(26 days)
Not Found
Not Found
No
The summary describes a manual resuscitator with a pressure monitor, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is intended to treat reversible apnea, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a manual resuscitator for artificial ventilation, which is a treatment, not a diagnostic process. Although it has a built-in pressure monitor, its primary purpose is indicated as providing ventilation, not diagnosing a condition.
No
The device is described as a "Manual Resuscitator with Built-in Pressure Monitor," which inherently implies a physical hardware component (the resuscitator and pressure monitor). The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide artificial ventilation for emergency treatment. This is a direct intervention on a patient's respiratory system, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use clearly points to a therapeutic device.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to provide mechanical support for breathing.
N/A
Intended Use / Indications for Use
The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to The V"Care Manual Resusciator with Dult In Frossale Inchier of reversible apnea, commonly associated with cardiopulmonary arrest.
Product codes
73 BTM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
SEP 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marge Walls-Walker Ventlab Corporation 3934 Highway 601 North Mocksville, NC 27028
Re: K012842
V*Care Manual Resuscitator with Built in Pressure Monitor Regulation Number: 868.5915 Regulation Name: Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: August 20, 2001 Received: August 23, 2001
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.
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
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Page 2 - Ms. Marge Walls-Walker
comply with all 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/cdrh/dsma/dsmamain.html
Sincerely yours,
James E. Dillard III
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
510(k) Number K012842
Device Name V*Care Manual Resuscitator with Built in Pressure Monitor
Indications for Use
The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to The V"Care Manual Resusciator with Dult In Frossale Inchier of reversible apnea, commonly associated with cardiopulmonary arrest.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CQRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use_ (Per 21 CFR 801.109)
Dak Th
Division of Cardiovascular & Respiratory Devices
510(k) Number K012842