PILAIRO NASAL PILLOWS MASK

K120027 · Fisher & Paykel Healthcare Limited · BZD · Feb 23, 2012 · Anesthesiology

Device Facts

• Record ID: K120027
• Device Name: PILAIRO NASAL PILLOWS MASK
• Applicant: Fisher & Paykel Healthcare Limited
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The F&P Pilairo Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Nasal Pillows Mask is intended for single-patient adult use in the home and multiplepatient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Device Story

Pilairo™ Nasal Pillows Mask is a CPAP interface; conveys pressurized, potentially humidified, or oxygen-enriched air to nares. Device consists of external connector, frame, face seal, and single stretchable head strap. Seal inflates at nostril entrance and around nose. Used in home or clinical settings; operated by patient or healthcare provider. Oxygen pressure port accessory available for oxygen therapy or gas monitoring. Output is delivery of therapeutic air pressure to patient airway; facilitates CPAP/Bi-Level ventilation therapy. Benefits include non-invasive respiratory support for diagnosed patients.

Clinical Evidence

Bench testing only. Performance compared to Opus HC482; biocompatibility compared to Zest Nasal Mask. No clinical data presented.

Technological Characteristics

Nasal pillows mask; inflating seal mechanism; single stretchable head strap; oxygen pressure port accessory. Connectivity: connects to external CPAP/Bi-Level device. Materials: biocompatible materials (referenced to Zest mask). Form factor: single-size design.

Indications for Use

Indicated for adult patients diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment. Suitable for home or clinical use.

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

• Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask (K063036)
• Fisher & Paykel Healthcare Zest Nasal Mask (K083832)

Submission Summary (Full Text)

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## Section 5 - 510(k) Summary

FEB 2 3 2012

# Fisher & Paykel HEALTHCARE

15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: [phone] Facsimile: [phone] Website: www.fphcare.com

K120027

| Contact Person | Tina Mason |
|---------------------|-------------------------------------------------------------------------------------------------|
| Date Prepared | 19 December 2011 |
| Trade Name | Pilairo™ Nasal Pillows Mask |
| Common Name | Nasal Pillows Mask |
| Classification Name | Non continuous ventilator IPPB<br>(21 CFR § 868.5905, product code BZD) |
| Predicate Devices | K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal<br>Mask |
| | K083832 Fisher & Paykel Healthcare Zest Nasal Mask<br>(predicate for material biocompatibility) |

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#### 5.1 Description

The Pilairo™ is a CPAP nasal pillows mask which has an external connector attached to a frame and face seal that encloses the nasal airway entrance, held in place by a single head strap. The external connector allows connection to a CPAP device. The device conveys pressurised air to the nares. The air may also be humidified and/or oxygen enriched.

An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

#### 5.2 Intended Use

The F&P Pilairo Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Nasal Pillows Mask is intended for single-patient adult use in the home and multiplepatient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

#### 5.3 Technological Characteristics Comparison

The Pilairo™ Nasal Pillows Mask is very similar to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask. Both masks are intended for non-continuous ventilation via CPAP and Bi-Level therapy, and deliver CPAP gasses through the nose.

The main difference is the way the seal is achieved; the Pilairo™ Nasal Pillows Mask has a soft and thin seal which inflates and seals on the entrance of the nostrils and around the nose whereas the Opus HC482 seals only on the entrance of the nostrils. Other differences are that the Opus HC482 has a larger head gear with four adjustment points as opposed to the Pilairo™ Nasal Pillows Mask which has a single stretchable strap. The Pilairo™ Nasal Pillows Mask has only one size, whereas the Opus HC482 has 3 sizes (the Pilairo™ Nasal Pillows Mask is designed to fit a large proportion of the patient population with only one size). The Pilairo™ Nasal Pillows Mask has a larger dead space due to the way it achieves a seal around the nose.

#### 5.4 Non-Clinical Tests

Testing of the Pilairo™ Nasal Pillows Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the Zest™ Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the Pilairo™ Nasal Pillows Mask to the predicate mask. Copies of test reports are included in Appendix B.

#### 5.5 Conclusion

The comparison of features, performance, and intended use demonstrate that the Pilairo™ Nasal Pillows Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and materials in the Zest™ Nasal Mask for biocompatibility. The Pilairo™ Nasal Pillows Mask has been demonstrated to be safe and effective for CPAP and Bi-Level ventilation therapy.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is oriented horizontally. The text is likely part of a document or sign.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2.3 2012

Ms. Tina Mason Regulatory Affairs Engineer Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place East Tamaki Auckland 1701 New Zealand

Re: K120027

Trade/Device Name: Pilairo™ Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: January 3, 2012 Received: January 3, 2012

Dear Ms. Mason:

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 approvisions 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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### Page 2 – Ms. Mason

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 incall that I DA mas made a atutes and regulations administered by other Federal agencies. of the Act of ally I edelar statules and squirements, including, but not limited to: registration Tournast comply whill an the Hel brequirements, and 01); medical device reporting and ilsung (21 CF R F at 607); latesting (21 CFR 803); good manufacturing (reporting of medical device retail in the quality systems (QS) regulation (21 CFR Part 820); practice requirements as bet return in were manation control provisions (Sections 531-542 of ' the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you aceste spoolite au .fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Thiso; preace net 807.97). For questions regarding the reporting of promation networks under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tourinay of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hr for

Anthony D. Watson, B.S., M.S., M.B.A. 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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## Section 4 - Indications For Use Statement

K/20027 510(k) Number:

Device Name:

Pilairo™ Nasal Pillows Mask

Indications for Use:

The F&P Pilairo Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Nasal Pillows Mask is intended for single-patient adult use in the home and multiplepatient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Schulthe

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

510(k) Number: k 120027