(98 days)
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.
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
The SERVO-i Ventilator System's acceptance criteria and testing are focused on its "MR environment option" which allows it to be used safely in conjunction with MRI scanners. The provided document is a 510(k) summary, which typically provides an overview of testing rather than a detailed study report.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for magnetic field strength, RF interference limits, or image artifacts) or precise, quantitative reported device performance values. Instead, it describes general claims of compatibility and safety.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| MR Compatibility Statement | The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1T, 1.5T, and 3T MR scanners. This implies that it is safe to use in the MR environment if specific conditions are met. |
| Ventilator Performance in MR Environment | The SERVO-i ventilator with MR option has been tested with 1.0, 1.5, and 3.0 Tesla (T) scanners without impairing its performance. |
| Impact on MR Image Quality | The SERVO-i ventilator with MR option has been tested with 1.0, 1.5, and 3.0 T scanners without impairing the image quality of the scanner. |
| Safety Margins | Vital parts of the ventilator have been tested for performance in excessive magnetic fields to evaluate the safety margins. (No specific margin values reported) |
| Electromagnetic Emission Reduction | The emission from the SERVO-i has been further decreased with the MR option to reduce the probability for artifacts on the scanner images. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the devices tested. It refers to "the SERVO-i ventilator with MR option" in general terms.
- Data Provenance: The document implies the testing was conducted by Maquet Critical Care AB, which is a Swedish company. The nature of the testing (e.g., lab testing, in-house verification) suggests it's prospective data generated specifically for this submission. There is no indication of patient data or retrospective studies for this specific MR compatibility claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the typical sense for clinical performance. The testing described appears to be engineering and compatibility testing to ensure the device functions correctly in an MR environment and does not interfere with the MRI scanner. Therefore, no information on the number or qualifications of clinical experts for ground truth is provided.
4. Adjudication Method for the Test Set
Not applicable. The testing described is technical verification and validation of MR compatibility, not clinical performance requiring adjudication of patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the technical compatibility and safety of the ventilator in an MR environment, not on the comparative clinical effectiveness or improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The testing performed on the SERVO-i ventilator with the MR option can be considered "standalone" as it evaluates the device's technical performance and its interaction with an MRI system, without direct human-in-the-loop performance being a primary outcome measure for the MR compatibility. The ventilator itself is a standalone medical device.
7. The Type of Ground Truth Used
The ground truth used for this testing is based on:
- Engineering specifications and regulatory standards for MR compatibility: The device must maintain its intended ventilatory function.
- MRI image quality assessment: The device must not cause unacceptable artifacts in the MR images.
- Magnetic field strength measurements: To ensure safety margins.
This is a technical ground truth rather than a clinical ground truth derived from expert consensus or pathology in a diagnostic context.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device (ventilator) and its MR compatibility, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML algorithm or training set discussed in the provided document.
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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: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38
Contact Persons for this submission:
Ms. Veronica Ekström Tele. Direct; (011) 46 8 730 7300 extension 7367 Email: veronica.ekstrom@maquet.com
USA Contact :
Mr. Jamie Yieh Director, Regulatory Affairs/Quality Assurance 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 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 | ClassificationNumber | 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
{1}------------------------------------------------
| MAQUET | Document TypeTraditional 510(k) | Section-Page131 (131) |
|---|---|---|
| Object/SubjectIndications for Use | Doc-IDEVU-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 (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 (301) 443-6597 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
§ 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).