(367 days)
Not Found
No
The summary describes a microprocessor-controlled ventilator with a software upgrade for a specific ventilation mode (APRV). There is no mention of AI, ML, or any related concepts like training data, test data, or complex algorithms beyond standard control logic for a ventilator.
Yes
The device is a ventilator, which provides ventilatory support to patients. This function directly treats a medical condition (respiratory failure or inadequacy) by assisting or replacing the patient's breathing, making it a therapeutic device.
No
Ventilators are therapeutic devices that provide breathing support, not diagnostic devices that identify or characterize a disease or condition.
No
The device described is a software upgrade (APRV Mode) for existing mechanical ventilators (Esprit and V200 Ventilators), which are hardware devices. The software functions as a mode within the hardware device, not as a standalone software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a mechanical ventilator providing ventilatory support to patients. This is a life-support device used directly on a patient, not a device used to examine specimens taken from the body.
- Device Description: The description details a mechanical ventilator with a software upgrade for a specific ventilation mode (APRV). This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro testing
- Using reagents or assays
The device is a therapeutic medical device used to assist with breathing.
N/A
Intended Use / Indications for Use
The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. They are intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The Esprit and V200 Ventilators are intended for use in either invasive or non-invasive applications.
The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician
Product codes
CBK
Device Description
The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. This modification to the currently marketed Esprit Ventilator and V200 Ventilators is the addition of the APRV Mode.
The APRV Mode is an optional software upgrade. It is both a breath type and ventilation mode intended for invasively ventilated adult and pediatric patient populations. APRV enables the ventilator to deliver gas via an endotracheal tube or tracheostomy tube at two levels of pressure (Press High and Press Low), and allows for spontaneous or supported breathing at both levels.
The APRV Mode is activated via a software download through an I-button and is integrated into the Esprit and V200 Ventilators in the same way as other currently released software options. It can either be installed in the factory or in the field as an upgrade to existing Esprit and V200 ventilators. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn APRV on and off.
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
The Esprit Ventilator is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician.
The Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
The V200 Ventilator is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician.
The V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
Intended User / Care Setting
qualified medical personnel
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)
Performance testing and a clinical simulation were conducted and support the assertion that the APRV Mode does not raise any new questions regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
JAN 1 3 2012
[Refer to 21 CFR 807.92]
| Owner: | Respironics California, Inc.
2271 Cosmos Court
Carlsbad, CA 92011 | | |
|-------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------|
| Contact Person: | Tamatha Ley
Regulatory Affairs Specialist
Phone: (760) 918-1026
Fax: (760) 918-0169 | | |
| Date Prepared: | January 10, 2011 | | |
| Proprietary Name: | Esprit Ventilator with APRV Option
V200 Ventilator with APRV Option | | |
| Common Name: | Ventilator | | |
| Classification
Name: | Continuous Ventilator (21 CR 868.5895, Product Code 73 CBK) | | |
| Predicate Devices: | Manufacturer
Respironics California, Inc.
Respironics California, Inc
CareFusion | Device Name
Esprit Ventilator
V200 Ventilator
Avea Ventilator | 510(k) Number
K981072
K102054
K013642 |
Intended Use of the Device:
The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. They are intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The Esprit and V200 Ventilators are intended for use in either invasive or non-invasive applications.
The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician
The intended use is the same as that of the predicate devices, except that the APRV Mode is for use on a subset of the patient population the original devices are cleared for (e.g. neonatal patients and non-invasive applications are excluded).
Device Description:
The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. This modification to the currently marketed Esprit Ventilator and V200 Ventilators is the addition of the APRV Mode.
1
The APRV Mode is an optional software upgrade. It is both a breath type and ventilation mode intended for invasively ventilated adult and pediatric patient populations. APRV enables the ventilator to deliver gas via an endotracheal tube or tracheostomy tube at two levels of pressure (Press High and Press Low), and allows for spontaneous or supported breathing at both levels.
The APRV Mode is activated via a software download through an I-button and is integrated into the Esprit and V200 Ventilators in the same way as other currently released software options. It can either be installed in the factory or in the field as an upgrade to existing Esprit and V200 ventilators. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn APRV on and off.
Substantial Equivalence:
The Esprit and V200 Ventilators with APRV Mode have the same intended use as the unmodified ventilators and similar design and technological characteristics as the other standard, currently marketed ventilators.
The APRV Mode incorporates a new mode of ventilation and a new breath type similar to the existing CareFusion Avea and unmodified Esprit and V200 Ventilators. All software activities, including verification and validation have been successfully completed in accordance with Respironics California, Inc. policies and procedures and the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005. In addition to the software verification and validation activities, performance testing and a clinical simulation were conducted and support the assertion that the APRV Mode does not raise any new questions regarding safety and effectiveness.
The technological characteristics of the currently marketed Esprit and V200 Ventilators with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, environmental specifications, and performance specifications remain unchanged. Changes to the operational software were to include the APRV Mode only. No changes are being made to any other mode of ventilation. Therefore, all other modes of ventilation are identical to those in the currently marketed Esprit and V200 Ventilators.
This submission contains comparative information, including documentation related to the aforementioned activities to conclude that the Esprit and V200 with APRV Mode is substantially equivalent to currently marketed devices cleared by the FDA. These changes do not raise any new questions regarding safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the staff and a stylized head at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 3 2012
Ms. Mary Funk Senior Manager, Regulatory Affairs Respironics California, Incorporated 2271 Cosmo Court Carlsbad, California 92130
Re: K110083
Trade/Device Name: Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode, V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode
Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 9, 2012 Received: January 10, 2012
Dear Ms. Funk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Funk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rh foc
t
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode Device Name:
Indications for Use:
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications and contains the following modes of ventilation:
- Assist/Control (A/C) .
- Synchronized Intermittent Mandatory Ventilation (SIMV) ●
- Continuous Positive Airway Pressure (CPAP) ●
×
- Spontaneous (Spont) .
- Spontaneous/Timed (Spont/T) ●
- Apnea (Backup Mode) .
The Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
Prescription Use
AND/OR
Over-the-Counter Use
(Part 21 CFR 801, Subpart D)
(Part 21 CFR 807, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign | |
|---|---|
| Division of Anesu. | Iowa General Hospital |
| Infection Control, Dental Services |
510(k) N
5
Indications for Use
510(k) Number (if known): K110083
V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode Device Name:
Indications for Use:
The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or non-invasive applications and contains the following modes of ventilation:
- Assist/Control (A/C) .
- Synchronized Intermittent Mandatory Ventilation (SIMV) ●
- Continuous Positive Airway Pressure (CPAP) .
- Spontaneous (Spont) .
- Spontaneous/Timed (Spont/T) .
- Apnea (Backup Mode) .
The V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
× Prescription Use
AND/OR
Over-the-Counter Use
(Part 21 CFR 801, Subpart D)
(Part 21 CFR 807, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
n Sigi. Til (Div. · Anest · sicingy, General Hospital DIVIs . . trol, Denices
510(k) Numb