Who is the manufacturer of RESPOND(R) Ventilator?

Corvent Medical, Inc. filed the 510(k) submission for RESPOND(R) Ventilator (K241135).

What is the FDA product code for RESPOND(R) Ventilator?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for RESPOND(R) Ventilator?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RESPOND(R) Ventilator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESPOND(R) Ventilator

Q: What are the predicate devices for RESPOND(R) Ventilator?

Respironics – Trilogy EVO – K181166.

K241135 · Corvent Medical, Inc. · CBK · Nov 13, 2024 · Anesthesiology

Device Facts

Record ID	K241135
Device Name	RESPOND(R) Ventilator
Applicant	Corvent Medical, Inc.
Product Code	CBK · Anesthesiology
Decision Date	Nov 13, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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.

Device Story

RESPOND Ventilator is a multi-patient, electro-mechanical, and pneumatic continuous ventilator. It uses a main blower for inspiratory pressure/flow and a PEEP blower for exhalation pressure control. An exhalation solenoid valve and area ratio valve manage gas flow and PEEP. A safety solenoid and area ratio safety valve provide occlusion protection. It delivers pressure control and volume modes (invasive/non-invasive) with 21-95% oxygen concentration. Operated by qualified personnel in hospitals and institutional settings. It provides continuous/intermittent positive pressure ventilation to assist or control patient breathing. Output includes ventilation therapy and various physiological measurements (e.g., tidal volume, minute ventilation, respiratory rate, pressures). Healthcare providers use these outputs to monitor patient status and adjust therapy settings. Benefits include mechanical respiratory support for patients requiring ventilation.

Clinical Evidence

Bench testing only. Performance testing included reliability, alarm testing, design control verification, software verification, electromagnetic compliance, electrical safety, packaging, environmental testing, waveform testing, and biocompatibility (ISO 18562-1). Summative usability testing performed with respiratory therapists met acceptance criteria. Comparative waveform evaluation demonstrated similar ventilatory performance to the predicate.

Technological Characteristics

Microprocessor-controlled, software-driven, electro-mechanical/pneumatic ventilator. Materials meet ISO 10993-1 (long-term) and ISO 18562-1 (permanent contact). Features dual-blower system (main and PEEP), solenoid-controlled exhalation/safety valves. Connectivity: Bluetooth for future data export. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55.

Indications for Use

Indicated for pediatric and adult patients weighing at least 38 kg requiring mechanical ventilation. Used in hospital, intra-hospital transport, and institutional settings (long-term acute care, skilled nursing, subacute care). Contraindicated for patients <38 kg, active pneumothorax, and where non-invasive ventilation is clinically precluded.

Regulatory Classification

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.

