(771 days)
Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.
Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.
Savina 300 is intended for the following environments of use:
-
In intensive care wards, recovery rooms and generally for hospital use
-
During the transport of ventilated patients within the hospital
-
During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)
-
During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)
Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO).
The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.
This document is a 510(k) Summary for the Dräger Savina 300 ventilator, claiming substantial equivalence to previously cleared devices. It does not contain a study proving that the device meets specific acceptance criteria in the way a clinical validation study for an AI/ML software device would. Instead, it demonstrates compliance with recognized performance standards to establish substantial equivalence.
Here's an breakdown based on the information provided, and where certain requested information might not be applicable or present for this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of "acceptance criteria" paired with "reported device performance" in the context of specific outcome metrics like sensitivity, specificity, or accuracy for a diagnostic device.
Instead, the "acceptance criteria" are implied by compliance with listed international and national standards relevant to medical electrical equipment, particularly for lung ventilators. The "reported device performance" is demonstrated by the device's design, functional specifications, and its claim of equivalence to existing devices that have already met these standards.
Here's a summarization of the relevant information provided under "List of Performance Testing" and "Comparison of Technological Characteristics":
| Acceptance Criteria (Implied by Standards & Predicate Equivalence) | Reported Device Performance (as claimed in 510(k) Summary) |
|---|---|
| Safety and Essential Performance (IEC 60601-1) | Complies with IEC 60601-1: 1988 + A1: 1991 + A2: 1995 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2: 2007 |
| Specific Requirements for Lung Ventilators - Critical Care (IEC 60601-2-12) | Complies with IEC 60601-2-12: 2001 |
| Programmable Electrical Medical Systems (IEC 60601-1-4) | Complies with IEC 60601-1-4: 1996 + A1: 1999 |
| Usability (IEC 60601-1-6) | Complies with IEC 60601-1-6: 2006 |
| Alarm Systems (IEC 60601-1-8) | Complies with IEC 60601-1-8: 2006 |
| Risk Management (ISO 14971) | Complies with ISO 14971: 2007, Corrected version 2007-10-01 |
| Reprocessing of Resterilizable Medical Devices (ISO 17664) | Complies with ISO 17664: 2004 |
| Medical Device Software - Software Life Cycle Processes (IEC 62304) | Complies with IEC 62304: 2006 |
| Environmental Conditions and Test Procedures for Airborne Equipment (RTCA-DO 160G) | Complies with RTCA-DO 160G: 2010 (applicable clauses for radiated electromagnetic emissions and mechanical safety) |
| Respiratory Gas Monitors (ISO 21647) | Complies with ISO 21647: 2005 |
| Biological Evaluation of Medical Devices (ISO 10993-1) | Complies with ISO 10993-1: 2009 + Cor. 1: 2010 |
| Ventilators Intended for Use in Critical Care (ASTM F1100-90 (Reapproved 1997)) | Complies with ASTM F1100-90 (Reapproved 1997) |
| Functional Equivalence to Predicate Devices | "The functionality is equivalent to the Infinity Acute Care System Workstation Critical Care and the flight transport indication is equivalent to the Oxylog 3000 Plus." (Page 4) |
| Technological Equivalence to Predicate Devices | "The technological concept of the Savina 300 is equivalent to Savina." (Page 4) |
| Intended Use | "The intended use and the functionalities as the predicate devices remain the same." (Page 11) |
| Ventilation Modes | Savina 300 provides comparable volume-controlled and pressure-controlled ventilation modes, support for spontaneous breathing, and special modes (Pages 5, 8). |
| Monitoring Capabilities | Savina 300 provides equivalent monitoring sensors (flow, pressure, O2, optional CO2) and displayed parameters (airway pressure, MV, VTi, FiO2, etCO2, etc.) to predicates (Pages 9, 10). |
| Environmental Conditions for Operation/Storage | Savina 300 meets or exceeds the environmental specifications of its predicates for temperature, atmospheric pressure, and humidity (Pages 9, 10). |
| Power Supply & Battery Bridging Time | Savina 300 mains power supply and internal battery bridging time (typ. 45 min) are comparable or improved (predicates 30 min, one predicate 4 hours) (Page 10). |
| Gas Supply Requirements | Savina 300 gas supply pressure, peak input flow, dew point, oil concentration, and particle size are within acceptable limits and comparable to predicates (Page 10). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable (N/A) in the context of this 510(k) submission. This document does not describe a clinical validation study involving a "test set" of patient data for evaluating a software algorithm. The "testing" referred to is performance testing against recognized standards for medical devices and a comparison of technical specifications to predicate devices. There is no patient data involved in this type of submission for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is N/A. As explained above, there is no "test set" or "ground truth" establishment in the context of expert review for a diagnostic AI/ML device in this submission. The device is a ventilator, and its performance is assessed against engineering standards and comparison to similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is N/A. No adjudication method for a test set is relevant to this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is N/A. The device is a ventilator, not a diagnostic imaging device or AI assistance tool for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is N/A. The Savina 300 is a physical medical device (ventilator) with integrated software, not a standalone algorithm. Its operation involves continuous interaction with a patient under the supervision of trained medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is N/A. "Ground truth" in the context of diagnostic accuracy is not relevant to this type of device and submission. The "truth" here is compliance with established performance standards and the functional equivalence of its technical characteristics to predicate devices.
