(77 days)
Not Found
Not Found
No
The description details a manually operated device where the clinician controls pressure and monitors using a manometer, with no mention of automated decision-making, data analysis, or learning algorithms.
Yes
The device is intended to provide controlled or assisted ventilation to patients suffering from respiratory insufficiency, which constitutes a therapeutic intervention.
No
The device is a pulmonary-assist device for ventilation and hyper-inflating lungs, not for diagnosing conditions. It is used for treatment, not for detection or diagnosis.
No
The device description clearly describes a physical "Hyperinflation Bag System" which is a hardware device used for ventilation. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pulmonary-assist device intended to provide controlled or assisted ventilation to patients." This describes a device used on a patient to support a physiological function (breathing).
- Mode of Operation: The mode of operation involves "forcing a volume of fresh gas into the patient via compression of the reservoir bag." This is a direct intervention on the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any tests on samples.
The device described is a therapeutic device used to assist with breathing, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for Use
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.
Product codes
73 NHK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Ventlab Corporation
Indications for Use:
510k Number :
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
3
Indications for Use:
510k Number :
Applicant: Ventlab Corporation
Device Name: Ventlab Hyperinflation Bag System
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.
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
OR
Over-The-Counter Use
Ola tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K013308