Predicate Devices

Respironics – Trilogy EVO – K181166

Related Devices

K143035 — Flight 60 Ventilator · Flight Medical Innovations , Ltd. · Mar 30, 2016
K222644 — Nihon Kohden NKV-440 Ventilator System · Nihon Kohden Orangemed, Inc. · May 31, 2023
K193056 — Puritan Bennett 980 Series Ventilator System · Covidien, LLC · Nov 20, 2020
K984535 — PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION · Puritan Bennett Corp. · Dec 28, 1998
K162738 — Puritan Bennett 980 Ventilator System · Covidien · Oct 27, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### 510(k) Summary 12-Nov-24 Page 1 of 11 | Sponsor: | CorVent® Medical, Inc. 4837 Amber Valley Pkwy S, Suite #2 Fargo, ND 58104 Tel - (443)928-9195 | |------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor Contact: | Richard S. Walsh, CEO | | Submission Correspondent: | Paul Dryden ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 Tel – 239-307-6061 | | Proprietary or Trade Name: Common/Usual Name: Classification Name: Classification CFR: Product Code: | RESPOND® Ventilator Ventilator, Continuous, Facility Care Continuous ventilator 868.5895 CBK | | Predicate Device: Common/Usual Name: Classification Name: Classification CFR: Product Code: | Respironics – Trilogy EVO – K181166 Ventilator, Continuous, Facility Care and Continuous, Ventilator, Home Use Continuous ventilator 868.5895 CBK & 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: {5}------------------------------------------------ ## 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. {6}------------------------------------------------ # 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 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. | 1The Trilogy EVO ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy EVO is intended for pediatric through adult 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 the appropriate accessories*. The ventilator is suitable for use in institutional, home, and non- emergency transport settings, for example wheelchair or personal vehicle. It may be used for both invasive and noninvasive ventilation. | Equivalent 1The RESPOND® Ventilator targeted patient population ≥38 kg (84 lbs.) represents lower risk in comparison with the predicate targeted population of ≥2.5kg (5.51 lbs.) as this corresponds to a Neonatal representing a much higher risk requiring higher levels of control, safety, performance, accuracy, and efficacy. Therefore, this difference does not raise different questions of safety and/or effectiveness. 2These are related to oximetry capabilities of the Trilogy EV300. RESPOND does not offer oximetry. Therefore, is not applicable this difference does not raise different questions of safety and/or effectiveness. | | Users | The RESPOND Ventilator is intended for use by qualified, trained personnel under 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 cmH2O PSV (Pressure Support Ventilation) with Apnea Backup Vent Does not have AVAPS-AE mode | A/C-PC: Assisted Control (Pressure Control) A/C-VC: Assisted Control (Volume Control) PSV: Pressure Support Ventilation SIMV-PC: Synchronized Intermittent Mandatory Ventilation (Pressure Control) SIMV-VC: Synchronized Intermittent Mandatory Ventilation (Volume Control) CPAP: Continuous Positive Airway Pressure S/T: Spontaneous/Timed Ventilation AVAPS-AE: Average Volume Assured Pressure Support | Equivalent Predicate offer an additional ventilation mode (AVAPS-AE), but this difference does not raise different questions of safety 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 and patients less than 10kg. • AVAPS feature is contraindicated for patients less than 10kg. | Equivalent Differences in contraindications are based on the differences in intended use populations that do not raise different questions of safety and/or effectiveness. | | TECHNICAL CHARACTERISTICS | | | | | Alarms | HIGH PRIORITY ALARMS System Inoperable System Inoperable Occlusion High Pressure High Pressure Flow Sensor Not Connected Flow Sensor Not Connected Flow Sensor Not Connected Flow Sensor Reversed (Medium Priority) Adjust O2 Wall Flow (Medium Priority) Apnea Disconnect / High Leakage Low Total Exhale Minute Ventilation (Medium Priority) Apnea High Pressure Total Loss of Power Temp Loss of Power | HIGH PRIORITY ALARMS Ventilator Inoperative Ventilator Service