CPAP NASAL MASK WITH PILLOWS

K071773 · Lifesource · BZD · Sep 12, 2007 · Anesthesiology

Device Facts

• Record ID: K071773
• Device Name: CPAP NASAL MASK WITH PILLOWS
• Applicant: Lifesource
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use. Environment of use - hospital, sub-acute institutions, sleep laboratories and home

Device Story

CPAP nasal mask with pillows; patient interface accessory for CPAP/bi-level systems. Components include headgear, shell/interface, and three sizes of nasal pillows. Features integral fixed leak port. Used in hospitals, sub-acute institutions, sleep labs, and home settings. Device maintains seal and position to deliver prescribed pressure (3-18 cm H2O) to patient airway. Healthcare provider selects mask size for patient; patient wears interface during sleep/therapy. Benefits include improved seal, comfort, and consistent therapy delivery for OSA treatment.

Clinical Evidence

Bench testing only. Comparative testing performed for flow vs. leak/pressure and dead space measurements. No clinical data provided.

Technological Characteristics

Materials: Polycarbonate and silicone (biocompatible per ISO 10993-1). Design: Nasal mask with pillows, headgear, and integral fixed leak port. Pressure range: 3-18 cm H2O. Dead space: 26 ml (interface), 2-4 ml (pillows). Mechanical device; no software or electronics.

Indications for Use

Indicated for adult patients with obstructive sleep apnea (OSA) or those requiring ventilatory support via CPAP or bi-level systems. No contraindications reported.

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

• Puritan Bennett - ADAM - K900164

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 – 510(k) Summary

K071773

LifeSource

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 4-Sep-07

| LifeSource<br>12621 W. 121st Terrace<br>Overland Park, KS 66213 | Tel - 913-681-9201 | SEP 12 2007 |
|-----------------------------------------------------------------|----------------------------------------------------------------------|-------------|
| Official Contact: | Pamela Squire | |
| Proprietary or Trade Name: | CPAP nasal mask with pillows | |
| Common/Usual Name: | Patient interface for use with CPAP systems | |
| Classification Name: | Ventilator, non-continuous (respirator), accessory<br>BZD - 868.5905 | |
| Device: | CPAP nasal mask with pillows | |
| Predicate Devices: | Puritan Bennett - ADAM - K900164 | |

#### Device Description:

The proposed nasal pillow patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

- . Three (3) sizes of nasal pillows to assure a good fit
- Integral fixed leak port, identical to the predicate .
- . Headgear for attachment

| Indications for Use: | A patient interface accessory for use with CPAP and bi-level<br>systems used in the treatment of adult OSA and / or ventilatory<br>support. Single patient, multi-use.<br><br>Environment of use – hospital, sub-acute institutions, sleep<br>laboratories and home |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
| Contraindications: | None |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 4-Sep-07

### Comparative table:

| Features | Predicate ADAM<br>K900164 | Proposed Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | A patient interface accessory for use<br>with CPAP and bi-level systems<br>used in the treatment of adult OSA<br>and / or ventilatory support. | A patient interface accessory for use<br>with CPAP and bi-level systems used in<br>the treatment of adult OSA and / or<br>ventilatory support. |
| | Not listed but typical of CPAP<br>patient interface devices | |
| Environment of Use | Hospital, sub-acute institutions,<br>sleep laboratories and home | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient,<br>Multi-use | Yes | Yes |
| Components | Headgear<br>Shell / Interface<br>Nasal pillows | Headgear<br>Shell / Interface<br>Nasal pillows |
| Dead space | Interface – 26 ml<br>Pillows – 2 to 4 ml | Interface – 26 ml<br>Pillows – 2 to 4 ml |
| Fixed leak port | Yes | Yes |
| Deliverable pressure<br>range | Not provided | Typical 3 to 18 cm H2O |
| Materials | Polycarbonate<br>Silicone | Polycarbonate<br>Silicone<br>Biocompatibility per ISO 10993-1 |
| Comparative testing<br>for safety and<br>efficacy | | Flow vs. Leak / Pressure<br>Dead space |

# Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate device, K900164.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three lines that form a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeSource C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134

SEP 1 2 2007

Re: K071773

Trade/Device Name: CPAP Nasal Mask with Pillows Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 27, 2007 Received: August 28, 2007

Dear Mr. Dryden:

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 proval of 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 offecting 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.

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#### Page 2 - Mr. Dryden

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.

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 Statement

### Page 1 of 1

| 510(k) Number: | K071773 (To be assigned) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CPAP Nasal mask with pillows |
| Indications for Use: | A patient interface accessory for use with CPAP and bi-<br>level systems used in the treatment of adult OSA and / or<br>ventilatory support. Single patient, multi-use. |
| | Environment of use - hospital, sub-acute institutions, sleep<br>laboratories and home |

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

Nul I. Page 9/10/07

(Civision Sign-Off) (Civision Sign-Old)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: