(218 days)
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.
The humidifier chambers offered for use with the SCT 3000.
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- Adult low flow humidifier chamber
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- Adult extended run humidifier chamber
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- Pediatric low compressible volume humidifier chamber
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- Adult hi flow humidifier chamber
This looks like a 510K submission for humidifier chambers, not an AI/ML medical device. As such, the requested information about acceptance criteria, clinical study designs, ground truth establishment, and AI performance metrics is not applicable to this document.
The document states:
- "Performance Testing: None applicable" - This explicitly indicates no specific performance tests were deemed necessary beyond comparison to predicate devices, which implies no formal clinical studies or detailed performance metrics were conducted or required.
- The entire submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than novel performance claims.
Therefore, I cannot extract the requested information from this document.
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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 CircleEnglewood, CO 80112 | Tel - (303) 790-4835Fax - (303) 799-0210 |
|---|---|
| Official contact: | Tom Dielmann, Director, Regulatory Affairs / Quality Assurance |
| Proprietary or Trade Name: | Accessories for Marquest SCT 3000 Heated HumidificationSystem |
| 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 - K903138HPD Medical - K864173Fisher & Paykel - K850647, K862923, K934140 |
| Device description: | The humidifier chambers offered for use with the SCT 3000. |
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- 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
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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 | Marquesthumidifier chambers | HPD Medical / Fisher & Paykelhumidifier chambers |
|---|---|---|
| UseIntended for use inanesthesia | Yes | Yes |
| Intended for use inrespiratory therapy | Yes | Yes |
| Indicated for use withheated humidifiers | Yes | Yes |
| Indicated for use with onlyspecific manufacturers heatedhumidifier | Yes | Yes |
| Indicated for single use | Yes | Yes |
| Indicated for use withadult and pediatric cases | Yes | Yes |
| DesignClear housing | Yes | Yes |
| 15 /22 mm fittings forconnection to circuit | Yes | Yes |
| Different sizes | Yes | Yes |
| Water inlet ports | Yes | Yes |
| Labeling delineating waterlevels on chamber | Yes | Yes |
| MaterialsPolystyrene /polycarbonate housing | Yes | Yes |
page 4 of 51
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Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996
page 3 of 3
Comparison to predicate devices: (continued)
| Attribute | Marquesthumidifier chambers | HPD Medical / Fisher & Paykelhumidifier 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.
§ 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).