(272 days)
NA
No
The summary describes a ventilator system with standard control and monitoring functions, alarms, and power backup. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is intended for "respiratory support, monitoring and treatment of pediatric and adult patients," which directly relates to treating a medical condition.
No
This device is a ventilator system intended for respiratory support, monitoring, and treatment, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components like a Patient Unit for gas mixing and administration, a User Interface, a dedicated controller circuit, and provisions for battery modules. It is a physical ventilator system with integrated software, not a software-only device.
Based on the provided information, the Servo-air ventilator system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "respiratory support, monitoring and treatment of pediatric and adult patients." This describes a device that interacts directly with the patient's respiratory system to provide therapy and monitoring.
- Device Description: The description details how the device delivers gases, controls ventilation modes, and monitors parameters related to the patient's breathing. It also mentions features like alarms and battery backup, all of which are characteristic of a life support or therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVD devices are designed to perform tests on these types of samples.
Therefore, the Servo-air ventilator system falls under the category of a therapeutic or life support device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Servo-air ventilator system is:
- intended for respiratory support, monitoring and treatment of 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
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The Servo-air 4.0 Ventilator 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.
The Servo-air 4.0 Ventilator System is based on the cleared predicate device Servo-U/n 2.1 Ventilator System (K180098), with some modifications. The ventilation modes in the Servo-air 4.0 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the Servo-air, and the cleared predicate device Servo-U/n 2.1.
The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration.
Servo-air contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).
The Servo-air 4.0 Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.
The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
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
pediatric and adult patients
Intended User / Care Setting
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
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:
Software
- Code review
- Static code analysis
- Unit tests
- Integration tests
Performance
- System testing
- Regression
- Free User testing
- Waveform testing
Biocompatibility
- Volatile Organic Compounds
- Particulate 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.
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.
NA
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).
0
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June 18, 2020
Maquet Critica Care AB % Mark Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K192604
Trade/Device Name: Servo-air 4.0 Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: May 15, 2020 Received: May 18, 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 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
1
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 mediation-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,
James J. Lee Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192604
Device Name Servo-air 4.0 Ventilator System
Indications for Use (Describe)
- The Servo-air ventilator system is
- · intended for respiratory support, monitoring and treatment of 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
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: September 13, 2019 Updated: May 7, 2020
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Trade Name: Servo-air 4.0 Ventilator System Model: Servo-air Model no: 68 82 000
Device Classification
Common Name Classification Number Class Regulation Number 510(k) Number
Ventilator, continuous, facility use CBK II 21 CFR 868.5895 K192604
Predicate Device Identification
Maquet Servo-U/n Ventilator System K180098
Reference Device Identification
NA
Indications for Use
The Servo-air ventilator system is:
- intended for respiratory support, monitoring and treatment of 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
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Device Description
The Servo-air 4.0 Ventilator 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.
The Servo-air 4.0 Ventilator System is based on the cleared predicate device Servo-U/n 2.1 Ventilator System (K180098), with some modifications. The ventilation modes in the Servo-air 4.0 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the Servo-air, and the cleared predicate device Servo-U/n 2.1.
The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration.
Servo-air contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).
The Servo-air 4.0 Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.
The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
| PREDICATE DEVICE | SUBJECT DEVICE | Comment | |
|---|---|---|---|
| 510(k) Number | K180098 | K192604 | - |
| Device name | SERVO-U 2.1 | Servo-air 4.0 | - |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB | Identical |
| Device Classification | CBK | CBK | Identical |
| Indications for Use | The SERVO-U 2.1 ventilator system is: |
| The SERVO-air 4.0 ventilator system is:
| Identical for
included parts |
| | intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients | intended for respiratory support, monitoring and treatment of pediatric and adult patients | Neonatal patient category excluded for subject device |
