HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER

K962220 · Marquest Medical Products, Inc. · BZE · Jan 14, 1997 · Anesthesiology

Device Facts

• Record ID: K962220
• Device Name: HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
• Applicant: Marquest Medical Products, Inc.
• Product Code: BZE · Anesthesiology
• Decision Date: Jan 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.

Device Story

Heated wire breathing circuits and limbs designed for use with SCT 3000 Heated Humidifier; various configurations for anesthesia and volume ventilation; includes breathing tubes, patient wye connectors, and breathing bags; single or dual heated wire options; available for ventilators with or without internal exhalation valves; may be packaged with accessories like filters, face masks, and gas sampling lines. Used in hospital settings (anesthesia, ICU, respiratory therapy) by clinicians. Provides heated, humidified gas to patients to maintain airway moisture and temperature during mechanical ventilation or anesthesia. Single-use device.

Clinical Evidence

Bench testing only. Device meets ASTM breathing systems standards.

Technological Characteristics

Heated wire breathing circuits; single or dual wire configurations; various lengths and styles for anesthesia and volume ventilators. Materials identical to standard breathing circuits (exempt from PMN). Complies with ASTM breathing systems standards. Single-use.

Indications for Use

Indicated for patients, including adults, pediatrics, and neonates, undergoing anesthesia or mechanical ventilation requiring use of the SCT 3000 heated humidifier.

Regulatory Classification

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.

Predicate Devices

• Marquest SCT 3000 (K903138)
• Marquest (Intec) Heated limb (K860941)
• Intertech (SIMS) (K881231)

Submission Summary (Full Text)

{0}

JAN 14 1997
The New Marq of Excellence
K962220

# 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:** 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<br/>(not humidifier or nebulizer)<br/>Subsection 868.5270

**Intended device:** Breathing circuits for use with SCT 3000 Heated Humidifier

**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 | 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 |

page 5 of 37

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page 6 of 37
# Non-Confidential Summary of Safety and Effectiveness (continued)
June 3, 1996
page 3 of 3

## Comparison to predicate devices: (continued)

| 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 |

## Differences

Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.