PORTABLE OXYGEN UNIT SCA900

K080243 · San Cheong Co. , Ltd. · CAN · Apr 7, 2009 · Anesthesiology

Device Facts

• Record ID: K080243
• Device Name: PORTABLE OXYGEN UNIT SCA900
• Applicant: San Cheong Co. , Ltd.
• Product Code: CAN · Anesthesiology
• Decision Date: Apr 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2700
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

Device Story

Portable oxygen delivery system; integrates cylinder, pressure regulator, flow meter, nasal cannula, and mask. Used in hospital and home healthcare settings. Operates by delivering supplemental oxygen at user-selectable flow settings via mask or cannula. Provides oxygen for deficiency and resuscitation. Benefits patients by providing portable, integrated oxygen supply. No electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Integrated portable oxygen delivery system comprising a compressed gas cylinder, pressure regulator, and flow meter. Mechanical device; no software, electronics, or energy source.

Indications for Use

Indicated for supplemental oxygen delivery to adults for oxygen deficiency and resuscitation. Emergency use requires trained personnel; all other applications are Rx only.

Regulatory Classification

Identification

A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

Predicate Devices

• Cyl-Fil Oxygen System (K061785)
• EZ-OX Plus (K053117)
• LIV (Linde Integrated Valve) (K063354)

Submission Summary (Full Text)

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K080243
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Portable Oxygen Unit SCA900 510(K) Submission

Sancheong Co., Ltd.

# APR - 7 2009

#### 510(K) Summary

Submitter Sancheong Co., Ltd. Chris Kim 185 Songmoon-ri, Yangji-Myunyongin-City Gyoung gi-do, South Korea Tel: [phone] Fax: [phone]

Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

Product Name: Portable Oxygen Unit SCA900

Common Name: Portable Oxygen Delivery System

Classification Name: Cylinder, Compressed Gas, and Valve

Product Code: CAN, KGA, ECX

Regulation Number: 868.2700

Device Class: Class I

#### General Description

The Portable Oxygen Unit SCA900 is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, regulator, nasal cannula and mask. The oxygen is delivered through the mask or nasal cannula with a range of user-selectable flow settings. This unit is suitable for use in all healthcare settings. including hospital and home healthcare.

#### Indication for Use

The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

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RU80243
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Sancheong Co., Ltd.

## Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

- . Cyl-Fil Oxygen System (K061785) manufactured by Responsive Respiratory Inc.
- EZ-OX Plus (K053117) manufactured by Air Liquide Healthcare America. .
- LIV (Linde Integrated Valve) (K063354) manufactured by Linde Gas Therapeutics. .

## Comparison to Predicate Devices

Testing and other comparisons have established that the subject of Portable Oxygen Unit SCA900 is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

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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, facing to the right. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

San Cheong Company, Limited C/o Mr. Jung Bae Bang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

APR - 7 2009

K080243 Re:

> Trade/Device Name: Portable Oxygen Unit SCA900 Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: 1 Product Code: CAN, ECX, KGA Dated: April 3. 2009 Received: April 3, 2009

Dear Mr. Bang:

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. Bang

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 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,

Shula A. Murphy, MD, Susan Reuma DDS, MD

Susan Runner, D.D.S., M.A. Acting 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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## Indication for Use

510(K) Number (if known): K080243

Device Name: Portable Oxygen Unit SCA900

Indication for Use:

The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

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

Over-The-Counter_ X

(Per 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)

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Aria Cles

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

510(k) Number: K080243