REMREST HEATED HUMIDIFIER

K050990 · Medical Industries America, Inc. · BTT · May 2, 2005 · Anesthesiology

Device Facts

• Record ID: K050990
• Device Name: REMREST HEATED HUMIDIFIER
• Applicant: Medical Industries America, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.

Device Story

RemRest Heated Humidifier is a respiratory accessory for CPAP devices; warms and humidifies breathing gases. Operates via conductive heating plate warming a water reservoir; air passes over water. Used in home, hospital, and institutional settings; operated by patients or clinicians. Provides heated/humidified air to patient airways to mitigate drying/irritation associated with CPAP therapy. Device connects between CPAP unit and patient interface. Includes thermal cutoff for safety. Output is humidified air stream; healthcare providers use device to improve patient comfort and compliance with CPAP therapy.

Clinical Evidence

No clinical data provided; bench testing only. Device performance specifications (temperature range 29.4°C to 65°C, humidity output 30 mg H2O/l @ 25 lpm, pressure drop 0.5 cm H2O @ 40 lpm) demonstrate equivalence to predicate technology.

Technological Characteristics

Heated plate humidifier; 400 ml water capacity. Power: 100-240 VAC. Temperature control settings 1-5 (29.4°C to 65°C). Includes thermal cutoff. Dimensions: 13.1" L x 8.4" W x 4.7" H; weight 2.5 lbs. dry. Standalone device for use with RemRest 900 series CPAP.

Indications for Use

Indicated for patients requiring CPAP therapy for treatment of Obstructive Sleep Apnea (OSA) who desire heated humidification to relieve airway dryness and irritation. No contraindications.

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

• Respironics - RemStar - K010263

Reference Devices

• Fisher & Paykel - HC 150 - K003973

Submission Summary (Full Text)

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#### Summary of Safety and Effectiveness 3.1

#### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 March 2, 2005

| Medical Industries America, Inc.<br>dba Evo Medical Solutions | |
|---------------------------------------------------------------|--------------------------------------------------------|
| 2636 – 289th Place | Tel:    [phone] |
| Adel, IA 50003-8021 | Fax:    [phone] |
| Official Contact: | Keith Theisen, Director of Engineering |
| Proprietary or Trade Name: | RemRest heated humidifier |
| Common/Usual Name: | Heated humidifier |
| Classification Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Predicate Devices: | Respironics - RemStar - K010263 |

# Device Description:

The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications:

Fisher & Paykel - HC 150 - K003973

| Size | 13.1" L x 8.4" W x 4.7" H |
|----------------|--------------------------------------|
| Weight | 2.5 lbs. dry |
| Water capacity | 400 ml (1 2/3 cups) |
| Power | 100-240 VAC 50/60Hz or 1.0 A max. |
| Heater setting | 1-5 (85°F to 149°F / 29.4°C to 65°C) |
| Humidity Range | 30 mg H2O/l @ 25 lpm |
| Pressure drop | 0.5 cm H2O @ 40 lpm |

#### Indications:

| Indications for Use -- | The evo Heated Humidifier is intended to warm and add<br>moisture to the breathing gases for administration to a patient. It<br>is used for patients requiring Continuous Positive Airway<br>Pressure (CPAP) therapy for the treatment of Obstructive Sleep<br>Apnea. The addition of heated humidification to this therapy<br>relieves the drying and irritating effects on the patient airways,<br>which may arise from the use of a CPAP system. Use only with<br>RemRest 900 series CPAP devices. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | Patients utilizing CPAP devices for OSA and desire to have<br>heated humidification |
| Environment of Use -- | Home, Hospital, and Institutional settings |

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### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 March 2, 2005

#### Comparison to Predicate Devices:

| | RemRest | Predicates |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Heated Humidifier | |
| Attributes | | |
| Indications for use | To warm and add moisture to the breathing<br>gases for administration to a patient. It is used<br>for patients requiring Continuous Positive<br>Airway Pressure (CPAP) therapy for the<br>treatment of Obstructive Sleep Apnea. The<br>addition of heated humidification to this<br>therapy relieves the drying and irritating effects<br>on the patient airways, which may arise from<br>the use of a CPAP system. | F&P - HC 150 - K003973<br><br>Respironics - RemStar with<br>humidifier - K010263<br><br>Same |
| Environments of use | Home, Hospital, Institutional | Same |
| Patient Population | Patients utilizing CPAP devices for OSA and<br>desire to have heated humidification | Same |
| Contraindications | None | Same |
| Technology | | |
| Method of heating | Heated plate | Yes |
| Temperature<br>controlled | Yes | Yes |
| Connects between<br>CPAP and patient | Yes | Yes |
| Thermal cutoff | Yes | Yes |

# Differences Between Other Legally Marketed Predicate Devices

There are no significant differences between the proposed device, RemRest Heated Humidifier, and the identified predicates.

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# Third Party Review Quality Assessment

| Section 1 – Submission Information | |
|------------------------------------|------------------|
| 510(k) No.: | K050990 |
| Third Party Organization: | Intertek / Artek |
| Third Party's Primary Reviewer(s): | Mel Devine |
| ODE/OIVD Division: | DAEID |
| Branch/Team: | ARDB |

| Section 2 – 510(k) Decision | |
|-----------------------------|-----------------------------------------|
| Third party recommendation: | SE x NSE ______ Other (specify): ______ |
| ODE/OIVD final decision: | SE x NSE ______ Other (specify): ______ |

| Section 3 – Assessment of Third Party Review | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------|----------------|
| Review Element | Rating (check one) | | |
| | Adequate | Minor Issue(s) | Major Issue(s) |
| a. Determination of device eligibility for third party review | x | | |
| b. Extent of pre-submission consultation with ODE/OIVD division | x | | |
| c. Organization and format of review documentation | x | | |
| d. Determination of 510(k) administrative completeness (screening review) | x | | |
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | x | | |
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | x | | |
| g. Rationale for conclusions and recommendation | x | | |
| h. Use of guidance documents and standards | x | | |
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | n/a | | |
| j. Scope of reviewer expertise and use of consulting reviewers | x | | |
| k. Other (specify): | | | |

Comments (explanation of ratings/issues): ___________________________________________________________________________________________________________________________________

Section 4 – ODE/OIVD Assessor Information

Assessed by: *Oalom* Date: *4/26/05* Tel. No.: *827 4479*

Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k).
DMC--Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Industries America, Incorporated C/O Mr. Ned E. Devine Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road, Boxborough, Massachusetts 01719 ·

Re: K050990

Trade/Device Name: RemRest Heated Humidifier Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: April 18, 2005 Received: April 19, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed yoursed the device is substantially equivalent (for the icierciccu above and have acteriminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conments of provises that have been reclassified in accordance with the provisions of Amendinents, or to de rouses and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval uppreation (The Act. The general controls provisions of the Act include controls provisions of the gistration, 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 If your device is classified (500 additional controls. Existing major regulations affecting (PMA), it may oc subject to sach adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can oc round in the announcements concerning your device in the Federal Register.

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# Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements moan mat I DA mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal business requirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 001), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon you be objection.
premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific ach of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Synette Michie Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use 3.3

Page 1 of 1

| 510(k) Number: | K050990 (To be assigned) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | RemRest Heated Humidifier |
| Indications for Use: | The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings. |

Prescription Use XX (Per CFR 801.109)

:

or

Over-the-counter use

# Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign

Division of ----------Infection Control. Duntal De Cests

510(k) Number...