(209 days)
The SERVO-i Ventilator System with Heliox option 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. The SERVO-i Ventilator System with Heliox option is also MR conditional.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
The predicate device SERVO-i Ventilator System is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's. The modified device adds an option, called "Heliox option", which is a mechanical adaptor along with software for SERVO-i Ventilator System integration.
The provided text is a 510(k) summary for the Maquet SERVO-i Ventilator System with Heliox option. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. Crucially, this document does not contain information about acceptance criteria, device performance metrics, or study designs used to prove the device meets specific performance criteria beyond establishing substantial equivalence for regulatory purposes.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of studies are typically found in more detailed technical documentation or clinical trial reports, which are not part of this 510(k) summary.
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K073179
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510(K) SUMMARY
As required by section 807.92(c)
JUN - 9 2008
Subscribers Name & Address
Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38
Contact Persons for this submission:
Mr. Micael Johansson Tele. Direct; (011) 46 8 730 79 58 Email: micael.johansson@maquet.se
Mr. Jamie Yieh USA Contact : Director, Regulatory Affairs Maquet, Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807 Phone: 908-947-2311 Fax: 908-947-2301 Email: jamie.yieh@maquet-inc.com
Trade Names
SERVO-i Ventilator System with Heliox option
Preparation date 2007-11-09
Device Classification
| Common Name | ClassificationNumber | Class | Regulation Number |
|---|---|---|---|
| Ventilator, continuous (Respirator) | 73 CBK | II | 21 CFR 868.5895 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Maquet, SERVO-i Ventilator System | K063404 |
| Viasys, Avea with Heliox option | K022674 |
| GE Datex-Ohmeda, Aptaer Heliox Delivery System | K041524 |
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Device Description
Summary of technological characteristics of modified Device and Predicate Device: The predicate device SERVO-i Ventilator System is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's. The modified device adds an option, called "Heliox option", which is a mechanical adaptor along with software for SERVO-i Ventilator System integration.
Intended Use of the Device:
The SERVO-i Ventilator System with Heliox option 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. The SERVO-i Ventilator System with Heliox option is also MR conditional.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
Comparison to predicate devices.
The subject device is comparable to the predicate devices in that the intended use is for delivery of Heliox, for the patient ranges of neonatal to adult, and in invasive and non-invasive applications. All devices utilize gas connectors or adapters and software enhancements.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird-like figure, constructed from thick, stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Maquet Critical Care AB C/O Mr. Jamie Yieh Director, Regulatory Affairs Maquet, Incorporated 1140 Route 22 East, Suite 202 Bridgewater, New Jersey 08807
Re: K073179
Trade/Device Name: SERVO-i Ventilator System with Heliox Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 12, 2008 Received: May 13, 2008
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 (OS) 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ches
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 (if known): K073179
Device Name: SERVO-i Ventilator System with Heliox option
Indications for Use:
The SERVO-i Ventilator System with Heliox option 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. The SERVO-i Ventilator System with Heliox option is also MR conditional.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
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)
hnd
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073179
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).