ENDURAVENT-5 VENTILATOR

K092263 · Providence Global Medical, Inc. · CBK · Jan 21, 2010 · Anesthesiology

Device Facts

• Record ID: K092263
• Device Name: ENDURAVENT-5 VENTILATOR
• Applicant: Providence Global Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.

Device Story

EnduraVent-5 is a self-contained, portable, non-magnetic ventilator for in-hospital transport. It operates via pneumatic timing and flow metering valves; gas flow is diverted to an exhalation valve diaphragm during inspiration to deliver gas to the patient, while flow ceases during expiration to allow exhalation to the atmosphere. The device is operated by healthcare personnel. It provides mechanical ventilation support to patients, benefiting those requiring respiratory assistance during transport. The device is a replication of the predicate Magellan Ventilator.

Clinical Evidence

Bench testing only. Performance testing confirmed the device operates as designed, verifying gas volumes, frequencies, and safety device function. Comparative bench testing was performed against the predicate Magellan Ventilator using identical protocols.

Technological Characteristics

Self-contained, portable, non-magnetic ventilator. Components: gas inlet connector, gas inlet filter, two timing valves, pilot actuator valve, flow metering valve, pressure-relief valve. Pneumatic operation; no electronic or software components described.

Indications for Use

Indicated for mechanical ventilation of adults and pediatric patients (>9 kg body weight) during in-hospital transport.

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

• Magellan Ventilator (K002951)

Submission Summary (Full Text)

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ho92263

JAN 2 1 2010

# 510(k) SUMMARY Providence Global Medical, Inc's EnduraVent-5 Ventilator

# Submitters Name, Address, Telephone Number, Contact Person and Date Prepared

Submitters Name: Helen Redd, President Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117 Telephone: [phone] Contact Person: Helen Redd, President Date Prepared: July 15, 2009

### Name of Device and Name/Address of Sponsor

EnduraVent-5 Ventilator Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117

# Common or Usual Name

Ventilator, Continuous, Facility Use

### Classification Name

Continuous Ventilator (21 C.F.R. § 868.5895)

#### Product Code

i

CBK

#### Predicate Device

Magellan Ventilator (K002951)

### Indications for Use

The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.

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### Technological Characteristics

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The EnduraVent-5 Ventilator is a self-contained, portable ventilator, consisting totally of non-magnetic components which include: (10 a gas inlet connector, (2) a gas inlet filter, (3) two timing valves, (4) a pilot actuator valve, (5) a flow metering valve, and, (6) a pressure-relief valve. During the inspiratory time phase of the system, a small portion of the gas flowing through the system is diverted to the exhalation valve diaphragm, inflating the diaphragm in sequence with the inspiratory time, thereby allowing the main gas flow from the Device to flow to the patient. During the expiratory phase, all ventilator gas flow ceases, the exhalation valve opens and the patients's exhaled gases flow to atmosphere. These characteristics are illustrated in the Operators and Service Manual, Attachment 1.

# Performance Data Verification of Device and Identical Predicate Device

Performance testing was conducted that confirms that the device operates as designed. In all instances, the EnduraVent-5 Ventilator functioned as intended and delivery of the gas volumes, frequencies, and safety devices was verified. Bench testing with the Endura-Vent-5 and the predicate Magellan Ventilator was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories

### Substantial Equivalence

The EnduraVent-5 Ventilator is as safe and effective as the predicate Magellan Ventilator. The EnduraVent-5 Ventilator has the same intended uses, exactly duplicated technological characteristics and components, and exactly the same principles of operations as its predicate device. Any minor labeling differences between the EnduraVent-5 Ventilator and its predicate device raise no new issues of safety or effectiveness. Thus, the EnduraVent-5 Ventilator is substantially equivalent.

The same person that developed the predicate (K002951) Magellan Ventilator, has now replicated the predicate device with the Endura Vent-5 Ventilator. The predicate device has been . in continuous production since 2000 with zero reported problems to either the FDA or the Manufacturer during that time.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Ms. Helen Redd President Providence Global Medical, Incorporated 4659 South 2300 East, 203 Salt Lake City, Utah 84117

JAN 21 2010

Re: K092263

Trade/Device Name: EnduraVent-5 Ventilator Regulation Number: 21CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 14, 2010 Received: January 14, 2010

Dear Ms. Redd ..

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.

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Page 2- Ms. Redd

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 (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.

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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Radiological Health

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

# Enclosure

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## Indications for Use Statement

510(k) Number (if known) K092263

Device Name: EnduraVent-5 Ventilator

Indications for Use:

EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only .

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-the -counter Use (21 C.F.R. Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

L. Schulten

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

**510(k) Number:** k092263

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