(181 days)
Not Found
No
The description focuses on standard ventilation modes, monitoring parameters, and alarms typical of mechanical ventilators. There is no mention of AI, ML, or any adaptive or learning algorithms.
Yes
The device is a mechanical ventilator used for the treatment of sub-acute care patients and provides various ventilation modes, which directly addresses medical conditions.
No
The device is described as a mechanical ventilator for treatment, not for diagnosing conditions. While it monitors ventilation parameters, this monitoring is for treatment administration and safety, not for diagnostic purposes.
No
The device description clearly describes a mechanical ventilator with hardware components for delivering air, monitoring parameters, and displaying information. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Carina is a mechanical ventilator. Its function is to assist or control a patient's breathing by delivering air or oxygen to their lungs. It monitors physiological parameters related to breathing (airway pressure, tidal volume, breath rate, minute volume).
- Lack of Specimen Analysis: The description of the Carina does not mention any analysis of biological specimens. It interacts directly with the patient's respiratory system.
Therefore, the Carina falls under the category of a therapeutic device, specifically a life support device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Carina is a long-term ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.
Product codes
CBK
Device Description
The Carina. is a mechanical ventilator for use inside a hospital (sub-acute care). It offers the following ventilation modes:
- · VC-SIMV (Volume controlled synchronized intermittent mandatory ventilation)
- · PC-AC (Pressure controlled assisted control)
- · PC-SIMV (Pressure controlled synchronized intermittent mandatory ventilation)
- · SPN-PS (VG) (Pressure Support + (volume guarantee))
- · SPN-CPAP (Continuous Positive Airway Pressure)
- · Apnoea ventilation in SPN group mode (for spontaneously breathing patients)
The device can be used for invasive and non invasive ventilation (e.g. trachea tube and mask ventilation). The device offers both high pressure oxygen inlet and oxygen via a low pressure oxygen inlet (max. 500 hPa/10L/min).
The device monitors the following ventilation parameters:
- · Airway pressure (PIP, Pmean, PEEP)
- · Inspiratory Tidal volume (VTi)
- · Breath rate (f)
- · Minutes volume (MV , MV leak)
- The device has the following user-settable alarms:
- · Airway pressure high
- · Minute volume high / low
- · Rapid shallow breathing (high frequency alarm)
- · Apnea alarm
- · Disconnection alarm
Flow and pressure curves are displayed on the display. Spontaneous breathing (Triggered breath) of a patient is indicated on the screen by an asterisk (*).
Airway pressure high as a dotted line is displayed on the screen.
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
For use by qualified medical personnel in hospital or medical rooms for sub-acute care patients.
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/1 description: The image shows the logo for Dräger medical. Above the logo is the number K07 2885. The Dräger medical logo is in a bold, sans-serif font. The text below the logo says "A Dräger and Siemens Company".
A Dräger and Siemens Company
510(k) Summary
APR - 7 2008
Applicants Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Manufacturer Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number :
9611500
Contact Person:
Dr. Karin Luebbers Senior Manager Requlatory Affairs
Tel. No.: + 49 (451) 882-5367 Fax No.: + 49 (451) 882-7-5367
Applicants US Contact Person
Ms. Kathy Anderson Sr. Director Regulatory Affairs
Tel. No .: (215) 660-2078 Fax No .: (215) 721-5424
Date submission was prepared:
2007-10-05
Device Name:
Common Name: Classification Name: Regulation Number: Class:
Carina Continuous Ventilator, CBK 21 CFR 868.5895 ll
(Section 5)
1
| 510(k) number | Trade name | Company |
|---|---|---|
| K984056 | LTV 1000 | PulmoneticSystems |
| K060705 | Carina Home | Dräger Medical b.v. |
| K982454 | BiPAP Vision | Respironisc |
Legally Marketed Device to which Substantial Equivalence is claimed:
Device Description:
The Carina. is a mechanical ventilator for use inside a hospital (sub-acute care). It offers the following ventilation modes:
- · VC-SIMV (Volume controlled synchronized intermittent mandatory ventilation)
- · PC-AC (Pressure controlled assisted control)
- · PC-SIMV (Pressure controlled synchronized intermittent mandatory ventilation)
- · SPN-PS (VG) (Pressure Support + (volume guarantee))
- · SPN-CPAP (Continuous Positive Airway Pressure)
- · Apnoea ventilation in SPN group mode (for spontaneously breathing patients)
The device can be used for invasive and non invasive ventilation (e.g. trachea tube and mask ventilation). The device offers both high pressure oxygen inlet and oxygen via a low pressure oxygen inlet (max. 500 hPa/10L/min).
The device monitors the following ventilation parameters:
- · Airway pressure (PIP, Pmean, PEEP)
- · Inspiratory Tidal volume (VTi)
- · Breath rate (f)
- · Minutes volume (MV , MV leak)
- The device has the following user-settable alarms:
- · Airway pressure high
- · Minute volume high / low
- · Rapid shallow breathing (high frequency alarm)
- · Apnea alarm
- · Disconnection alarm
Flow and pressure curves are displayed on the display. Spontaneous breathing (Triggered breath)
of a patient is indicated on the screen by an asterisk (*).
Airway pressure high as a dotted line is displayed on the screen.
2
Intended Use:
Carina
- long-term ventilator for ventilator-dependent patients or ventilator-assisted patients
- For treatment of sub-acute care patients in hospital or medical rooms
- For invasive ventilation or non-invasive ventilation
- For patients with a tidal volume of at least100 mL
- For use by qualified medical personnel
Substantial Equivalence:
The intended use of the ventilator is comparable to the referenced predicate devices.
The comparison of the data shows similar values for the key performance data. Proposed device shows similar operating principle, ventilations mode, values for ventilator performance data and integrate monitoring functionality when compared to the legally marked devices.
In summary Dräger Medical AG & Co. KG has demonstrated that the proposed devices are safe and effective. They are considered to be substantially equivalent to currently marketed predicate devices which have been previously cleared by the FDA.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The background is plain and white, which makes the text stand out.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Draeger Medical AG & Company KG C/O Ms. Kathy Anderson Senior Director Regulatory Affairs Dracger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
porated
Re: K072885
Trade/Device Name; CarinaTM Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 25, 2008 Received: March 28, 2008
Dear Ms. Anderson
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.
Image /page/3/Picture/10 description: The image shows a partial view of a seal or emblem, likely belonging to a government or organizational entity. The visible text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES," arranged in a circular fashion around the emblem. The emblem itself features a stylized design, possibly representing a symbol or logo associated with health and human services.
APR - 7 2008
4
Page 2 - Ms. Anderson
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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Sittie Y. Molina Omd.
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
5
Indications for Use
510(k) Number (if known):
Device Name: Carina™
Indications For Use:
The Carina is a long-term ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.
Federal law restricts this device to sale by or on the order of a physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Min Thidal
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K072885