V200 INTELLI-TRAK OPTION

K110795 · Respironics California, Inc. · CBK · Aug 19, 2011 · Anesthesiology

Device Facts

• Record ID: K110795
• Device Name: V200 INTELLI-TRAK OPTION
• Applicant: Respironics California, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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. The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.

Device Story

V200 Ventilator is a microprocessor-controlled, electrically powered mechanical ventilator for invasive or non-invasive support. IntelliTrak software option adds a new triggering and cycling mechanism based on the equation of motion to improve patient-ventilator synchrony. Operated by qualified medical personnel in clinical settings. IntelliTrak is activated via a GUI button; can be installed factory-direct or as a field upgrade. Output is mechanical ventilation; healthcare providers use the system to manage patient respiratory support. Benefits include improved synchrony between patient and ventilator.

Clinical Evidence

Bench testing only. Performance of the V200 with IntelliTrak was compared to the predicate V200 using flow triggering (3 LPM) and cycling (25% of peak flow). No clinical data provided.

Technological Characteristics

Microprocessor-controlled, electrically powered mechanical ventilator. IntelliTrak option utilizes an algorithm based on the equation of motion for triggering and cycling. Software-based modification integrated into existing GUI. No changes to control mechanism, operating principle, energy type, patient interface ergonomics, or environmental specifications.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring continuous or intermittent ventilatory support. IntelliTrak option indicated for adult and pediatric patients in invasive applications only. Prescription use by qualified medical personnel.

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

• V200 Ventilator (K102054)

Submission Summary (Full Text)

{0}------------------------------------------------

A. K110795
AUG 19 2011

# 510(k) Summary

#### [Refer to 21 CFR 807.92]

| Owner: | Respironics California, Inc.<br>2271 Cosmos Court<br>Carlsbad, CA 92011 | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Applicant: | Mary Funk<br>Senior Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | |
| Application<br>Correspondent: | Bob Marshall<br>Director, Regulatory & Quality Engineering<br>Regulatory & Quality Solutions, LLC<br>Phone: [phone] x105 | | |
| Date Prepared: | July 1, 2011 | | |
| Proprietary Name: | V200 Ventilator with IntelliTrak Option | | |
| Common Name: | Ventilator | | |
| Classification Name: | Continuous Ventilator (21 CR 868.5895, Product Code 73 CBK) | | |
| Predicate Devices: | Manufacturer<br>Respironics California, Inc. | Device Name<br>V200 Ventilator | 510(k) Number<br>K102054 |

#### Description of Device Modification

The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The IntelliTrak Software Option will add a new triggering and cycling mechanism based on the equation of motion for the purpose of improving patient-ventilator synchrony. The IntelliTrak software option is activated and is integrated into the V200 in the same way as other currently marketed V200 software options. It can either be installed in the factory or in the field as an upgrade to existing V200 ventilators. The IntelliTrak option is added to the currently commercially released software version and instrument. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn IntelliTrak on and off.

{1}------------------------------------------------

# Intended 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.

The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.

# Determination of Substantial Equivalence

The predicate device is the unmodified V200 Ventilator.

- The proposed V200 Ventilator IntelliTrak option is identical to the existing V200 Ventilator with the exception of the addition of the IntelliTrak option.
- The IntelliTrak option incorporates a new option for triggering and eveling a breath. The . subsequent breath delivery (inhalation) is unchanged by the addition of the IntelliTrak.

Bench performance testing was performed for the new option and performance was compared between the Respironics V200 with flow triggering set at 3 LPM and cycling set at 25% of peak flow and the Respironics V200 IntelliTrak option.

### Conclusion

The V200 Ventilator with IntelliTrak option has the same intended use as the currently marketed predicate ventilator.

The IntelliTrak option incorporates a new option for triggering and cycling a breath. 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 data demonstrates that the IntelliTrak option does not raise any new questions regarding safety and effectiveness.

The technological characteristics of the currently marketed 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 made to include the IntelliTrak option only.

This submission contains comparative information, including documentation related to the aforementioned activities to conclude that the V200 Ventilator with IntelliTrak option is substantially equivalent to currently marketed devices cleared by the FDA. These changes do not raise any new questions regarding safety and effectiveness.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Respironics California, Incorporated C/O Mr. Robert M. Marshall Director, Regulatory & Quality Engineering Regulatory & Quality Solutions, LLC 3919 William Penn Highway Murrysville, Pennsylvania 15668-8550

AUG 1 9 2011

Re: K110795

Trade/Device Name: V200 Ventilator with IntelliTrak Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 30, 2011 Received: August 1, 2011

Dear Mr. Marshall:

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.

{3}------------------------------------------------

Page 2 - Mr. Marshall

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 (OS) 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 /ucm ! 1 5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Cintron Q. m

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

{4}------------------------------------------------

#### 4 Indications for Use

510(k) Number (if known):

Device Name: V200 Ventilator with IntelliTrak Option

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 noninvasive applications.

The IntelliTrak option provides new triggering and functionality that is intended for use only with adult and pediatric patients in invasive applications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k110795