(164 days)
Not Found
No
The description details a mechanical and electronic system for oxygen delivery based on pressure and flow settings, with no mention of learning algorithms or data-driven decision making.
Yes
This device provides supplemental oxygen to patients, which is a therapeutic intervention.
No
The device is described as providing supplemental oxygen by vaporizing liquid oxygen and dispensing it to a patient. It is not described as detecting, monitoring, or diagnosing any medical condition.
No
The device description clearly outlines multiple hardware components including a dewar, vaporizer coil, regulators, valves, manifold, and a printed circuit board. While it includes an "electronic printed circuit board conserving device (digital)", this is a hardware component, not solely software.
Based on the provided information, the Caire Spirit 300 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides supplemental oxygen to patients by vaporizing liquid oxygen and dispensing it. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the components and operation of a liquid oxygen delivery system. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Caire Spirit 300 is a medical device used for oxygen therapy, which falls under a different regulatory category than IVDs.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
BYJ
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ambulatory healthcare patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
Suite 316
JUN 1 6 2008
510(K) Summary
Koroo23
Phone: 770.425.4470 Fax: 770.425.4740
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 ali.choudary@chart-ind.com
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
1
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
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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)
z Vhuf
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
K80023