MODIFICATION TO: SPIRIT

K080023 · Caire, Inc. · BYJ · Jun 16, 2008 · Anesthesiology

Device Facts

• Record ID: K080023
• Device Name: MODIFICATION TO: SPIRIT
• Applicant: Caire, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Jun 16, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral digital electronic conserving device (DOCD). The spirit 300 is neither a life sustaining nor life supporting device.

Device Story

Spirit 300 is a portable liquid oxygen unit; stores 0.3L liquid oxygen in vacuum-insulated cryogenic dewar. Operates by vaporizing liquid oxygen via vaporizer coil; economizer regulator manages gas draw from headspace (if pressure >20 PSI) or liquid from bottom of dewar (if <20 PSI). Manifold directs gas to either continuous flow outlet (2 LPM) or digital electronic conserving device (DOCD). Conserving device delivers oxygen in pulse doses at onset of inhalation; settings equivalent to 1, 1.5, 2, 3, 4, and 5 LPM. Used by ambulatory patients; provides supplemental oxygen to improve mobility. Healthcare provider prescribes flow settings; patient uses device for oxygen delivery. Benefits include extended duration of oxygen supply via economizer and pulse-dose delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable liquid oxygen unit; vacuum-insulated cryogenic dewar (0.3L capacity); vaporizer coil; economizer regulator; pressure relief valves; manifold; digital electronic conserving device (PCB). Energy source: electronic conserving device (battery/power not specified).

Indications for Use

Indicated for ambulatory patients requiring supplemental oxygen. Not for life-sustaining or life-supporting use.

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

• Spirit 300 (K013251)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "CHART" in white letters against a black, rounded, oblong background. The word is in all capital letters and appears to be a logo or brand name. A registered trademark symbol is located in the bottom right corner of the black background.

#### Caire Inc. a Chart Industries Company

1800 Sandy Plains Industrial Parkway

Marietta, GA 30066-6363

www.chart-ind.com

Suite 316

JUN 1 6 2008

### 510(K) Summary

Koroo23

Phone: [phone] Fax: [phone]

#### Submitter:

Caire, Inc 1800 Sandy Plains Industrial Parkway Marietta, GA 30066-6363

Contact Person:

Zulfigar Ali Choudary BioMedical Quality & Regulatory Affairs Manager

Phone Number: Facsimile Number: E-Mail Address:

770-257-1276 770-425-4740 [e-mail]

Date Prepared:

Device Name Classification Name: Medical Device Class: Classification Panel: Product Code: CFR Section: Requlation Description: November 12, 2007

Spirit 300 Portable Liquid Oxygen Unit Anesthesiology BYJ 865.5655 Portable Liquid Oxygen Unit

Predicate Device:

::::

.05 Apr

Spirit 300 [FDA 510(K) K013251]

#### Device Description:

Device Deseription.
The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a

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longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

#### Indications for use:

Indications for use.
The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral digital electronic conserving device (DOCD). The spirit 300 is neither a life sustaining nor life supporting device.

# Statement of Technical Characteristics Comparison:

Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251.

134

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 6 2008

Mr. Zulfiqar Ali Choudary Quality and Regulatory Affairs Manager Caire, Incorporated 1800 Sandy Plains Industrial Parkway. Suite 316 Marietta, Georgia 30066

Re: K080023

Trade/Device Name: Spirit 300 Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: May 21, 2008 Received: May 27, 2008

Dear Mr. Choudary:

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. Choudary

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.

Syble J. Michie DmD.

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: Spirit 300

Indications for Use:

The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.

Prescription Use (Part 21 CFR 801 Subpart D) and/or

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

510(k) Number:

K80023