ESPRIT VENTILATOR, MODEL V1000

K034040 · Respironics, Inc. · CBK · Jan 21, 2004 · Anesthesiology

Device Facts

• Record ID: K034040
• Device Name: ESPRIT VENTILATOR, MODEL V1000
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• 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 to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications. Esprit is not intended for use in the presence of flammable anesthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.

Device Story

Esprit Ventilator (Model V1000) is a microprocessor-controlled, electrically powered mechanical ventilator for adult and pediatric patients. Device provides continuous or intermittent ventilatory support in invasive or non-invasive settings. Modification adds 'VCV Demand Flow' software option, providing additional flow/volume during volume-controlled mandatory and assist breaths when operator settings do not satisfy patient demand. Once enabled, feature is always available. Operated by qualified medical personnel in clinical environments. Output assists clinicians in managing patient respiratory needs; feature enhances patient comfort and synchrony by meeting demand beyond set parameters.

Clinical Evidence

No clinical data. Performance supported by software verification and validation testing conducted in accordance with FDA's 1998 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Technological Characteristics

Microprocessor-controlled, electrically powered mechanical ventilator. Software-based VCV Demand Flow enhancement. No new technological characteristics introduced. Connectivity and hardware specifications unchanged from predicate.

Indications for Use

Indicated for adult and pediatric patients requiring continuous or intermittent ventilatory support via invasive or non-invasive applications. Contraindicated for use in the presence of flammable anesthetics.

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 (K023350/K981072)
• Bear 1000 Ventilator (K912619/A)
• Servoi Ventilator System (K022132)

Submission Summary (Full Text)

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#### ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

## 510(k) SUMMARY

JAN 2 1 2004

| Company: | Respironics California, Inc. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2271 Cosmos Court<br>Carlsbad, CA-92009 |
| Contact: | Anil Bhalani<br>Manager, QA/RA |
| Date prepared: | December 26, 2003 |
| Product Common Name: | Continuous Ventilator |
| Product Proprietary Name: | Esprit Ventilator<br>Model Number: V1000 |
| Device Classification: | Class II (Special Controls) and 840<br>Continuous Ventilator per 21 CFR 868.5895 and<br>Diagnostic Spirometer per 21 CFR 868.1<br>Procode: CBK and BZG |
| Predicate Devices: | Esprit Ventilator (K023350/K981072)<br>Bear 1000 Ventilator (K912619/A)<br>Servoi Ventilator System (K022132) |

# Description of Device Modification:

The VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.

# 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 to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Esprit is not intended for use in the presence of flammable anesthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.

# Technological Characteristics:

The Esprit ventilator does not incorporate any new technological characteristics with the addition of the VCV Demand Flow option.

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KB4040

#### ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

## Determination of Substantial Equivalence:

The Esprit Ventilator with the VCV Demand Flow option has similar performance characteristics, the same intended use, the same environment of use and patient populations as currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices. The addition of this new feature does not raise new questions of safety and effectiveness for the Esprit.

## Summary of Performance Testing:

Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met.

#### Conclusion:

The technological characteristics of the Esprit ventilator with the VCV Demand Flow and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Anil Bhalani Manager of QA/RA Respironics, Incorporated 2271 Cosmos Court Carlsbad, CA 92009-1517

Rc: K034040

Trade/Device Name: Esprit Ventilator, Model V1000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 26, 2003 Received: December 29, 2003

Dear Mr. Bhalani:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became of 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 interstate conmisive prior to tray been reclassified in accordance with the provisions of Amendinens, of to devroos and nave ooch (Act) that do not require approval of a premarket the rederal Food, Drag, and Commens , therefore, market the device, subject to the general approval appreation (1 Million). The general controls provisions of the Act include controls 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 (FMA), it may be subject to sace of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Bhalani

Please be advised that I DA's issuance of a substantial equivalence determination does not Fleast be advisod that I Dr. determination that your device complies with other requirements mean that I Dr mai maal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal babet's requirements, including, but not limited to: registration 1 our must comply with and are reveling (21 CFR Part 801); good manufacturing practice and fisting (21 CF A real of 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) This letter will are .. The FDA finding of substantial equivalence of your device to a premaired 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), If you desire spleetive at 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 Inter 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/dsma/dsmamain.html.

Sincerely yours,

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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### ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

# Indications for Use

510(k) Number (if known): K034040

Esprit Ventilator with VCV Demand Flow Option Device Name:

Indications for Use:

The Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, The Espit Pennancel was ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

MB 20/04

| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

BHWunderhauer

on Sign-C of Anesthesiology, General Hospital,

510(k) Number: K034040

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