VENTLAB NASAL CPAP CANNULA

K040726 · Ventlab Corp. · BZD · Jun 3, 2004 · Anesthesiology

Device Facts

• Record ID: K040726
• Device Name: VENTLAB NASAL CPAP CANNULA
• Applicant: Ventlab Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring CPAP therapy (i.e., CPAP, BiLevel). Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Ventlab Nasal CPAP Cannula functions as a patient interface accessory for positive pressure ventilation devices (CPAP/BiLevel). It delivers pressurized air to patients with Obstructive Sleep Apnea. Used in clinical or home settings under physician prescription. Device facilitates airway pressure delivery to assist patient breathing; benefits include management of sleep apnea symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal cannula interface for positive pressure ventilation. Device is a non-continuous ventilator accessory (Product Code: BZD).

Indications for Use

Indicated for patients suffering from Obstructive Sleep Apnea requiring positive pressure ventilation therapy (CPAP or BiLevel).

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.

Submission Summary (Full Text)

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## JUN 0 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert M. Kelly Director Regulatory Affairs Quality Assurance Ventlab Corporation 2934 Highway 601 North Mocksville, North Carolina 27028

Re: K040726

Trade/Device Name: Ventlab Nasal CPAP Cannula Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 18, 2004 Received: March 25, 2004

Dear Mr. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares were is substantially equivalent (for the reletenced above and nave actemmed are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree pror to thay been reclassified in accordance with the provisions of Amendinents, on to devrees mat narvic Act (Act) that do not require approval of a premarket the rederal Pood, Drug, that Cosments , therefore, market the device, subject to the general approval appreation (1 MIT). " The general controls provisions of the Act include controls provisions of the First - Insting 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 (FMA), it may of subject to sach additions, Title 21, Parts 800 to 898. In the Close of your device can be found in the Could of Postering your device in the Federal Register.

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Page 2 - Mr. Kelly

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualice of a subscriptions with other requirements
mean that FDA has made a determination that your device with other Federal agencies mean that FDA has made a decemmanon that your and regulations and more of the Act of the Act or registrative of the Act or any rederal statutes and regirations, including, but not limited to: registration
You must comply with all the Act stars and a cold meanufacturing practice You must comply with an the Act 3 requirements increat 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labelling (21 CFR Part 803), 3561 Part 820); and if requirements as set forth in the quality systems (QS) regulars (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-54 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children and Charles of Charles of volusions of your device to a I his letter will anow you to begin manced.ing your device of your device to a premarket notification. The PDA Inding of otobalized of rour 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), If you desire specific advice for your device of the same . Also, please note the regulation please contact the Office of Comphance are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act its tall f may obtail other general miormation on your resp.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binasa 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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:

unknown 510k Number :

Applicant: Ventlab Corporation

Device Name: Ventlab Nasal CPAP Cannula

The Ventlab Nasal CPAP Cannula is an accessory to positive pressure The Ventiab Nasal CPAP Califical is an aboooory to people Sleep Apnea requiring
ventilation devices for patients suffering from Obstructive Sleep Apnea requiring
Posts for p ventifation device to: paint therapy (i.e., CPAP, BiLevel).

Federal (USA) law restricts this device to sale by or on the order of a physician.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Cuy Sylvorn

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta 510(k) Number