delivering it to the patient's airway. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SCT 3000 does not perform this function.
N/A
Intended Use / Indications for Use
The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.
Product codes (comma separated list FDA assigned to the subject device)
73 BTT
Device Description
Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.
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, neonate, and pediatric
Intended User / Care Setting
Hospital, anesthesia, ICU, respiratory therapy, home healthcare
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:
Meets UL 544, Medical and Dental Equipment / Patient Care Equipment
Meets CSA C22.2 No. 125-M1984, Electromedical Equipment
Meets ANSI Z79.9-1979, Humidifiers and Nebulizers for Medical Use
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.
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
§ 868.5450 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
JUL 1 6 1997
Page 1 of 5
| Marquest Medical Products, Inc.
1 1039 East Lansing Circle
Englewood, CO 80112 | Tel - (303) 790-4835
Fax - (303) 799-0210 |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Thomas W. Dielmann,
Vice President, Regulatory Affairs / Quality Assurance |
| Proprietary or Trade Name: | SCT 3000 Heated Humidifier |
| Common / Usual Name: | Heated Humidifier |
| Classification Name: | Respiratory Gas Humidifier
Subsection 868.5450 |
| Intended Device: | SCT 3000 uses breathing circuits and humidification
chambers to precisely control the delivery of gas
temperature and humidity to the patient. |
| Predicate Devices: | Marquest SCT 3000 - K903138
Fisher & Paykel 730 Respiratory Humidifier - K913368 |
| Device Description /
Indicated Use: | Servo-Controlled Tracking SCT 3000 heated humidifier is
designed to provide heated, humidified gas to a patient
whose own humidification system - the nose and upper
airway - is compromised. The unit is used primarily during
anesthesia or prolonged respiratory therapy to prevent
damage to the upper airway and lungs caused by dry gas
while helping to maintain the patient's body temperature
stable. |
1
page 2 of 5
| Device Description /
Indicated Use (continued): | The whole system, including disposable humidification
chambers, heated wire breathing circuits and no-wire (vent)
circuits, achieves precise control of delivered gas
temperature and humidity by a servo controlled
mechanism.
The SCT 3000 employs a feedback loop where the
temperature input from the thermistors controls the heating
elements. The SCT 3000 has two thermistors that provide
analog input. This information, in turn, is used to control
the amount of time that the two heating elements are cycled
on/off. The SCT's microprocessor - the Intel P80C32,
regulates this servo mechanism. the advanced design allows
simple operation, sophisticated diagnostic routines and
superior safety features to be built into the instrument,
resulting in better performance and safer operation. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted Population: | Adult, neonate, and pediatric |
| Environment of Use: | Hospital, anesthesia, ICU, respiratory therapy, home
healthcare |
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘ
2
page 3 of 5
Comparison to Predicate Devices:
| Attribute | Marquest
SCT 3000 | Fisher & Paykel
MR 730 |
|-----------------------------------------------------------------------|----------------------|---------------------------|
| Use
Indicated for anesthesia | Yes | Yes |
| Indicated for respiratory therapy | Yes | Yes |
| Population - adult, pediatric, neonate | Yes | Yes |
| Indicated for use only with specific
manufacturers heated circuits | Yes | Yes |
| Use with heated wire circuits | Yes | Yes |
| Use with no-wire circuits | Yes | Yes |
| Single patient use applications | Yes | Yes |
| Reusable circuits application | Yes | Yes |
| Heated wire operation | Yes | Yes |
| No-wire operation | Yes | Yes |
| For use with low flow chambers | Yes | Yes |
| For use with high flow chambers | Yes | Yes |
3
page 4 of 5
Comparison to Predicate Devices:
| Attribute | Marquest
SCT 3000 | Fisher & Paykel
MR 730 |
|------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Use (continued)
For use with ventilators - with or
without exhalation valves | Yes | Yes |
| For use with anesthesia systems | Yes | Yes |
| For use with various heated wire
circuit configurations | Yes | Yes |
| For use with various no-wire
circuit configurations | Yes | Yes |
| Design
Microprocessor controlled | Yes | Yes |
| High Temperature Alarm | Yes - Distal
Temperature
1 degree C
of Set Temp. | Yes - Distal
Temperature
2 degrees C
of Set Temp. |
| Low Temperature Alarm | Yes - Distal
Temperature