LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA

K040642 · Draeget Medical AG & Co. Kgaa · CBK · Jun 2, 2004 · Anesthesiology

Device Facts

• Record ID: K040642
• Device Name: LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
• Applicant: Draeget Medical AG & Co. Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.

Device Story

LPO (Low-Pressure-Oxygen) option for Dräger Savina intensive care ventilator; enables oxygen supply from low-pressure sources (e.g., oxygen concentrators) as alternative to high-pressure O2 sources; device operates by managing O2 concentration supply and monitoring; used in intensive care, recovery rooms, and intra-hospital transport; operated by clinicians; provides ventilation support for patients with tidal volumes ≥ 50 ml; output allows healthcare providers to maintain ventilation therapy when high-pressure oxygen is unavailable; benefits include increased flexibility in oxygen source selection and continued patient respiratory support.

Clinical Evidence

Bench testing only. No clinical data provided. Design, development, and verification performed in accordance with FDA guidance and internal standards to ensure safety and effectiveness.

Technological Characteristics

Ventilator software option (SW 3.n) for Savina system; enables low-pressure oxygen input; provides O2 concentration monitoring; operates as an add-on to existing ventilator hardware; regulatory class II; product code CBK.

Indications for Use

Indicated for intensive care patients requiring long-term ventilation with a tidal volume starting at 50 ml.

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.

Predicate Devices

• Savina (K023289)
• TBird Vela (K020746)

Submission Summary (Full Text)

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## 510(k) Summary (Section 9)

## 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 [phone] |
|-----------|-----------------------|
| Fax No.: | 011 49 [phone] |

### Applicants US Contact Person

Mr James J. Brennan Director Regulatory Affairs

Tel. No.: [phone] [phone] Fax No.:

#### Date the Summary was prepared

March 08, 2004

#### Device Name

Trade Name: Common Name: Classification Name:

LPO Option LPO Option for Dräger Intensive Care Ventilator Savina Ventilator, Continuous (per 21 CFR 868,5895)

## Legally marketed device to which Substantial Equivalence is claimed

Savina (K023289) Manufactured by Dräger Medical AG & Co. KGaA; Germany. Distributed in the United States by Dräger Medical Inc.

TBird Vela (K020746) Manufactured by VIASYS Healthcare (TBird). Distributed in the United States by VIASYS Healthcare Inc.

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Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a lighter font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional.

## Description of the Device

Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more Savina is a long tornit vorm vorms, recovery rooms, inter and intra hospital transport and and is aculities. LPO means Low-Pressure-Oxygen and allows the supply of oxygen Subacute care ludiliked: "Lir & moantsource (such as an oxygen concentrator), independently if high pressure O2 sources. The external low pressure oxygen source is to be provided by the of nigh produce of ouroot. The entilation performance. The only difference between HPO and LPO mode is the supply and monitoring of the O2 concentration. The LPO Option is available for Savina with SW 3.n.

## Intended Use

Long-term Ventilator for intensive care. For patients requiring tidal volume starting at 50 ml.

## Substantial Equivalence

The intended use of Savina SW 3.n with LPO Option is covered by the referenced predicate devices

- Savina SW 2.n
- Tbird Vela

The technical characteristics of the LPO option do not raise new questions regarding safety or effectiveness. Furthermore the labeling of Savina SW 3.n with LPO provides similar information as the predicate devices except for the subject of this submission.

Information provided in the 510(k) Premarket Notification supports the determination of information providence. Design, development and verification of the device was performed in accordance with FDA guidances and company internal standards. The testing and analysis of assults 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 3.n including the LPO option is safe and effective. Savina SW 3.n with LPO is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by the FDA.

213

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2004

Dräger Medical AG & Co. KGaA C/O Mr. James J. Brennan Drager Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K040642

Trade/Device Name: LPO Option for Drager Intensive Care Ventilator Savina Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 14, 2004 Received: May 17, 2004

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 11 70ar de review 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 r read be act not a a determination that your device complies with other requirements of the Act that 1 27 Placal statutes and regulations administered by other Federal agencies. You must

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Page 2 -- Mr. James J. Brennan

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Act stequirements, Microsons, College of Courter of Creation All of Cart of Carting the Actually of CFR Part 807); labeling (21 CFRT art 800); good maxart 820); and if applicable, the electronic Torin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This product factation confor pro fillers (second states as described in your Section 510(k) letter will anow you to begin marketing your ubstantial equivalence of your device to a legally premarket nother 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 If you desire specific advice for your ac 1100 on 646. Also, please note the regulation entitled, and Colliaci the Office of Complance at (3st notification" (21CFR Part 807.97). You may obtain " Misbranding by reference to premants. Iouslited. Set from the Division of Small
other general information on your responsibilities under the Act from the 1990s 638.000 other gelleral Information on your responses Assistance at its toll-free number [phone] or Manufacturers, International and Solless http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K 040642 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Device Name: | Savina |
| Indications For Use: | Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml. |

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cuyigliom

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(Division Sian-Off) Division of Inesmesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040642