HUMID-HEAT

K993773 · Hudson Rcj AB · BTT · Sep 13, 2000 · Anesthesiology

Device Facts

• Record ID: K993773
• Device Name: HUMID-HEAT
• Applicant: Hudson Rcj AB
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Humid-Heat™ is intended for use as an active respiratory humidifier to heat and humidify dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.

Device Story

Humid-Heat™ is an active respiratory humidifier for adult patients in intensive care or anesthesia. It receives dry breathing gases from a ventilator; pumps external water onto a wick within an HME; evaporates water via an electrical heater to provide physiologically optimized gases (37°C, 100% relative humidity). System components include supply unit, heater, temperature probe, HME, and water feed set. Operated via a four-button keypad (minute volume setting, start/stop, power). Device eliminates condensation in circuits, removes need for water traps or heated wires, and reduces water consumption. By preventing delivery of cool, dry gases, it mitigates thickened mucus and decreased cilia activity, supporting long-term ventilation.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 601-1), performance, and environmental testing. No clinical data provided.

Technological Characteristics

Active respiratory humidifier. Components: supply unit, heater, temperature probe, HME, water feed set. Principle: external water pumped onto wick, evaporated by electrical heater. Output: 37°C ± 2°C; 44 mg H2O/L (active), 30 mg H2O/L (passive). Compatible with volume and pressure-controlled ventilators. Keypad interface. Electrical safety per IEC 601-1.

Indications for Use

Indicated for adult patients under intensive care or anesthesia requiring mechanical ventilation via endotracheal tube, tracheostomy tube, or face mask to receive heated and humidified breathing gases.

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

• Fisher & Paykel Dual Servo Controlled Heated Respiratory Humidifiers (K913368)
• Fisher & Paykel MR850 (K983112)

Submission Summary (Full Text)

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# SECTION 2. SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Hudson RCI AB summary for the Humid-Heat™

| SUBMITTER'S NAME: | Hudson RCI AB (Formerly Louis Gibeck AB) |
|---------------------|-----------------------------------------------|
| ADDRESS: | Box 711<br>SE-194 27 Upplands Väsby<br>Sweden |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 612-574-1976 |
| FAX NUMBER: | 612-571-2437 |
| DATE OF SUBMISSION: | November 1, 1999 |

#### Identification of device 1.

Proprietary Name: Humid-Heat™ Common Name: Respiratory gas humidifier Classification Status: Class II per regulations 868.5450 Product Codes: 73 BTT

#### Equivalent devices 2.

Hudson RCI AB believes the Humid-Heat™ is substantially equivalent to Fisher & Paykel Dual Servo Controlled Heated Respiratory Humidifiers, cleared for marketing under 510(k) K913368.

#### Description of the Device ર્જ

Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal, tracheostomy tube or a face mask to adult patients under intensive care or anesthesia. Patients receive physiologically optimized breathing gases (37°C, 100% relative humidity) instead of the dry and cool breathing gases they would otherwise receive if connected directly to a ventilator. They thus avoid the thickened mucus, decreased cilia activity and secretions trapped in the lower airways that are often caused by exposure to cool, dry gases. By heating and humidifying the supplied breathing gases, Humid-Heat™ overcomes these problems and provides optimal conditions for long-term ventilation.

Heating and humidification take place close to the patient, thereby eliminating the problem of condensation in ventilator circuits. Humid-Heat™ does not require any water traps or heated wires and water consumption is reduced. Humid-Heat™ is suitable for use with volume and pressure-controlled ventilators.

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The Humid-Heat™ consists of five main components: the supply unit, the heater, the temperature probe, the HME and the water feed set. It is controlled with a keypad consisting of four buttons; up/down buttons to set the minute volume of the ventilator, start button, stop button, and the power switch.

#### Intended use 4.

The Humid-Heat™ is intended for use as an active respiratory humidifier to heat and humidify dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.

#### Technological characteristics, comparison to predicate device. ਪੰਜ

Like the predicate devices, the Humid-Heat™ is intended to add moisture to, and to warn, the breathing gases for administration to a patient.

| Characteristic | Predicate device: Fisher &<br>Paykel MR850, K983112 | Humid-Heat ™ |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To warm and add humidity to<br>gases delivered to patients<br>requiring mechanical<br>ventilation. | Same |
| Airway Temperature<br>output | 30-39° C marked<br>29-40° C actual | 37° C± 2° C |
| Moisture output | At least 30 mg H2O/L if<br>temperature of gas delivered<br>to patient is set to 37° C for a<br>given continuous flow. | 44 mg H2O/L active VT 800 ml<br>30 mg H2O/L passive VT 800 ml |
| Technical background | The warmth and moisture are<br>supplied by passing the<br>breathing gas over heated<br>water while the temperature<br>of the gas flowing through the<br>breathing circuit is<br>maintained by a heated wire. | The supply unit pumps external<br>water onto a wick in the HME.<br>The water on the wick is<br>evaporated by an electrical<br>heater. |
| Ventilator systems | Mechanical ventilation or<br>positive pressure breathing<br>assistance | Volume and pressure-controlled<br>ventilators |
| Passive humidification | Maximal 20 mg H2O/L | 30 mg H2O/L passive VT 800 ml |

Comparison table

#### 6. Discussion of performance testing.

An extensive collection of tests have been conducted and successfully completed, including electrical safety (IEC 601-1), performance and environmental testing.

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#### 7. Conclusion

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It is the conclusion of Hudson RCI AB that the Humid-Heat™ is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

1999 - 1999

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2000

Hundson RCI AB c/o Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, MN 55432

K993773 Re : Hudson RCI AB Humid-Heat™ Regulatory Class: II (two) Product Code: 73 BTT August 17, 2000 Dated: August 18, 2000 Received:

Dear Ms. Bundy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is che device foreioned (for the indications for use stated in the enclosure) to legally marketed predicate 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 In actoration with anoou therefore, market the device, subject to the general controls provisions of the Act. The general controls enc general 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 II yours 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this conse 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 - Ms. Constance G. Bundy

This letter will allow you to begin marketing your device as described inis lecter will arrow you co icention. The FDA finding of substantial in your 510 (x) promainsice to a legally marketed predicate device equivalence of your device of a region and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you destre bpooriis and additionally 809.10 for in vitro reguration (=vices), please contact the Office of Compliance at Graghosere devices // plonally, for questions on the promotion and (Jor) 53 1010. Hauter, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, (901) 37 1000 by reference to premarket notification" (21 CFR 807.97). firstranding by rereation on your responsibilities under the Act may ocher general information of Small Manufacturers Assistance at its be obtained from the 22138-2041 or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James B. Dillard III
Director

Directbr Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

## B. INDICATIONS FOR USE

510(k) Number K993773

Device Name: Humid-Heat™

## Indications for Use:

The Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry rile fruinid-riour - 18 an actro respirator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.

(Please do not write below this line - continue on another page if needed)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993773 |

| Prescription Use | <div style="text-align:center;">✓</div> |
|----------------------|-----------------------------------------|
| (Per 21 CFR 801.109) | |
| OR | |
| Over the Counter Use | |