NASAL-AIR CRITICAL CARE

K031896 · Innomed Technologies · MNS · Jan 14, 2004 · Anesthesiology

Device Facts

• Record ID: K031896
• Device Name: NASAL-AIR CRITICAL CARE
• Applicant: Innomed Technologies
• Product Code: MNS · Anesthesiology
• Decision Date: Jan 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Device Story

Nasal-Aire Critical Care is a single-use, disposable ventilator interface accessory. It consists of a soft silicone nosepiece with two exhaust ports and two nasal cannulae, connected to tubing that terminates in a Y-shaped coupling. The device connects to any positive pressure ventilator (CPAP or Bi-Level) via a standard 22mm port. It is used in hospital settings by clinicians to deliver noninvasive ventilation to adult patients. The interface facilitates the delivery of pressurized air (3-35 cm H2O) through the nasal passages. By providing a comfortable, size-customizable fit, it enables effective respiratory support, helping to treat respiratory insufficiency or obstructive sleep apnea. The device allows for pressure monitoring during therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by biocompatibility requirements and functional bench testing comparing the device to predicate systems regarding pressure delivery, material safety, and interface compatibility.

Technological Characteristics

Materials: Silicone (latex-free). Sensing/Actuation: Passive interface for positive pressure ventilation. Energy Source: None (powered by external ventilator). Dimensions: 7-inch tubing, various nosepiece sizes. Connectivity: Standard 22mm ventilator connection. Sterilization: Provided non-sterile. Software: None.

Indications for Use

Indicated for adult patients requiring noninvasive ventilation for respiratory insufficiency or obstructive sleep apnea, for use with CPAP or Bi-Level devices in hospital settings.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• BiPAP Vision Ventilatory Support System (K982454)
• Knightstar 330 Ventilator and Breeze Sleepgear Interface (K003075)
• Nasal-Aire II (K022465)
• Mirage Full Face Mask Series (K022465)

Submission Summary (Full Text)

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# JAN 1 4 2004

K031896

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENE

| Submitter's Name: | InnoMed Technologies Inc. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 506 Garden St. Greensburg PA 15601 USA |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Frank Pelc |
| Date: | October 17, 2003 |
| Proprietary Name: | Nasal-Aire Critical Care |
| Classification: | Class II, 1. CFR 868.5895 MNT 2. 868.5905 BZD |
| Classification Name: | 1. Ventilator, Continuous, Non-Life Supporting<br>2. Accessory to Continuous Ventilator |
| Predicate Devices: | K982454, BiPAP Vision Ventilatory Support System<br>and Whisper Swivel exhalation port as cleared with use<br>for this ventilator; Manufacturer: Respironics Inc. |
| | K003075, Knightstar 330 Ventilator and Breeze<br>Sleepgear Interface with Nasal Pillows Assembly as<br>interface recommended for use by the manufacturer<br>with this ventilator; Manufacturer: Puritan-Bennett. |
| | K022465, Nasal-Aire II, Innomed Technologies |
| | K023244, Mirage Full Face Mask Series, ResMed, Inc. |

Device Description - Nasal-Aire Criticial Care is ventilator interface accessory intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Nasal-Aire Critical Care consists of a soft nosepiece with two exhaust ports and two soft nasal cannula for fitting into the nasal openings. Connected on each side of the nosepiece is a length of tubing. The two lengths of tubing are joined at the opposite ends by a "Y"-shaped coupling, forming a loop with the nosepiece at one end and the "Y" coupling at the other. At the base of the "Y" coupling is a port for connection of the Nasal-Aire Critical Care to a positive pressure ventilation device. The Nasal-Aire Critical Care is compatible with any positive pressure ventilator containing a 22mm connection. Nasal-Aire Critical Care will be offered in various sizes designed for a comfortable and compliant fit for a wide variety of nare sizes.

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Substantial Equivalence - Biocompatability requirements and functional testing relative to the intended use of the Nasal-Aire Critical Care have been satisfactorily completed to show that it is as safe and effective as the predicate devices.

The table below, comparing the Nasal-Aire Critical Care to predicate devices, shows that it is comparable to other devices cleared for similar intended use.

| Attribute | Nasal-Aire Critical<br>Care (Subject device) | KnightStar 330<br>Ventilator w/Breeze<br>Interface | Mirage Full Face<br>Mask Series | Vision Ventilator<br>System w/Whisper<br>Swivel |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use with<br>CPAP or Bi-Level device<br>to provide noninvasive<br>ventilation for the<br>treatment of respiratory<br>insufficiency or<br>obstructive sleep apnea. | Non-invasively treat<br>spontaneously breathing<br>patients weighing 30kg or<br>more who suffer from<br>respiratory insufficiency<br>and/or obstructive sleep<br>apnea. | Intended for multiple<br>patient use for adult<br>patients prescribed<br>continuous positive<br>airway pressure<br>(CPAP) and bi-level<br>therapy. | Intended to augment<br>the breathing of<br>spontaneously<br>breathing adult patients<br>suffering from<br>respiratory failure,<br>respiratory<br>insufficiency, or<br>obstructive sleep<br>apnea. |
| Intended<br>Environment:<br>Hospital/Institutional<br>Use | Yes | Yes | Yes | Yes |
| Offered in Various<br>sizes | Yes | Yes (interface) | Yes | No |
| Intended for Single<br>Patient Use | Yes | Yes (interface) | No, multiple patient | Yes (interface) |
| Provided<br>Non-Sterile | Yes | Yes (interface) | Yes | Yes (interface) |
| Compatible with<br>22mm ventilator<br>connection | Yes | Yes | Yes | Yes |
| Treatment delivered<br>through Nasal<br>Passages | Yes | Yes (interface) | Yes and mouth | N/A |
| CPAP Swivel | | | | |

Yes (interface)

Yes

Yes

Connection

Yes

#### Comparison of Features

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・

:

| Attribute | Nasal-Aire Critical<br>Care (Subject device) | KnightStar 330<br>Ventilator w/Breeze<br>Interface | Mirage Full Face<br>Mask Series | Vision Ventilator<br>System w/Whisper<br>Swivel |
|-----------------------------------|----------------------------------------------|----------------------------------------------------|---------------------------------|-------------------------------------------------|
| Pressure delivery<br>3-35 cm H2O | Yes | Yes | Yes | Yes |
| Allows for pressure<br>monitoring | Yes | Yes | Yes | Yes |
| Intended Population | Adult | Adult | Adult | Adult |
| Patient Contact<br>Material | Silicone | Silicone | Silicone | N/A |
| Interface: Tubing<br>Length | 7" | 15/18" | unknown | N/A |
| Latex Free | Yes | Yes | Yes | N/A |

:

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes extending upwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

InnoMed Technologies Incorporated Mr. Frank Pelc Director, Regulatory Affairs Northeast Division 506 Garden Street Greensburg, Pennsylvania 15601

Re: K031896

Trade/Device Name: Nasal-Aire Critical Care Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS, BZD Dated: October 18, 2003 Received: October 21, 2003

Dear Mr. Pelc:

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. Pelc

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/dsma/dsmamain.html.

Sincerely yours,

Charles

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

510(k) Number:

Applicant: InnoMed Technologies

Device Name: Nasal-Aire Critical Care

#### Indications for Use:

Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Prescription Use

Over-the counter Use

fAul

Anesthesiology, General Hospital, Infection Control, Dent

510(k) Number: K031896