ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

K071212 · Respironics California, Inc. · CBK · Jul 30, 2007 · Anesthesiology

Device Facts

• Record ID: K071212
• Device Name: ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
• Applicant: Respironics California, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ESPRIT ventilatory 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

Device Story

Esprit Ventilator is a microprocessor-controlled, electrically powered mechanical ventilator for clinical use by qualified medical personnel. It provides invasive or non-invasive ventilatory support. The 'Speaking Mode' software option allows tracheostomized patients to vocalize by closing the exhalation valve to direct gas past vocal cords, eliminating the need for an external speaking valve. The device monitors exhaled gas pressure to detect tracheostomy tube disconnection or occlusion. It features a touch-screen GUI, integral air source, variable oxygen concentration (21-100%), and battery backup. Clinicians use the output to manage patient ventilation and assess vocalization capability. Benefits include improved patient communication and integrated monitoring of airway integrity during speech attempts.

Clinical Evidence

Bench testing only. Performance testing verified Speaking Mode operability across various breathing modes (VCV, A/C, SIMV, CPAP, Pressure Support, Flow-Trak), alarm performance (disconnect/occlusion), trigger accuracy, and GUI behavior. Testing confirmed that Speaking Mode is unavailable for neonatal patients, inactive after power cycling, and disabled during specific alarms. No clinical data was required.

Technological Characteristics

Microprocessor-controlled, electrically powered mechanical ventilator. Features touch-screen GUI, integral air source, and battery backup (30-min primary, 3-hour secondary). Connectivity includes RS-232 and Vuelink. Software-based control of exhalation valve for vocalization. No changes to hardware or manufacturing processes from predicate.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring continuous or intermittent ventilatory support via invasive or non-invasive applications. Speaking Mode is indicated for tracheostomized adult and pediatric patients meeting assessment criteria to enable vocalization without a speaking valve.

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)

Submission Summary (Full Text)

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Ko71212

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JUL 3 0 2007

510(k) Summary

Submitter: Respironics Inc. Address: 2271 Cosmos Court Carlsbad, CA 92011 Contact: Mara Caler Telephone: [phone] Fax: [phone] Email: mara.caler(@Respironics.com Date: 30 April 2007

Trade name: Esprit Ventilator Speaking mode 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)

#### 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

### Substantial Equivalence to Predicate Devices:

Predicate device: Esprit Ventilator, K981072 The proposed Esprit Ventilator is identical to the existing Esprit Ventilator with the exception of the addition of the Speaking Mode option.

List of Similarities:

- Similar intended use the intended use is unchanged .
- The Esprit Ventilator is intended for use by qualified medical personnel in o 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.

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- Similar patient circuit the patient circuit is unchanged .
- o The patient circuit is unchanged.
- 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.
- The breathing system is under microprocessor control 트
- The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
- The integral air source is built into the ventilator, eliminating the 피 requirement for a central compressor and piped, medical grade wall air and/or an individual stand alone compressor for each ventilator.
- The ability to provide variable oxygen concentrations (21% to 해 100% O2) from a 35 to 80 PSIG medical oxygen gas source, including medical grad gas cylinders with suitable regulators
- The ability to operate on a re-chargeable primary battery for 30 트 minutes (nominal)
- The ability to be powered by a secondary DC power source (24 L VDC) for up to 3 hours
- Same technology the technology is unchanged ●
- The ESPRIT ventilator 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.

List of Differences:

- Indications for Use ●
- The Speaking mode software option allows tracheostomized adult and o pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve (e.g., the Passy-Muir valve).
- Breathing modes: .
- The breathing modes available during active Speaking Mode include ০ pressure control and volume control in A/C, SIMV and CPAP, Pressure Support and Flow Trak. Speaking Mode option is not available while in the NPPV mode. Neonatal option are not available when in Speaking Mode.

The currently marketed Esprit ventilator and the Esprit ventilator with Speaking Mode option both analyze pressure to trigger and cycle the ventilator. In currently marketed ventilators, an external (closed) Speaking Valve is installed to allow the exhaled gas to flow past the vocal cords. In the Speaking Mode option, the Esprit exhalation valve is closed, so that the exhaled gas is allowed to flow past the vocal cords. The exhaled gas pressure is measured to evaluate if (a) the tracheostomy tube has become disconnected or (b) if the tracheostomy tube has become occluded.

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Substantial equivalence was established by performance testing. The Table describing the performance testing follows:

| Parameter | Purpose | Pass/Fail |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Speaking Mode (SM)<br>operability | SM operates with VCV with A/C,<br>SIMV, and CPAP; is not functional<br>with NPPV; operates with Flow-Trak;<br>operates with Pressure Support;<br>operates on both adult and pediatric<br>patient types | Pass |
| Speaking Mode<br>operability | SM is not available for Neonatal<br>patients; is not active after power<br>cycling; is not available when specific<br>alarms are active | Pass |
| Speaking mode and I-<br>trigger | I-trigger will automatically adjust to<br>pressure triggering if flow triggering is<br>the current trigger type; that only<br>pressure triggering is allowed while in<br>SM; test the accuracy of pressure<br>triggering | Pass |
| Speaking Mode<br>graphical user interface | Test the ventilator behavior when SM<br>is not installed; confirm the SM<br>related dialogs; test the ventilator<br>behavior when SM is deactivated;<br>confirm that PEEP is always set to<br>zero when SM is active | Pass |
| Speaking Mode alarms<br>and settings | Confirm alarm performance, including<br>patient disconnect | Pass |
| Speaking Mode alarms<br>and settings | Confirm alarm performance, including<br>occlusion alarm | Pass |
| Apnea alarm | Confirm that if apnea alarm occurs<br>while in SM, exhalation valve opens<br>during exhalation | Pass |
| Maneuvers not available | Confirm that Respiratory Mechanics<br>and expiratory Hold Maneuvers are<br>not available when SM is active | Pass |
| Parameter | Purpose | Pass/Fail |
| Displayed patient data | Confirm that data displays are<br>appropriate | Pass |
| Trending | Confirm that trending values are<br>trended/not trended when SM is active | Pass |
| Breath delivery | Confirm that exhalation valve is<br>closed during inhalation and<br>exhalation while in SM | Pass |
| Communications | Confirm that RS 232 and Vuelink<br>communications are operable | Pass |

## Summary of Validation Testing

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### Conclusion:

:

This testing demonstrates 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

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

JUL 3 0 2007

Re: K071212

Trade/Device Name: Esprit Ventilator Speaking Mode Option Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 12, 2007 Received: July 16, 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 vour 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 vours.

Suttie G. Michael DMD.

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

#### 510(k) Number (if known): K071212

Device Name: Esprit Ventilator (Speaking Mode Option)

Indications for Use:

The ESPRIT ventilatory 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

X Prescription Use (Part 21 CFR 801, Subpart D) Over-the-Counter Use (Part 21 CFR 801, Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

ch (acting)
(Division Sign-Off)

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vision of Anesthesiology, General Hospital. tion Control. Dental Devices

510(k) Number: k071212