MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM

K020281 · Ventlab Corp. · NHK · Feb 11, 2002 · Anesthesiology

Device Facts

• Record ID: K020281
• Device Name: MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
• Applicant: Ventlab Corp.
• Product Code: NHK · Anesthesiology
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical routine of hyper-inflating the patient's lung(s). The operating clinician controls peak pressure and monitors pressures within the system by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve. Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Manual pulmonary-assist device; provides ventilation via compression of reservoir bag to force fresh gas into patient lungs. Includes built-in manometer for clinician monitoring of peak pressure; optional pop-off valve for high-pressure control. Used by clinicians in clinical settings to manage respiratory insufficiency. Output is visual pressure monitoring via manometer; clinician adjusts manual compression based on observed pressure to benefit patient through hyper-inflation of lungs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual hyperinflation bag system; includes integrated manometer for pressure monitoring and optional pop-off valve for pressure relief. Non-continuous ventilator classification (Class II).

Indications for Use

Indicated for patients suffering from respiratory insufficiency requiring pulmonary-assist ventilation. Prescription use only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Ms. Marge Walls-Walker Ventlab Corporation 2934 Highway 601 North Mocksville, NC 27028

Re: K020281

Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: Class II (two) Product Code: 73 NHK Dated: January 24, 2002 Received: January 28, 2002

Dear Ms. Walls-Walker:

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. Marge Walls-Walker

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 or any I vatural 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Dak Tills

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2: Indications for Use Statement

510k Number : K02028 |

Applicant: Ventlab Corporation

Device Name: Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended ventiab or portation a rigented ventilation to patients. It is designed for patients to provide oon respiratory insufficiency. The system's mode of operation is to hypersuffering from rooplutery a volume of fresh gas into the patient via compression of ventilate a pation by Croing a routine of hyper-inflating the patient's lung(s) over the reservoir bag: "Typloa. The operating clinician controls peak pressure and monitors several reophaller of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.

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__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K020281