WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER

K962223 · Marquest Medical Products, Inc. · BTT · Jan 14, 1997 · Anesthesiology

Device Facts

• Record ID: K962223
• Device Name: WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
• Applicant: Marquest Medical Products, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Jan 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Humidifier chambers designed for use with Marquest SCT 3000 heated humidifier system; hold water for gas humidification. Available in multiple configurations: adult low flow, adult extended run, pediatric low compressible volume, and adult high flow. Used in hospital, anesthesia, ICU, and respiratory therapy environments by clinicians. Features clear housing, 15/22 mm circuit fittings, water inlet ports, and water level markings. Provides humidified air to patients to support respiratory therapy.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established through comparative analysis of design, materials, and intended use against predicate devices.

Technological Characteristics

Materials: Polystyrene/polycarbonate housing, aluminum base/heating plate. Design: Clear housing, 15/22 mm circuit fittings, water inlet ports, water level labeling. Form factor: Multiple sizes (adult low/high flow, extended run, pediatric low compressible volume).

Indications for Use

Indicated for adult and pediatric patients requiring respiratory gas humidification via the SCT 3000 heated humidifier system in hospital, anesthesia, ICU, or respiratory therapy settings.

Regulatory Classification

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.

Predicate Devices

• Marquest SCT 3000 (K903138)
• HPD Medical (K864173)
• Fisher & Paykel (K850647)
• Fisher & Paykel (K862923)
• Fisher & Paykel (K934140)

Submission Summary (Full Text)

{0}

JAN 14 1997
The New Marq of Excellence
K962223

# Non-Confidential Summary of Safety and Effectiveness
June 3, 1996

page 1 of 3

| Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, CO 80112 | Tel - [phone]
Fax - [phone] |
| --- | --- |

**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)<br/>Subsection 868.5450

**Intended device:** Humidifier chambers for use with SCT 3000 Heated Humidifier

**Predicate devices:**
- Marquest SCT 3000 - K903138
- HPD Medical - K864173
- Fisher &amp; 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

{1}

Non-Confidential Summary of Safety and Effectiveness (continued)
June 3, 1996
page 2 of 3

Environment of use:
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}

page 5 of 51
# Non-Confidential Summary of Safety and Effectiveness (continued)
June 3, 1996

## 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.