LAMIN AIR

K080516 · Remgenic, LLC · BZD · Jun 23, 2008 · Anesthesiology

Device Facts

• Record ID: K080516
• Device Name: LAMIN AIR
• Applicant: Remgenic, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 23, 2008
• 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 bilevel systems used in the treatment of adult OSA and / or ventilatory support.

Device Story

LaminAir CPAP nasal mask is a patient interface accessory for CPAP and bi-level systems; used in hospitals, homes, sub-acute care settings, and sleep labs. Device delivers positive airway pressure to patients; features three sizes of nasal inserts, integral fixed leak port, and headgear for secure positioning. Designed to maintain seal and comfort during therapy. Operated by patient or clinician; output is the delivery of prescribed pressure to the airway. Benefits include effective treatment of OSA and ventilatory support.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Materials: Polypropylene, PVC tubing, silicone. Components: Nasal inserts (3 sizes), headgear, fixed leak port. Form factor: Nasal mask/pillow interface. Connectivity: None (mechanical accessory). Sterilization: Not specified.

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.

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

• InnoMed - Nasal Aire (K022465)

Submission Summary (Full Text)

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

K080516

RemGenic

# Non-Confidential Summary of Safcty and Effectiveness

Page 1 of 2 22-Feb-08

JUN 2 3 2008

| RemGenic LLC |
|------------------------|
| 3734 Lincoln Place Dr. |
| Des Moines, IA 50312 |

| | Tel - 515-339-7722 |
|----------------------------|----------------------------------------------------------------------|
| Official Contact: | Russell Bird |
| Proprietary or Trade Name: | LaminAir CPAP nasal mask |
| 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: | InnoMed - Nasal Aire K022465 |

#### Device Description:

The proposed nasal 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 inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment

| Indications for 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 and Multi-patient, multi-use |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings, sleep labs |
| Contraindications: | None |

. ﺔ ﺍﻟ

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-Feb-08

## Comparative table:

| Features | Predicate InnoMed<br>Nasal Airc<br>K022465 | Proposed Device |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | An accessory to positive pressure<br>ventilation devices for patients<br>suffering from OSA requiring positive<br>pressure breathing therapy (i.e. CPAP,<br>bi-level) | A patient interface accessory for use with<br>CPAP and bi-level systems used in the<br>treatment of adult OSA and / or ventilatory<br>support. |
| Environment of Use | Home, Hospital, Sub-acute Institutions,<br>Sleep labs | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient, multi<br>use<br>Multi-patient, multi-<br>use | Yes under K022465 clearance | Yes |
| Multiple sizes of nasal<br>cushions | Yes - five | Yes - three |
| Components | Headgear<br>Nasal prongs<br>Tubing<br>Connector | Headgear<br>Nasal prongs<br>Tubing<br>Connectors |
| Dead space | Nasal pieces - 5 to 18 ml | Nasal piece - largest 23 ml |
| Fixed leak port | Yes | Yes |
| Materials | Polypropylene<br>PVC tubing<br>Silicone | Polypropylene<br>PVC tubing<br>Silicone |

## Differences Between Other Legally Marketed Predicate Devices:

.

The proposed device is viewed as substantially equivalent to the predicate device, K022465.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 3 2008

RemGenic LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K080516

Trade/Device Name: LaminAir CPAP Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 13, 2008 Received: May 14, 2008

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 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 – 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 (OS) 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,

Susan Runnes
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:

K080516

Device Name: LaminAir CPAP nasal mask

Indications for Use:

A patient interface accessory for use with CPAP and bilevel systems used in the treatment of adult OSA and / or ventilatory support.

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)

# #

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

510(k) Number: K080516