(203 days)
The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg.
The RESPOND(R) Ventilator is intended for use in a hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.
The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.
The RESPOND® Ventilator is a multi-patient continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen/air to the breathing gas.
The ventilator provides both pressure control and volume modes of therapy and can provide both invasive and non-invasive ventilation. The device is compatible with both passive HME and heated humidification patient circuits, as well as nebulization with an ultrasonic nebulizer. The ventilator is equipped with an oxygen mixing module, which allows oxygen to be delivered to the patient within a range of 21% to 95% concentration.
The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. RESPOND® is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.) and is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND® Ventilator is intended for use by qualified and trained personnel.
I am sorry, but the provided text does not contain the requested information about acceptance criteria, device performance, sample size, ground truth, or study details. The document is a 510(k) summary for a medical device (RESPOND® Ventilator), primarily focused on demonstrating substantial equivalence to a predicate device. It discusses the device's indications for use, technological characteristics, and a broad overview of non-clinical performance testing without providing specific acceptance criteria or detailed study results in the format you've requested.
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Image /page/0/Picture/0 description: The image shows the date Wednesday, November 13, 2024. The text is in a clear, sans-serif font. The date is written out in full, with the day of the week, month, day, and year all clearly visible. The image is simple and straightforward, with the focus entirely on the date.
CorVent Medical, Inc. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K241135
Trade/Device Name: RESPOND(R) Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: October 14, 2024 Received: October 15, 2024
Dear Paul Dryden:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241135
Device Name RESPOND(R) Ventilator
Indications for Use (Describe)
The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg.
The RESPOND(R) Ventilator is intended for use in a hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.
The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 12-Nov-24 Page 1 of 11
| Sponsor: | CorVent® Medical, Inc.4837 Amber Valley Pkwy S, Suite #2Fargo, ND 58104Tel - (443)928-9195 |
|---|---|
| Sponsor Contact: | Richard S. Walsh, CEO |
| Submission Correspondent: | Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704Tel – 239-307-6061 |
| Proprietary or Trade Name:Common/Usual Name:Classification Name:Classification CFR:Product Code: | RESPOND® VentilatorVentilator, Continuous, Facility CareContinuous ventilator868.5895CBK |
| Predicate Device:Common/Usual Name:Classification Name:Classification CFR:Product Code: | Respironics – Trilogy EVO – K181166Ventilator, Continuous, Facility Care andContinuous, Ventilator, Home UseContinuous ventilator868.5895CBK & NOU |
| Device Description: |
The RESPOND® Ventilator is a multi-patient continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen/air to the breathing gas.
The ventilator provides both pressure control and volume modes of therapy and can provide both invasive and non-invasive ventilation. The device is compatible with both passive HME and heated humidification patient circuits, as well as nebulization with an ultrasonic nebulizer. The ventilator is equipped with an oxygen mixing module, which allows oxygen to be delivered to the patient within a range of 21% to 95% concentration.
The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. RESPOND® is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.) and is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND® Ventilator is intended for use by qualified and trained personnel.
Principles of Operation
The RESPOND® is electro-mechanically and pneumatically operated, providing mechanical ventilation using:
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510(k) Summary 12-Nov-24 Page 2 of 11
- . Using blowers in the generation of pressure and flow:
- the Main blower to control inspiration pressure and o
- the PEEP blower to control the PEEP pilot pressure which controls exhalation pressure o during exhalation
- Exhalation System ●
- An exhalation solenoid valve is used to switch the pilot pressure from the inspiratory limb o during inspiration to the PEEP blower during exhalation valve. This ensures the exhalation valve is closed during inspiration and open during exhalation.
- An area ratio exhalation valve is used to perform two functions: o
- . Prevent gas venting through the exhalation valve during inspiration.
- Control PEEP expiratory pressure during exhalation. .
- . Safety System
- A safety solenoid valve is used to switch the pilot pressure from the inspiratory limb to o atmosphere to the area ration safety valve in the event of a sustained occlusion.
- An area ratio safety valve is used to perform two functions: o
- . Prevent gas venting through the exhalation valve during normal operation.
- . Direct gas from the inspiratory limb to atmosphere in the event of a sustained occlusion via the Safety Valve.
Indications for Use:
The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND® Ventilator is intended for pediatric through adult patients weighing at least 38 kg.
The RESPOND® Ventilator is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.
