RESMED MERIDIAN MASK

K050142 · Resmed, Ltd. · BZD · Mar 1, 2005 · Anesthesiology

Device Facts

• Record ID: K050142
• Device Name: RESMED MERIDIAN MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Meridian Nasal Mask is intended for Single Patient multi-use by adult patients (>66lb/30Kg) prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinics and/or home environments.

Device Story

Nasal mask interface for CPAP or bilevel ventilation; covers nose; connects via tubing to airflow generator. Used in hospitals, clinics, or home environments by patients. Non-invasive delivery of positive airway pressure to lungs. Single-patient, multi-use accessory. Healthcare provider prescribes therapy; patient wears mask to receive treatment for respiratory conditions. Benefits include non-invasive respiratory support.

Clinical Evidence

Bench testing only. Performance testing derived from risk analysis conducted to ensure design input requirements met. Materials biocompatibility testing performed per ISO 10993 standards.

Technological Characteristics

Nasal mask interface; non-invasive; single-patient multi-use. Materials compliant with ISO 10993. Connects to CPAP/bilevel devices via tubing. No electronic components or software.

Indications for Use

Indicated for adult patients (>66lb/30Kg) requiring CPAP or bilevel positive airway pressure therapy in hospital, clinic, or home settings.

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

• Modular Mask (K961783)

Submission Summary (Full Text)

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K050142

MAR 1 - 2005

## 510(k) SUMMARY—Meridian Mask

| Submitter Name: | ResMed Ltd |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 97 Waterloo Road, North Ryde NSW 2113, Australia |
| Contact Person: | David D'Cruz, VP Regulatory & Clinical Affairs US |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | January 20, 2005 |
| Device Trade Name: | ResMed Meridian Mask |
| Name/<br>Device<br>Common<br>Classification Name: | Nasal Mask |
| Predicate Devices: | K961783 Modular Mask -- cleared as part of the VPAP II ST<br>system |
| Device Description: | The Meridian Mask is a respirator mask covering the nose. It is<br>a patient interface accessory to CPAP and bilevel devices for<br>use in hospitals, clinics and at home. |
| Intended Use: | The Meridian Nasal Mask is intended for Single Patient<br>multi-use by adult patients (>66lb/30Kg) prescribed<br>continuous positive airway pressure (CPAP) or bilevel<br>therapy in hospitals, clinics and/or home environments. |

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| | Meridian Mask |
|------------------------|---------------------------------------|
| Sponsor:<br>ResMed Ltd | Special 510(k) Premarket Notification |
| | |

### Device Technological Characteristics and Comparison to Predicate Device(s):

The Meridian Mask is strapped to the patient's face covering the nose. It is connected via tubing to a CPAP I rie Mendian Mask is brapped to the passure ventilation is thus applied to the lungs in a non-invasive way. The Meridian Mask is a single patient re-use medical accessory.

The Meridian Mask is a modified version of the Modular Mask (cleared by FDA in K961783). The Meridian I ho wondar mask to a mountially equivalent to the Modular Masks have the same intended Mask is snown to be substantially oquharent wisteristics and a similar manufacturing process.

#### Risk Analysis and Performance Data:

The risk analysis for the modified device is provided in section 5.2.1. Performance testing derived from the risk analysis is provided (section 5.2.2) in order to demonstrate safety and effectiveness of the Meridian Mask and ensure that the design input requirements have been met.

#### Materials Biocompatibility:

The materials used for the mask components, which contact the skin and/or the air-path, are compliant rrio hiatonale assamor in - Where materials have not been cleared for use by the FDA, the ISO 10993 reports have been included, section 5.4.

#### Conclusion:

The results of the performance data and materials biocompatibility testing show that the mask is substantially equivalent with the unmodified predicate mask.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three parallel lines forming its body and wings. The eagle is facing left. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Public Health Service

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed, Limited C/O Mr. David D'Cruz Vice President, Regulatory & Clinical Affairs US ResMed, Corporated 14040 Danielson Street Poway, California 92064-6857

Re: K050142

Trade/Device Name: Meridian Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 20, 2005 Received: January 24, 2005

Dear Mr. D'Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosare) (3 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are exactions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Costience Act (71ct) that do not require of the general controls provisions of the Act. The r ou may, mercrore, mans. of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is clusined (600 as 100 m) and or regulations affecting your device can may be subject to suel addrents esulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ents concerning your device in the Federal Register.

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#### Page 2 -- Mr. D'Cruz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuance or our device complies with other requirements of the Act that FDA has made a decemmation and Journer Federal agencies. You must of any Pederal Statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, morable, and manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regarding (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) I ills lence with anow you to oegin maineg of substantial equivalence of your device to a legally prematicated predicated. The PDF intellight 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 If you desire specific at no 10. 90. [phone]. Also, please note the regulation entitled, Connaol the Office of Coase to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Suza Kunre

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): Ko50142

Meridian Mask Device Name:

Indications For Use:

The Meridian Nasal Mask is intended for Single Patient multi-use by adult patients (>66lb/30Kg) The Mendlan Nasal Mask is intended for Single Fatish Make and Market therapy in hospitals, clinics and/or home environments.

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)

Cuyberom

Theor Clan Off Infrancof Anestheriology, General Hospital, modion Control, Dental Devices 10:21 Number

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