8. The sample size for the training set
This information is N/A. As this is a medical device (ventilator) and not an AI/ML software device trained on data, there is no "training set."
9. How the ground truth for the training set was established
This information is N/A. No training set exists for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
Dräger Medical GmbH Mr. Ulrich Schröder Director Regulatory & Clinical Affairs Moislinger Allee 53-55 23542 Luebeck, Germany
Re: K121886
Trade/Device Name: Savina 300 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 10, 2014 Received: June 16, 2014
Dear Mr. Schröder:
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. 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.
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Page 2 - Mr. Schroeder
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K121886
Device Name
SAVINA 300
Indications for Use (Describe)
Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.
Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.
Savina 300 is intended for the following environments of use:
-
In intensive care wards, recovery rooms and generally for hospital use
-
During the transport of ventilated patients within the hospital
-
During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)
-
During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Anya C. Harry -S 2014.08.08 10:45:21 -04'00'
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Image /page/3/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.
510(k) Summary according to 21 CFR 807.92
Applicants Name and Address:
Draeger Medical GmbH Moislinger Allee 53-55 23542 Luebeck Germany
Establishment Registration Number: 9611500
Contact Person:
Ulrich Schröder Director Regulatory & Clinical Affairs
Tel. No.: + 49 (451) 882-3648 Fax No.: + 49 (451) 882-3018
Applicants US Contact Person
Beth Zis Director Regulatory Affairs
Tel. No.: 978 3798 285 Fax No.: 978 3798 335
Date submission was prepared:
June 2012
Device Name:
Trade Name: Savina 300 Common Name: Intensive Care Ventilator
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Classification:
Class 2
| Regulation No. | Device | Product Code |
|---|---|---|
| Preferred Code:868.5895For predicates:868.5895 | Ventilator, continuous, facility use | 73CBK |
| Ventilator, continuous, facility use | 73CBK |
Reason for the 510(k): Substantial Equivalence
The technological concept of the Savina 300 is equivalent to Savina. The functionality is equivalent to the Infinity Acute Care System Workstation Critical Care and the flight transport indication is equivalent to the Oxylog 3000 Plus.
| 510(k) No. | Trade name | Company |
|---|---|---|
| K003068 | Savina | Draeger Medical GmbH |
| K023289 | Savina NIV Option | Draeger Medical GmbH |
| K040642 | Savina with LPO | Draeger Medical GmbH |
| K093633 | Infinity Acute Care SystemWorkstation Critical Care | Draeger Medical GmbH |
| K103625 | Oxylog 3000 Plus | Draeger Medical GmbH |
Legally Marketed Device to which Substantial Equivalence is claimed:
Executive Summary
This submission comprises the critical care ventilator Savina 300 for the ventilation of adult and pediatric patients in intensive care units, in recovery rooms and generally for hospital use. Savina 300 is also intended during the transport of ventilated patients within the hospital, during secondary transport from one hospital to another and during transport flights with fixed-wing aircraft.
Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO).
The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.
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Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the two dots above the "a" are also blue. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.
