INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

K031176 · Invacare Corp. · BTT · Mar 25, 2004 · Anesthesiology

Device Facts

• Record ID: K031176
• Device Name: INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
• Applicant: Invacare Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA). The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

Device Story

Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP system. Device adds moisture to the patient circuit to relieve airway drying and irritation caused by CPAP therapy. Used in home settings by adult patients (>30 kg) diagnosed with Obstructive Sleep Apnea. Device improves patient comfort during CPAP treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Heated humidifier accessory for CPAP systems. Provides moisture to the patient circuit. Designed for home use with the Invacare Polaris EX CPAP.

Indications for Use

Indicated for adult patients (>30 kg) diagnosed with Obstructive Sleep Apnea (OSA) using the Invacare Polaris EX CPAP system in a home setting.

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 Heated Humidifier (K012633)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS Invacare Polaris EX Heated Humidifier

| Submitter's Information: | Invacare Corporation<br>One Invacare Way<br>Elyria, Ohio 44036<br>Phone: [phone]<br>Facsimile: [phone] |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Janice Brownlee<br>Director, Regulatory Affairs |
| Name of Device: | Invacare Polaris EX Heated Humidifier |
| Common or Usual Name: | Heated Humidifier |
| Classification Name: | Humidifier, Respiratory Gas, (Direct Patient<br>Interface) |
| Predicate Device(s): | Respironics REMstar Heated Humidifier<br>(K012633, 2/28/02). |

### Intended Use

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA). The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

## Device Description

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort. The addition of heated humidification relieves the drying and irritating effects on the patient airways, which may result from the use of a CPAP system.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing health and human services.

Public Health Service

MAR 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Invacare Corporation Ms. Janice Brownlee Director, Regulatory Affairs One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125

Re: K031176

Trade/Device Name: Invacare Polaris EX Heated Humidifier, Model ISP4000 Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: March 16, 2004 Received: March 23, 2004

Dear Ms. Brownlee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (.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 Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the light a Register.

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Page 2 - Ms. Brownlee

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office 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 Division 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/dsma/dsmamain.html.

Sincerely yours,

Clus
Chris Liu, Ph.D.

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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#### 510(k) Number (if known): K031176

Device Name: Invacare Polaris EX Heated Humidifier

#### Indications For Use:

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

GHAWthl

on of Anesthesiology, General Hospital, Infection Control, Dental Dev

510(k) Number:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)