VENTVIEW, MODEL 8414095

K012177 · Drager Medizintechnik GmbH · CBK · Sep 4, 2001 · Anesthesiology

Device Facts

• Record ID: K012177
• Device Name: VENTVIEW, MODEL 8414095
• Applicant: Drager Medizintechnik GmbH
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 4, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

VentView is a PC-based software application designed to interface with Dräger Savina, Evita 2 dura, and Evita 4 ventilators. It receives ventilation parameters and status messages from the connected ventilator and displays this data in graphical and numerical formats. The device is intended for use by clinicians in a clinical setting to monitor patient ventilation status. By providing a centralized visual representation of ventilator data, it assists healthcare providers in assessing patient respiratory status and making informed clinical decisions regarding ventilator management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based software application; functions as a display interface for ventilation parameters and status messages; compatible with Dräger Savina, Evita 2 dura, and Evita 4 ventilators.

Indications for Use

Indicated for use as a PC-based software program to display ventilation parameters and status messages in graphical and numerical formats for patients connected to Dräger Savina, Evita 2 dura, and Evita 4 ventilators.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone]. 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 [phone] or [phone] 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

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE) k) Number

(Optional Format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)