CLARISSA INFANT NCPAP CANNULA

K032922 · Airways Ltd., Inc. · CBK · Sep 22, 2004 · Anesthesiology

Device Facts

• Record ID: K032922
• Device Name: CLARISSA INFANT NCPAP CANNULA
• Applicant: Airways Ltd., Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.

Device Story

Patient interface for continuous positive airway pressure (CPAP) delivery; consists of soft medical-grade silicone coaxial pouch with protruding cannula tips inserted into infant nares; swivel adapter connects to 10mm breathing circuits/ventilators; features attachment loops for head bonnet; used in hospital/institutional environments; provides positive pressure to support infant breathing; minimizes dead space via internal tube connection; benefits patient by facilitating non-invasive respiratory support.

Clinical Evidence

Bench testing only. Performance data demonstrates equivalent flow resistance and dead space volume compared to predicate devices.

Technological Characteristics

Patient interface for continuous flow CPAP; materials: medical-grade silicone (cannula), polyurethane foam (head bonnet); design: coaxial pouch with swivel adapter for 10mm circuits; connectivity: connects to standard CPAP circuits/ventilators; non-powered, passive device.

Indications for Use

Indicated for administration of CPAP to continuously monitored neonatal and infant patients in hospital/institutional 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

• Argyle CPAP Nasal Cannula (K811409)
• Neotech Binasal Airway (K792018)
• Medicomp CPAP Nasal Cannula (K861280)
• Hudson Infant Nasal CPAP Cannula (K871157)
• Ackrad Infant Nasal Cannula (K895031)

Submission Summary (Full Text)

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# SEP 2 2 2004

# 510(k) Summary of Safety and Effectiveness Airways Development, LLC Clarissa™ Infant nCPAP Cannula (K032922)

| Submitted By: | Airways Development, LLC<br>209 North 14th Street<br>Kenilworth, NJ 07033 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 20, 2004 |
| Contact Person: | Robert Landis<br>Vice President, Product Development<br>Airways Development, LLC<br>209 North 14th Street<br>Kenilworth, NJ 07033<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | Clarissa Infant n-CPAP Cannula |
| Common Name: | Infant CPAP Nasal Cannula |
| Classification Name and Reference: | Ventilator, Continuous, Facility Use<br>21CFR 868.5895 |
| Device Product Code and Panel Code: | CBK<br>Anesthesiology Panel |
| Predicate Devices: | Argyle CPAP Nasal Cannula (K811409)<br>Neotech Binasal Airway (K792018)<br>Medicomp CPAP Nasal Cannula (K861280)<br>Hudson Infant Nasal CPAP Cannula (K871157)<br>Ackrad Infant Nasal Cannula (K895031) |

### Device Description:

The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding silicone cannula tips that fit into the infant's nares. Continuous flow circulates through the coaxial pouch under positive pressure from which the patient breathes via the cannula. The distal end of the pouch has a swivel adapter with three external ports and one external port. One external port is for pressure and the other two are in-flow and out-flow ports which are bi-directional. The internal port on the swivel adapter is the connection for the internal tube leading to the proximal cannula to minimize dead space.

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### Intended Use:

The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.

### Technological Characteristics

The Clarissa"™ Infant nCPAP Cannula is a patient interface designed to be used with continuous flow CPAP circuits or ventilators in the continuous flow CPAP mode. The cannula tips are inserted into the nasal passage to affect a seal for the continuous flow to produce CPAP.

The air input end has a swivel adapter that connects to 10mm breathing circuits. During actual use the wide part of the pouch lays on the infant's forehead and the narrow portion extends down to the nasal openings where cannula tips protrude out of the pouch at a 90 degree angle. The device has built-in attachment loops to facilitate attachment to head bonnet.

The device material is a soft expandable and flexible medical grade silicone. The only materials to contact the patient are the silicone cannula and polyurethane foam head bonnet.

### Performance Data

The test data submitted demonstrates that the proposed Clarissa Infant nCPAP Cannula performance is essentially equivalent to the above listed predicate devices. Testing completed shows devices provide essentially equivalent flow resistance and dead space volume.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## SEP 2 2 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Airways Development, LLC C/O Mr. Richard J. Larkin Regulatory Affairs Consultant R.J. Larkin Consulting, Incorporated 209 North 14th Street, P.O. Box Kenilworth, New Jersey 07033-0496

Re: K032922

Trade/Device Name: Clarissa™ Infant nCPAP Cannula Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 14, 2004 Received: September 15, 2004

Dear Mr. Larkin:

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. Larkin

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 vours.

Susan Rumm

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): K032922

Device Name: Clarissa™ Infant nCPAP Cannula

Indications For Use: The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.

Prescription Use X (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)

Cecefybleen

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