SPIRIT 300

K013251 · Caire, Inc. · BYJ · Dec 18, 2001 · Anesthesiology

Device Facts

• Record ID: K013251
• Device Name: SPIRIT 300
• Applicant: Caire, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

Portable liquid oxygen unit; stores 0.3L liquid oxygen in vacuum-insulated cryogenic dewar. Vaporizer coil warms oxygen; economizer regulator manages gas/liquid draw based on internal pressure (20 PSI threshold). Electronic conserving device delivers oxygen in pulse doses at onset of inhalation (approx. 15 ml/LPM setting) or continuous flow (2 LPM). Used by ambulatory home patients. Conserving device extends duration compared to continuous flow. Healthcare providers prescribe flow settings (1, 1.5, 2, 3, 4, 5 LPM). Device improves patient mobility by providing portable supplemental oxygen.

Clinical Evidence

Bench testing only. Non-clinical testing compared oxygenation performance of Spirit 300 against Caire Stroller, Puritan-Bennett HELiOS, and DeVilbiss LP05PP. Results indicated Spirit 300 oxygenates similarly to predicates, with higher sensitivity noted compared to the DeVilbiss unit.

Technological Characteristics

Vacuum-insulated cryogenic dewar (0.3L capacity), vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic conserving device. Oxygen delivery: pulse dose (electronic) or continuous flow. Dimensions/weight: smaller than Stroller. Connectivity: none. Power: electronic PCB for conserving device.

Indications for Use

Indicated for ambulatory home healthcare 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

• Caire Stroller (K800742)
• Puritan Bennett HELiOS (K993220)
• DeVilbiss LP05PP (K833994)

Submission Summary (Full Text)

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CAIRE. MVE

# DEC 1 8 2001

K013251

# 510(k) Summary

| Applicant: | CAIRE Inc. |
|-------------------|-------------------------------------------------------|
| Address: | 3505 County Road 42 West<br>Burnsville, MN 55306-3803 |
| Contact: | Roger Briese<br>Bio-Medical Engineering Manage |
| Phone Number: | [phone] |
| Facsimile Number: | [phone] |
| E-Mail Address: | [e-mail] |
| Date: | September 20, 2001 |
| Device Name: | Spirit 300 |
| Device Class: | II |

Classification Panel: Anesthesiology 868.5655 CFR Section: BYJ Product Code:

# Legally Marked Device to Which Substantially Equivalency is Claimed:

Caire Stroller [FDA 510(k) #K800742] Puritan Bennett HELiOS [FDA 510(k) #K993220] DeVilbiss LP05PP [FDA 510(k) #K833994]

#### Description of the Device:

The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 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 longer duration time for the unit, because it allows the gas in the dewar head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos 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 dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

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#### MVE CAIRE.

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# KO 13251

#### Intended Use of the Device:

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

### Technological Characteristics: CAIRE Spirit 300 vs. CAIRE Stroller

The main technical difference between these devices is that the Spirit 300 incorporates an integral electronic conserving device to deliver oxygen doses with patient inhalation, while the Stroller delivers oxygen in a continuous flow. The Spirit 300 is also smaller in both size and weight than the Stroller. However, the dewar design, plumbing style, fill connectors, relief safety valves and vent valves of these devices are either quite similar, if not common. With the method of oxygen delivery being the core technical difference, the non-clinical testing clearly shows that the Spirit 300 oxygenates similarly to the Stroller.

#### Technological Characteristics: CAIRE Spirit 300 vs. Puritan-Bennett HELiOS

The main technical difference between these devices is that the Spirit 300 incorporates an integral electronic conserving device to deliver oxygen doses with patient inhalation, while the HELiOS incorporates a pneumatic conserving device to deliver the oxygen doses. Other than this technical point, the Spirit 300 and HELiOS are quite similar in other technical/physical aspects. Again, the non-clinical testing clearly shows that the Spirit 300 oxygenates similarly (if not significantly better) than HELiOS.

# Technological Characteristics: CAIRE Spirit 300 vs. DeVilbiss #LP05PP

The technical design of the Spirit 300 and the DeVilbiss #LP05PP are quite similar. The physical size of the two devices is different. The Spirit 300 is a 0.34L capacity unit, while the DeVilbiss #LP05PP is a 0.49L capacity unit. Specific to the conserving devices are very similar in technical operation. Again, the non-clinical testing clearly shows that the Spirit 300 oxygenates similarly to the DeVilbiss product. Note the non-clinical testing indicated that the Spirit 300 is more sensitive than this DeVilbiss product. This explains why the Spirit 300 oxygenated a little better at the higher flow settings.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2001

Caire, Inc. c/o Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite #104 New Brighton, MN 55112-1891

Re: K013251 Spirit 300 Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: Class II (two) Product Code: 73 BYJ Dated: December 7, 2001 Received: December 10, 2001

Dear Mr. Job:

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 I ou may ontrols 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. Mark Job

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

N. Dallas Teller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

SPIRIT 300 Device Name:_

Indications For Use:

The CAIRE Spirit 300 will provide a source of supple for ambulatory home healthcare patients by raporizing medical grade liquia axygen and then dispensing it to the patient via an integral electronic conserving anserving dev

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription

(Optional Format 3-10-98)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013251