(54 days)
Not Found
Not Found
No
The summary describes a software program for displaying ventilation data, with no mention of AI, ML, or related concepts.
No
The device is described as a PC program for displaying ventilation parameters, not for providing therapy or actively treating a condition. It provides information to the user but does not directly interact with the patient to produce a therapeutic effect.
No
Explanation: The device, VentView, is described as a "PC program for displaying ventilation parameters and status messages." Its function is solely to display data from Drager ventilators, not to interpret, analyze, or provide any diagnostic conclusions based on that data. It acts as a display interface rather than a tool for diagnosis.
Yes
The device is described as a "PC programm" for displaying data from ventilators, explicitly stating it is software and not mentioning any associated hardware components it provides.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display ventilation parameters and status messages from ventilators. This is related to monitoring and managing a patient's breathing, which is a physiological process, not an in vitro examination of specimens from the human body.
- Device Description: The description reinforces the intended use – it's a PC program for displaying data from ventilators.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
Therefore, VentView is a software device used in the clinical setting to support patient care by displaying data from medical equipment, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
Product codes
73 CBK
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 2001
Mr. James J. Brennan Dräger Medical AG & Co. KGaA c/o Dräger Medical, Inc. 3135 Quarry Road Telford, PA 18969
Re: K012177
VentView Regulation Number: 868.5895 Regulatory Class: II (two) Product Code: 73 CBK Dated: August 15, 2001 Received: August 21, 2001
Dear Mr. Brennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and we no nove we) to legally marketed predicate devices marketed in interstate commerce buiced in also are, so 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). You may, therefore, market the device, subject to the general controls Cooniette 110 (110 ) - The general controls provisions of the Act include requirements for annual provisions of ation 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1) affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
1
Page 2 - Mr. James J. Brennan
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and it your ding of substantial equivalence of your device to a legally marketed nothloate 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 11 you as a surfall for in vitro diagnostic devices), please contact the Office of Compliance at additionally 0091100114, 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 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,
Denk Telle
J. E. Dillard, III
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) Number (if known): KO12177
VentView Device Name:
Indications For Use:
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) k) Number
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)