RAPHAEL

K022679 · Hamilton Medical AG · CBK · Oct 22, 2003 · Anesthesiology

Device Facts

• Record ID: K022679
• Device Name: RAPHAEL
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RAPHAEL ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg, The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.

Device Story

Microprocessor-controlled critical care ventilator; provides mandatory or spontaneous breaths with preset oxygen concentration. Inputs provided by user via LCD display, keyboard, and rotary dial. Operates on AC power with battery backup for intra-hospital transport. Used in hospital settings by trained personnel under physician supervision. Provides audible and visual alarms for patient and ventilator status. Benefits patients by supporting respiratory function; output allows clinicians to monitor and adjust ventilation parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled critical care ventilator. Powered by AC with battery backup. User interface includes LCD display, keyboard, and rotary dial. Supports adult, pediatric, and infant patients (5-200 kg). Pneumatic system design similar to Galileo. Not MRI compatible.

Indications for Use

Indicated for adult, pediatric, and infant patients weighing 5-200 kg requiring continuous ventilation. Contraindicated for use in the presence of flammable anesthetic agents or within MRI magnetic fields.

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

• Galileo (K001686)
• Dräger Evita 2 Dura (K970165)
• Siemens Servo-i (K010925)
• Puritan Bennett 840 (K984535)

Submission Summary (Full Text)

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OCT 2 2 2003

K022679, RAPHAEL 510(k) Submission

**510(k) Summary**

| APPLICANTS NAME AND ADDRESS | Hamilton Medical AG<br>Via Nova<br>CH-7403 Rhaezuens<br>Switzerland |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| APPLICANTS CONTACT PERSON | Mr. Andreas Scheibe<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| APPLICANTS CONTACT PERSON IN<br>THE USA | Hamilton Medical Inc.<br>Mr. David Thompson<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| DATE THE SUMMARY WAS<br>PREPARED | 08/07/2003 |
| COMMON NAME | Continuous Ventilator |
| PROPRIETARY NAME | RAPHAEL |
| PURPOSE OF SUBMISSION | New device |
| CLASSIFICATION | Name: Ventilator, Continuous (per 21 CFR 868.5895)<br>Panel: Anesthesiology<br>Code: CBK |
| REGULATORY STATUS | 1. Current Device Class: Class 2<br>2. Performance Standards & Special Controls: None Exist |

LEGALLY MARKETED DEVICES TO WHICH HAMILTON MEDICAL IS CLAIMING SUBSTANTIAL
EQUIVALENCE

| Galileo | 510(k)#: K 001686 | -Manufactured by Hamilton Medical AG |
|---------------------|-------------------|-----------------------------------------|
| Dräger Evita 2 Dura | 510(k)#: K 970165 | -Manufactured by Dräger Medizintechnik |
| Siemens Servo-i | 510(k)#: K 010925 | -Manufactured by Siemens-Elema AB |
| Puritan Bennett 840 | 510(k)#: K984535 | -Manufactured by Nellcor Pruritan Benne |

## DEVICE DESCRIPTION

The RAPHAEL is an microprocessor controlled critical care ventilator system.

RAPHAEL supplies mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation for adult, pediatric, and infant patients weighing between 5 and 200kg.

It is powered by AC with a battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.

The user interface consists of a LCD-display, a display panel keyboard to open windows, and central rotary dial knob (press-and-turn element) for selecting, setting, and confirming inside the window.

The user provides inputs to the RAPHAEL microprocessor system through the keys and the press-and-turn element. RAPHAEL provides audible and visual patient-related, and ventilator-related alarms.

Accessories to connect RAPHAEL to the patient airway opening are the same as for GALILBO, found substantially equivalent in the 510(k) file number K001686.

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#### INTENDED USE

The RAPHAEL ventilator is designed for intensive care ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg.

## INTENDED OPERATOR

The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.

## INTENDED PATIENT POPULATIONS

Patients with body weight between 5 kg and 200 kg.

#### INTENDED USE ENVIRONMENT

The RAPHAEL ventilator is intended for use at the bedside and for transport within a hospital -type facility, provided compressed gas is supplied.

The RAPHAEL ventilator is not to be used in the presence of flammable anesthetic agents. The RAPHAEL ventilator is not to be used in a magnetic field of a MRI equipment.

## SUBSTANTIAL EQUIVALENCE

The functionality for the RAPHAEL critical care ventilator is equivalent to the GALILEO and partly also to Servo i, Evita 2 Dura and Puritan Bennett 840.

The design of RAPHAEL and the pneumatic concept are similar to those of GALILEO.

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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 stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. J. David Thompson Hamilton Medical, Incorporated Post Office Box 30008 Reno, Nevada 89520

Re: K022679

Trade/Device Name: Raphael Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 21, 2003 Received: July 30, 2003

Dear Mr. Thompson:

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.

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# Page 2 -Mr. Thompson

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/dsma/dsmamain.html

Sincerely yours.

Susan Runno

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 STATEMENT

| 510(k) Number: | K022679 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | RAPHAEL ventilator |
| Indication for Use: | The RAPHAEL ventilator is a continuous ventilator designed for ventilation of<br>adult, pediatric, and infant patients weighing between 5 and 200 kg, The<br>RAPHAEL ventilator is intended for use by properly trained personnel under the<br>direct supervision of a licensed physician. The RAPHAEL ventilator is intended for<br>use in a hospital or hospital-type facility, including use at a patient bedside or for<br>intra-facility transport, provided compressed gas is supplied. |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lihua W. Pinto for JHW

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number _ KO226079

Prescription Use:
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________