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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Esprit Ventilator and V200 Ventilator with APRV Option.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which typically summarizes the validation rather than detailing the full study protocols and results. As such, some specific details like exact acceptance criteria or raw performance data might not be explicitly stated in quantitative terms.

Acceptance Criteria and Reported Device Performance

The document states that "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."

Since this is a 510(k) for an addition of a mode (APRV) to existing cleared ventilators, the acceptance criteria are generally focused on demonstrating that this new mode performs as intended and does not negatively impact the overall safety and effectiveness of the existing device. The performance is assessed against the established specifications and safety profile of the predicate devices.

Acceptance Criteria Category	Reported Device Performance (as inferred from the document)
Software Verification & Validation	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.
Performance Testing (APRV Mode)	Conducted, supports that the APRV Mode performs as intended for invasively ventilated adult and pediatric patients and does not raise new questions regarding safety and effectiveness.
Clinical Simulation (APRV Mode)	Conducted, supports that the APRV Mode performs as intended for invasively ventilated adult and pediatric patients and does not raise new questions regarding safety and effectiveness.
Technological Characteristics (Ventilator Base)	Unchanged (control mechanism, operating principle, energy type, ergonomics of patient interface, firmware, environmental specifications, performance specifications).
Non-APRV Ventilation Modes Functionality	Identical to those in the currently marketed Esprit and V200 Ventilators.
Safety & Effectiveness	No new questions regarding safety and effectiveness raised by the addition of the APRV Mode.
Intended Use	The APRV Mode is intended for use for invasively ventilated adult and pediatric patients, a subset of the patient population for the original cleared devices, aligning with the "same intended use" principle for substantial equivalence.

Study Details

Due to the nature of the provided document (510(k) summary), many of the specific details for a full study report are not present. Information below is extracted or inferred from the text.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: Not explicitly stated. The document mentions "performance testing and a clinical simulation." For a ventilator, performance testing typically involves bench testing on a ventilator, and a clinical simulation usually involves scenarios or mock patients rather than a large cohort of real patients.
- Data Provenance: Not specified. Given the context of performance testing and clinical simulation, it would likely be laboratory or in-house data rather than patient data from specific countries. It's prospective in the sense that the testing was conducted on the modified device.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. For performance and clinical simulations of a ventilator, the "ground truth" would be the expected performance according to engineering specifications, physiological models, and clinical guidelines. This would typically be established by internal engineering, clinical, and regulatory experts within Respironics.
Adjudication Method for the Test Set:
- Not specified. Given the nature of performance testing and clinical simulation for a medical device's functional mode, adjudication methods (like 2+1 reads) typical for diagnostic image analysis are not directly applicable. Performance is usually assessed against predefined technical and clinical thresholds.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or conducted as described. This type of study is more common for diagnostic imaging AI devices where human reader performance (with and without AI assistance) is being evaluated against ground truth. The current device is a ventilator with an added mode, not a diagnostic tool requiring reader interpretation in the same way. The evaluation focused on the device's functional performance and safety.
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, in essence. The "performance testing" and "clinical simulation" mentioned for the APRV Mode would constitute a standalone evaluation of the algorithm's (software's) performance within the ventilator system, independent of human interpretation or assistance during operation. The software's outputs (e.g., pressure, flow, volume delivery as per the APRV settings) are directly measured and compared against specifications.
Type of Ground Truth Used:
- For performance testing: Engineering specifications, physiological models, and established clinical parameters for ventilation. These would define the expected output and behavior of the APRV mode under various simulated patient conditions.
- For clinical simulation: Clinically acceptable ranges and responses as determined by medical professionals or established medical guidelines for ventilation.
Sample Size for the Training Set:
- Not applicable / Not specified. This device is a software-controlled mechanical ventilator, not a machine learning or AI algorithm that 'learns' from a training dataset in the typical sense (e.g., image recognition). The "training" for such a system involves software development, coding, and internal validation against design specifications, not a dataset of examples.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there isn't a "training set" in the sense of data used to train a machine learning model. The software's logic and behavior are designed based on established medical science, engineering principles for mechanical ventilation, regulatory requirements, and internal development methodologies. The "ground truth" during development and testing refers to what the device is designed to do and what it should achieve safely and effectively.

Summary

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K110083

510(k) Summary

JAN 1 3 2012

[Refer to 21 CFR 807.92]

Owner:	Respironics California, Inc.2271 Cosmos CourtCarlsbad, CA 92011
Contact Person:	Tamatha LeyRegulatory Affairs SpecialistPhone: (760) 918-1026Fax: (760) 918-0169
Date Prepared:	January 10, 2011
Proprietary Name:	Esprit Ventilator with APRV OptionV200 Ventilator with APRV Option
Common Name:	Ventilator
ClassificationName:	Continuous Ventilator (21 CR 868.5895, Product Code 73 CBK)
Predicate Devices:	ManufacturerRespironics California, Inc.Respironics California, IncCareFusion	Device NameEsprit VentilatorV200 VentilatorAvea Ventilator	510(k) NumberK981072 K102054 K013642

Intended Use of the Device:

The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician

Device Description:

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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.

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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

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

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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

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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

Regulation Number and Section

§ 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).