Savina 300 provides the following ventilation modes:
Volume-controlled ventilation:
- · VC-CMV (Volume Control-Continuous Mandatory Ventilation)
- · VC-AC (Volume Control-Assist Control)
- · VC-SIMV (Volume Control-Synchronized Intermittent Mandatory Ventilation)
- · VC-MMV (Volume Control-Mandatory Minute Volume Ventilation)
Pressure-controlled ventilation:
- · PC-SIMV+ (Pressure Control Synchronized Intermittent Mandatory Ventilation plus)
- · PC-APRV (Pressure Control Airway Pressure Release Ventilation)
- · PC-AC (Pressure Control Assist Control)
Support of spontaneous breathing:
· SPN-CPAP (Spontaneous-Continuous Positive Airway Pressure)
Additionally the ventilation unit features special modes to complement the ventilation modes. If breathing of a spontaneously breathing patient stop, Apnea Ventilation switches over automatically to volume-controlled mandatory ventilation.
By switching on the flow trigger, the mandatory strokes are synchronized with the patient's spontaneous breathing attempts.
With AutoFlow, the inspiration flow is decelerated and regulated and thus pressure peaks can be avoided.
The human interface supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation.
The Savina 300 produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits. The Savina 300 can interface with specific Dräger Medical therapeutically and diagnostic equipment, as well as third party devices via a MEDIBUS data connection.
Savina 300 provides CO2 measurement as waveform and end tidal CO2 measurement.
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Indications for Use:
Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (11lbs) bodyweight.
Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring.
Savina 300 is intended for the following environments of use:
-
In intensive care wards, recovery rooms and generally for hospital use
-
During the transport of ventilated patients within the hospital
-
During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)
-
During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)
List of Performance Testing:
Performance complies with the following standards:
| Applied external Standards | |
|---|---|
| IEC 60601-1 : 1988 + A1: 1991+ A2: 1995 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2: 2007 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic compatibility - Requirements andtests |
| IEC 60601-2-12: 2001 | Medical electrical equipment - Part 2-12:Particular Requirements for the safety of lungventilators - critical care ventilators |
| IEC 60601-1-4: 1996 + A1: 1999 | Medical Electrical Equipment - Part 1-4: Generalrequirements for safety - Collateral standard:Programmable Electrical Medical Systems |
| IEC 60601-1-6 : 2006 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard - Usability |
| IEC 60601-1-8: 2006 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systems |
| ISO 14971: 2007, Correctedversion 2007-10-01 | Medical devices - Application of risk managementto medical devices |
| ISO 17664: 2004 | Sterilization of medical devices - information tobe provided by the manufacturer for thereprocessing of resterilizable medical devices |
| IEC 62304: 2006 | Medical Device Software - Software Life CycleProcesses |
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| Applied external Standards | |
|---|---|
| RTCA-DO 160G: 2010All applicable clauses referringto radiated electromagneticemissions and mechanicalsafety | Environment Conditions and Test Procedures forAirborne Equipment |
| ISO 21647: 2005 | Medical electrical equipment - Particularrequirements fort he basic safety and essentialperformance of respiratory gas monitors withTechnical Corrigendum |
| ISO 10993-1: 2009 + Cor. 1:2010 | Biological Evaluation of medical devices - Part 1:Evaluating and testing |
| FDA Draft Reviewer Guidancefor Ventilators: 1995 | |
| ASTM Standard F1100 - 90(Reapproved 1997) | Standards Specification for Ventilators Intendedfor Use in Critical Care |
Comparison of Technological Characteristics between Savina 300 and Predicates
| Specification | Savina 300 SW 4.n | Savina(legally marketed device) | IACS WS CC(legally marketed device) | Oxylog 3000 Plus(legally marketed device) |
|---|---|---|---|---|
| ManufacturerUS FDA 510(k) number | Dräger Medical GmbHK121886 | Dräger Medical GmbHK003068 (Savina) | Dräger Medical GmbHK093633 | Dräger Medical GmbHK103625 |
| K023289 (NIV Option)K040642 (LPO Option) | ||||
| FDA Regulation number | To be assigned | 868.5895 | 868.5895 | 868.5895 |
| FDA Product code | CBK | CBK | CBK | CBK |
| FDA Classification | Continuous ventilator,Class 2 | Continuous ventilator,Class 2 | Continuous ventilator,Class 2 | Continuous ventilator,Class 2 |
| Intended use | Savina 300 is a ventilatorintended for the ventilation ofadults and pediatric patientsstarting from 5 kg (11 lbs)bodyweight. | Long-term ventilator forintensive care. For patientsrequiring 50 mL tidalvolume upwards. | The Infinity Acute CareSystem WorkstationCritical Care (in thefollowing called IACS WSCC) is intended for theventilation of adult,pediatric and neonatalpatients. | The Oxylog 3000 plus isa time-cycled, volumecontrolled and pressurecontrolled emergencyand transport ventilatorfor patients requiringmandatory or assistedventilation with a tidalvolume from 50 mLupwards. |
| Intended User | Savina 300 is only intendedto be used by trainedmedical personnel | Savina is only intended tobe used by trained medicalpersonnel | IACS WS CC is onlyintended to be used bytrained medicalpersonnel | Oxylog 3000 plus is onlyintended to be used bytrained medicalpersonnel |
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SAVINA 300
Image /page/8/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the two dots above the "a" are also blue. The background is white.
