NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM

K033000 · Essex Cryogenics of Missouri, Inc. · BYJ · Mar 22, 2004 · Anesthesiology

Device Facts

• Record ID: K033000
• Device Name: NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
• Applicant: Essex Cryogenics of Missouri, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic, Expedited Review

Indications for Use

The NPTLOX is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.

Device Story

NPTLOX is a portable, thermally insulated container storing 20 liters of liquid oxygen (99.9%). It converts liquid oxygen to gaseous oxygen for therapeutic delivery to ambulatory or litter patients. The system features six outlet ports providing a maximum combined flow of 66 LPM at 50 ± 5 psig. It supports integration with flow control valves, humidifier bottles, resuscitators, and ventilators. Used in military settings, it is operated by military personnel. The device includes a pressure gauge and a battery-powered liquid oxygen quantity indicator. It improves upon the predicate device by increasing oxygen capacity, patient outlets, and delivery rates, while optimizing evaporation rates to reduce liquid oxygen loss during standby.

Clinical Evidence

Bench testing only. Extensive capability, performance, and environmental testing were conducted to verify specifications. No clinical data was required or provided.

Technological Characteristics

Vacuum-insulated cryogenic container; 20-liter liquid oxygen capacity; 50 ± 5 psig delivery pressure; 6 outlet ports; 66 LPM maximum combined flow. Powered by two 9-volt batteries for the quantity indicator. No other electronics or software. Mechanical operation.

Indications for Use

Indicated for military personnel requiring therapeutic oxygen delivery in military settings. The device converts liquid oxygen to gaseous oxygen for delivery at 50 psig nominal.

Regulatory Classification

Identification

A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

Predicate Devices

• Portable Therapeutic Liquid Oxygen System (PTLOX) (K880183)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The text is oriented diagonally, running from the lower-left to the upper-right corner of the image. The characters are somewhat stylized and slightly distorted, giving the impression of being written quickly or with a degree of artistic flair. The text string appears to be "K033000".

MAR 2 2 2004

## Summary for 50C-0083-1 NPTLOX

Essex Cryogenics of MO., Inc.

8007 Chivvis Drive, 63123 314-832-8208 Fax: [phone] (306) Phone: Elizabeth Hunnicutt Contact: 02/24/04 Date of revised summary:

Next Generation Portable Therapeutic Liquid Oxygen Trade Name: System Portable Liquid Oxygen System Common Name: Portable Liquid Oxygen Unit Classification Name: CFR 21 § 868.5655, Product Code: BYJ Class II Anesthesiology

Legally Marketed Device which substantial equivalence is claimed: Portable Therapeutic Liquid Oxygen System (PTLOX) 510(k) K880183

Description: The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form, which provides therapeutic oxygen to patients. This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed below.

- 1240 DISS Flow control valves and humidifier bottles 나
- Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs �
- Impact 754 Eagle Ventilators の

The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients according to one or more of these approved methods.

The system will be filled by current liquid oxygen storage/filling systems used in the United States Military. The design of the NPTLOX is a modification to the existing predicate device, the Portable Therapeutic Liquid Oxygen (PTLOX) 510(k) K880183. The major modifications are an improvement in maximum oxygen delivery rate, increased number of patient outlets and increased oxygen capacity.

The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet

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

fitting. The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. The NPLTOX has an accessory kit that includes three of each of the following: medical hoses, 0-15 LPM flow control valves, and humidifier bottles. The LOX capacity of the system is 20 liters. Oxygen delivery pressure is displayed via a pressure gauge. The LOX quantity can be periodically displayed via a LOX quantity indicator that is powered by two 9 volt batteries. There is no other electronics or software in the NPTLOX.

Indications for use: The NPTLOX is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military settings only.

Comparison with the PTLOX: Both devices include a vacuum insulated cryogenics container, with the LOX capacity and the resultant dimensional increase being the significant change. The system has been optimized in the NPTLOX to improve the normal evaporation rate, allowing for less liquid oxygen loss during standby.

Testing: Extensive capability, performance, and environmental testing has been accomplished on the NPTLOX with no issues arising regarding its safety and efficiency. The combined testing and analysis of resplits provides assurance that the device meets its specifications and is safe/and effective for its intended use.

"lizabeth Hunnicutt Feb 27, 2001
Elizabeth Hunnicutt, Quality Engineer/Regulatory Affairs

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

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures connected at the shoulders, with flowing lines representing movement or energy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2004

Ms. Elizabeth Hunnicutt Quality Engineer / Regulatory Affairs Essex Cryogenics of MO., Incorporated 8007 Chivvis Drive St. Louis, MO 63123-2395

Re: K033000

Trade/Device Name: Next Generation Portable Therapeutic Liquid Oxygen System Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: February 27, 2004 Received: March 4, 2004

Dear Ms. Hunnicutt:

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. In addition, if you wish to change or expand your current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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.

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

Page 2 -- Ms. Elizabeth Hunnicutt

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/dsma/dsmamain.html.

Sincerely yours,

Chiu-Ling, Ph.D.

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

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

## Indications for Use

510(k) Number (if known): K033000

Device Name: Next Generation Therapeutic Liquid Oxygen System

Indications For Use:

The NPILOX is intended to convert liguid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.

Prescription Use ਮੈ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Af Wuthen

Page 1 of

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K033000