← Product Code [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) · K023289 # OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 (K023289) _Drager Medizintechnik GmbH · CBK · Jan 15, 2003 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K023289 ## Device Facts - **Applicant:** Drager Medizintechnik GmbH - **Product Code:** [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK.md) - **Decision Date:** Jan 15, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 868.5895 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml. ## Device Story The NIV Option for the Savina ventilator enables non-invasive ventilation (NIV) via mask application. The device is used in intensive care, recovery rooms, transport, and subacute care. It functions by allowing the user to select between 'Tube' (standard) and 'Mask' (NIV) application modes during machine preparation. In 'Mask' mode, the device adapts integrated monitoring to the specific needs of mask-ventilated patients. The system is operated by clinicians. It provides ventilation support to patients, potentially improving care delivery for those requiring non-invasive respiratory support. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics The device is a continuous ventilator (21 CFR 868.5895). It features a software-based NIV option (SW 2.0) that allows switching between 'Tube' and 'Mask' application modes. The system includes integrated monitoring adapted for mask ventilation. It is designed for long-term intensive care use. ## Regulatory 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. ## Predicate Devices - Evita 4 / Evita 2 dura with option NIV ([K010093](/device/K010093.md)) - Savina ([K003068](/device/K003068.md)) ## Reference Devices - Savina SW 1.n ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "K013289" in a handwritten style, with the "K" being larger than the other characters. Below this, the text "NIV Option for Savina" is printed in a smaller, more formal font. A line is drawn underneath the text "NIV Option for Savina". # 510(k) Summary (Section 9) ## JAN 1 5 2003 ## Summary of Safety and Effectiveness #### Applicants Name and Address Dräger Medical AG & Co. KGaA Moislinger Allee 53-55 D-23542 Lübeck Germany #### Applicants Contact Person Mr. Ulrich Schröder Manager Regulatory Affairs Tel. No .: 011 49 (451) 882-3648 011 49 (451) 882-4351 Fax No.: #### Applicants US Contact Person Mr James J. Brennan Director Regulatory Affairs Tel. No.: (215) 721-5400 Fax No.: (215) 721-5412 #### Date the Summary was prepared September 27, 2002 #### Device Name Trade Name: Common Name: Classification Name: NIV Option NIV Option for Dräger Intensive Care Ventilator Savina Ventilator, Continuous (per 21 CFR 868.5895) ## Legally marketed device to which Substantial Equivalence is claimed Evita 4 / Evita 2 dura with option NIV (K010093) Manufactured by Dräger Medical AG & Co. KGaA Germany. Manufactured and Distributed in the United States by Dräger Medical Inc. Savina (K003068) Manufactured by Dräger Medical AG & Co. KGaA; Germany. Distributed in the United States by Dräger Medical İnc. 188 {1}------------------------------------------------ ## Description of the Device Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more and is used in the intensive care areas, recovery rooms, inter and intra hospital transport and subacute care facilities. NIV means Non-Invasive Ventilation and supports the mask application mode. The NIV Option is available for Savina with SW 2.0. The NIV Option for Savina expands the range of available ventilation strategies to include Non-Invasive Ventilation. NIV is not a new ventilation mode but a different format to deliver ventilation to the patient. With the NIV Option activated, the user can switch the ventilator during preparation of the machine into one of two application modes: a) "Tube" application mode, b) "Mask" application mode. The "Tube" application mode corresponds to the reqular behavior of the device if the NIV option is not activated. If the "Mask" application mode is selected, the user gains the option to configure parts of the device integrated monitoring to adapt the specific need of the mask ventilated patient. ### Intended Use Long-term Ventilator for intensive care. For patient requiring tidal volume starting at 50 ml. ## Substantial Equivalence The intended use of Savina SW 2.n with NIV Option is covered by the referenced predicate devices Savina SW 1.n Evita 4 and Evita 2 dura SW 4.n with NIV The technical characteristics of the NIV option do not raise new questions regarding safety or Furthermore the labelling of Savina SW 2.n with NIV provides similar effectiveness. information as the predicate devices. Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development and verification of the device was performed in accordance with FDA quidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use. In summary Dräger Medical AG & Co. KGaA has demonstrated that Savina SW 2.n including the NIV option to be safe and effective. Savina SW 2.n with NIV is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA. 189 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 5 2003 -Dräger Medical AG & Company KGaA C/O Mr. James J. Brennan Director, Regulatory Affairs Drager Medical Incorporated 3135 Quarry Road Telford, Pennsylvania 18969 Re: K023289 Trade/Device Name: Savina Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 12, 2002 Received: December 16, 2002 Dear Mr. Brennan: 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. {3}------------------------------------------------ ### Page 2 - Mr. Brennan 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 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), 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) you may obtain. 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, Sina Russo Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ Page_1 of 1 510(k) Number (if known): Device Name:_Savina Indications For Use: Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) Susan Runs (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 011 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K023289](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K023289) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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