(14 days)
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 ventilate 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 several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.
Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve
The provided text describes a 510(k) premarket notification for a medical device called the "Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve." This document is a clearance letter from the FDA, and as such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.
FDA 510(k) clearance letters primarily state that a device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. They generally do not include the underlying performance study results, acceptance criteria, sample sizes, ground truth methodologies, or details about expert involvement.
To answer your questions, one would typically need access to the original 510(k) submission document itself, which contains the summary of safety and effectiveness, including performance data and the study design.
Therefore, based solely on the provided text, I can state the following:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The text does not contain any specific acceptance criteria or detailed performance metrics. It only states that the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The text does not describe any specific test set, its sample size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The text does not mention any experts or ground truth establishment relevant to a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. The text does not describe any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a mechanical hyperinflation bag system, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance would not be applicable or expected.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The text does not detail any ground truth methodologies. For a mechanical device like this, performance testing would typically involve engineering and bench testing against established standards for flow, pressure, etc., rather than clinical "ground truth" as you might see for diagnostic AI.
8. The sample size for the training set:
- Not applicable / Cannot be provided. There's no indication of a "training set" as this is not an algorithm requiring machine learning. Performance testing for a mechanical device would not involve a training set in this context.
9. How the ground truth for the training set was established:
- Not applicable / Cannot be provided. As above, no training set is mentioned or implied for this type of device.
In summary, the provided FDA clearance letter is a regulatory document affirming substantial equivalence, not a scientific publication detailing performance studies. The information requested typically resides in the 510(k) Summary or other accompanying technical reports submitted to the FDA, which are not part of this document.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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
§ 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).