(92 days)
K#971947, K#963042
Not Found
No
The device description and performance studies focus on standard oxygen concentration technology and electrical/mechanical components, with no mention of AI or ML.
Yes
The device is intended to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic intervention.
No
Explanation: The device is an oxygen concentrator intended to provide supplemental oxygen, not to diagnose medical conditions. Its function is therapeutic, not diagnostic.
No
The device description clearly details physical hardware components such as molecular sieves, a power supply, a trolley with wheels, and a protective cover, indicating it is a hardware device with potentially embedded software for control and alarms.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car." This describes a therapeutic device that delivers a substance (oxygen) to the patient's body.
- Device Description: The description details how the device extracts oxygen from ambient air and delivers it to the patient. It focuses on the mechanical and electrical aspects of oxygen delivery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body) by delivering oxygen directly to the patient.
N/A
Intended Use / Indications for Use
The TravelSome Standard Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use from house current through the unit's incorporated power supply (110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.
The TravelSome Standard Portable Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car.
Product codes
CAW
Device Description
The TraveSome® Standard Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use off standard house current through the unit's incorporated power supply. The TravelSome uses two molecular sieves to extract oxygen from ambient air, which is similar to most 510(k) cleared oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 3.0 L/min in the demand mode. The unit has a detachable trollev with two wheels and a telescoping handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst blows and splashes. An alarm warns of low oxygen concentration, lack of current, excessive internal temperature and blocked air inlet filter. The incorporated AC power supply, called the "Switching Power Supply for TravelSome Standard Portable Oxygen Concentrator", is manufactured by an OEM vendor and incorporated into the TravelSome Standard unit by Sim Italia S.r.l., the manufacturer of the TravelSome Standard unit. The power has UL and TUV certification. The code number for the power supply is PM 200. The input power requirements are 110/220 VAC, 50/60 Hz.
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
Home, during travel by car
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)
Non-Clinical Tests: Test bench testing was performed, stated to be the same as that used on the current predicate device.
Clinical Tests: None were deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#971947, K#963042
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Attachment #15
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: Ko 30233.
1. Submitter's Identification:
Sim Italia S.r.l. Via Gramsci. 9 40018 S. Pietro in Casale (B0) ltalv
Date Summary Prepared:
January 21, 2003
2. Name of the Device:
TravelSome Standard Portable Oxygen Concentrator
3. Predicate Device Information:
-
- Innosan Travelair® "S" Portable Oxygen Concentrator, Model NO. M 407001853 (with AC Power Supply Accessory), K#971947, Sim Italia S.r.I., Italy.
-
- Innosan Travelair® "S" Portable Oxygen Concentrator, K#963042, Sim Italia s.r,l., Italy.
4. Device Description:
The TraveSome® Standard Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use off standard house current through the unit's incorporated power supply. The TravelSome uses two molecular sieves to extract oxygen from ambient air, which is similar to most 510(k) cleared oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 3.0 L/min in the demand mode. The unit has a detachable trollev with two wheels and a telescoping handle to provide maneuverability. It has a
1
hinged cover across the top panel to protect against the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst the entry of fluids, and a soft plastic textile cover which further protects the unit aqainst blows and splashes. An alarm warns of low oxygen concentration, lack of current, excessive internal temperature and blocked air inlet filter. The incorporated AC power supply, called the "Switching Power Supply for TravelSome Standard Portable Oxygen Concentrator", is manufactured by an OEM vendor and incorporated into the TravelSome Standard unit by Sim Italia S.r.l., the manufacturer of the TravelSome Standard unit. The power has UL and TUV certification. The code number for the power supply is PM 200. The input power requirements are 110/220 VAC, 50/60 Hz.
5. Intended Use:
The TravelSome Standard Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use from house current through the unit's incorporated power supply (110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.
Indications For Use:
The TravelSome Standard Portable Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car.
6. Comparison to Predicate Devices:
In comparison to our previous 510(k) cleared devices, the modifications are as follows:
- Internal power supply. 1)
-
- Sieve bed material.
-
- Alarm
- Electronic pressure sensor 4)
-
- "Demand" flow of 3 lpm.
-
- Trolley and handle.
-
- Cover
2
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
There are no substantial changes to the unit other than those indicated in the enclosed information.
Test bench testing is the same as that used on the current predicate device.
8. Discussion of Clinical Tests Performed:
There are no substantial changes to the technical specifications and current function of the unit. Therefore no clinical tests were deemed necessary.
9. Conclusions:
The unit is substantially the same as the predicate device, with only an increased flow due to unit modifications as herein described, to the benefit of the user; power loss alarm, and increased portability/safety with the new trolley and insulated cover.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2003
Sim Italia s.r.1. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck. New York 11021
Re: K030233
Trade/Device Name: TravelSome Standard Portable Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: March 31, 2003 Received: April 2, 2003
Dear Ms. Goldstein-Falk:
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.
4
Page 2 - Ms. Goldstein-Falk
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 (OS) 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 vour device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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-firee number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patura Ciacciatte/fox
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment #14
Page ___ 1 of 1
510(k) Number (if known): _ Ko30233
Device Name TravelSome Standard Portable Oxygen Concentrator
Indications For Use:
The TravelSome Standard Portable Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home, or during travel by car.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use only
Pitman Clements
General Hospital.
510(k) Number: