GOLOX-93

K081779 · Respironics, Inc. · BYJ · Sep 19, 2008 · Anesthesiology

Device Facts

• Record ID: K081779
• Device Name: GOLOX-93
• Applicant: Respironics, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Sep 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GoLox-93 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.

Device Story

GoLox-93 is a portable, double-walled vacuum-insulated cryogenic vessel; stores ~1 lb liquid oxygen at 22 psig. Operates via heat exchange tubing, relief valves, and pneumatic conserving device; converts liquid oxygen to gaseous oxygen for delivery via nasal cannula. Used by patients requiring supplemental oxygen; ambulatory use inside/outside home. Modification of GoLox USP (K072723) specifically to enable filling with 93% liquid oxygen from Respironics Home Liquefaction Systems; fill connector prevents filling from stationary USP oxygen vessels. Mechanical device; no electronics or software. Benefits patients by providing portable supplemental oxygen.

Clinical Evidence

Bench testing only. Verification testing confirmed the fill connector mates with liquefaction systems and prevents connection to stationary vessels.

Technological Characteristics

Double-walled vacuum-insulated cryogenic vessel; 1 lb liquid oxygen capacity; 22 psig operating pressure. Includes heat exchange tubing, relief valves, and pneumatic conserving device. Plastic enclosure. Mechanical device; no electronics, software, or energy source required for operation. Designed for specific fill connection compatibility with Respironics Home Liquefaction Systems.

Indications for Use

Indicated for patients requiring supplemental oxygen due to difficulty extracting oxygen from ambient air. Intended for ambulatory use inside and outside the home. 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 GoLox USP (K072723)
• Caire Spirit Model HAS (K050153)

Reference Devices

• Respironics PLOX (K050414)

Submission Summary (Full Text)

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GoLox -93

| Date of Submission | June 20, 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]<br>724-387-4120 t<br>724-882-4120 c<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-93 |
| Predicate Device(s) | Respironics GoLox USP (K072723)<br>Caire Spirit Model HAS (K050153) |
| Reason for submission | device modification |

# Substantial Equivalence

The GoLox-93 has the following similarities to the previously cleared predicate device:

- ロ Same intended use.
- ロ Same operating principle.
- D Same technology.
- D Same manufacturing process.

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The GoLox-93 is a modification to the GoLox USP (K072723) to enable it to be filled with 93% liquid oxygen from the Respironics Home Liquefactions Systems. The GoLox- 93 is identical to the GoLox USP except for the fill connection. The fill connector has changed to allow filling with 93% oxygen from liquefaction systems only and prevents filling with USP oxygen from stationary vessels.

The GoLox USP (K072723) was a modification of the Respironics PLOX (K050414). Comprehensive testing was performed to determine equivalence between the GoLox USP (K072723 and PLOX (K050414). Additional testing provided includes verification that the fill connector mates with liquefaction systems and not with stationary vessels.

### Intended Use

The GoLox-93 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.

## Device Description

The GoLox-93 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-93 is a mechanical device and does not contain any electronics or software. The GoLox-93 is designed to be refilled only from Respironics Home Liquefaction Systems.

(End of Tab.)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the left side of the eagle.

Public Health Service

SEP 1 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

Re: K081779 Trade/Device Name: GoLox-93 Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: June 20, 2008 Received: June 23, 2008

Dear Ms. Yurko:

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 vour 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. Yurko

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 (Scctions 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,

Z.Kommell-Lendimo Bell

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

#### Enclosures

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### Indications for Use

510(k) Number (if known): ________________

Device Name: __ GoLox-93

The GoLox -93 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 _____________________________________________________________________________________________________________________________________________________________ Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: