(218 days)
Not Found
No
The summary describes heated wire breathing circuits and a heated humidifier, with no mention of AI or ML capabilities.
No
This device is a heated wire circuit used with a humidifier for breathing circuits during anesthesia or mechanical ventilation. It supports existing therapeutic interventions (anesthesia, mechanical ventilation) but is not, by itself, a device that directly treats a medical condition.
No
The device is described as heated wire circuits for breathing, used with a humidifier for patients undergoing anesthesia or mechanical ventilation. Its purpose is to facilitate breathing and humidification, not to diagnose medical conditions.
No
The device description explicitly states "Heated wire circuits" and "Various configurations of anesthesia, volume ventilator circuits and heated limbs," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "breathing circuits for patients under going anesthesia or mechanical ventilation." This describes a device used on a patient to facilitate breathing, not a device used to test samples from a patient to diagnose a condition.
- Device Description: The description mentions "anesthesia, volume ventilator circuits and heated limbs." These are components of a breathing support system, not diagnostic tools.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for direct patient support during medical procedures, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.
Product codes
73 BZE
Device Description
Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.
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, pediatric and neonates.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(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" written in a stylized font. Above the text is a stylized letter "Q" made up of thick, black lines. The letter "Q" is designed in a way that it looks modern and abstract. A horizontal line is present under the text.
JAN 14 1997
Non-Confidential Summary of Safety and Effectiveness June 3, 1996
page 1 of 3
Marquest Medical Products, Inc. Tel - (303) 790-4835 Fax - (303) 799-0210 11039 East Lansing Circle Englewood, CO 80112 Official contact: Tom Dielmann, Director, Regulatory Affairs / Quality Assurance Proprietary or Trade Name: Heated wire breathing circuits and limbs Common/Usual Name: Heated wire breathing circuits and limbs Classification Name: 73 BZE - Breathing systems heater w/wo controller (not humidifier or nebulizer) Subsection 868.5270 Breathing circuits for use with SCT 3000 Heated Humidifier Intended device: Predicate devices: Marquest SCT 3000 - K903138 Marquest (Intec) - Heated limb - K860941 Intertech ( SIMS) - K881231 Device description: Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.
Indicated use:
Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.
Targeted population:
Any patient utilizing the SCT 3000 heated humidifier. Adult, pediatric and neonates.
Environment of use: Hospital, anesthesia, ICU, respiratory therapy
page 4 of 37
1
Non-Confidential Summary of Safety and Effectiveness (continued)
June 3, 1996
page 2 of 3
Comparison to predicate devices:
| Attribute | Marquest
Heated Wire Circuits | Intertech / SIMS
Heated Wire Circuits |
|------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------|
| Use | | |
| Indicated for anesthesia | Yes | Yes |
| Indicated for respiratory therapy | Yes | Yes |
| Population - adult, pediatric,
neonate | 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 |
| Design | | |
| Various patient wye connectors | Yes | Yes |
| Breathing Tubes various lengths | Yes | Yes |
| Breathing Bags - various sizes | Yes | Yes |
| Single or dual heated wires | Yes | Yes |
| Anesthesia - rebreathing and
non-rebreathing styles | Yes | Yes |
| Volume ventilator - different styles
for ventilator manufacturers | Yes | Yes |
| Offered for ventilators without
internal exhalation valves | Yes | Yes |
| Packaged with other devices -
Filters, Face Mask,
Gas sampling lines, etc. | Yes | Yes |
| Attribute | Marquest
Heated Wire Circuits | Intertech / SIMS
Heated Wire Circuits |
| Materials
Utilize same materials as
standard breathing circuits
exempt from PMN | Yes | Yes |
| Performance Testing
Meets ASTM breathing systems
standard | Yes | Yes |
page 5 of 37
:
ﺤ
2
Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996
page 3 of 3
Comparison to predicate devices: (continued)
Differences
Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.
ﻌﺠﻤﻨ