RAPHAEL COLOR ASV VENTILATOR

K071194 · Hamilton Medical AG · CBK · Oct 18, 2007 · Anesthesiology

Device Facts

• Record ID: K071194
• Device Name: RAPHAEL COLOR ASV VENTILATOR
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RAPHAEL ColorASV ventilator is intended to provide positive pressure ventilatory support in intensive care units. The ventilator is intended for intensive care ventilation of adult and pediatric patients weighing between 5 and 200 kg. The device is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ColorASV ventilator is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed air is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. In the USA, federal law restricts this device to sale by or on the order of a physician.

Device Story

Intensive care ventilator for adult/pediatric patients (5-200 kg); provides positive pressure ventilation. Features Adaptive Support Ventilation (ASV) mode; ASV maintains clinician-set minute ventilation without exceeding preset plateau pressure. ASV operation: breath-by-breath patient assessment; calculation of optimal breath pattern using Otis minimal work of breathing method; automatic adjustment of mandatory rate and inspiratory pressure. Used in ICU, bedside, or hospital transport by trained personnel under physician supervision. Output displayed for clinician monitoring; assists in managing apnea or low-drive conditions by automatically transitioning to spontaneous ventilation. Benefits include optimized ventilation patterns and reduced clinician intervention requirements.

Clinical Evidence

Bench testing only. Performance/qualification testing of the ASV feature conducted at modular, integration, and system levels. Ventilator performance evaluated per ASTM Standard F1100-90. No performance deviations observed.

Technological Characteristics

Continuous ventilator; software-modified version of K052863. Includes Adaptive Support Ventilation (ASV) mode. Operates on microcomputer system. Complies with ASTM F1100-90. Requires external compressed air supply.

Indications for Use

Indicated for intensive care ventilation of adult and pediatric patients weighing 5-200 kg. Contraindicated for use in presence of flammable anesthetic agents, ignition sources, or MRI environments.

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

• HAMILTON RAPHAEL Color (K052863)
• HAMILTON GALILEO GoldASV (K061090)

Submission Summary (Full Text)

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K071194

Image /page/0/Picture/1 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a stylized "H" enclosed in a circle. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in a smaller, sans-serif font.

OCT 1 8 2007

# 510(k) Summary

| 510(k) OWNER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>CH-7402 Bonaduz<br>Switzerland |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider<br>Phone: [phone]<br>Fax:<br>[phone]<br>e-mail: [e-mail] |
| PREPARATION DATE: | September 26, 2007 |
| TRADE NAME: | RAPHAEL ColorASV |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use<br>(21 CFR 868.5895, Product Code CBK) |
| REASON FOR THIS 510(K)<br>SUBMISSION: | The RAPHAEL ColorASV is a software<br>modified version of the legally marketed<br>device RAPHAEL Color (K052863) |
| LEGALLY MARKETED DEVICES<br>TO WHICH EQUIVALENCE IS<br>BEING CLAIMED: | HAMILTON RAPHAEL Color<br>510(k) Number: K052863 |
| | HAMILTON GALILEO GoldASV<br>510(k) Number: K061090 |

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K071194

Image /page/1/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" and "MEDICAL" in large, bold letters. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in smaller letters. The logo is simple and professional, and it conveys the company's focus on medical technology.

#### DEVICE DESCRIPTION

The RAPHAEL Color's is a software modified version of the legally marketed device RAPHAEL Color (K052863).

The RAPHAEL Color^SV is a full-functioned intensive care ventilator. It can ventilate adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL Color488 offers a full spectrum of modalities, from the conventional to the new included Adaptive Support Ventilation, ASV.

ASV is designed to maintain at least the minute ventilation set by the clinician. ASV does this without exceeding a preset plateau pressure. ASV provides full ventilation in apnea or low-drive conditions, and then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps:

- 1. Assess the patient breath-by-breath.
- Calculate an optimal breath pattern based on the minimal work of breathing 2. method by Otis (J Appl Physiol 1950: 592-607).
- Approach the target by automatically adjusting mandatory rate and inspiratory 3. pressure.

#### INTENDED USE

The RAPHAEL Color \$60 ventilator is intended to provide positive pressure ventilatory support in intensive care units.

The ventilator is intended for intensive care ventilation of adult and pediatric patients weighing between 5 and 200 kg.

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

The RAPHAEL Color^sy ventilator is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed air is supplied.

The device is not to be used in the presence of flammable anesthetic agents or other ianition sources.

The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment.

In the USA, federal law restricts this device to sale by or on the order of a physician.

#### SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES

The indication statements for the RAPHAEL Color 400 ventilator are comparable to those for the predicate devices.

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KC71194

Image /page/2/Picture/1 description: The image shows the logo for Hamilton Medical. The logo has the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a circle with the letter "H" inside. Below the word "MEDICAL" is the phrase "MAKING TECHNOLOGY SERVE MANKIND" in a smaller font.

All technological characteristics and performance specifications of the RAPHAEL Color 58 ventilator are equivalent to those of the predicate device RAPHAEL Color (K052863), except for the new added ASV mode.

The ASV mode is comparable with the ASV mode of the predicate device HAMILTON GALILEO GoldASV (K061090).

#### SUMMARY OF NON-CLINICAL PERFORMANCE TESTS

The performance/qualification testing of the new added feature ASV has been done on modular, integration and system level. There were no performance deviations observed or documented during testing.

The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-90. No new question rose regarding safety and effectiveness of the complete instrument and its new feature.

As the implementation of the new software feature does not include any new hardware, certain tests could be omitted. However, the impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing.

#### CONCLUSION

The ventilator RAPHAEL Color404 is, inclusive the new added ASV mode, substantially equivalent in safety and effectiveness to the HAMILTON RAPHAEL Color (K052863) and the HAMILTON GALILEO GoldASV ventilators.

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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 text is likely part of a document or sign, indicating an affiliation with a public health organization.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 1 8 2007

Mr. Joerg Schneider Quality Engineer, R & D Hamilton Medical AG Via Crusch 8 CI-7402 Bonaduz SWITZERLAND

Re: K071194

Trade/Device Name: RAPHAEL Color Asv Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 2, 2007 Received: October 5, 2007

Dear Mr. Schneider:

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. Schneider

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 vour 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.

Syndie Y. Michael Oud.

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

K071194 510(k) Number:

RAPHAEL ColorAsv Device Name:

- The RAPHAEL Color^sV ventilator is a continuous ventilator Indication for Use: designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorASV ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color450 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.
メ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mirt Kland

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

510(k) Number: