(203 days)
Not Found
No
The provided text describes a standard mechanical ventilator with various modes and features, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is a ventilator, which provides positive pressure ventilation to assist patient breathing, directly treating a medical condition.
No
The device provides mechanical ventilation (a treatment), not a diagnosis. Its function is to assist or control breathing, not to identify a medical condition.
No
The device description clearly indicates it is a physical ventilator that delivers oxygen/air, provides pressure and volume modes, and is compatible with patient circuits and nebulizers. This is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The RESPOND(R) Ventilator is a mechanical device that assists or controls breathing by delivering air and oxygen directly to the patient's lungs. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it provides "continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation." This is a direct therapeutic intervention, not a diagnostic test performed on a sample.
The description and intended use align with a life support or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
CBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric through adult patients weighing at least 38 kg
Intended User / Care Setting
Intended User: qualified, trained personnel under the direction of a licensed clinician.
Care Setting: hospital (including intra-hospital transport), and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance testing:
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Respironics – Trilogy EVO – K181166
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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.
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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