The RESPOND® Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.
Environments of use:
The RESPOND® Ventilator is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.
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510(k) Summary
| Characteristic | Subject Device:RESPOND® Ventilator | Predicate Device:Trilogy EVO Ventilator - K181166 | Determination |
|---|---|---|---|
| Indications for Use | The RESPOND® Ventilator provides continuous or intermittent positivepressure ventilation for the care of individuals who require mechanicalventilation. The RESPOND® Ventilator is intended for pediatric through adultpatients weighing at least 38 kg.The RESPOND® Ventilator is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care,skilled nursing facilities, long-term care, and subacute care facilities.The RESPOND® Ventilator is intended for use by qualified, trained personnelunder the direction of a licensed clinician. | 1The Trilogy EVO ventilator provides continuous or intermittentpositive pressure ventilation for the care of individuals who requiremechanical ventilation. Trilogy EVO is intended for pediatric throughadult patients weighing at least 2.5 kg.2The ventilator can measure, display, record, and alarm SpO2, FiO2,CO2, Respiratory Rate, and Pulse Rate data when integrated with theappropriate accessories*.The ventilator is suitable for use in institutional, home, and non-emergency transport settings, for example wheelchair or personalvehicle. It may be used for both invasive and noninvasive ventilation. | Equivalent1The RESPOND® Ventilator targeted patientpopulation ≥38 kg (84 lbs.) represents lower riskin comparison with the predicate targetedpopulation of ≥2.5kg (5.51 lbs.) as thiscorresponds to a Neonatal representing a muchhigher risk requiring higher levels of control,safety, performance, accuracy, and efficacy.Therefore, this difference does not raise differentquestions of safety and/or effectiveness.2These are related to oximetry capabilities of theTrilogy EV300. RESPOND does not offeroximetry. Therefore, is not applicable thisdifference does not raise different questions ofsafety and/or effectiveness. |
| Users | The RESPOND Ventilator is intended for use by qualified, trained personnelunder the direction of a licensed clinician. | Clinicians (respiratory and non-respiratory) and physicians. | Equivalent |
| Ventilation Types | Invasive and Non-Invasive. | Invasive and Non-Invasive. | Equivalent |
| Ventilator Modes | PC (Pressure Control)VC (Volume Control)PSV (Pressure Support Ventilation)SIMV-PC (Synchronized Intermittent Mandatory Ventilation - Pressure Control)SIMV-VS (Synchronized Intermittent Mandatory Ventilation - Volume Control)PSV at 0 cmH2OPSV (Pressure Support Ventilation) with Apnea Backup VentDoes not have AVAPS-AE mode | A/C-PC: Assisted Control (Pressure Control)A/C-VC: Assisted Control (Volume Control)PSV: Pressure Support VentilationSIMV-PC: Synchronized Intermittent Mandatory Ventilation (PressureControl)SIMV-VC: Synchronized Intermittent Mandatory Ventilation (VolumeControl)CPAP: Continuous Positive Airway PressureS/T: Spontaneous/Timed VentilationAVAPS-AE: Average Volume Assured Pressure Support | EquivalentPredicate offer an additional ventilationmode (AVAPS-AE), but this differencedoes not raise different questions ofsafety and/or effectiveness.AVAPS-AE is a patented breath mode. |
| Patient Contact Type | Indirect Contact with Gas Pathway | Indirect Contact with Gas Pathway | Equivalent |
