(287 days)
No
The summary does not mention AI or ML, and the device description focuses on standard ventilation modes and measurements like Edi, which are not inherently AI/ML driven. The performance studies listed are standard software and hardware verification/validation, not AI/ML model training or testing.
Yes
The device is intended for "respiratory support, monitoring and treatment," which directly addresses a therapeutic need for patients.
Yes
This device monitors physiological parameters (e.g., Electrical activity of the diaphragm (Edi), CO2 and flow/pressure measurements) and provides alarms if parameters vary beyond limits, which are characteristics of a diagnostic device. While its primary function is respiratory support, the monitoring aspects contribute to diagnosis and ongoing assessment of the patient's condition.
No
The device description explicitly states that the system consists of a "Patient Unit where gases are mixed and administered" and a "User Interface where the settings are made and ventilation is monitored," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Servo-u/n/u MR Ventilator Systems are described as devices for "respiratory support, monitoring and treatment." They deliver gases, monitor breathing efforts (Edi), and provide ventilation.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. While it monitors physiological parameters like Edi and potentially CO2 (with accessories), this is done in vivo (within the living body) or at the point of gas exchange, not through laboratory analysis of a collected sample.
- Intended Use: The intended use clearly states respiratory support and treatment, not diagnostic testing of biological samples.
Therefore, the Servo-u/n/u MR Ventilator Systems fall under the category of life support or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Servo-u Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
The Servo-n Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
The Servo-u MR Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
- to be used in MR environment according to specified conditions
- with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.
The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.
The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.
The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.
NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.
Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonatal, pediatric and adult patients (adult not applicable for Servo-n)
Intended User / Care Setting
Healthcare providers in professional healthcare facilities and for transport within these facilities. The Servo-u MR Ventilator System is also to be used in MR environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified devices meet the design input requirements. This includes:
Software: Code review, Static code analysis, Unit tests, Integration tests.
Performance: Specification and system-level verification testing, Waveform testing.
Biocompatibility: Volatile Organic Compounds, Particulate testing, Leachable testing.
Human Factors Validation Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Maquet Servo-u/n Ventilator System, K180098
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Maquet Critical Care AB % Mark Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K201874
Trade/Device Name: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: July 6, 2020 Received: July 7, 2020
Dear Mark Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) TBD
Device Name Servo-u Ventilator System 4.1 Servo-n Ventilator System 4.1 Servo-u MR Ventilator System 4.1
Indications for Use (Describe)
The Servo-u Ventilator System is:
- · intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
- to be used only by healthcare providers
- · to be used only in professional healthcare facilities and for transport within these facilities
The Servo-n Ventilator System is:
- · intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
- · to be used only by healthcare providers
- · to be used only in professional healthcare facilities and for transport within these facilities
The Servo-u MR Ventilator System is:
- · intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
- · to be used only by healthcare providers
- · to be used only in professional healthcare facilities and for transport within these facilities
- · to be used in MR environment according to specified conditions
- with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Getinge, a company that provides equipment and systems for healthcare and life sciences. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol. The symbol is composed of four curved shapes arranged in a circular pattern, creating a sense of movement and connection.
510(k) SUMMARY
as required by section 21 CFR 807.92
| Device owner | Maquet Critical Care AB
Röntgenvägen 2
SE-171 54 Solna, Sweden
Tel: (011) 46 10 335 7300 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons for this submission: | Mr. David Ardanius
Regulatory Affairs Manager
Phone: direct: (011) 46 10 335 7300
Email: david.ardanius@getinge.com |
| Application Correspondent: | Mr. Mark N. Smith
Manager, Regulatory Affairs
Getinge
45 Barbour Pond Drive
Wayne, NJ 07470
Email: mark.n.smith@getinge.com
Phone: 585-272-5274 |
Date prepared: August 31, 2020
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| Trade Name : | Model: | Model no: |
|---|---|---|
| Servo-u 4.1 Ventilator System | Servo-u | 66 94 800 |
| Servo-n 4.1 Ventilator System | Servo-n | 66 88 600 |
| Servo-u MR 4.1 Ventilator System | Servo-u MR | 68 88 800 |
Device Classification
Common Name Classification Number Class Regulation Number
Ventilator, continuous, facility use CBK II 21 CFR 868.5895
Predicate Device Identification
| Maquet Servo-u/n Ventilator System | K180098 | |
|---|---|---|
| -- | ------------------------------------ | --------- |
Reference Device Identification
| Maquet Servo-i Ventilator System | K123149 |
|---|---|
| Nihon Kohden NKV-550 | K181695 |
| Hamilton-G5 | K193228 |
Indications for Use
The Servo-u/n/u MR Ventilator Systems are:
- . intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients (adult not applicable for Servo-n)
- to be used only by healthcare providers .
- to be used only in professional healthcare facilities and for transport within these . facilities
The Servo-u MR Ventilator System to be used in MR environment according to specified conditions:
- . with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss .
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Image /page/5/Picture/0 description: The image shows the logo for Getinge, a company that provides equipment and systems to healthcare and life science industries. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol resembling four arrows pointing inward towards a central point. The color scheme is primarily a dark blue, giving the logo a professional and modern appearance.
