CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110

K072885 · Draeger Medical AG & Co. KG · CBK · Apr 7, 2008 · Anesthesiology

Device Facts

• Record ID: K072885
• Device Name: CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
• Applicant: Draeger Medical AG & Co. KG
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Carina is a mechanical ventilator for sub-acute hospital care; operated by qualified medical personnel. Inputs include high-pressure or low-pressure oxygen sources; patient airway connection via trachea tube or mask. Device provides multiple ventilation modes: VC-SIMV, PC-AC, PC-SIMV, SPN-PS (VG), SPN-CPAP, and apnea ventilation. System monitors airway pressure (PIP, Pmean, PEEP), inspiratory tidal volume, breath rate, and minute volume. Real-time flow and pressure curves are displayed; spontaneous breathing indicated by screen icon. User-settable alarms include high airway pressure, minute volume limits, rapid shallow breathing, apnea, and disconnection. Output allows clinicians to manage respiratory support; adjust ventilation parameters based on monitored data; and optimize patient oxygenation and ventilation. Benefits include sustained respiratory support for patients requiring long-term assistance.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison of performance specifications to predicate devices.

Technological Characteristics

Mechanical ventilator for invasive/non-invasive use. Supports high-pressure and low-pressure (max 500 hPa/10L/min) oxygen inlets. Features integrated monitoring for airway pressure, tidal volume, and breath rate. Includes visual display for flow/pressure curves and alarm management. Software-controlled ventilation modes (VC-SIMV, PC-AC, PC-SIMV, SPN-PS, SPN-CPAP).

Indications for Use

Indicated for long-term ventilator-dependent or ventilator-assisted patients in sub-acute hospital/medical settings requiring invasive or non-invasive ventilation. Patient population limited to those with tidal volume ≥ 100 mL. Prescription only.

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

• LTV 1000 (K984056)
• Carina Home (K060705)
• BiPAP Vision (K982454)

Submission Summary (Full Text)

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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 [phone] Fax No.: + 49 (451) 882-7-5367

#### Applicants US Contact Person

Ms. Kathy Anderson Sr. Director Regulatory Affairs

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

#### 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)

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| 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.

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#### 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.

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#### 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

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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 [phone]. 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 [phone] or [phone] 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

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# 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