(218 days)
Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.
Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heated Humidifier.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. Instead, the document describes "Heated wire breathing circuits and limbs" and compares them to predicate devices, focusing on attributes like intended use, design, and materials.
The document discusses "Performance Testing" by stating that the device "Meets ASTM breathing systems standard," but it doesn't provide details about:
- Specific acceptance criteria: What are the numerical or qualitative thresholds that define "meeting the ASTM standard" for this device?
- A study proving compliance: There's no description of a study (e.g., methodology, results, sample sizes) that demonstrates the device actually meets the ASTM standard.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or study types like MRMC or standalone. The document's purpose is to outline the device's characteristics and its similarity to existing devices for regulatory submission, not to detail the results of a performance study against specific acceptance criteria.
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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
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Non-Confidential Summary of Safety and Effectiveness (continued)
June 3, 1996
page 2 of 3
Comparison to predicate devices:
| Attribute | MarquestHeated Wire Circuits | Intertech / SIMSHeated Wire Circuits |
|---|---|---|
| Use | ||
| Indicated for anesthesia | Yes | Yes |
| Indicated for respiratory therapy | Yes | Yes |
| Population - adult, pediatric,neonate | Yes | Yes |
| Indicated for use withheated humidifiers | Yes | Yes |
| Indicated for use with onlyspecific manufacturers heatedhumidifier | 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 andnon-rebreathing styles | Yes | Yes |
| Volume ventilator - different stylesfor ventilator manufacturers | Yes | Yes |
| Offered for ventilators withoutinternal exhalation valves | Yes | Yes |
| Packaged with other devices -Filters, Face Mask,Gas sampling lines, etc. | Yes | Yes |
| Attribute | MarquestHeated Wire Circuits | Intertech / SIMSHeated Wire Circuits |
| MaterialsUtilize same materials asstandard breathing circuitsexempt from PMN | Yes | Yes |
| Performance TestingMeets ASTM breathing systemsstandard | Yes | Yes |
page 5 of 37
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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
§ 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).