| Contraindications | • Active Pneumothorax.• Neonatal, Infant, and Pediatric patients (less than 38 kg).• Where non-invasive ventilation is precluded by clinical practice. | • Inability to maintain a patent airway or adequately clear secretions.• Risk aspirating gastric contents.• Acute sinusitis or otitis media.• Epistaxis, causing pulmonary aspiration of blood.• Hypotension.• AVAPS-AE therapy mode is contraindicated for invasive use andpatients less than 10kg.• AVAPS feature is contraindicated for patients less than 10kg. | EquivalentDifferences in contraindications are based on thedifferences in intended use populations that donot raise different questions of safety and/oreffectiveness. |
| TECHNICAL CHARACTERISTICS | |||
| Alarms | HIGH PRIORITY ALARMSSystem Inoperable System InoperableOcclusion High Pressure High PressureFlow Sensor Not Connected Flow Sensor Not Connected Flow Sensor NotConnectedFlow Sensor Reversed (Medium Priority)Adjust O2 Wall Flow (Medium Priority)Apnea Disconnect / High LeakageLow Total Exhale Minute Ventilation (Medium Priority)Apnea High Pressure Total Loss of PowerTemp Loss of Power | HIGH PRIORITY ALARMSVentilator InoperativeVentilator ServiceRequired ObstructionHigh ExpiratoryPressure HighInspiratory PressureExternal Flow SensorFailedExternal Flow Sensor CableDisconnected External Flow Sensor | EquivalentBoth devices are compliant with thealarm's required per ISO 80601-2-12 andIEC 60601-1-8. Therefore, differences inalarms do not raise different questions ofsafety and/or effectiveness. |
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510(k) Summary 12-Nov-24
Page 4 of 11
| rade 4 of Ti | |
|---|---|
| Battery Low (≤5 mins) and Battery Low (≤10 mins) | Not Connected External Flow Sensor |
| Battery Depleted | Reversed |
| Active Exhalation Valve | |
| Speaker Fault Watchdog Failure High / Low Currents High / Low Voltages | Filed Check AEV Pilot |
| System Signal Failure | Line |
| Ambient Temperature Too High or Low System Temperature Too High or | Proximal Pressure Line Disconnected |
| Low | Oxygen Regulation |
| Apnea | |
| MEDIUM PRIORITY ALARMS | Circuit Disconnected |
| Set Volume Not Reached | Low MinVent (Low Minute |
| (Covered in the High Priority Alarm above) | Ventilation) Low Respiratory Rate |
| Low Inspiratory Pressure Low Inspiratory Pressure O2 Supply Failure | High Inspiratory Pressure (Volumes |
| O2 Supply Failure High Exhale Tidal Volume Low Exhaled Tidal Volume | Modes) Loss of All Power |
| High Total Exhale Minute Ventilation | |
| High Respiratory Rate Low Total Exhale Minute Ventilation | Low Battery at 10 Minutes |
| FiO2 Too Low FiO2 Too High | Internal Battery Depleted (Low Priority) |
| Battery Low (≤10 mins) | |
| MEDIUM PRIORITY ALARMS | |
| Loss of Main Power (On Battery) | Circuit Leakage |
| Battery Not Present Battery Not Charging Battery Over Temperature | Rebreathing |
| High PEEP Low PEEP | Detected Volume |
| Flow Sensor Reverse Adjust O2 Wall Flow | Under Delivery |
| Settings Data Corrupt Request Ventilation Stop | Loss of CO2 Signal Loss of SpO2 Signal |
| CO2 Sensor Adapter Zero | |
| Required Check/Change CO2 | |
| Airway Adapter CO2 Sensor | |
| Failure | |
| FiO2 Sensor | |
| Disconnected | |
| Replace FiO2 Sensor | |
| Low Expiratory Pressure | |
| Low Inspiratory Pressure (Pressure | |
| Modes) Low Oxygen Inlet Pressure | |
| High Oxygen Inlet | |
| Pressure High Tidal | |
| Volume | |
| Low Tidal Volume | |
| High Min Vent (High Minute | |
| Ventilation) High Respiratory Rate | |
| Low Inspiratory Pressure Alarm (Volume | |
| Modes) Low SpO2 | |
| High | |
| SpO2 | |
| Low | |
| EtCO2 | |
| High | |
| EtCO2 | |
| Low | |
| FiO2 | |
| High | |
| FiO2 | |
| Low Battery at 20 Minutes | |
| Replace Detachable Battery (Low Priority) | |
| Replace Detachable Battery (Low Priority) | |
Image /page/7/Picture/3 description: The image is a blank white canvas with a thin black line running vertically along the left side. The line extends from the top to the bottom of the image, creating a stark contrast against the white background. The rest of the image is devoid of any other features or elements.
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510(k) Summary 12-Nov-24 Dogo E of 44
| Page 5 of 11 | ||
|---|---|---|
| Replace Detachable Battery (Low Priority)Replace Detachable Battery (Low Priority) | ||
| Principle of Operation | Microprocessor Controlled.Electronic Control.Software Driven. | Microprocessor Controlled. ElectronicControl.Software Driven. |
| Setting/RangeBreath Rate | Range: 3 - 70 bpmResolution: 1 bpmAccuracy: $\pm$ 1 bpm | Range: 0 - 80 bpmResolution: 1 bpm |
| Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator |
|---|---|---|
| Setting/Range PressureControl | Range: 5 - 40 cmH2OResolution: 1 cmH2OAccuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 60 cmH2OResolution: 1 cmH2OAccuracy: ± (2 + 4% of setting) cmH2O |
| Setting/Range SupportPressure | Range: 0 - 40 cmH2OResolution: 1 cmH2OAccuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 60 cmH2OResolution: 1 cmH2OAccuracy: ± (2 + 4% of actual) cmH2O |
| Setting/Range Tidal Volume | Range: 150 - 2000 ml BTPSResolution: 5 ml for values 100 to 295; 10 ml for values ≥300 ml to 790 ml and 50 mlfor values≥800Accuracy: ± (4 + 15% of setting with no leak) mL | Range: 35 – 2000 ml (70 to 2000 ml for adult)Resolution: 1 mlAccuracy: ± (4 ml + 15% of setting) |
| Setting/Range InspiratoryTime | Range: 0.4 - 3.0 secResolution: 0.1 secAccuracy: ± (0.1 + 1% of setting) | Range: 0.3 - 5.0 sec*Controls min/max: 0.3 - 3.0Resolution: 0.1 sec*Constrained to prohibit an inverse I:E ratio |
| Equivalent | |
|---|---|
| EquivalentDifferences in breath rate arenonsignificant, thus do not raise differentquestions of safety and/or effectiveness,as ultimately the clinician is responsiblefor setting the patient breath rate basedon their expertise and the patient needs. |
rmination
ivalent
erences in pressure control range are significant, thus do not raise different stions of safety and/or effectiveness, as nately the clinician is responsible for ing the pressure trol based on their expertise and the ent needs.
ivalent
erences in support pressure are significant, thus do not raise different stions of safety and/or effectiveness, as nately the clinician is responsible for ing it based on their expertise the patient needs.
ivalent
erences in Tidal Volume range is ted to differences in patient populations , Neonatal, Pediatric), thus do not raise rent questions of safety and/or ctiveness, as ultimately the clinician is onsible for setting the tidal volume ed on their expertise and the patient ds.
ivalent
erence in inspiratory range time is significant, thus do not raise different stions of safety and/or effectiveness, ultimately, the
cian is responsible for setting it based heir expertise and the patient needs.
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| 510(k) Summary12-Nov-24Page 6 of 11 | |||
|---|---|---|---|
| Setting/Range PEEP | Range: 0 – 20 cmH2OResolution: 1 cmH2OAccuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 35 cmH2O for active exhaust circuits Resolution: 1 cmH2OAccuracy: Not shown | |
| Leak Compensation | The RESPOND Ventilator estimates leaks in PC, VC, and PS breaths wherepressure increases nonlinearly as a function of pressure, compensating for thedisplayed inspired (Vti) and exhaled tidal volume (Vte) measurements for leaklosses. It does not compensate exhaled minute ventilation (MVe), or leaks lost todelivered volume in VC mode. | The ventilator compensates for a leak that occurs between theventilator and the external flow sensor. Leaks that aredownstream of the external flow sensor are not compensatedfor in measurement of inhaled or exhaled tidal volume. Leaksthat are downstream of the external flow sensor arecompensated for triggering. | |
| Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | |
| MEASURED & DISPLAYED VALUES | |||
| Measured/Displayed TidalVolume(Vti / Vte) | Name: Vti and VteRange: 0 to 2000 ml (max in VC) but capable up to 9999 ml (see notebelow) Resolution: in increments of 1 mlAccuracy: ± (4 ml + 15% of actual) | Name: Vti and VteRange: 0 to 2000 mlResolution: in increments of 1 mlAccuracy: ± (4 ml + 15% of actual) for volumes ≥ 35 ml± 10 ml for volumes < 35 ml | |
| Measured/DisplayedMinuteVentilation(MVe) | Name: MVeRange: 0 to 99 L/minResolution: in increments of 0.1 L/min < 10 L/min and 1 L/min ≥ 10 L/minAccuracy: ± (0.1 L/min + 15% of actual) | Name: MVeRange: 0 to 30 L/minResolution: in increments of 0.1 L/minAccuracy: Not stated | |
| Measured/Displayed FiO2 | Name: FiO2Range: 16% to100% Resolution: inincrements of 1%Accuracy: ± (3% O2 of actual reading)The oxygen flow range may be set between 0 and 60 L/min.The ventilator only be used with a low flow oxygen source (i.e., maximum 10 psi atinlet). | Name: FiO2Range: 21% to 100%Resolution: in increments of1%Accuracy: ± (2.5% FiO2 + 2.5% of actual reading) within a 24-hoursensor calibration period, or a change in altitude | |
| Measured/Displayed Leak% | Name:Leak%Range:0% to100%Resolution: in increments of 1%Accuracy: function of delivered volume and Vti accuracy | Not Shown | |
| Measured/Displayed Est.Leak Flow | Name: LeakRange: 0 to 200 L/minResolution: in increments of 1L/min Accuracy: Not stated | Name: LeakRange: 0 to 200 L/minResolution: in increments of 0.1 L/minAccuracy: Not stated | |
| Measured/DisplayedRespiratory Rate | Name: RRRange: 0 to 99 BPMResolution: in increments of 1BPM Accuracy: ± 1 BPM | Name: RRRange: 0 to 90 BPMResolution: in increments of 1 BPMAccuracy: Not stated | |
| 510(k) Summary12-Nov-24Page 7 of 11 | |||
| Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | |
| Measured/Displayed PEEP | Name: PEEPRange: 0 to 60 cmH2OResolution: in increments of 0.1 cmH2OAccuracy: ± (2 cmH2O + 4% of actual) | Not Shown | |
| Measured/Displayed PeakInspiratoryFlow | Name: PFRange: 0 to 250 L/minResolution: in increments of 1 L/minAccuracy: ± (1 L/min + 7% of reading) | Name: PIFRange: 0 to 200 L/minResolution: in increments of 0.1 L/minAccuracy: Not stated | |
| Measured/DisplayedPeak InspiratoryPressure | Name: PIPRange: 0 to 60 cmH2OResolution: in increments of 1 cmH2OAccuracy: ± (2 cmH2O + 4% of actual) | Name: PIPRange: 0 to 90 cmH2OResolution: in increments of 0.1 cmH2OAccuracy: ± (2 cmH2O + 4% of actual) | |
| Measured/Displayed MeanAirway Pressure | Name: MAPRange: 0 to 60 cmH2OResolution: in increments of 0.1 cmH2O for MAP < 10Accuracy: ± (2 cmH2O + 4% of actual) | Name: MAPRange: 0 to 90 cmH2OResolution: in increments of 0.1 cmH2OAccuracy: ± (2 cmH2O + 4% of actual) | |
| Measured/Displayed I:ERatio | Name: I:ERange: 1: XXX and XXX:1 where XXX = 0.1 to 999Accuracy: ± (50ms of inspiratory time) | Name: I:ERange: 9.9:1 to 1:9.9Accuracy: Not stated | |
| Measured/DisplayedPlateauPressure | Name: PPLResolution: in increments of 1 cmH2OAccuracy: ± (2 cmH2O + 4% of actual) | Not Shown | |
| Bluetooth Connectionfor Export DataFunctions | RESPOND Ventilator has Bluetooth connection capability for future data export. | Trilogy EV300 utilizes a Bluetooth connection for export data functions(refer to Trilogy EVO User Manual Section 7.4). | |
| Inspiratory LimbResistance | 2.1 cmH2O/L/s @ 60 L/min (HME) Max 6 cmH2O/L/s2.0 cmH2O/L/s @ 60 L/min (HH) Max 7 cmH2O/L/s | Inspiratory/expiratory resistance: up to 5 cmH2O at:• 30 L/min for adult (20 to 22 mm) circuit size, | |
| 510(k) Summary12-Nov-24Page 8 of 11 | |||
| Expiratory LimbResistance | $3.5 cmH2O/L/s @ 60 L/min (HME) Max 7 cmH2O/L/s$$4.0 cmH2O/L/s @ 60 L/min (HH) Max 7 cmH2O/L/s$ | • 15 L/min for pediatric (14 to 16 mm) or pediatric/adult (19 mm) circuitsize, and• 2.5 L/min for infant (9 to 13 mm) circuit size.Compliance: up to 4 ml/cmH2O | 201.12.4.108(f) and201.103(b) pressurepatient- connection$6.0 cmH2O$ at 30 L/minl/min flowrates. |
| VBS (Patient Circuit)Compliance | < 4 mL/cmH2O (for passive HME)< 6 mL/cmH2O (for active heated humidification) | Not disclosed | Differences are $\pm$ 0.predicate 5 cmH2O.considered equivaledifferent questions oeffectiveness. |
| Exhalation Control | • Dual Limb Circuit with Exhalation Valve connected to Exhalation Manifold.• Pneumatically Controlled Exhalation Valve.• Electronically Controlled PEEP. | • Active Exhalation Valve Line Connection for ActivePAP and ActiveFlow Circuits.• Dual Limb Active Exhalation Valve Connection (from patient).• Pneumatically Controlled Exhalation Valve.• Electronically Controlled PEEP. | Equivalent |
| Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | Determination |
| ENVIRONMENTAL & OPERATING CHARACTERISTICS | |||
| Operating RelativeHumidity | 15 - 90% Noncondensing | 5 - 93% Noncondensing | Equivalent |
| OperatingAtmosphericPressure | 700 - 1060 hectopascals (hPa)70 - 106 kilopascals (kPa) | 620 - 930 hectopascals (hPa)62 - 106 kilopascals (kPa) | EquivalentDifferences in altituddo not raise differand/or effectiveness |
| Operating Altitude | Up to 9,842 feet (3,000 meters) | -384 meters to 3954 meters (-1,261 - 12,971 feet) | EquivalentDifferences in altituddifferent questions oeffectiveness. |
| OperatingTemperature | 10°C - 30°C (50°F - 86°F) | 0°C - 40°C (32°F - 104°F) | EquivalentDifferences in tempominor and do not raof safety and/or effe |
| Store /TransportTemperature | -20°C - 50°C (-4°F - 122°F) | Storage: - 25° C - 70°C (13°F - 158°F)Transient: -20°C - 50°C (-4°F - 122°F) | EquivalentDifferences in tempominor and do not raof safety and/or effe |
| Store / TransportRelative Humidity | 15 - 90% Noncondensing | 5 - 93% Noncondensing | EquivalentDifferences in RH raand do not raise osafety and/oreffectiveness. |
| Biocompatibility | Per ISO 10993-1:2018 - Long-term exposurePer ISO 18562-1:2017 - Permanent contact | Per ISO 10993-1:2018 - Long-term exposurePer ISO 18562-1:2017 - Permanent contact | Equivalent |
uivalent
e trilogy PEEP range is higher but such gh PEEPs are rarely used clinically and crease tient mortality.
quivalent
Determination
Equivalent
Differences in Tidal Volume measured/displayed capabilities do not raise different questions of safety and/or effectiveness.
Equivalent
Differences in Minute Ventilation measured / displayed capabilities do not raise different questions of safety and/or effectiveness. The RESPOND Ventilator does not limit the
displayed value.
Equivalent
Differences in FiO2 measured/displayed capabilities do not raise different questions of safety and/or effectiveness. The RESPOND
Ventilator does not limit the displayed value.
Equivalent
Differences measured/displayed capabilities do not raise different questions of safety and/or effectiveness.
Equivalent
Equivalent
The RESPOND Ventilator does not limit the displayed value.
