INVACARE POLARIS EX CPAP, MODEL ISP3000

K031064 · Invacare Corp. · BZD · Mar 12, 2004 · Anesthesiology

Device Facts

• Record ID: K031064
• Device Name: INVACARE POLARIS EX CPAP, MODEL ISP3000
• Applicant: Invacare Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

Device Story

Invacare Polaris EX CPAP provides positive airway pressure therapy for adult patients with Obstructive Sleep Apnea. Device utilizes impeller blower to generate airflow; microprocessor-based control system monitors pressure via integrated sensor. Features exhalation unloading mechanism using single stepper motor valve to reduce breathing resistance. System includes flow generator, patient circuit, exhalation port, and optional humidifier. Operated in home or clinical settings; prescribed by physicians. Provides continuous positive airway pressure to maintain airway patency during sleep, improving patient respiratory function and sleep quality.

Clinical Evidence

Bench testing only.

Technological Characteristics

Impeller blower; microprocessor-based control system; pressure sensor; single stepper motor valve for exhalation unloading; 120V AC, 60Hz power; patient circuit with exhalation port; optional humidifier.

Indications for Use

Indicated for adult patients (>30 kg) with Obstructive Sleep Apnea (OSA) requiring positive airway pressure therapy.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Respironics REMstar Pro with C-Flex CPAP System (K021861)
• Invacare Polaris CPAP (K982242)

Submission Summary (Full Text)

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MAR 1 2 2004

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

#### Submitter's Information:

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

### Contact Person:

Janice K. Brownlee Director of Regulatory Affairs and Quality Systems

Manufacturing Location/Establishment Registration Number Invacare Corporation 2101 E. Lake Mary Blvd. Sanford, Florida 32773 Establishment Registration Number: 1031452

Name of Device: Invacare Polaris EX CPAP

Common or Usual Name: CPAP

#### Classification Name: Ventilator, Non-continuous (Respirator)

Predicate Device(s): Respironics REMstar Pro with C-Flex CPAP System (K021861, 6/19/02). Invacare Polaris CPAP (K982242, 01/27/1999)

#### Intended Use

The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

#### Similarities/Differences with the predicate device(s):

Similarities:

- Intended use is the same. All units are intended to provide positive । airway pressure therapy to adult patients
- । The REMstar Pro and the Polaris EX CPAP both have exhalation unloading features
- All units use an impeller blower as the source of positive pressure ।
- All units consist of a flow generator (blower), patient circuit, । exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz

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Differences:

- The Invacare Polaris CPAP EX differs from the Invacare Polaris -CPAP in that it has a single stepper motor valve as part of the exhalation unloading feature

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Public Health Service

MAR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031064

Trade/Device Name: Invacare Polaris EX CPAP Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: March 8, 2004 Received: March 9, 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 Federal Register.

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

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Page 2 - Ms. Brownlec

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 your 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,

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

510(k) Number (if known): K031064/S1

Device Name: Invacare Polaris EX CPAP

Indications for Use:

The intended use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30 kg) for treatment of Obstructive Sleep Apnea (OSA)

Signature

(Division Sigh-Off) (Livision Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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