(14 days)
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No
The description focuses on mechanical ventilation and pressure monitoring, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to provide assisted ventilation to patients suffering from respiratory insufficiency, which directly addresses a health condition.
No
The device is described as a "pulmonary-assist device" intended to "provide assisted ventilation to patients." Its mode of operation is to "ventilate a patient by forcing a volume of fresh gas into the patient." While it monitors respiratory parameters with a built-in manometer, this monitoring is for controlling ventilation rather than diagnosing a condition.
No
The device description clearly indicates a physical "Hyperinflation Bag System" with a "reservoir bag," "built-in manometer," and "optional Pop-Off Valve," all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Ventlab Hyperinflation Bag System is a pulmonary-assist device that directly ventilates a patient by forcing gas into their lungs. This is a therapeutic intervention performed on the patient, not a diagnostic test performed on a specimen.
The description clearly states its purpose is to "provide assisted ventilation to patients" and "ventilate a patient by forcing a volume of fresh gas into the patient." This is a life-support or therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-inflate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors pressure by means of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.
Product codes
73 NHK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lung(s)
Indicated Patient Age Range
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Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
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__________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K020281