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Equivalent
Differences in PEEP measured/displayed capabilities do not raise different questions of safety and/or effectiveness. ISO 80601-2-12 requires the neasurement of PEEP. Equivalent Differences in Peak Inspiratory Flow neasured/displayed capabilities do not aise different questions of safety and/or effectiveness. etermination Equivalent Differences in Peak Inspiratory Pressure measured/displayed capabilities do not aise different questions of safety and/or ffectiveness. The RESPOND Ventilator does not limit the displayed value. Equivalent Differences in Mean Airway Pressure neasured/displayed capabilities do not aise different questions of safety and/or effectiveness. The RESPOND Ventilator does not limit he displayed value. Equivalent Differences in I:E Ratio measured/displayed capabilities do not raise different questions of safety and/or effectiveness. Equivalent in Plateau Differences Pressure measured/displayed capabilities do not raise different questions of safety and/or effectiveness. Equivalent Equivalent ISO 80301-2-12:2020, section
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201.103(b) pressure drop measured at patient- connection port shall not exceed 6.0 cmH2O at 30 L/min, 15 L/min, and 2.5 l/min flowrates. Differences are ± 0.4 cmH2O from the predicate 5 cmH2O. Therefore, they are considered equivalent and do not raise different questions of safety and/or effectiveness. Equivalent Determination Equivalent Equivalent Differences in altitude range are minor and do not raise and/or effectiveness. Equivalent Differences in altitude range do not raise different questions of safety and/or effectiveness. Equivalent Differences in temperatures range are minor and do not raise different questions of safety and/or effectiveness. Equivalent Differences in temperatures range are minor and do not raise different questions of safety and/or effectiveness. Equivalent Differences in RH range are unsignificant and do not raise different questions of safety and/or effectiveness. Equivalent
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| Standards | IEC 60601-1:2020 Ed.3+A1:A2IEC 60601-1-2 Edition 4.1 2020-09IEC 60601-1-8 Edition 2.2 2020-07IEC TR 60601-4-2 Edition 1.0 2016-05ISO 80601-2-55 Second edition 2018-02 | 510(k) Summary12-Nov-24Page 9 of 11 |
|---|---|---|
| Similar |
quivalent
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510(k) Summary 12-Nov-24 Page 10 of 11
Substantial Equivalence Discussion
The table above compares the key features of the proposed subject device with the identified predicate device.
Though each of the devices' principles of operation, namely intended for patients that require mechanical ventilation are equivalent, there are minor differences. However, these differences do not raise new questions of safety or efficacy.
Indications for Use:
The indications for use are similar in that each device is to provide continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. However, the predicate device includes indications specific to oximetry capabilities, whereas RESPOND® does not offer oximetry.
This difference does not raise different or new questions of safety and/or effectiveness.
Environment for Use:
The subject device is indicated for use in hospital settings, whereas the predicate is indicated for use in not only the hospital but also the home and non-emergency transport settings.
This difference does not raise different or new questions of safety and/or effectiveness.
Patient Population:
The subject device is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.): whereas the predicate device (Trilogy EVO) is intended for pediatric through adult patients weighing at least 2.5 kg. The subject device's patient population is a subset of the predicate's population.
This difference does not raise different or new questions of safety and/or effectiveness.
Ventilation Modes:
The technology of a blower powered positive pressure source with pressure and flow sensors to regulate flow and pressure are similar. The subject device provides the following ventilatory modes: PC, VC, PSV, SIMV-PC, SIMV-VS, PSV at 0 cmH2O, PSV with Apnea Backup Vent. Predicate offer an additional ventilation mode (AVAPS-AE), but this difference does not raise different or new questions of safety and/or effectiveness. Both ventilators meet the minimum requirements of ISO 80601-2-12 for performance specifications.
Alarms:
Both the subject device and predicate device offer a variety of high and medium priority alarms. Though the offered alarms may differ, both devices are compliant with the alarm's required per ISO 80601-2-12 and IEC 60601-1-8. Differences in alarms do not raise different questions of safety and/or effectiveness.
Conclusion on the Discussion of Differences:
In review of the comparative table and the noted differences, none of the differences raised different or new questions of safety or effectiveness.
Discussion of Testing Performed
Non-clinical Performance testing:
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510(k) Summary 12-Nov-24 Page 11 of 11
The subject device was subjected to performance tests including reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing. The testing completed is summarized below:
- IEC 60601-1:2020 ●
- IEC 60601-1-2:2020 ●
- IEC 60601-1-8:2020 ●
- ISO 80601-2-12:2020
- ISO 18562-1 suite of biocompatibility tests ●
- . Comparative waveform evaluation between the subject device and predicate demonstrated that the ventilatory performance is similar.
Additionally, the non-clinical performance testing of a set of ventilation modes as described above, along with complete software verification testing, as applicable. The data demonstrates that the subject device's technological characteristics are substantially equivalent with the predicate device.
Usability:
Summative usability tests were performed with a user group of respiratory therapists. The results demonstrated that the subject device meets the HF acceptance criteria.
Substantial Equivalence Conclusion
CorVent® Medical concludes that the RESPOND® Ventilator is substantially equivalent in Indications for Use, technology, design, performance, user interface, and use context to the primary predicate the Respironics Trilogy EVO (K181166). The sponsor has demonstrated via comparative bench testing and through non-clinical testing that the subject device does not raise different or new concerns of safety when compared to the predicate. Therefore, the subject device is substantially equivalent to the predicate device.
§ 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).