CARINA HOME

K060705 · Draeger Medical B.V. · CBK · Jun 14, 2006 · Anesthesiology

Device Facts

• Record ID: K060705
• Device Name: CARINA HOME
• Applicant: Draeger Medical B.V.
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended use of the Canna home is round-the-clock pressure controlled and pressure regulated volume controlled ventilation of patients with respiratory insufficiency, using room air, also with additional oxygen. The Carina home is intended for use by people without medical qualifications (patients and caregivers) as well as qualified medical and technical personnel. The device is intended for use with patients with a tidal volume of 100 mL upwards. It can be used invasive and non-invasive, for both controlled and assisted ventilation. The device can be used in Home Care environments, in and out of hospital, in stationary position (lying or sitting) or in a vehicle (e.g. car). Federal law restricts this device to sale by or on the order of a physician.

Device Story

Carina home is a software-controlled ventilator providing pressure-controlled and pressure-regulated volume-controlled ventilation. It delivers respiratory support using room air, optionally supplemented with oxygen, to patients with respiratory insufficiency (tidal volume ≥100 mL). Operated by patients, caregivers, or medical personnel in home, hospital, or mobile environments. Device functions as a life-support system; provides both invasive and non-invasive ventilation. Healthcare providers use device settings to manage patient ventilation; output allows for continuous respiratory support. Benefits include round-the-clock respiratory assistance in various settings.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per IEC60601-1, IEC60601-1-2, and ASTM F1246 standards. Testing included mechanical, electrical, and biocompatibility assessments, alongside hazard analysis and system-level qualification to confirm design requirements were met.

Technological Characteristics

Pressure-controlled and pressure-regulated volume-controlled ventilator. Features integrated HEPA filtration. Operates on room air with optional oxygen enrichment. Designed for stationary or mobile use. Software-controlled architecture. Complies with IEC60601-1 (electrical safety), IEC60601-1-2 (EMC), and ASTM F1246 (ventilator standards).

Indications for Use

Indicated for patients with respiratory insufficiency requiring pressure-controlled or pressure-regulated volume-controlled ventilation. Suitable for patients with tidal volumes of 100 mL or greater. Intended for invasive or non-invasive, controlled or assisted ventilation in home, hospital, or transport settings.

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

• iVent 201 Portable Ventilator (K052554)
• LTV 1000 Ventilator (K040790)
• Air Safety HEPA and non-HEPA Filters (K033008)
• Savina (K003068)
• Siemens Servo Ventilator 300A (K970839)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Notification Carina ™home QM06_049

Kobo705

Image /page/0/Picture/2 description: The image shows the logo for Dräger Medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. The word "medical" is in a thinner, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font.

510(k) Summary

acc. to 807.92

JUN 1 4 2006

| Submitter's Name and Address: | Dräger Medical b.v.<br>Kanaaldijk 29<br>5683CR Best<br>The Netherlands |
|-----------------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Hans Venings<br>Vice President Processes, Quality and Regulatory Affairs |
| | Phone: [phone]<br>Fax: [phone] |
| Applicants US Contact Person: | Ms Monica Ferrante<br>Director, Regulatory Affairs |
| | Phone: [phone]<br>Fax: [phone] |
| Date submission was prepared: | 2006-03-10 |
| Device Name: | |
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous |
| Regulation Number: | 21 CRF 868.5895 |
| Class: | II |
| Legally Marketed Device Identification: | Carina home |

#### Device Description:

the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen).

#### Intended Use:

The Intended use of the Canna home is round-the-clock pressure controlled and pressure regulated volume controlled ventilation of patients with respiratory insufficiency, using room air, also with additional oxygen. The Carina home is intended for use by people without medical qualifications (patients and caregivers) as well as qualified medical and technical personnel. The device is intended for use with patients with a tidal volume of 100 mL upwards. It can be used invasive and non-invasive, for both controlled and assisted ventilation. The device can be used in Home Care environments, in and out of hospital, in stationary position (lying or sitting) or in a vehicle (e.g. car).

type TEMPLATE release status RELEASED

effective date 30.09.2004

number DMS PQ2160 A4

{1}------------------------------------------------

510(k) Notification Carina™ home QM06 049

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 thinner font. Below the logo, it says "A Dräger and Siemens Company". The logo is simple and professional.

#### Predicate Devices:

| 510(k) Number | Device Name |
|---------------|--------------------------------------|
| K052554 | iVent 201 Portable Ventilator |
| K040790 | LTV 1000 Ventilator |
| K033008 | Air Safety HEPA and non-HEPA Filters |
| K003068 | Savina |
| K970839 | Siemens Servo Ventilator 300A |

### Substantial Equivalence:

The Carina home is similar to the homecare features to he iVent 201 (K052554) and the LTV 1000 (K040790).

It incorporates a pressure regulated volume controlled ventilation mode like the PRCV mode of the Siemens Servo Ventilator 300A (K970839).

It uses an integrated HEPA filter similar to HEPA filters from Air Safety Limited (K033008).

The Carina home and the iVent 201 are both software controlled ventilators using the same operating principle and can be used for invasive as well as non invasive ventilation.

The performance data of both ventilators is comparable, with the exception of some parameters. However, for these parameters, performance data is comparable with the LTV 1000 ventilator (K040790)

#### Summary of Performance Testing:

Safety testing was conducted per IEC60601-1, IEC60601-1-2, ASTM F1246 and other applicable standards with respect to mechanical, electrical and biocompatibility.

The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met.

Qualification included hazard analysis, system level qualification and verification / validation tests.

TEMPLATE

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2006

Dräger Medical, B.V. C/O Ms. Monica Ferrante Director, Regulatory Affairs Dräger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K060705

Trade/Device Name: Carina™Home Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 10, 2006 Received: March 16, 2006

Dear Ms. Ferrante:

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 - Ms. Ferrante

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,

Chiu Lin, Ph.D.

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 STATEMENT

Indications for Use

5.10(k) Number (if known):

Device Name: Carina™home

Indications for Use:

the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.

gn-CT)
on of Anesthesiology, General Hospital,
-don Control, Dental Devices

Number: K060

Prescription Use J (Part 21 CFR 801 Subpart D)

ರಿ

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

のです。 このため、それではないと思います。 このため、 には、 には、 には、 に、 に、 して、 して

| template / rev. | - / - |
|-----------------|-----------------------------------------|
| | CVI HC USA |
| | Indicated Use Statement Carina home USA |
| reference | STD321672 |
| revision | 2 |
| page / of | 3 / 3 |

:

..