Required Obstruction High Expiratory Pressure High Inspiratory Pressure External Flow Sensor Failed External Flow Sensor Cable Disconnected External Flow Sensor | Equivalent Both devices are compliant with the alarm's required per ISO 80601-2-12 and IEC 60601-1-8. Therefore, differences in alarms do not raise different questions of safety and/or effectiveness. | {7}------------------------------------------------ ## 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. {8}------------------------------------------------ #### 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. Electronic Control. Software Driven. | | Setting/Range Breath Rate | Range: 3 - 70 bpm Resolution: 1 bpm Accuracy: $\pm$ 1 bpm | Range: 0 - 80 bpm Resolution: 1 bpm | | Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Setting/Range Pressure Control | Range: 5 - 40 cmH2O Resolution: 1 cmH2O Accuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 60 cmH2O Resolution: 1 cmH2O Accuracy: ± (2 + 4% of setting) cmH2O | | Setting/Range Support Pressure | Range: 0 - 40 cmH2O Resolution: 1 cmH2O Accuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 60 cmH2O Resolution: 1 cmH2O Accuracy: ± (2 + 4% of actual) cmH2O | | Setting/Range Tidal Volume | Range: 150 - 2000 ml BTPS Resolution: 5 ml for values 100 to 295; 10 ml for values ≥300 ml to 790 ml and 50 ml for values ≥800 Accuracy: ± (4 + 15% of setting with no leak) mL | Range: 35 – 2000 ml (70 to 2000 ml for adult) Resolution: 1 ml Accuracy: ± (4 ml + 15% of setting) | | Setting/Range Inspiratory Time | Range: 0.4 - 3.0 sec Resolution: 0.1 sec Accuracy: ± (0.1 + 1% of setting) | Range: 0.3 - 5.0 sec* Controls min/max: 0.3 - 3.0 Resolution: 0.1 sec *Constrained to prohibit an inverse I:E ratio | | | Equivalent | |--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Equivalent Differences in breath rate are nonsignificant, thus do not raise different questions of safety and/or effectiveness, as ultimately the clinician is responsible for setting the patient breath rate based on 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. {9}------------------------------------------------ | | | 510(k) Summary 12-Nov-24 Page 6 of 11 | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Setting/Range PEEP | Range: 0 – 20 cmH2O Resolution: 1 cmH2O Accuracy: ± (2 + 4% of setting) cmH2O | Range: 0 - 35 cmH2O for active exhaust circuits Resolution: 1 cmH2O Accuracy: Not shown | | | Leak Compensation | The RESPOND Ventilator estimates leaks in PC, VC, and PS breaths where pressure increases nonlinearly as a function of pressure, compensating for the displayed inspired (Vti) and exhaled tidal volume (Vte) measurements for leak losses. It does not compensate exhaled minute ventilation (MVe), or leaks lost to delivered volume in VC mode. | The ventilator compensates for a leak that occurs between the ventilator and the external flow sensor. Leaks that are downstream of the external flow sensor are not compensated for in measurement of inhaled or exhaled tidal volume. Leaks that are downstream of the external flow sensor are compensated for triggering. | | | Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | | | MEASURED & DISPLAYED VALUES | | | | | Measured/Dis played Tidal Volume (Vti / Vte) | Name: Vti and Vte Range: 0 to 2000 ml (max in VC) but capable up to 9999 ml (see note below) Resolution: in increments of 1 ml Accuracy: ± (4 ml + 15% of actual) | Name: Vti and Vte Range: 0 to 2000 ml Resolution: in increments of 1 ml Accuracy: ± (4 ml + 15% of actual) for volumes ≥ 35 ml ± 10 ml for volumes < 35 ml | | | Measured/Dis played Minute Ventilation (MVe) | Name: MVe Range: 0 to 99 L/min Resolution: in increments of 0.1 L/min < 10 L/min and 1 L/min ≥ 10 L/min Accuracy: ± (0.1 L/min + 15% of actual) | Name: MVe Range: 0 to 30 L/min Resolution: in increments of 0.1 L/min Accuracy: Not stated | | | Measured/Dis played FiO2 | Name: FiO2 Range: 16% to 100% Resolution: in increments 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 at inlet). | Name: FiO2 Range: 21% to 100% Resolution: in increments of 1% Accuracy: ± (2.5% FiO2 + 2.5% of actual reading) within a 24-hour sensor calibration period, or a change in altitude | | | Measured/Dis played Leak% | Name: Leak% Range: 0% to 100% Resolution: in increments of 1% Accuracy: function of delivered volume