| | to be used only by healthcare providers | to be used only by healthcare providers | |
| | to be used only in professional healthcare facilities and for transport within these facilities | to be used only in professional healthcare facilities and for transport within these facilities | |
| | For NAVA and Edi monitoring, it is in addition intended:
*to provide monitoring of the patient's breathing drive
*to improve synchrony between the | | No NAVA and Edi monitoring for subject device) |
COMPARISSON TO PREDICATE
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| PREDICATE DEVICE | SUBJECT DEVICE | Comment | |
|---|---|---|---|
| 510(k) Number | K180098 | K192604 | - |
| Device name | SERVO-U 2.1 | Servo-air 4.0 | - |
| ventilator system and patient when | |||
| the electrical signal from the brain to | |||
| the diaphragm is active | |||
| *for use on all patients with no | |||
| contraindication for | |||
| insertion/exchange of | |||
| a nasogastric tube | |||
| Patient range | Neonatal to adult patient populations | Pediatric to adult patient | |
| populations | Identical for | ||
| included parts | |||
| Reduced; | |||
| Neonatal patient | |||
| category excluded | |||
| for subject device | |||
| Ventilation Modes | • Volume Control (VC) | ||
| • Pressure Control (PC) | |||
| • Volume Support (VS) | |||
| • Pressure Support (PS) | |||
| • Pressure Support (CPAP) | |||
| • Pressure Regulated Volume | |||
| Control (PRVC) | |||
| • SIMV (SIMV(PC)+PS, | |||
| SIMV(PRVC)+PS, | |||
| SIMV(VC)+PS) | |||
| • Automode (PC-PS, PRVC-VS, | |||
| VC-VS) | |||
| • Bi-Vent/APRV | |||
| • NIV (NIV PC, NIV PS) | |||
| • NAVA | |||
| • NIV NAVA | |||
| • Nasal CPAP | • Volume Control (VC) | ||
| • Pressure Control (PC) | |||
| • Volume Support (VS) | |||
| • Pressure Support (PS) | |||
| • Pressure Support (CPAP) | |||
| • Pressure Regulated Volume | |||
| Control (PRVC) | |||
| • SIMV (SIMV(PC)+PS, | |||
| SIMV(PRVC)+PS, | |||
| SIMV(VC)+PS) | |||
| • Automode (PC-PS, PRVC-VS, | |||
| VC-VS) | |||
| • Bi-Vent/APRV | |||
| • NIV (NIV PC, NIV PS) | Identical for | ||
| included parts | |||
| NAVA, NIV | |||
| NAVA and Nasal | |||
| CPAP are not | |||
| included in subject | |||
| device. | |||
| Breathing Therapies | • High Flow therapy | • High Flow therapy | Identical |
Comparison of Intended Use/Indications Use
There are no changes to the Intended Use or Indications for Use between the subject device and the predicate device, with exception to the removal of NAVA which is not part of the indications for use for the subject device.
Comparison of Technology Characteristics
The Servo-air 4.0 is based on the cleared predicate device Servo-U/n 2.1 (K180098), with adaptions to be wall-gas independent, and modifications noted in the description below. Software algorithms for ventilation and alarms are the same. Furthermore, the ventilation modes in the Servo-air 4.0 are the same as the cleared predicate device.
The following changes have been made to Servo-air 4.0 compared to the cleared predicate device Servo-U/n 2.1 (K180098):
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. Mechanics and attachment of the panel
Compared to the predicate device the panel has been changed from a 15" capacitive touch screen to a 12" resistive touch screen. The general layout, functionality and screen resolution (1024x768) remains the same compared to the subject device.
The panel is fixed to the device via hinges instead of being mounted to either the mobile cart, a table or railing, as for the predicate device. As part of the change of panel changed has also been done to the PCBs.
The alarm indicator on the panel of the subject device flashes with the same colors and frequency as the alarm indicator on the screen, compared to the predicate device where the lamp does not flash together with the alarm.
The subject device has different physical dimensions. The casing has been changed from cast aluminum to steel and plastic.
The carrier is based on the same system as the predicate device, but the shelf and the pillar attached to the base of the carrier has been modified to fit the dimensions of the subject device.
Software and user interface ●
Software updates have been made to accommodate the modifications to the system. The Servo-air 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 ●
Compared to the predicate device the Handle, Mounting kit for Compressor Mini on Mobile Cart, and Pendant/bed holder have been removed. The handle is now integrated in the design of the subject device which is also not intended to be bedside mounted and thus the Pendant/bed holder is removed. The Compressor Mini is not an accessory for the subject device so the mounting kit is excluded.
The following components have been changed; Support Arm, Mobile cart, Humidifier Holder and shelf base to accommodate the physical changes to the cart.
New components specific for the subject device include the battery module, battery charger, cabinet, air inlet filter and dust filter.
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. Power system
The subject device maximum power consumption has increased from 80W to 100W and the power supply electronics have been modified to accommodate this.
The battery has been changed from NiMH to Li-ion batteries. However, the battery system backup time range for the subject device is within the range specified for the predicate device.
● Blower module
The Servo-air adds the use of a turbine/blower module with an ambient humidity and temperature sensor. The turbine generates a controlled airflow from the ambient air and is controlled by the blower module. An air flow meter measurement of the mixed (air+O2) gas flow is used.
As a result of these changes some performance specifications are also changed for the subject device.
| 1. | The noise level has increased from