LINDE INTEGRATED VALVE (LIV)

K063354 · Linde Gas Therapeutics · ECX · Apr 17, 2007 · Anesthesiology

Device Facts

• Record ID: K063354
• Device Name: LINDE INTEGRATED VALVE (LIV)
• Applicant: Linde Gas Therapeutics
• Product Code: ECX · Anesthesiology
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2700
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. 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

LIV (Linde Integrated Valve) is a portable oxygen delivery system comprising an integrated cylinder, valve, regulator, flow meter, and shock-absorbing guard. It accepts compressed oxygen gas as input. The device transforms high-pressure cylinder gas into user-selectable flow rates for patient delivery; it also provides a DISS-1240 connection for standard 50psig oxygen output. Used in hospitals, outpatient centers, imaging centers, and home healthcare settings; operated by clinicians or patients. The device features an active contents gauge and an optional bed hanger. It benefits patients by providing a portable, integrated, and MR-conditional oxygen source. Healthcare providers use the flow selector to adjust oxygen delivery based on clinical need.

Clinical Evidence

Bench testing only. The device was evaluated for MRI compatibility per the CDRH Magnetic Resonance Working Group document (1997) and ASTM 2503-05. Aluminum cylinders conform to 21CFR49 § 178.46 specifications.

Technological Characteristics

Integrated portable oxygen system; aluminum cylinders (21CFR49 § 178.46); single-stage piston-style regulator; flow rate selector; DISS-1240 pressure outlet; active contents gauge; shock-absorbing guard. MR-conditional up to 3.0T (ASTM 2503-05).

Indications for Use

Indicated for pediatric and adult patients requiring supplemental oxygen. Used for oxygen deficiency and resuscitation in emergency settings by trained personnel, or for other medical applications under prescription. MR-conditional up to 3.0T.

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

• MEDICYL-E-Lite Portable Oxygen System (K033897)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Linde" in a stylized, cursive font. The word is white against a black background, creating a strong contrast. The "L" has a large, sweeping curve that extends over the rest of the word, adding a touch of elegance to the design. The overall impression is clean and modern.

510(k) Summary LIV (Linde Integrated Valve) 510(k) Number: _ K 0 6 335 4

APR 17 2007

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

#### 1.0 APPLICANT'S INFORMATION

Edward W. Siurek III Dir., Operational Quality Institutional Business Division Linde Gas Therapeutics PH: [phone] Mobile: [phone] E: [e-mail] Medical Establishment Registration No .: 3003900188

#### 2.0 SUBMITTER'S INFORMATION

James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44147 PH/FX: +1 440.546.4936 Mobile: [phone] E: [e-mail] http://www.coastalcg.com

#### 3.0 DATE

October 31, 2006

#### 4.0 DEVICE INFORMATION

Trade/Proprietary Name:

| Trade/Proprietary Name: | LIV (Linde Integrated Valve) |
|-------------------------|----------------------------------------|
| Common Name: | LIV (Linde Integrated Valve) |
| DEVICE NAME: | Cylinder, Compressed Gas, and Valve |
| Classification Panel: | Cardiovascular and Respiratory Devices |
| Classification Number: | 868.2700 |
| Product Nomenclature: | Regulator, Pressure, Gas Cylinder |
| Product Code(s): | CAN |

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| Classification Number: | 868.2610 |
|------------------------|----------------------------------------|
| Product Nomenclature: | Gauge, Gas Pressure, Cylinder/Pipeline |
| Product Code(s): | BXH |
| Classification Number: | unclassified |
| Product Nomenclature: | Cylinder, Compressed Gas, and Valve |
| Product Code(s): | ECX |
| Classification Number: | unclassified |
| Product Nomenclature: | Cylinder, Gas (Empty) |
| Product Code(s): | KGA |

#### 5.0 DEVICE CLASSIFICATION

Empty compressed gas cylinders and compressed gas cylinder with valve assemblies are unclassified devices, and reviewed by the Anesthesiology and Respiratory Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.

Gas cylinder pressure requlators and gas pressure gauges are Class I devices and exempted from pre-market notification.

#### PREDICATE DEVICE(s) 6.0

K033897 MEDICYL-E-Lite Portable Oxygen System

#### 7.0 DEVICE DESCRIPTION

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

#### 8.0 INDICATIONS FOR USE

The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. 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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#### 9.0 TECHNOLOGICAL CHARACTERISTICS

A summary comparison of technological characteristics, including design and materials is provided in the table below:

| Parameter | LIV (Linde Integrated Valve) | MEDICYL-E-Lite<br>K033897 |
|--------------------------------------|--------------------------------|--------------------------------|
| Valve/Regulator | | |
| Flowrate Selector and Flow<br>Outlet | yes | yes |
| Pressure Outlet | yes | no |
| Cylinder On/Off | yes | yes |
| Filling Port | active;<br>w/ non-return valve | active;<br>w/ non-return valve |
| Contents Gauge | active | non-active |
| Excess Flow Device | yes | yes |
| Residual Pressure Valve | yes | yes |
| Burst Disk | yes | yes |
| Single stage piston style | yes | yes |
| Guard | | |
| Hand grip | 2 grip | 2 grip |
| Access Ports | yes | yes |
| Color | green | green |
| Cylinder | | |
| Sizes | D, E | D, E |
| Materials/construction | Aluminum | Aluminum |
| MRI Compatibility | yes; tested up to 3.0T | yes; tested up to 3.0T |

The manufacturer believes that the technological characteristics of the IV (Linde Integrated Valve) is substantially similar to those of the predicate device.

#### 10.0 PERFORMANCE DATA

The aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders.

The LIV (Linde Integrated Valve) has been evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, dated February 7, 1997.

#### 11.0 STATEMENT OF SUBSTANTIAL EQUIVALENCE

Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the LV (Linde Integrated Valve) is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Linde Gas Therapeutics C/O Mr. James J. Rogers General Manager Coastal Consulting Group, Limited P.O. Box 470218 Broadview Heights, Ohio 44147

APR 1 7 2007

Re: K063354

Trade/Device Name: LIV (Linde Integrated Valve) Regulation Number: None Regulation Name: Cylinder, Compressed Gas and Valve Regulatory Class: Unclassified Product Code: ECX Dated: March 19, 2007 Received: March 20, 2007

Dear Mr. Rogers:

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. Rogers

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 vours.

Sylitte Y. Michlew Omd

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: LIV (Linde Integrated Valve

Indications for Use:

The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. 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 rah Uized or otherwise secured to prevent falling and rolling.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND

Over-the-Counter Use _ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

18 051-399 sion of Anesthesiology, General Hospital, Joseon Control, Dental Devices

C(k) Number: K 06

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