INSPIRATION VENTILATOR SYSTEM

K051550 · eVent Medical, Ltd. · CBK · Jul 12, 2005 · Anesthesiology

Device Facts

• Record ID: K051550
• Device Name: INSPIRATION VENTILATOR SYSTEM
• Applicant: eVent Medical, Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Inspiration™ Ventilator System is intended to provide continuous ventilation for patients requiring respiratory support. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressure-based or volume-based continuous respiratory support with tidal volumes as low as 5 mL and inspiratory pressures as low as 1 cm H2O. The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device may be used for intra-hospital transport within a hospital or hospitaltype facility. The device is not intended for transport between hospitals or hospitaltype facilities. The device is not to be used in the presence of flammable anesthetics. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

Device Story

Inspiration™ Ventilator System provides continuous respiratory support via pressure-based and volume-based mandatory/spontaneous breaths. Device modification enables tidal volume settings down to 5 mL (previously 10 mL). Operates in hospital/clinical settings; managed by trained personnel. Inputs include patient respiratory parameters; system delivers mechanical ventilation. Output provides life-sustaining respiratory support; clinicians monitor settings to adjust therapy based on patient needs. Benefits include precise low-volume ventilation for infants and adults requiring respiratory assistance.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per FDA software guidance and internal quality procedures. Compliance with international standards (EN60601-1, EN60601-1-2, CAN/CSA C22.2 No. 601-1M90, UL 2601-1, EN 794-1) demonstrates device meets specifications.

Technological Characteristics

Continuous ventilator; pressure/volume-based ventilation. Software-controlled tidal volume delivery (5 mL minimum). Compliant with EN60601-1, EN60601-1-2, EN 794-1. Connectivity/materials not specified beyond existing cleared predicate design.

Indications for Use

Indicated for infant through adult patients requiring respiratory support for various clinical conditions in hospital, hospital-type facilities, and during intra-hospital transport. 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

• InspirationTM Ventilator (K030341)
• Servoi Ventilator (K010925)

Submission Summary (Full Text)

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# JUL 1 2 2005

051550

### SUMMARY OF SAFETY AND EFFECTIVENESS

| SUBMITTER: | eVent Medical Ltd.. |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE: | June 10, 2005 |
| COMMON NAME: | Continuous Ventilator |
| PROPRIETARY NAME: | Inspiration ^TM Ventilator System |
| CONTACT: | Robbie Walsh, VP Regulatory Affairs and<br>Quality Assurance<br>eVent Medical Ltd.<br>6A Lisoban Business Park<br>Tuam Road<br>Galway,<br>Ireland.<br>Tel: + 353 91 764472<br>Fax: + 353 91 764379 |
| CLASSIFICATION: | Class II per 21 CFR 868.5895<br>Continuous Ventilator |
| PREDICATE DEVICES: | eVent Medical Ltd.. is claiming substantial equivalence to the following two predicate medical devices: |

| Predicate Device | 510(k) Number | Classification |
|-------------------------------------------------|---------------|-----------------------------------------------------------|
| eVent Medical Ltd..<br>InspirationTM Ventilator | K030341 | Class II,<br>Continuous Ventilator<br>per 21 CFR 868.5895 |
| Siemens - Elma AB.<br>Servoi Ventilator | K010925 | Class II,<br>Continuous Ventilator<br>per 21 CFR 868.5895 |

#### A Device Description:

The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to

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set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device.

This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.

- B Intended Use:
The device intended use is the same as that of the cleared device, the Inspiration™ Ventilator system and is re-stated below.

Purpose and Function of the Device:

The Inspiration™ Ventilator System is intended to provide continuous ventilation for patients requiring respiratory support. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

Intended Patient Population:

The intended patient population includes infant through adult patients who require pressure-based or volume-based continuous respiratory support with tidal volumes as low as 5 mL and inspiratory pressures as low as 1 cm H2O.

Intended Environment of Use:

The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device may be used for intra-hospital transport within a hospital or hospitaltype facility. The device is not intended for transport between hospitals or hospitaltype facilities.

The device is not to be used in the presence of flammable anesthetics.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel

Indication for Use:

The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

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#### Substantial Equivalence C

The intended use of the Inspiration™ Ventilator is the same as that for standard, currently marketed critical care ventilators. The materials and design of this currently marketed of the predicate devices. The technical characteristics of the Inspiration™ Ventilator System do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the Inspiration™ Ventilator System provides similar information as the predicate devices.

Information provided in the 510(k) submission supports the determination of substantial equivalence. Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as a guidance and per internal company requirements. The Inspiration™ Ventilator device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994, EN 794-1 and 93/42/EEC Medical Device Directive.

The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.

In summary eVent Medical Ltd. has demonstrated the Inspiration™ Ventilator System to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.

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Image /page/3/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and body.

Public Health Service

Jul. 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robbie Walsh, VP Regulatory Affairs and Quality Assurance eVent Medical Limited 6A Lisoban Business Park Tuam Road Galway, Ireland

Re: K051550

Trade/Device Name: Inspiration™ Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 10, 2005 Received: June 14, 2005

Dear Mr. Walsh:

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 - Mr. Walsh

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,

Auy Sulom be
Chin Lin, Ph.D.

Chiu Lin, PhD 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: | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Inspiration™ Ventilator |
| Indications for Use: | The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport. |
| Prescription Use _X_ | AND/OR _ Over-The-Counter-Use |

(Part 21 CFR 801 Subpart D)

(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)

Aver Sucion

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthesionsy, "Divises 0

510(k) Number: K0515

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