ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000

K072450 · Respironics California, Inc. · CBK · Dec 12, 2007 · Anesthesiology

Device Facts

• Record ID: K072450
• Device Name: ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
• Applicant: Respironics California, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for useradjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

Device Story

The Esprit Ventilator Auto-Trak Sensitivity Option is an add-on to the existing Esprit ventilator platform. It utilizes microprocessor-controlled pressure and flow monitoring to automatically manage inspiratory triggering and expiratory cycling. By continuously analyzing pressure and flow patterns, the system compensates for circuit leaks up to 60 L/min, eliminating the need for manual sensitivity adjustments. The device is operated by qualified medical personnel in clinical settings. The system provides real-time leak-compensated ventilation, which improves patient comfort and simplifies setup, particularly during non-invasive ventilation (NIV). The output is displayed on the ventilator's integrated touch screen, allowing clinicians to monitor patient-ventilator synchrony and leak status. This automation reduces the risk of auto-triggering and prolonged inspiratory time, potentially enhancing patient outcomes by maintaining effective ventilation despite changing clinical conditions.

Clinical Evidence

Clinical study compared the Auto-Trak (test) and Flow Triggering (control) groups. Primary endpoints included performance equivalence, patient preference, and safety (adverse event rates). Results demonstrated that Auto-Trak performed as well as or better than the predicate, with no increase in adverse events.

Technological Characteristics

Microprocessor-controlled, electrically powered mechanical ventilator. Features touch screen GUI, integral air source, variable O2 concentration (21-100%), and battery backup. Software-based Auto-Trak algorithm provides automated, leak-compensated trigger and cycle sensitivity. No changes to hardware or manufacturing processes from predicate.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring continuous or intermittent invasive or non-invasive mechanical ventilatory support. Auto-Trak option specifically indicated for adult and pediatric patients to provide automated, leak-compensated trigger and cycle sensitivity.

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

• Esprit Ventilator (K981072)
• Vision Ventilator with Auto-Trak (K982454)
• Evita XL Ventilator with 'Option Mask Ventilation NIV' (K980642)

Submission Summary (Full Text)

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K072450
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# RESPIRONICS®

# 510(k) Summary

Submitter: Respironics Inc. Address: 2271 Cosmos Court Carlsbad, CA 92011 Telephone: [phone] Fax: [phone]

DEC 1 2 2007

Contact: Mara Caler Regulatory Affairs Telephone: [phone] Fax: [phone] Email: mara.caler(@respironics.com

Date Prepared: 15 August 2007

Trade name: Esprit Ventilator Auto-Trak Sensitivity Option Common Name (Device Type): Continuous Ventilator Classification Regulation (CFR): 21 CR 868.5895 Class: 2 Product Code: 73 - CBK Panel: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (73)

### Predicate Device:

Esprit Ventilator (K981072) Vision Ventilator with Auto-Trak (K982454) Evita XL Ventilator with "Option Mask Ventilation NIV" (K980642)

#### 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 and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically triggers and cycles breathing without the need for user-adjustment of Itrigger (sensitivity) and E-cycle thresholds.

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# Substantial Equivalence to Predicate Devices:

The predicate device is the Esprit Ventilator Flow Triggering option and the Esprit Ventilator Auto Trak Sensitivity option ..

- The proposed Esprit Ventilator Auto-Trak is identical to the existing Esprit . Ventilator with the exception of the addition of the Auto-Trak option.
- The Esprit Ventilator Auto-Trak is similar to the Vision Ventilator with Auto-. Trak as identified in Table 3, Section 12, page 31 and to the Drage Evita (included because is it is similarly classified device (73-CBK)).
- Bench performance testing was performed for the new option and clinical . performance was compared between the Respironics Esprit Flow Triggering option and the Respironics Esprit Auto-Trak option.

List of Similarities:

- Similar intended use the intended use is unchanged .
- o 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 is intended for use in either invasive or non-invasive applications.
- Similar patient circuit the patient circuit is unchanged .
- The patient circuit is unchanged. o
- Same operating principle the operating principle is unchanged .
- The ESPRIT ventilatory is a microprocessor controlled, electrically o powered, mechanical ventilator. There have been no changes to the operating principle of the equipment.
- M The breathing system is under microprocessor control
- . The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
- 트 The integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual stand alone compressor for each ventilator.
- 트 The ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical oxygen gas source, including medical grad gas cylinders with suitable regulators
- 프 The ability to operate on a re-chargeable primary battery for 30 minutes (nominal)
- The ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours
- . Same technology - the technology is unchanged
- The ESPRIT ventilatory is a microprocessor controlled, electrically O powered, mechanical ventilator. There have been no changes to the technology or equipment hardware.
- Same manufacturing process the manufacturing process is unchanged .
- There have been no changes to the manufacturing processes for the o equipment.

