HOME-AWAY SYSTEM, MODEL 1041

K042944 · In-X Corporation · CAW · Apr 15, 2005 · Anesthesiology

Device Facts

• Record ID: K042944
• Device Name: HOME-AWAY SYSTEM, MODEL 1041
• Applicant: In-X Corporation
• Product Code: CAW · Anesthesiology
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

Device Story

Home-Away System, Model 1041 functions as accessory to oxygen concentrator and liquid oxygen (LOX) stroller; liquefies oxygen received from concentrator for delivery to LOX stroller; delivers up to 3 L/min gaseous oxygen directly to patient. Used in home setting by patients. Device enhances usability, manufacturability, and safety of oxygen therapy delivery. Output provides supplemental oxygen to patient; assists in managing oxygen supply for home use. Not life-sustaining or life-supporting.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Accessory to oxygen concentrator and LOX stroller. Liquefaction system. Compatible with > 5 L/min USP 93% oxygen concentrators. Proprietary mating valve for LOX stroller connection. Tested for EMC/EMI, shock, vibration, and environmental safety.

Indications for Use

Indicated for pediatric and adult patients requiring supplemental oxygen therapy in the home as an aid or adjunct to oxygen concentrators and liquid oxygen storage systems. No contraindications.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Predicate Devices

• Home-Away System (K004047)

Submission Summary (Full Text)

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

#### APR 1 5 2005 510(k) Summary

| SUBMITTER: | In-X Corporation<br>6753 E. 47th Ave. Drive, Unit D<br>Denver, CO 80216 |
|----------------------|------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Douglas Powell, In-X Corporation President<br>Phone: [phone] ext 103<br>Fax: [phone] |
| DATE PREPARED: | October 22, 2004 |
| DEVICE TRADE NAME: | Home-Away System, Model 1041 |
| 510(K) NUMBER | K042944 |
| PRODUCT CODES | CAW/BYJ |
| REGULATION NUMBER | 868.5440/868.5655 |
| REGULATORY CLASS | Class II (two) |
| COMMON/USUAL NAME: | Accessory to oxygen concentrator and liquid oxygen<br>stroller |
| CLASSIFICATION NAME: | Portable Oxygen Generator |
| | Portable Liquid Oxygen Unit |
| PREDICATE DEVICE: | The Home-Away System<br>510(k) Number: K004047 |

### DEVICE DESCRIPTION:

The Home-Away System, Model 1041 is an accessory to an oxygen concentrator and liquid oxygen (LOX) stroller. It liquefies oxygen that is received from an oxygen nquia entygen (t, and delivers it to a LOX stroller for patient use. While performing these functions, it is also capable of delivering up to 3 L/min of gaseous oxygen directly to the patient. In these respects, the Home-Away System, Model 1041 is the same as its to the payment Home-Away System. The Home-Away System, Model 1041 incorporates prounders from the cleared device that enhance its usability, manufacturability, consistent performance, durability, reliability, and safety.

### INDICATIONS FOR USE:

The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering

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

supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

## STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The Home-Away System, Model 1041 is substantially equivalent to the cleared Home-Away System (K004047). They are both compatible with oxygen concentrators that deliver > 5 L/min USP 93% oxygen and are approved by In-X Corporation. The Home-Away System is compatible with any bottom-fill type LOX stroller; whereas, the Home-Away System, Model 1041 is only compatible with LOX strollers that utilize a proprietary mating valve.

Substantial equivalence was based on performance testing of the Home-Away System, Model 1041 consisting of analysis of oxygen for impurities, USP 93% oxygen testing, EMC/EMI testing, safety testing, transfill testing, production rate testing, shock and vibration testing, package testing, environmental testing, and residue testing.

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping lines, resembling an abstract representation of a human form or a symbol related to health and well-being.

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douglas Powell President In-X Corporation 6753 East 47th Avenue, Unit D Denver, Colorado 80216

Re: K042944

Trade/Device Name: Home-Away System, Model 1041 Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW, BYJ Dated: April 11, 2005 Received: April 12, 2005

Dear Mr. Powell:

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.

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

Page-2 Mr. Powell

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 (OS) 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,

Clive

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): | ( (

Device Name: Home-Away System, Model 1041 Indications for Use: The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

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

Over-the-Counter Use (21 CFR 801 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Qus LS

nar. Sien-Off) sion of Annsthesiology, General Hospital, Jotion Control, Demai Devices

Number: K042944

Page 1 of ___1