| Specification | Savina 300 SW 4.n | Savina(legally marketed device) | IACS WS CC(legally marketed device) | Oxylog 3000 Plus(legally marketed device) | |||||
|---|---|---|---|---|---|---|---|---|---|
| Environment of use | Savina 300 is intended forthe following environmentsof use:- In intensive care wards, inrecovery rooms andgenerally for hospital use- During the transport ofventilated patients within thehospital- During secondary transportfrom one hospital to another(without trolley, monitor notmounted on Savina 300)- During transport flightswith aircraft (without trolley,monitor not mounted onSavina 300) | - In the Intensive Careward, in the recovery roomand generally for hospitaluse.- During transfer ofventilated patients withinthe hospital.- During secondarytransport from one hospitalto another. | Suitable for stationaryuse in hospitals orhospital-like facilities orfor intrahospital patienttransport.Not intended for use in:- In hyperbaric chambers- For magneticresonance imaging(MRT, NMR, NMI)- With flammable gasesor anesthetic agents- In areas withcombustible or explosivesubstances- In rooms withoutadequate ventilation | - Mobile use foremergency patients, inboth outdoor andindoor environments.- During transport inambulances oraircraft, includinghelicopters.- In accident andemergencydepartments.- When movingventilated patientsaround the hospital.- In the recovery room. | |||||
| Modes of ventilation | Volume-controlledventilation:VC-CMVVC-ACVC-SIMVVC-MMVPressure-controlledventilation:PC-AC,PC-SIMV+PC-APRVSupport of spontaneousbreathing:SPN-CPAP/PS | Volume-controlledventilation:IPPVIPPV AssistSIMVPressure-controlledventilation:SIMV+Support of spontaneousbreathing:CPAP/ASB | Volume-controlledventilation:VC-CMVVC-ACVC-SIMVVC-MMVPressure-controlledventilation:PC-ACPC-SIMV+PC-APRVSupport of spontaneousbreathing:SPN-CPAP/PSSPN-CPAP/VSSPN-PPS | Volume-controlledventilation:VC-CMVVC-ACVC-SIMV/PSPressure-controlledventilation:PC-SIMV+Support of spontaneousbreathing:SPN-CPAPSPN-CPAP/PS | |||||
| Non Invasive Ventilation | √ | √ | √ | √ | |||||
| Pressure Limited Ventilation(PLV) | Optional in VC modeswithout AF | Optional with IPPV, SIMV,SIMV/ASB | Optional in VC modeswithout AF | -- | |||||
| Apnea Ventilation | Optional with VC-SIMV,SPC-CPAP | Optional with SIMV,SIMV/ASB, CPAP/PS | Optional with PC-SIMV,PC-BIPAP, VC-MMV,VC-SIMV, SPN-PPS,SPN-CPAP, SPN-CPAP/VS | Optional with SpnCPAP | |||||
| Pressure Support (PS)(Assisted SpontaneousBreathing) (ASB)) | Oprional with SPN-CPAP,PC-BIPAP, VC-SIMV | Optional with CPAP,BIPAP, SIMV | Optional with PC-SIMV,VC-SIMV, PC-BIPAP,SPN-CPAP, VC-MMV,Var. PS | Optional with VC-SIMV,PC-SIMV+, SpnCPAP | |||||
| Flow triggerIntrinsic PEEP | √Optional | √-- | √Optional | √-- | |||||
| Inspiratory termination criterion | √ | -- | √ | -- | |||||
| Sigh | Optional: 2 strokes / 3 min | Optional: 2 strokes / 3 min | Optional: variable | (optional) with VC-CMV,VC-AC, VC-SIMV | |||||
| AutoFlow | (optional) with VC-CMV, VC-AC, VC-SIMV, VC-MMV | (optional) with IPPV, SIMV | (optional) with VC-CMV,VC-SIMV, VC-MMV, VC-AC | ||||||
| Special procedures: | - Man. insp./hold- Exp. Hold. | - Insp./hold | - Exp. Hold. | - Insp./hold | |||||
| Medication nebulization | optional | optional | optional | -- | |||||
| 02 suction | √ | √ | √ | -- | |||||
| Therapy types | Monitoring sensors: | - Invasive ventilation (Tube) | -- | - Invasive ventilation(Tube) | -- | ||||
| Flow sensor | √ | √ | √ | -- | |||||
| Pressure sensor | √ | √ | √ | -- |
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SAVINA 300
Image /page/9/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue, and the two dots above the "a" are also blue. The word is horizontally oriented and centered.