and Vti accuracy | Not Shown | | | Measured/Dis played Est. Leak Flow | Name: Leak Range: 0 to 200 L/min Resolution: in increments of 1 L/min Accuracy: Not stated | Name: Leak Range: 0 to 200 L/min Resolution: in increments of 0.1 L/min Accuracy: Not stated | | | Measured/Displayed Respiratory Rate | Name: RR Range: 0 to 99 BPM Resolution: in increments of 1 BPM Accuracy: ± 1 BPM | Name: RR Range: 0 to 90 BPM Resolution: in increments of 1 BPM Accuracy: Not stated | | | 510(k) Summary 12-Nov-24 Page 7 of 11 | | | | | | Characteristic | Subject Device: RESPOND® Ventilator | Predicate Device: Trilogy EVO Ventilator | | Measured/Dis played PEEP | Name: PEEP Range: 0 to 60 cmH2O Resolution: in increments of 0.1 cmH2O Accuracy: ± (2 cmH2O + 4% of actual) | Not Shown | | | Measured/Disp layed Peak Inspiratory Flow | Name: PF Range: 0 to 250 L/min Resolution: in increments of 1 L/min Accuracy: ± (1 L/min + 7% of reading) | Name: PIF Range: 0 to 200 L/min Resolution: in increments of 0.1 L/min Accuracy: Not stated | | | Measured/Displayed Peak Inspiratory Pressure | Name: PIP Range: 0 to 60 cmH2O Resolution: in increments of 1 cmH2O Accuracy: ± (2 cmH2O + 4% of actual) | Name: PIP Range: 0 to 90 cmH2O Resolution: in increments of 0.1 cmH2O Accuracy: ± (2 cmH2O + 4% of actual) | | | Measured/Displa yed Mean Airway Pressure | Name: MAP Range: 0 to 60 cmH2O Resolution: in increments of 0.1 cmH2O for MAP < 10 Accuracy: ± (2 cmH2O + 4% of actual) | Name: MAP Range: 0 to 90 cmH2O Resolution: in increments of 0.1 cmH2O Accuracy: ± (2 cmH2O + 4% of actual) | | | Measured/Dis played I:E Ratio | Name: I:E Range: 1: XXX and XXX:1 where XXX = 0.1 to 999 Accuracy: ± (50ms of inspiratory time) | Name: I:E Range: 9.9:1 to 1:9.9 Accuracy: Not stated | | | Measured/Dis played Plateau Pressure | Name: PPL Resolution: in increments of 1 cmH2O Accuracy: ± (2 cmH2O + 4% of actual) | Not Shown | | | Bluetooth Connection for Export Data Functions | 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 Limb Resistance | 2.1 cmH2O/L/s @ 60 L/min (HME) Max 6 cmH2O/L/s 2.0 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) Summary 12-Nov-24 Page 8 of 11 | | | Expiratory Limb Resistance | $3.5 cmH2O/L/s @ 60 L/min (HME) Max 7 cmH2O/L/s$ $4.0 cmH2O/L/s @ 60 L/min (HH) Max 7 cmH2O/L/s$ | • 15 L/min for pediatric (14 to 16 mm) or pediatric/adult (19 mm) circuit size, and • 2.5 L/min for infant (9 to 13 mm) circuit size. Compliance: up to 4 ml/cmH2O | 201.12.4.108(f) and 201.103(b) pressure patient- connection $6.0 cmH2O$ at 30 L/min l/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 equivale different questions o effectiveness. | | 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 Active Flow 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 Relative Humidity | 15 - 90% Noncondensing | 5 - 93% Noncondensing | Equivalent | | Operating Atmospheric Pressure | 700 - 1060 hectopascals (hPa) 70 - 106 kilopascals (kPa) | 620 - 930 hectopascals (hPa) 62 - 106 kilopascals (kPa) | Equivalent Differences in altitud do not raise differ and/or effectiveness | | Operating Altitude | Up to 9,842 feet (3,000 meters) | -384 meters to 3954 meters (-1,261 - 12,971 feet) | Equivalent Differences in altitud different questions o effectiveness. | | Operating Temperature | 10°C - 30°C (50°F - 86°F) | 0°C - 40°C (32°F - 104°F) | Equivalent Differences in tempo minor and do not ra of safety and/or effe | | Store / Transport Temperature | -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) | Equivalent Differences in tempo minor and do not ra of safety and/or effe | | Store / Transport Relative Humidity | 15 - 90% Noncondensing | 5 - 93% Noncondensing | Equivalent Differences in RH ra and do not raise o safety and/or effectiveness. | | Biocompatibility | Per ISO 10993-1:2018 - Long-term exposure Per ISO 18562-1:2017 - Permanent contact | Per ISO 10993-1:2018 - Long-term exposure Per 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. {10}------------------------------------------------ #### 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 {11}------------------------------------------------ 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 Di…

RESPOND(R) Ventilator

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

RESPOND(R) Ventilator

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!