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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TravelSome Standard Portable Oxygen Concentrator:

Based on the provided 510(k) summary, the device is an oxygen concentrator, and the submission focuses on its substantial equivalence to predicate devices, rather than establishing de novo performance criteria through new clinical trials.

The document explicitly states: "There are no substantial changes to the technical specifications and current function of the unit. Therefore no clinical tests were deemed necessary." This indicates that the safety and effectiveness are established by demonstrating similarity to already cleared predicate devices, not by meeting specific performance thresholds in new studies.

Therefore, for aspects related to clinical performance, direct acceptance criteria in the traditional sense (e.g., specific sensitivity/specificity thresholds) and studies proving those criteria are not presented in this document. Instead, the "acceptance criteria" are effectively that the device's performance is equivalent to its predicates, as shown through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define specific "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" described is largely about the device's functional characteristics and how they compare to the predicates.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Oxygen Concentration	Performance ("increased flow") should be "to the benefit of the user" and similar to or better than predicate devices. (No specific concentration percentage is provided for predicate or new device).	"nonadjustable flow of approximately 1.2 L/min continuous and approximately 3.0 L/min in the demand mode." The submission notes "only an increased flow due to unit modifications... to the benefit of the user."
Operating Modes	Should include continuous and demand modes, similar to predicate's function.	"two switch-selectable operating modes, continuous and demand"
Alarm Functionality	Must include alarms for critical conditions, similar to or improved over predicate devices.	"An alarm warns of low oxygen concentration, lack of current, excessive internal temperature and blocked air inlet filter." Explicitly mentions "power loss alarm" as an improvement.
Power Supply	Must accommodate specified power inputs and have appropriate certifications.	Incorporated AC power supply (OEM) manufactured with UL and TUV certification. Input power: 110/220 VAC, 50/60 Hz. Intended for use in automobile (battery) or house current (110 VAC, 60 Hz or 220 VAC, 50 Hz).
Portability/Safety	Should meet safety expectations, possibly with improvements over predicate.	"detachable trolley with two wheels and a telescoping handle" (increased portability). "hinged cover" and "soft plastic textile cover" to protect against fluid entry and blows/splashes (increased safety).
General Operation	"Technical specifications and current function... substantially the same" as predicate devices.	"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."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable in the context of clinical testing. For non-clinical bench testing, no specific sample sizes are mentioned. The document states: "Test bench testing is the same as that used on the current predicate device."
Data Provenance: Not applicable for clinical data, as no clinical tests were performed or deemed necessary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No experts were involved in establishing ground truth for clinical performance, as no clinical tests were performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No external adjudication for clinical performance was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an oxygen concentrator, not an AI-powered diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an oxygen concentrator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical efficacy. The "ground truth" for substantial equivalence is based on the previously cleared predicate devices' performance, established through their own regulatory processes (which are not detailed here). For the modified components, the "ground truth" for their performance is derived from bench testing, and their similarity to the predicate, as determined by the manufacturer.

8. The sample size for the training set

Not applicable. No training set for an algorithm was used.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm was used.

Summary

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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:

1. Innosan Travelair® "S" Portable Oxygen Concentrator, Model NO. M 407001853 (with AC Power Supply Accessory), K#971947, Sim Italia S.r.I., Italy.
1. Innosan Travelair® "S" Portable Oxygen Concentrator, K#963042, Sim Italia s.r,l., Italy.

4. Device Description:

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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)
1. Sieve bed material.
1. Alarm
Electronic pressure sensor 4)
1. "Demand" flow of 3 lpm.
1. Trolley and handle.
1. Cover

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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.

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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.

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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

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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:

Regulation Number and Section

§ 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).