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 Description

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the CAIRE Spirit 300, a portable liquid oxygen unit. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined.

The document primarily focuses on establishing substantial equivalence to predicate devices (CAIRE Stroller, Puritan Bennett HELiOS, DeVilbiss LP05PP) based on technological characteristics and non-clinical testing. It states that the Spirit 300 "oxygenates similarly" to the predicate devices.

Therefore, I cannot provide the requested information in the format because the data is not present in the provided text.

Here's why and what information is available:

Acceptance Criteria and Reported Device Performance: This information is typically found in performance testing reports, which are not included here. The document only generically states "non-clinical testing clearly shows that the Spirit 300 oxygenates similarly" to predicate devices. It notes slight differences, such as the Spirit 300 being "more sensitive" and oxygenating "a little better at the higher flow settings" than the DeVilbiss product.
Sample Size (test set) and Data Provenance: Not specified. "Non-clinical testing" is mentioned, but no details on the number or type of tests, or the origin of any data, are provided.
Number of Experts and Qualifications: Not specified. This typically relates to ground truth establishment for diagnostic or interpretive devices, which the Spirit 300 is not.
Adjudication Method: Not applicable or specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. The Spirit 300 is an oxygen delivery device.
Standalone (algorithm only) performance: Not applicable. This device is not an algorithm, but a physical medical device.
Type of ground truth used: Not applicable in the context of diagnostic performance. For a device like this, performance would be measured against engineering specifications (e.g., oxygen flow rate, concentration, duration).
Sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

Description of the Device: The Spirit 300 is a small, lightweight liquid oxygen portable unit with a vacuum-insulated cryogenic dewar, vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic printed circuit board conserving device, and protective case. It has a 0.3-liter liquid oxygen capacity.
Intended Use: Provides supplemental oxygen for ambulatory home healthcare patients by vaporizing medical grade liquid oxygen and dispensing it via an integral electronic conserving device. It is not a life-sustaining or life-supporting device.
Technological Characteristics vs. Predicate Devices:
- CAIRE Stroller: Spirit 300 has an integral electronic conserving device (delivers doses with patient inhalation) vs. Stroller's continuous flow. Spirit 300 is smaller/lighter. Dewar design, plumbing, fill connectors, relief valves, and vent valves are similar. Non-clinical testing showed similar oxygenation.
- Puritan-Bennett HELiOS: Spirit 300 has an integral electronic conserving device vs. HELiOS's pneumatic conserving device. Otherwise, similar. Non-clinical testing showed similar (or significantly better) oxygenation.
- DeVilbiss #LP05PP: Similar technical operation of conserving devices. Spirit 300 is 0.34L capacity vs. DeVilbiss 0.49L. Non-clinical testing showed similar oxygenation, with Spirit 300 being more sensitive and oxygenating "a little better at the higher flow settings."

Summary

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CAIRE. MVE

DEC 1 8 2001

K013251

510(k) Summary

Applicant:	CAIRE Inc.
Address:	3505 County Road 42 WestBurnsville, MN 55306-3803
Contact:	Roger BrieseBio-Medical Engineering Manage
Phone Number:	(952) 882-5071
Facsimile Number:	(952) 882-5175
E-Mail Address:	roger.briese@chart-ind.com
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:

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MVE CAIRE.

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KO 13251

Intended Use of the 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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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle, there is a symbol consisting of three stylized, overlapping shapes that resemble birds in flight or abstract human figures.

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription

(Optional Format 3-10-98)

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

Regulation Number and Section

§ 868.5655 Portable liquid oxygen unit.

(a)
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.(b)
Classification. Class II (performance standards).