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- Breathing modes there are no new breath types or breathing modes required. .
List of Differences:

- . Indications for Use
- The Auto-Trak Sensitivity option automatically triggers and cycles o breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds.
- Algorithms used to determine triggering and cycling sensitivity thresholds .
- o Triggering: Auto-Trak monitors changes in pressure and flow patterns throughout exhalation, applying compensation for circuit leaks and triggering an inspiration.
- Automatically adjusts I-Trigger and E-cycle in the face of . changing leaks
- Provides leak-compensated ventilation .
- · Compensation for leaks up to 60 L/min
- O Reduces auto-triggering and I-time too long alarms/conditions
- Cycling: Auto-Trak automatically cycles breathing based on the pressure and flow patterns at the end of inspiration and beginning of expiration. The threshold used to cycle each breath changes with the patient's breathing pattern and lung dynamics.
- . Improved patient comfort especially in NIV
- Makes it easier to set up the patient (no need to set triggering and cycling criteria) .

| Software Parameter | Purpose | Pass/Fail |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Breath Delivery | | |
| Flow Triggering | To validate the accuracy of the flow<br>triggered breaths during Auto-Trak<br>triggering | Pass |
| Auto-Trak Triggering -<br>Bias Flow | To validate the accuracy of the bias<br>flow used during Auto-Trak<br>triggering; to check for Auto-Trak<br>triggering when leaks are constant and<br>during changes of pt Leak during<br>Exhalation and Inhalation | Pass |
| Auto-Trak Triggering -<br>Back up Pressure Trigger | To validate that breaths can also be<br>triggered using the back up pressure<br>trigger when Auto-Trak is active | Pass |

| | | Table 1: Software testing results: | | |
|--|--|------------------------------------|--|--|
|--|--|------------------------------------|--|--|

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| Software Parameter Purpose 24 4 % | | Pass/Fail |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Auto-Trak Triggering -<br>Mask Off Test | To validate that in CPAP or non-<br>invasive modes, breaths will not auto-<br>cycle if a patient's mask is taken off,<br>then returned to the patient, when<br>Auto-Trak is active | Pass |
| Auto-Trak Triggering -<br>High Leak Test | To validate that when Auto-Trak is<br>active, and a large leak is suddenly<br>blocked, the ventilator will not<br>truncate more than one breath | Pass |
| Exhalation Sensitivity<br>with and without Auto-<br>Trak active | To validate the Auto-Trak<br>performance when Auto-Trak is active<br>and not active | Pass |
| Exhalation Sensitivity<br>decreasing with Auto-<br>Trak active | To validate the Auto-Trak Sensitivity<br>when Exhalation is not detected.<br>When flow is not detected at the<br>exhalation flow sensor at the start of<br>exhalation, Auto-Trak will<br>compensate by decreasing the exhaled<br>flow sensitivity for the next breath | Pass |
| Exhalation Sensitivity<br>Increasing with Auto-<br>Trak | To validate the Auto-Trak<br>performance when Auto-Trak is active<br>and not active. | Pass |

# Table 2: Performance Testing Results

| Test Parameter | Purpose |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Auto-Trak triggering and<br>cycling performance | Auto-Trak performance was evaluated in the clinical<br>trial. |
| Leak Compensated Bias<br>Flow | To evaluate the accuracy of the bias flow at the<br>ventilator output for 6 leak conditions |
| High Leak Alarm | To evaluate the new high leak alarm |
| Patient Leak Display | To evaluate the number of breaths before a new<br>displayed value is stabilized and the accuracy of the<br>displayed value |

:

·

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#### Clinical Investigation:

The primary efficacy objective of this study was to show equivalence in the proportion of subjects in the Auto-Trak (test) and Flow Triggering (control) treatment groups. The primary safety objective of this study was to evaluate the rate of adverse events during the intervention.

Based on the success criteria (at least equivalent performance and patient preference and no increase in adverse events over the predicate device), Auto-Trak was shown to be substantially equivalent in performance, patient preference and no increase in adverse events.

#### Conclusion:

Performance testing and clinical data demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 2 2007

Ms. Mara Caler Regulatory Affairs Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92011

Re: K072450

Trade/Device Name: Esprit Ventilator Auto-Trak Sensitivity Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 5, 2007 Received: November 6, 2007

Dear Ms. Caler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Caler

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smitte Y. Michie Omis.

Chiu Lin, Ph.D. 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

# K072450 510(k) Number (if known)

Device Name: Esprit Ventilator Auto-Trak Sensitivity Option

#### 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 noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for useradjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

Prescription Use X (Part 21 CFR 801, Subpart D)

And/or

Over-the-Counter Use (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-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072450