NEPTUNE HYPERBARIC VENTILATOR

K082351 · Level-5, Inc. · CBK · Jan 2, 2009 · Anesthesiology

Device Facts

• Record ID: K082351
• Device Name: NEPTUNE HYPERBARIC VENTILATOR
• Applicant: Level-5, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Neptune Hyperbaric Ventilator provides mechanical ventilation to patients undergoing hyperbaric therapy. System comprises two main components: Control Module (external to hyperbaric chamber) and Patient Breathing Circuit (internal to chamber). Control Module houses pressure regulators and timing valves to manage inspiratory/expiratory time and flow; monitors chamber and regulator pressures. Patient Breathing Circuit includes exhalation valve, pressure relief valve, and pressure gauge; connects to patient endotracheal tube. Three high-pressure hoses link components through chamber door. Safety features include airway pressure gauge, adjustable pressure relief valve, and hand-operated oxygen flush valve. Operated by clinical staff to support respiration during hyperbaric treatment.

Clinical Evidence

Bench testing only. Performance testing confirmed device operates as designed, verifying delivery of gas volumes, frequencies, and functionality of safety devices.

Technological Characteristics

Pneumatic system consisting of external Control Module and internal Patient Breathing Circuit. Components include pressure regulators, timing valves, pressure gauges, exhalation valve, and pressure relief valve. Connectivity via three high-pressure hoses through chamber door. No electronic or software-based control mentioned; operation is mechanical/pneumatic.

Indications for Use

Indicated for patients in respiratory failure or requiring mechanical ventilation during hyperbaric 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

• Sechrist Industries, Inc.'s Hyperbaric Ventilator Model 500A (K760852)

Submission Summary (Full Text)

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K082351
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## 510(k) SUMMARY

# JAN - 2 2009

## LEVEL-5, INC.'S NEPTUNE HYPERBARIC VENTILATOR

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

Howard M. Holstein Regulatory Counsel to Level-5, Inc. Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Phone: [phone]

Facsimile: [phone] Date Prepared: December 31, 2008

## Name of Device and Name/Address of Sponsor

Neptune Hyperbaric Ventilator

Level-5, Inc. 8005 Shannon Industrial Park Lane Atchison, KS 66002

## Common or Usual Name

Ventilator, Continuous (respirator)

#### Classification Name

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

#### Product Code

CBK .

#### Predicate Device

Sechrist Industries, Inc.'s Hyperbaric Ventilator Model 500A (K760852)

#### Indications for Use

The Neptune 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 Neptune 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 and timing valves for control of inspiratory time, expiratory time, and inspiratory flow, as well as 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 valye, 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 door. 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 Neptune Hyperbaric Ventilator that are supplied with the device.

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

#### Performance Data

Performance testing was conducted that confirms that the device operates as designed. In all instances, the Neptune Hyperbaric Ventilator functioned as intended; delivery of the gas volumes, frequencies, and safety devices was verified.

#### Substantial Equivalence

The Neptune Hyperbaric Ventilator is as safe and effective as the Sechrist Hyperbaric Ventilator Model 500A. The Neptune Hyperbaric Ventilator has the same intended uses, similar technological characteristics, and similar principles of operation as its predicate device. The minor technological differences between the Neptune and its predicate device raise no new questions of safety or effectiveness. Thus, the Neptune Hyperbaric Ventilator is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 2 2009

Level-5, Incorporated C/O Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington DC 20004

Re: K082351

Trade/Device Name: Neptune Hyperbaric Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 22, 2008 Received: December 22, 2008

Dear Mr. Holstein:

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. Holstein

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Chris Evert

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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## Indications for Use Statement

0 4 2331 510(k) Number (if known) _

Device Name: Neptune Hyperbaric Ventilator

Indications for Use:

The Neptune Hyperbaric Ventilator is indicated for use with patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric 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)

_
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K082351