ATLANTIS HYPERBARIC CHAMBER VENTILATOR

K092264 · Providence Global Medical, Inc. · CBK · Dec 17, 2009 · Anesthesiology

Device Facts

• Record ID: K092264
• Device Name: ATLANTIS HYPERBARIC CHAMBER VENTILATOR
• Applicant: Providence Global Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

Device Story

Atlantis Hyperbaric Ventilator provides mechanical ventilation to patients inside hyperbaric chambers. System comprises two main components: Control Module (external to chamber) and Patient Breathing Circuit (internal to chamber). Control Module regulates oxygen flow, inspiratory/expiratory timing, and monitors pressures via regulators, valves, and gauges. Three high-pressure hoses connect modules through chamber bulkhead. Patient Breathing Circuit connects to patient endotracheal tube for oxygen delivery. Safety features include airway pressure gauge, adjustable pressure relief valve, and hand-operated oxygen flush valve. Operated by clinicians to manage respiratory support during hyperbaric therapy; output allows physician-directed ventilation control, benefiting patients requiring respiratory support in high-pressure environments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design identity to the predicate device.

Technological Characteristics

System consists of an external Control Module and internal Patient Breathing Circuit connected by three high-pressure hoses. Components include pressure regulators, timing valves, pressure gauges, exhalation valve, pressure relief valve, and oxygen flush valve. Operates via pneumatic control of oxygen flow. No software or electronic algorithm described.

Indications for Use

Indicated for pediatric and adult patients in respiratory failure or requiring mechanical ventilation during hyperbaric chamber therapy.

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

• Neptune Hyperbaric Ventilator (K082351)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

DEC 1 7 2009

Re: K092264

Trade/Device Name: Atlantis Hyperbaric Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 19, 2009 Received: November 25, 2009

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

Enclosure

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#### Indications for Use Statement

510(k) Number (if known) K092264

Device Name: Atlantis Hyperbaric Ventilator

Indications for Use:

The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

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 (ODE)

L. Schultt

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

510(k) Number: K092264

0000 Ved

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## 510(k) SUMMARY

# PROVIDENCE GLOBAL MEDICAL, INC.'s, ATLANTIS HYPERBARIC 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

Atlantis Hyperbaric 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

CBK

### Predicate Device

Level-S, Inc.'s Neptune Hyperbaric Ventilator (K082351)

#### Indications for Use

The Atlantis Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.

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### Technological Characteristics

The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device.

Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.

#### Substantial Equivalence

The Atlantis Hyperbaric Ventilator is as safe and effective and is an exact duplicate of the predicate, designed and built by the same person as the predicate Neptune Hyperbaric Ventilator, who is now Vice-President of the Company.

The Atlantis Hyperbaric Ventilator has the same intended uses, exactly the same technological characteristics, and exactly the same principles of operations as its predicate device. Any minor technological differences between the Atlantis and its predicated device raise no new issues of safety or effectiveness. Thus, the Atlantis Hyperbaric Ventilator is substantially equivalent.