SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800

K063404 · Maquet Critical Care AB · CBK · Feb 15, 2007 · Anesthesiology

Device Facts

• Record ID: K063404
• Device Name: SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
• Applicant: Maquet Critical Care AB
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1.T. 1.5T and 37 MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.

Device Story

The SERVO-i Ventilator System is a platform providing respiratory assistance to neonates, infants, and adults. It monitors patient respiratory status and delivers ventilation support. The device is intended for use by healthcare providers in hospital settings and during in-hospital transport. This submission introduces an 'MR Environment' option, allowing the ventilator to be used in proximity to 1.0T, 1.5T, and 3.0T MRI scanners. The modification involves testing vital components in excessive magnetic fields to ensure performance and safety, and reducing electromagnetic emissions to minimize image artifacts. The device is classified as MR Conditional; safe operation requires adherence to the specific MR Environment Declaration provided with the system. The ventilator provides clinicians with respiratory monitoring and therapy, enabling patient care within the MRI suite.

Clinical Evidence

Bench testing only. Performance was evaluated in 1.0T, 1.5T, and 3.0T magnetic resonance environments. Testing confirmed that the ventilator maintains performance and does not impair scanner image quality when used according to the MR Environment Declaration.

Technological Characteristics

Ventilator platform with selectable ventilation modes. MR Conditional modification includes shielding and component testing for operation in 1.0T, 1.5T, and 3.0T magnetic fields. Reduced electromagnetic emissions to minimize MRI artifacts. System includes MR Environment kit (on-site or factory installed).

Indications for Use

Indicated for neonates, infants, and adults with respiratory failure or respiratory insufficiency requiring treatment and monitoring. For use by healthcare providers in hospitals, healthcare facilities, and for in-hospital transport.

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

• SERVO-i Ventilatory System (K041223)
• Aestiva/5 MRI GE, Datex-Ohmeda Inc. (K050055)
• IC-2A Bio-med Devices Inc. (K896380)
• MVP-10 Bio-med Devices Inc. (K896391)
• iVent 201 VersaMed Medical Systems Inc. (K061627)

Submission Summary (Full Text)

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K063404

Traditional 510(k)

130 (131) Doc-ID Issue no 01

Indications for Use

EVU-120150

510 (k) Summary

as required by section 807.92(c)

# Subscribers Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: [phone] Fax: [phone]

Contact Persons for this submission:

Ms. Veronica Ekström Tele. Direct; (011) 46 8 730 7300 extension 7367 Email: [e-mail]

USA Contact :

Mr. Jamie Yieh Director, Regulatory Affairs/Quality Assurance Maquet Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807 Phone: [phone] Fax: [phone] Email: [e-mail]

# Trade Names

SERVO-i Ventilator System article no .; 64 87 800 MR Environment option: MR Environment kit (on-site) 66 71 712 and (factory installed) 66 72 289

### Device Classification

| Common Name | Classification<br>Number | Class | Regulation Number |
|----------------------------------------------------------------|--------------------------|-------|-------------------|
| Ventilator, Continuous (Respirator) | 73 CBK | II | 868.5895 |
| Predicate Device Identification | | | |
| Legally marketed devices to which equivalence is being claimed | | | |
| SERVO-i Ventilatory System | | | K041223 |
| Aestiva/5 MRI GE, Datex-Ohmeda Inc. | | | K050055 |
| IC-2A Bio-med Devices Inc. | | | K896380 |
| MVP-10 Bio-med Devices Inc. | | | K896391 |
| iVent 201 VersaMed Medical Systems Inc. | | | K061627 |

FEB 1 5 2007

Doc-ID
EVU-120150

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| MAQUET | Document Type<br>Traditional 510(k) | Section-Page<br>131 (131) |
|---------------------------------------|-------------------------------------|---------------------------|
| Object/Subject<br>Indications for Use | | Doc-ID<br>EVU-120150 - 01 |

#### Device Description

The ventilator is a platform with several selectable ventilation modes, which monitor patients whom need respiratory assistance. The MR environment option makes it possible to qualify the Servo-i ventilator to be used in MR environment

#### Indications for use:

The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1.T. 1.5T and 37 MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.

# Summary of technological characteristics of modified Device and Predicate Device: MR Environment option

The SERVO-i ventilator with MR option have been tested with 1.0, 1.5, 3.0 T scanners without impairing its performance or the image quality of the scanner.

Vital parts of the ventilator have been tested for performance in excessive magnetic fields to evaluate the safety margins.

The emission from the SERVO-i has been further decreased with the MR option to reduce the probability for artifacts on the scanner images.

Each scanner and its environment forms an individual device. The MR Environment Declaration describes how a SERVO-i with MR option can be qualified to be used with an MR scanner forming a safe Medical System.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three curved lines representing the body and a ribbon-like element at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maquet Critical Care AB C/O Mr. Jamie Yieh Director, Regulatory Affairs/Quality Assurance Maquet, Incorporated 1140 Route 22 East. Suite 202 Bridgewater, New Jersey 08807

FEB 15 2007

Re: K063404

Trade/Device Name: SERVO-i Ventilator System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 24, 2007 Received: January 26, 2007

Dear Mr. Yieh:

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. Yieh

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 vours.

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: SERVO-i Ventilator System

Indications For Use:

The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator is classified as MR Conditional for 1.T, 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

Mark Wahlund

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Cantrol, Dental D

\$10(k) Number