MASKMEDIC CONCEPT NASAL MASK

K060067 · Maskmedic · BZD · Jul 14, 2006 · Anesthesiology

Device Facts

• Record ID: K060067
• Device Name: MASKMEDIC CONCEPT NASAL MASK
• Applicant: Maskmedic
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use.

Device Story

Maskmedic Concept Nasal Mask is a silicone elastomer nasal mask; interfaces with standard 16 mm ventilator tubing via 22 mm terminal fitting; secured by neoprene harness. Used in medical facilities or home settings by patients requiring CPAP or bi-level positive airway pressure therapy. Device delivers pressurized air from external ventilator to patient airway. Provides non-invasive respiratory support. Performance verified via comparative testing against predicate; ensures stability under extreme environmental conditions and cleaning cycles.

Clinical Evidence

Bench testing only. Comparative performance testing demonstrated equivalence to the predicate device. Testing confirmed performance is maintained after cleaning and storage in extreme environmental conditions.

Technological Characteristics

Silicone elastomer nasal mask; neoprene harness; 16 mm ventilator tubing connection with 22 mm terminal fitting. Passive interface device; no energy source. Non-sterile. Mechanical design.

Indications for Use

Indicated for patients requiring CPAP, bi-level positive airway pressure, or non-continuous ventilation. Suitable for use in medical facilities or home settings. Intended for single-patient, multi-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

• Resmed Mirage Activa (K030798)

Submission Summary (Full Text)

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KO60067

# 510(K) SUMMARY

JUL 1 4 2006

Contact Person: Elaine Duncan Paladin Medical Inc. PO Box 560 Stillwater MN 55082 Tel: [phone] Fax: [phone]

| Brand Name: | Maskmedic Concept Nasal Mask |
|----------------------|--------------------------------------------|
| Common Name: | Nasal Mask |
| Classification Name: | Non-continuous ventilator (21CFR 868.5905) |
| Product Code: | BZD |
| Predicate Device: | Resmed Mirage Activa (K030798) |
| Date Prepared: | 21 December 2005; Revised July 10, 2006 |

### Description Of The Device:

The device is a silicone elastomer nasal mask composed of a moulded, form fitting face mask, connected to standard 16 mm ventilator tubing via a standard 22 mm terminal fitting and fitted with a neoprene harness.

### Indications For Use:

The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multo-use.

Summary of Equivalence: The Maskmedic Concept Nasal Mask is substantially equivalent to the Resmed Mirage Activa (K030798). Both the Maskmedic Concept Nasal Masy aqd the predicate devices are nasal masks suitable for use with currently marketed standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices.

The technical designs and manufacture are essentially identical to the predicate devices, being composed of a form fitting nasal mask and harness, and connected to 16 mm ventilator, cubing via a standard 22 mm terminal fitting. Comparative performance testing has demonstrated performance equivalent to the predicate device, and the performance of the device is not compromised by storage in extreme environmental conditions or after cleaning. A risk assessment concluded that there were no significant new safety concerns raised by the design of the Maskmedic Concept Nasal Mask.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

Maskmedic Pty. Ltd. C/O Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K060067

Trade/Device Name: Maskmedic Concept Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 10, 2006 Received: July 11, 2006

Dear Ms. Duncan:

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.

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 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. Duncan

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,

Judite Y. Michael Davis.

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): K060067:

Device Name: Maskmedic Concept Nasal Mask

Indications For Use:

The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

liuu Sylvain

on of Anesthesiology, General Hospital, non Control, Dental Device

Number: K066067

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