SCT 3000 HEATED HUMIDIFIER

K970478 · Marquest Medical Products, Inc. · BTT · Jul 16, 1997 · Anesthesiology

Device Facts

• Record ID: K970478
• Device Name: SCT 3000 HEATED HUMIDIFIER
• Applicant: Marquest Medical Products, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Jul 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and/or heated gas being delivered to patients.

Device Story

SCT 3000 Heated Humidifier provides heated, humidified gas to patients with compromised upper airway humidification. Device uses breathing circuits and humidification chambers to deliver gas; prevents airway/lung damage from dry gas; maintains patient body temperature. Operated by healthcare professionals in hospitals, ICU, anesthesia, or home settings. System employs feedback loop using two thermistors for analog temperature input; Intel P80C32 microprocessor regulates heating elements via servo-controlled mechanism. Microprocessor manages heating element duty cycles (on/off) based on thermistor feedback. Device features diagnostic routines, safety alarms (high/low temperature), and visual displays. Output is controlled gas temperature and humidity. Benefits include stable patient temperature and protection of respiratory mucosa.

Clinical Evidence

Bench testing only. Device performance validated against safety standards including UL 544 (Medical and Dental Equipment), CSA C22.2 No. 125-M1984 (Electromedical Equipment), and ANSI Z79.9-1979 (Humidifiers and Nebulizers).

Technological Characteristics

Microprocessor-controlled (Intel P80C32) heated humidifier. Uses pass-over wick humidification. Feedback loop utilizes two thermistors for analog temperature sensing to control heating elements. Supports heated wire and no-wire breathing circuits. Safety features include high/low temperature alarms and diagnostic routines. Meets UL 544, CSA C22.2 No. 125-M1984, and ANSI Z79.9-1979 standards. Reusable device, supplied clean non-sterile.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring heated and/or humidified gas delivery via breathing circuits during anesthesia or respiratory therapy. Contraindications not specified.

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)
• Fisher & Paykel 730 Respiratory Humidifier (K913368)

Submission Summary (Full Text)

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K970478

# Non-Confidential Summary of Safety and Effectiveness
## February 5, 1997

JUL 16 1997
Page 1 of 5

Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, CO 80112

Tel - [phone]
Fax - [phone]

**Official Contact:**
Thomas W. Dielmann,
Vice President, Regulatory Affairs / Quality Assurance

**Proprietary or Trade Name:**
SCT 3000 Heated Humidifier

**Common / Usual Name:**
Heated Humidifier

**Classification Name:**
Respiratory Gas Humidifier
Subsection 868.5450

**Intended Device:**
SCT 3000 uses breathing circuits and humidification chambers to precisely control the delivery of gas temperature and humidity to the patient.

**Predicate Devices:**
Marquest SCT 3000 - K903138
Fisher & Paykel 730 Respiratory Humidifier - K913368

**Device Description / Indicated Use:**
Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable.

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# Non-Confidential Summary of Safety and Effectiveness (continued)
## February 5, 1997

page 2 of 5

### Device Description / Indicated Use (continued):

The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism.

The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.

### Targeted Population:

Adult, neonate, and pediatric

### Environment of Use:

Hospital, anesthesia, ICU, respiratory therapy, home healthcare

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page 3 of 5
# Non-Confidential Summary of Safety and Effectiveness (continued)
## February 5, 1997

### Comparison to Predicate Devices:

| Attribute | Marquest SCT 3000 | Fisher & Paykel MR 730 |
| --- | --- | --- |
| Use | | |
| Indicated for anesthesia | Yes | Yes |
| Indicated for respiratory therapy | Yes | Yes |
| Population - adult, pediatric, neonate | Yes | Yes |
| Indicated for use only with specific manufacturers heated circuits | Yes | Yes |
| Use with heated wire circuits | Yes | Yes |
| Use with no-wire circuits | Yes | Yes |
| Single patient use applications | Yes | Yes |
| Reusable circuits application | Yes | Yes |
| Heated wire operation | Yes | Yes |
| No-wire operation | Yes | Yes |
| For use with low flow chambers | Yes | Yes |
| For use with high flow chambers | Yes | Yes |

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# Non-Confidential Summary of Safety and Effectiveness (continued)
## February 5, 1997

### Comparison to Predicate Devices:

| Attribute | Marquest SCT 3000 | Fisher & Paykel MR 730 |
| --- | --- | --- |
| **Use (continued)**
For use with ventilators - with or without exhalation valves | Yes | Yes |
| For use with anesthesia systems | Yes | Yes |
| For use with various heated wire circuit configurations | Yes | Yes |
| For use with various no-wire circuit configurations | Yes | Yes |
| **Design**
Microprocessor controlled | Yes | Yes |
| High Temperature Alarm | Yes - Distal Temperature > 1 degree C of Set Temp. | Yes - Distal Temperature > 2 degrees C of Set Temp. |
| Low Temperature Alarm | Yes - Distal Temperature < 4 degrees C of Set Temp. | Yes - Distal Temperature < 4 degrees C of Set Temp. |

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page 5 of 5
Non-Confidential Summary of Safety and Effectiveness (continued)
February 5, 1997

| Attribute | Marquest SCT 3000 | Fisher & Paykel MR 730 |
| --- | --- | --- |
| Design (continued)
Maximum Heater Plate Temperature | 98 degrees C | 110 degrees C |
| Humidification Method | Pass Over Wick | Pass Over Wick |
| Alarm Mute | 1 Minute | 3 Minutes |
| Other Features | Pause Mode | Standby Mode |
| Safety Alarms | Yes - Visual Display of All Alarms | Yes - Visual Display or Error Code Display |
| Performance Testing
Meets UL 544, Medical and Dental Equipment / Patient Care Equipment | Yes | Yes |
| Meets CSA C22.2 No. 125-M1984, Electromedical Equipment | Yes | Yes |
| Meets ANSI Z79.9-1979, Humidifiers and Nebulizers for Medical Use | Yes | Yes |

## Differences

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

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Thomas W. Dielmann
Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, Colorado 80112

JUL 16 1997

Re: K970478
SCT 3000 Heated Humidifier
Regulatory Class: II (two)
Product Code: 73 BTT
Dated: May 28, 1997
Received: June 2, 1997

Dear Mr. Dielmann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas W. Dielmann

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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The New Marq of Excellence

Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, Colorado 80112 U.S.A.
303 790 4835 phone
303 799 0210 fax

Section # 3
Labeling (continued)

## C. Indications for Use Statement

Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number K970478 (to be assigned)

Device Name: SCT 3000 Heated Humidifier

Indications for Use: The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and/or heated gas being delivered to patients.

Targeted Population: Adult, neonate, and pediatric

Environment of Use: Hospital, anesthesia, ICU, respiratory therapy, home healthcare

Disposable / Reusable: Reusable - Supplied Clean Non-Sterile

Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970478

Prescription Use ☑ (per 21 CFR 801.109)
or
Over - The - Counter Use

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