(83 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ventilation features and oxygen supply options.
Yes
The device is a ventilator, used to assist with breathing for patients, which directly treats a medical condition.
No
This device is described as a "Long-term ventilator for intensive care," which is a therapeutic device, not a diagnostic one. Its function is to support breathing, not to diagnose a condition.
No
The device description clearly describes a "long term ventilator unit" which is a hardware device. While it mentions software (SW 3.n) as an option, the core device is a physical ventilator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Long-term ventilator for intensive care." This describes a device used to support breathing in patients, which is a life support function, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a ventilator unit that provides breathing support. It mentions oxygen supply and monitoring, but these are related to the ventilation process itself, not to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. A ventilator is a therapeutic device used to assist with breathing.
N/A
Intended Use / Indications for Use
Long-term ventilator for intensive care. For patients requiring tidal volume starting at 50 ml.
Product codes
CBK
Device Description
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.
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
intensive care
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)
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/2 description: The image shows the logo for Dräger medical, along with the text "A Dräger and Siemens Company". Above the logo is the text "K040642" in a handwritten style. The Dräger logo is in bold, while the word "medical" is in a thinner font.
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 (451) 882-3648 |
|---|---|
| Fax No.: | 011 49 (451) 882-4351 |
Applicants US Contact Person
Mr James J. Brennan Director Regulatory Affairs
Tel. No.: (215) 721-5400 (215) 721-5412 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.
1
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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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight.
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
3
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 (800) 638-2041 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
4
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
Page 1 of _1
(Division Sian-Off) Division of Inesmesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040642