| Specification | Savina 300 SW 4.n | Savina(legally marketed device) | IACS WS CC(legally marketed device) | Oxylog 3000 Plus(legally marketed device) |
|---|---|---|---|---|
| O2 sensor | ✓ | ✓ | ✓ | -- |
| Proximal temperature sensor | -- | -- | -- | -- |
| CO2 sensor | ✓ (optional) | -- | ✓ | ✓ |
| Ventilation and DeviceMonitoring: | ||||
| Airway pressure, PAW | ✓ | ✓ | ✓ | ✓ |
| Expiratory minute volume, MV | ✓ | ✓ | ✓ | ✓ |
| Inspiratory tidal volume, VTiInspiratory O2 concentration,FiO2 | ✓ | ✓ | ✓ | -- |
| End-expiratory CO2concentration, etCO2 | ✓ (optional) | -- | ✓ (optional) | ✓ |
| Apnoe time, TApnoe | ✓ | ✓ | ✓ | -- |
| Respiratory rate, fspn | ✓ | ✓ | ✓ | ✓ |
| Logistic alarms (power-, gassupply failure), machinemalfunction | ✓ | ✓ | ✓ | ✓ |
| Displays | - Curves; three at a time | -- | - Curves; four at a time | - Curve |
| - Numeric parameters | - Numeric parameters | - Numeric parameters | - Numeric parameters | |
| - Lists for measured valuesand set valuesGraphic trends | -- | - Lists for measuredvalues and set valuesGraphic trends | -- | |
| Numeric trends | -- | Numeric trends | -- | |
| Loops | -- | Loops | -- | |
| Logbook | -- | Logbook | -- | |
| Control principle | time-cycled, volume-constant, pressure-controlled | time-cycled, volume-constant, pressure-controlled | time-cycled, volume-constant, pressure-controlled | time-cycled, volume-constant, pressure-controlled |
| Software controlled device | Yes | Yes | Yes | Yes |
| Display and control unit | ||||
| Screen size | 12,1" | -- | 17" | -- |
| Touchscreen | ✓ | -- | ✓ | -- |
| ✓Operating elements | Large color screen withinformation and controlsneeded for adjustmentand control of ventilationtherapy. Function softkeys on thescreen for rapid accessand selection of majorfunctions. Central rotary knob foradjustment andconfirming settings onthe screen. 6 hard keys for essentialmaneuvers and Alarmreset / Audio paused | -- | Large color screenwith information andcontrols needed foradjustment andcontrol of ventilationtherapy. Function softkeys onthe screen for rapidaccess and selectionof major functions. Central rotary knobfor adjustment andconfirming settingson the screen. 1 hard keys for audiopaused | -- |
| Environmental Conditions | ||||
| During operation | ||||
| Temperature | 5 to 40 °C (41 to 104 °F) | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104°F) | -20 to 50 °C (-4 to122 °F) |
| Atmospheric pressure | 700 to 1060 hPa (10.20 to15.30 psi) | 700 to 1060 hPa (10.20 to15.30 psi) | 700 to 1060 hPa (10.20to 15.30 psi) | 570 to 1200 hPa (8.27 to17.40 psi) |
| Relative humidity | 5 to 90 % withoutcondensation | 5 to 90 % withoutcondensation | 5 to 90 % withoutcondensation | 5 to 95% withoutcondensation |
| During operation with expiratoryfilter MP01781 | ||||
| Temperature | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104°F) | -- |
| Specification | Savina 300 SW 4.n | Savina(legally marketed device) | IACS WS CC(legally marketed device) | Oxylog 3000 Plus(legally marketed device) |
| Atmospheric pressure | 700 to 1060 hPa (10.20 to15.30 psi) | 700 to 1060 hPa (10.20 to15.30 psi) | 700 to 1060 hPa (10.20to 15.30 psi) | -- |
| Relative humidity | 10 to 90 % withoutcondensation | 5 to 90 % withoutcondensation | 5 to 90 % withoutcondensation | -- |
| During storage andtransportation | ||||
