SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

K040221 · Maquet Critical Care AB · CBK · Feb 20, 2004 · Anesthesiology

Device Facts

• Record ID: K040221
• Device Name: SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
• Applicant: Maquet Critical Care AB
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Special
• 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 health care providers in hospitals or health care facilities and for in-hospital transport. Note: The Servo-i Ventilator System is not intended to be used with any anesthetic agents.

Device Story

Servo-i Ventilator System provides respiratory support and monitoring for neonates, infants, and adults. Device operates in hospital settings, including bedside and in-hospital transport, managed by professional healthcare providers. System delivers ventilation therapy; monitors patient respiratory status. Modification involves adjusting low minute volume alarm threshold for infants to 0.06 l/min. Device is not compatible with anesthetic agents or MRI environments. Output assists clinicians in managing respiratory failure or insufficiency, facilitating patient stabilization and treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Continuous ventilator system for neonates, infants, and adults. Features include selectable ventilation modes, patient monitoring, and adjustable alarm thresholds. Designed for bedside and in-hospital transport. Not MRI compatible. Does not use anesthetic agents.

Indications for Use

Indicated for neonates, infants, and adults with respiratory failure or respiratory insufficiency. Intended for use in hospitals, healthcare facilities, and for in-hospital transport. Not for use with anesthetic agents or in 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

• Servo Ventilator 300 A (K970839)
• Servo-i Ventilatory System (K022132)
• Evita 4 (K980642)

Submission Summary (Full Text)

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K040221

Document Type

Special 510(k)

Section-Page 17(38) Dxc-ID Issue no EVU-111185 - 02

Servo-iVentilator System -510(k) Summary

# 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 Person for this submission: Official Correspondent:

Anders Palm tele. direct; (011) 46 8 730 74 88 [e-mail]

USA Contact :

Jamie Yieh Manager Regulatory Submissions, Maquet Inc. Cellphone; 908-227-8807 [e-mail]

# Trade Names

Servo-i Ventilator System

article no .; 64 87 800 E407E

#### 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 | 510(k) # |
|----------------------------------------------------------------|----------|
| Servo Ventilator 300 A, | K970839 |
| Servo-i Ventilatory System | K022132 |
| Evita 4, | K980642 |

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| MAQUET | Document Type<br>Special 510(k) | Section-Page<br>18(38) | |
|------------------------------------------|---------------------------------|------------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo-iVentilator System -510(k) Summary | | EVU-111185 | - 02 |

## Device Description (for detailed description see Section F)

The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).

# Summary of technological characteristics of modified Device and Predicate Device:

#### Low minute volume alarm

The Servo-i low minute volume alarm for infants has been changed from 0,10 l/min to 0,06 1/min, the same as that of the Servo-i's predicate, the SV300 ventilator.

### Intended Use of the Device:

The intended use(s) and indications of the Servo-i application, as described in its labelling, are the same as the intended uses and indications for the unmodified Servo-i.

The intended use is the same including;

- the proposed change of the low minute volume alarm from 0,10 to 0,06 I/min -
#### Intended Use of the Device:

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 health care providers in hospitals or health care facilities and for in-hospital transport.

Note: The Servo-i Ventilator System is not intended to be used with any anesthetic agents.

#### Intended operator:

Servo-is a ventilator system with advanced functionality. It may be used only by professional health care providers who have sufficient experience in ventilator treatment.

#### Intended Patient Population:

Infant for patient weight 0.5-30 kg Servo-i

#### Intended Use Environment:

The Servo-i Ventilator System is designed to be used at the bedside and for in-hospital transport. The Servo-i Ventilator System is not intended to be used with any anesthetic agents. The Servo-i Ventilator System is not compatible for use in a MRI magnetic field

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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 features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB 2,0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maquet Critical Care AB c/o Mr. Jamic Yieh Maquet, Incorporated 186 Wood Avenue South Iselin, New Jersey 08830

Re: K040221

K040221
Trade/Device Name: Servo-i Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 26, 2004 Received: February 2, 2004

Dear Mr. Yieh:

We have reviewed your Section 510(k) premarket not intent to market the device the device t We have reviewed your Scellon 910(t) promised is substantially equivalent (for the referenced above and have determined the use the marketed predicate devices marketed in
indications for use stated in the enclosure) to legally af the Modical Device indications for use stated in the chelosares to tegation date of the Medical Device interstate commerce pror to May 20, 1770, the ssifted in accordance with the provisions of
Amendments, or to devices that have been recessive annrovel of a premated Amendments, of to devices mat nave been rocability that do not require approval of a premaint the Federal Food, Drug, and Cosmene Acc (recre, market the device, subject to the general approval appircation (r.MA). Tod may, moreloroplans of the Act include controls provisions of the Act. "The general of and of any and on any and on requirements for annual regainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III ( If your device is classified (sec above) into entrols. Existing major regulations affecting (PMA), it may be subject to such additional confress and regulations, Title 21, Yarts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Feder your device can be found in the Code of I eachd regulation in the Ecderal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a substanter with other requirements
mean that FDA has made a determination that your device Foderal agencies mean that FDA has made a decemination that Jour and Jour and Submissered by other Federal agencies.

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Page 2 – Mr. Jamie Yieh

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801 CFR Part 800'; and i and listing (21 CFR I art 607), labeling (27 cms (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections as decembed applicable, the electronic product radiation you to begin marketing your device as described.
21 CFR 1000-1050. This letter will allow you to man and substantial squivelance 21 CFR 1000-1030. This letter will and 1000 of substantial equivalence in your Section 510(k) premance from to the results in a classification for your of your device to trigate your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de at [phone]. Also, please note the regulation please contact the entification of Complains of (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinan 2001 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clu L

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): K040221

Device Name: Servo-i Ventilator System

Indications For Use:

Indications For Use:
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range The Servo' Ventilator System is miended jor treatinent instituting of pfficiency. Servo' is
of neonates, infants and adults with respiratory failure or respiratory insuffici of neonates, infanis and dauls want respiratory Jalane of respective or healthcare facilities and for in-hospital transport.

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)

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