Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter for the Ventlab Hyperinflation Bag System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed devices. It outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot provide the requested information about acceptance criteria and the study based on the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

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

K013308 Re: Ventlab Hyperinflation Bag System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NHK

Dear Ms. Walls-Walker:

This letter corrects our substantially equivalent letter of December 20, 2001, regarding the I his letter corrects our substantally equir active identified the product code as 73 BZD. This is in
Ventlab Hyperinflation Bag System. Our letter identified the product c vential 113 permination code is 73 NHK as indicated above.

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substantially interestate referenced above and nave uctchillned the actredicate devices marketed in interstate for use stated in the encrosule) to regally manced proured in Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 28, 1970, the characted and the Federal Food, Drug, devices that have been recassince in accordance who a premarket approval applications of the Act The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general magate You may, merelore, market the devices, subject of an annual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the fiel 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 If your device is classified (SCC above) into exist rease agor regulations affecting your device can
may be subject to such additional controls. Existing major regulation E may be subject to such accultions. Entrolis: Entroling in Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 devel Pag be found in the Code of I caetal Regerning 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 Please be advised that FDA s Issualic of a substition only his with other requirements of the Act
that FDA has made a determination that your device couplies . You must that FDA has made a decemmanon alax youn issered by other Federal agencies. You must or any Federal statutes and regulations adminities to registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, monamasturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if amlicable, the electronic CFR Part 807); labeling (21 CFR 1 all 601); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
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) I his letter will allow you to oegill hanceling your artist equivalence of your device to a legally premarket notification. The PDA miding of backantal vijana was thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your device on oursely of your contact the Office of additionally 21 CFR Part 809 . 10 this nations on the promotion and advertising of
Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising Compliance at (301) 594-4646. Additionally, For quest (301) 594-4639. Also, please note the your device, picase comace of its reference to premarket notification' (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarks abteined from the regulation entitled, "Misoranuming of Telection of the Act may be obtained from the Other general miorination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 zon fda gov /cdrh/dsma/dsmamain.html

Sincerely yours,

Bram 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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Ventlab Corporation

Indications for Use:

510k Number :

K013308

Applicant: Ventlab Corporation

Device Name: Ventlab Hyperinflation Bag System

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device Ventlab Corporation's Hypenhlation Bag System's a patients. It is designed for intended to provide controlled or assisted vehilation to patients mode of operation is to
patients suffering from respiratory insufficiency. The system's mode of operation is patients suffering from respiratory insulties of fresh gas into the patient via
hyper-ventilate a patient by forcing a volume of fresh gas into the patient will hyper-ventilate a patient by forcing a volume of heather the per-inflating the
hyper-ventilate a patient bag. Typical treatment consists of hyper-ifflating the compression of the reservir bag. T ypcal treating conside or high patient's lung(s) over several respiration cycles. The openating climit
peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use✓
OR
Over-The-Counter Use__

Xola Heh
Division of Cardiovascular & Respiratory Devices
510(k) Number
R013308

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Indications for Use:

510k Number :

Applicant: Ventlab Corporation

Device Name: Ventlab Hyperinflation Bag System

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V

Over-The-Counter Use

Ola tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K013308

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).