| Temperature | -20 to 60 °C (-4 to 140 °F) | -20 to 70 °C (-4 to 158 °F) | -20 to 60 °C (-4 to 140°F) without PS500-15 to 40 °C (5 to 104 °F)with PS500 | -40 to 75 °C (-40 to167 °F) |
| Atmospheric pressure | 600 to 1200 hPa (8.7 to17.40 psi) | 600 to 1200 hPa (8.70 to17.40 psi) | 500 to 1060 hPa (7.25 to15.37 psi) | 570 to 1200 hPa (8.27 to17.40 psi) |
| Relative humidity | 10 to 95 % withoutcondensation | 10 to 95 % withoutcondensation | 5 to 95 % withoutcondensation | 5 to 95% withoutcondensation |
| Operating Data | ||||
| Mains power supply | ||||
| Mains power connection | 100 V to 240 V, 50/60 Hz | 100 V to 240 V, 50/60 Hz | 100 V to 240 V, 50/60 Hz | 100 V to 240 V,50/ 60 Hz |
| Current consumption | 2.6 A (-4 to 104 °F) /1.3 A (104° to 122 °F) | |||
| At 230 V | max. 1.3 A | max. 1.1 A | max. 0.8 A VentilationUnit with Medical Cockpit | -- |
| At 100 V | max. 3.4 A | max. 3.4 A | max. 1.8 A VentilationUnit with Medical Cockpit | -- |
| Protection Class | ||||
| Temp.Sensor AWT01(sensor connected) | Type BF | Type BF | Type BF | Type BF |
| Expiratory valve andbreathing hoses | Type BF | Type BF | Type BF | Type BF |
| CO2 sensor (sensorfitted) | Type BF | Type BF | Type BF | -- |
| Internal battery | ||||
| Type | Lead-acid gel batteries,sealed, maintenance-free | Lead-acid gel batteries,sealed, maintenance-free | NiMH battery, sealed,maintenance-free | Lithium ion battery |
| Capacity | 3.5 Ah | 3.5 Ah | 2.5 Ah | 2.4 Ah |
| Voltage | 24 V | 24 V | 24 V | 19 V |
| Time bridged followinga mains power failure with newand fully chargedinternalbattery | typ. 45 min | min. 30 minutes (typically40 minutes) | min. 30 minutes | 4 hours |
| Gas supply | ||||
| O2 gauge pressure | 3 bar (43.5 psi) -10 % to 6.0bar (87 psi) | 3 bar (43.5 psi) -10 % to6.0 bar (87 psi) | -- | -- |
| 02 peak input flow | 180 L/min (at 2.8 bar inputpressure) | 180 L/min (at 2.8 bar inputpressure) | 130 L/min (at 2.8 bar(40.6 psi) input pressure)180 L/min (at 4.0 bar(58.0 psi) input pressure) | -- |
| Dew point | 5 °C (41 °F) below ambienttemperature | 5 °C (41 °F) below ambienttemperature | 5 °C (41 °F) belowambient temperature | -- |
| Oil concentration | <0.1 mg/m3 | <0.1 mg/m3 | <0.1 mg/m3 | -- |
| Particle size | Dust-free air (filtered withfilter size <1 µm) | Dust-free air (filtered withfilter size <1 µm) | Dust-free air (filtered withfilter size <1 µm) | -- |
| Gas consumption | ||||
| Output for ventilation | Depends on ventilationsettings | Depends on ventilationsettings | Depends on ventilationsettings | -- |
| Output for pneum.Medicament nebuliser | Medical air or O2 max. 2.0bar (or 210 kPa or30.5 psi), max. 10 L/min | Medical air or O2 max. 2.0bar (29 psi),max. 10 L/min | Medical air or O2 max.2.1 bar (210 kPa or 30.5psi),max. 11 L/min | -- |
| Automatic gas switch-over | n.a. | n.a. | If one gas fails, thedevice switches over tothe other gas | -- |
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SAVINA 300
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Conclusion:
The intended use and the functionalities as the predicate devices remain the same. The function and the principle of operation as well as the characteristics are equal. In summary, the Savina 300 described in this submission is substantially equivalent to the predicate devices.
§ 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).