RESPIRONICS GOLOX

K072723 · Respironics, Inc. · BYJ · Mar 20, 2008 · Anesthesiology

Device Facts

• Record ID: K072723
• Device Name: RESPIRONICS GOLOX
• Applicant: Respironics, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The GoLox is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Device Story

GoLox is a portable liquid oxygen unit; double-walled vacuum-insulated cryogenic vessel; holds ~1 lb liquid oxygen at 22 psig. Input: liquid oxygen from stationary refill units. Operation: liquid oxygen converts to gaseous oxygen via internal heat exchange tubing and warming coils; pressure regulated by relief valve; pneumatic conserving device manages flow. Output: near-ambient temperature gaseous oxygen delivered via single lumen nasal cannula. Used by patients in ambulatory settings (home/outside). Healthcare provider prescribes device; patient operates for supplemental oxygen delivery. Benefits: provides portable oxygen therapy for patients with respiratory difficulty.

Clinical Evidence

Bench testing only. No clinical data provided. Testing verified equivalence to predicate device (K050414) regarding connection/disconnection of proprietary connector, oxygen purity, and flow rates under specified environmental conditions.

Technological Characteristics

Double-walled vacuum-insulated cryogenic vessel; plastic enclosure; heat exchange tubing; warming coils; pneumatic conserving device; relief valves. Dimensions/Capacity: ~1 lb liquid oxygen. Energy: Passive (cryogenic pressure). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring supplemental oxygen via nasal cannula who have difficulty extracting oxygen from ambient air. Intended for ambulatory use inside and outside the home. Not for life support or life sustaining use. No contraindications.

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

• Respironics PLOX (K050414)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a handwritten string of characters and numbers. The string begins with the letters 'K0', followed by the numbers '72723'. After the numbers, there is a forward slash '/' and then the letter 'S' with a superscript '2'. Below the numbers '72723' is the word 'GoLox'.

| Date of Submission | February 5, 2008 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Zita A. Yurko<br>Director Regulatory Affairs<br>Respironics, Inc.<br>1740 Golden Mile Highway<br>Monroeville, PA 15146<br>[e-mail] |
| | 724-387-4120 t<br>724-882-4120 с<br>724-387-7490f |
| Classification Reference | 21 CFR 868.5655 |
| Product Code | BYJ - Portable Liquid Oxygen Unit |
| Common/Usual Name | Portable Liquid Oxygen Unit |
| Proprietary Name | Respironics GoLox USP |
| Predicate Device(s) | Respironics PLOX (K050414) |

# Substantial Equivalence

The GoLox has the following similarities to the previously cleared predicate device:

- □ Same intended use.
- O Same operating principle.
- □ Same technology.
- □ Same manufacturing process.

The PLOX was cleared in K050414 for delivering oxygen to patients after being filled with USP 99% oxygen from stationary liquid vessels.

©2008 Respironics Inc.

02/06/08

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Comprehensive testing was performed to determine equivalence between the GoLox and PLOX (K050414). Testing included connection/disconnection of proprietary connector, purity and flowrates in stated environmental conditions.

# Intended Use

The GoLox is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

# Device Description

The GoLox is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox USP s designed to be refilled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

(End of Tab.)

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The text is in all capital letters.

MAR 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K072723

Trade/Device Name: GoLox USP Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: March 7, 2008 Received: March 11, 2008

Dear Mr. Devine:

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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Image /page/3/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Page 2 - Mr. Devine

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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/industry/support/index.html.

Sincerely yours,

Sutta Y. Michael Davis

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

510(k) Number (if known):

Device Name: GoLox USP

The GoLox USP is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vivi Thule

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

K072723 510(k) Number:

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