PIONEER U121 SERIES CPAP

K041823 · Merits Health Products Co., Ltd. · BZD · May 10, 2005 · Anesthesiology

Device Facts

• Record ID: K041823
• Device Name: PIONEER U121 SERIES CPAP
• Applicant: Merits Health Products Co., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

Device Story

Pioneer U121 Series CPAP is a home-use device for Obstructive Sleep Apnea (OSA) treatment. Device consists of motor-driven blower and microprocessor-based control system. Air is drawn through filter, pressurized by blower, and delivered to patient via 22 mm flexible tubing and standard nasal mask with exhaust port. Microprocessor monitors motor speed to regulate delivered air pressure. Device is operated by patient in home environment. Output is continuous positive air pressure to upper airway to maintain patency. Device does not provide patient monitoring or life support functions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, performance specifications, and bench testing confirming the device meets specifications.

Technological Characteristics

Motor-driven blower; microprocessor-based control system; 22 mm internal diameter flexible tubing; standard nasal mask with exhaust port; AC power source. Technology is established; no specific materials or standards cited.

Indications for Use

Indicated for adult patients suffering from Obstructive Sleep Apnea (OSA). Used in the home setting to deliver continuous positive airway pressure to the upper airway. Not for life support; no patient monitoring capabilities.

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

• Invacare Polaris CPAP System (K982242)

Submission Summary (Full Text)

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K041823

## MAY 1 0 2005

### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

### "510(k) SUMMARY"

| 9.1 Trade/Proprietary Name: | Pioneer U121 Series CPAP |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9.2 Common/Usual Name: | CPAP(Continuous Positive Airway Pressure)<br>and the control control control controlled to the consideration of the consideration of the consistent of the contribution of the contribution of the contribution of the cont |

- 9.3 Classification Name:
Ventilator, Noncontinuous (Respirator)

#### Comparison to Currently Marketed Devices 9.4

The Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the Invacare Polaris CPAP System (K982242).

#### 9.5 Device Description

The Pioneer U121 Series CPAP operates using standard AC Power from a wall outlet. This U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motordriven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit.

The pressurized air is delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. This device only requires minimal cleaning and periodic dealer service checks to ensure optimum performance.

#### 9.6 Indications for Use

The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

#### Technological Characteristics 9.7

This Pioneer U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motor-driven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit. The microprocessor controls the pressure of air delivered by monitoring the speed of motor-driven blower. This technology is well established and has been used in other legally marketed products. There are no major technological differences.

#### Performance Data 9.8

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

#### 9.9 Conclusion

Based on the design, performance specifications and testing and intended use, the Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the currently marketed device.

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MAY 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Chao Merits Health Products Company Limited 9 Road 36, Taichung Industrial Park Taichung, TAIWAN, R.O.C.

Re: K041823

Trade/Device Name: Pioneer U121 Series CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 18, 2005 Received: April 21, 2005

Dear Mr. Chao:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have to rown a your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to devices that has the Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval upprovision (1 the Act. The general controls provisions of the Act include controls provibrons of the sixtration, 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 (FMR), it may be subjoct to back adding Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chao

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 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/industry/support/index.html.

Sincerely yours,

SM Schui Om,D.

Chiú 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

K041823 * 10(k) File Number:

Merits Health Products Pioneer U121 Series CPAP Device Name:

Indications For Use:

The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

ﺒ

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ques Sul

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

510(k) Number: K0918

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