Device Description
The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.
The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.
The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.
The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.
NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.
Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).
6
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COMPARISSON TO PREDICATE
Comparison of Intended Use/Indications Use
The Indications for Use for the proposed Servo-u/n/u MR Ventilator Systems 4.1 are identical to the predicate device Servo-u/n 2.1 Ventilator System (K180098 with the addition of MR environment to Servo-u MR.
MAQUET bases this 510(k) notification on that the Servo-u/n/u MR 4.1 fulfil the appropriate product standards and is substantially equivalent with the already cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098).
Comparison of Technology Characteristics
The Servo-u/n/u MR Ventilator Systems 4.1 are modifications of the previously cleared Servo-u/n Ventilator Systems 2.1 (K180098).
The following changes have been made to Servo-u/n/u MR Ventilator Systems 4.1 compared to the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098):
Servo-u MR, Mechanical adaptions and Magnetic Field Indicator -
Compared to the predicate device, a magnetic field indicator and mobile cart with autolock are added. Also the panel is modified.
The patient unit is permanently attached to the mobile cart and can therefore not be detached once assembled.
Cable Shielding ferrites have been added to the panel cable and panel connector to protect the components from the induced magnetic field. The panel cable is fixated in the panel to increase the robustness.
The panel arm on the user interface is not adjustable. However, it is possible to rotate and tilt the user interface.
A Magnetic Field Indicator (MFI) is introduced to the system. The intent of the MFI is to assist the user when placing the ventilator in the MR environment by continuously indicating the magnetic field.
An auto-lock handle is added. When the handle is released, the brakes automatically lock all four wheels. When the handle is depressed, the wheels are unlocked, enabling the user to move the ventilator.
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Additionally, the nebulizer port is plugged and it is not possible to attach drawers or place compressor mini on the mobile cart.
Software and user interface -
Software modifications have been made to add new functionality such as:
- -OLT trends (Open Lung Tool)
- OLT RM (Recruitment maneuver) -
- OLT SRM (Stepwise RM) -
- TP (Transpulmonary pressure) -
- SI (Stress index) -
- -Heliox
- -The possibility of setting PEEP to 0 cmH2O
- Minor improvements of the Total PEEP and Dynamic compliance calculations and the Circuit compliance compensation.
- -Minor corrections
The Servo-u/n/u MR software is considered a Major Level of Concern. Software verification was performed according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and according to the standard IEC 62304 "Medical device software - Software life-cycle processes".
-Components
The label of the Y sensor module pressure port is changed from PAW to PAUX. Compared to the predicate device an adapter for Heliox connection is added. CO2 module updated due to last-time-buy.
Y-piece, angled label change to disposable
Increased stability of Support arm by added clamp holder
-Alarms
The following adjustments and changes have been implemented for the alarms.
The algorithm linked to triggering of the alarm "Patient circuit disconnected" has been improved and split into two alarm types of the same priority; "Patient circuit disconnected" and "Check Tubing".
Minor improvements of the alarm handling for the Y sensor
Non-clinical Testing and Performance
Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified devices meet the design input requirements:
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Software
- Code review
- Static code analysis ●
- Unit tests ●
- Integration tests ●
Performance
- Specification and system-level verification testing
- Waveform testing
Biocompatibility
- . Volatile Organic Compounds
- Particulate testing
- Leachable testing
Human Factors Validation Testing
The following product standards are included in the verification:
- ANSI/AAMI ES 60601-1:2005 + A1:2012, Medical electrical equipment ● Part 1: General requirements for basic safety and essential performance, Recognition Number 19-4
- IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Test, Recognition Number 19-8
- . IEC 60601-1-8:2006 + A1:2012, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Recognition Number 5-76
- ISO 80601-2-12:2011, Medical electrical equipment -- Part 2-1: Particular ● Requirements For The Safety Of Lung Ventilators - Critical Care Ventilators, Recognition Number 1-98
- ISO 80601-2-55:2018, Medical electrical equipment -- Part 2-55: Particular . requirements for the basic safety and essential performance of respiratory gas monitors, Recognition Number 1-140
- . IEC 62133-1:2017, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications -Part 1: Nickel Systems
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The connector to High-Pressure gas is in accordance with CGA V-5:2008, Recognition Number 1-81.
Biocompatibility evaluation of the Servo-u/n/u MR 4.1 is in accordance with ISO 10993-1:2018, recognition number 2-258 and ISO 18562-1:2017, recognition number 1-134.
Processing of Health Care Products evaluation of the Servo-u/n/u MR 4.1 is in accordance with ANSI AAMI ISO 17664:2017, recognition number 14-515 included the extent of recognition.
Conclusion for Substantial Equivalence
The subject devices and the predicate device have the same intended use. There are no new type questions of safety and effectiveness for the subject devices that pose significant safety or effectiveness concerns as compared to the cleared predicate device. MAQUET has conducted risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design input requirements and the appropriate product standards. MAQUET concludes that the performance data for the subject devices shows that they are substantially equivalent to the cleared predicate device.