PIXI PEDIATRIC MASK

K102224 · Resmed, Ltd. · BZD · Dec 10, 2010 · Anesthesiology

Device Facts

• Record ID: K102224
• Device Name: PIXI PEDIATRIC MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device. The Pixi Pediatric mask is: • to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) or bilevel therapy has been prescribed • intended for single-patient re-use in the home environment and single-patient re-use in the hospital/institutional environment

Device Story

Pixi Pediatric Mask is a vented nasal mask interface for CPAP or bilevel therapy. Device channels airflow from a positive pressure source to patient's nose; held in place by adjustable headgear. Used in home or hospital/institutional environments by pediatric patients aged 2-7. Mask incorporates vent holes to flush CO2. Connects to standard air delivery hoses via conical connectors. Constructed from molded plastic, silicone elastomer, and fabric/nylon headgear. Device is prescription-only and intended for single-patient re-use.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included physical and functional deadspace, assembly integrity, material biocompatibility (ISO 10993-1), cleaning/transport/storage validation, and pressure-flow/flow-impedance characteristics. CO2 performance demonstrated to be substantially equivalent to predicate.

Technological Characteristics

Materials: molded plastic, silicone elastomer, fabric/nylon headgear (ISO 10993-1 compliant). Interface: silicone elastomer. Connectivity: standard conical connectors for air delivery hose. Features: integrated vent holes for CO2 flushing. Form factor: pediatric nasal mask with adjustable headgear.

Indications for Use

Indicated for children aged 2 to 7 years prescribed CPAP or bilevel therapy for noninvasive airflow delivery.

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

• MiniMe Pediatric Mask (K090935)

Submission Summary (Full Text)

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**RESMED**

:!

:

K102224

Pixi Pediatric Traditional 510k

_____________________________________________________________________________________________________________________________________________________________________________

| Date Prepared | 3 August, 2010 | DEC 1 0 2010 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter | Ms. Tracey Bullivant | |
| Official Contact | Mr. David D'Cruz - V.P. US Medical and Regulatory Affairs<br>9001 Spectrum Center Boulevard, San Diego, CA 92123<br>Tel: [phone] | |
| Device Trade Name | Pixi™ Pediatric Mask | |
| Device Common Name/<br>Classification Name | Vented Nasal Mask;<br>Accessory to Noncontinuous Ventilator (IPPB) | |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) | |
| Predicate Devices | MiniMe Pediatric Mask (K090935) | |
| Description | The Pixi Pediatric Mask provides an interface such that airflow<br>from a positive pressure source is directed to the patient's nose.<br>The mask is held in place with adjustable headgear that straps<br>the mask to the face. | |
| | The Pixi Pediatric Mask is safe when used under the conditions<br>and purposes intended as indicated in the labeling provided<br>with the product. | |
| | The Pixi Pediatric Mask is a prescription device supplied non-<br>sterile. | |
| Intended Use | The Pixi Pediatric Mask channels airflow noninvasively to a<br>patient from a continuous positive airway pressure (CPAP) or<br>bilevel device. | |
| | The Pixi Pediatric Mask is:<br>• to be used by children aged between 2 and 7 for whom<br>continuous positive airway pressure (CPAP) or bilevel<br>therapy has been prescribed<br>• intended for single-patient re-use in the home environment<br>and single-patient re-use in the hospital/institutional<br>environment | |
| Technological<br>Characteristics | The new device provides a seal to the patient's face via a<br>silicone elastomer interface whereas the predicate mask uses<br>an alternative elastomer. | |
| | Both the masks incorporate vent holes to provide continuous air<br>leak to flush out and minimize the amount of CO2 re-breathed<br>by the patient. The design of the mask components in the new<br>mask is such that the incorporation of these vent-holes does not<br>interfere with the intended performance of the mask. | |
| | Both masks connect to a conventional air delivery hose | |

3 August, 2010

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RESMED

between the mask and the positive airway-pressure source via standard conical connectors. The new device is constructed using molded plastic and silicone components and fabric / nylon headgear. All the components are fabricated using materials deemed safe (ref: ISO 10993-1). The main differences between the new device and the predicate is in the components, their design/geometry and how individual components interface with each other. Non-Clinica! Performance Bench testing of the physical and functional deadspace was Testing conducted on both the new and predicate devices to demonstrate that the mask design provides adequate venting. The new device has undergone assembly integrity testing to demonstrate mechanical integrity of the mask during normal use and reasonable abuse scenarios, as well as material safety testing to demonstrate biocompatibility of components. The mask has also been subjected to bench testing to validate cleaning, transport and storage conditions, and to measure the pressure-flow and flow- impedance characteristics. Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new device. The CO2 performance of the new device has been Performance Data demonstrated to be substantially equivalent to the predicate. The new device, the Pixi Pediatric mask, is substantially Substantial Equivalence equivalent to the predicate device, the MiniMe Pediatric mask: Conclusion it has the same intended use; it is intended for a subset of the patient population; ﺘ it has similar technological characteristics; ー it does not raise new questions of safety and effectiveness;

- it is at least as safe and effective. .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black and appears against a white background. A period follows the word "Service".

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

RESMED Limited C/O Mr. David D'Cruz RESMED Corporation 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K102224

Trade/Device Name: Pixi™ Pediatric Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 18, 2010 Received: October 21, 2010

Dear Mr. D'Cruz:

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. 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 Eederal Register.

DEC 1 0 2010

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Page 2- Mr. D'Cruz

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.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 premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
fam 2 Rossetend
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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RESMED

K102224

Pixi Pediatric Traditional 510k

## Indication for Use

DEC 1 0 2010

510{k} Number (if known): Pixi™ Pediatric Mask Device Name: Indication for Use

The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device.

The Pixi Pediatric mask is:

- to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) � or bilevel therapy has been prescribed
- intended for single-patient re-use in the home environment and single-patient re-use in the . hospital/institutional environment

Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) (Part 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)

Page 1 of 1

3 August 2010

(Division Sign-Off) (Division Sign-Ult)
Division of Anesthesiology, General Hospital 14
Seneral Canated, Dental Devices Division of Anostrol, Dental Devices

1022

510(k) Number: