The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use with a power supply accessory (off of a mains current - 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.

Device Description

The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use with an AC power supply accessory. The Travelair® uses two molecular sieves to extract oxygen from ambient air; this is similar to most domestic 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 2.6 L/min in the demand mode. The unit has two large wheels, one small caster, and an adjustable handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids. An alarm warns of low oxygen concentration, excessive internal temperature and blocked air inlet filter.

AI/ML Overview

The provided text is a 510(k) summary for the Innosan Travelair® "S" Plus Portable Oxygen Concentrator. It describes the device, its intended use, and its comparison to a predicate device. The core of the submission revolves around demonstrating substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a study with a defined test set, ground truth, or expert review process, as would be typical for a novel device or AI/ML-based system.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present "acceptance criteria" in the traditional sense of measurable performance thresholds for a novel device. Instead, it refers to compliance with existing guidance documents and standards to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met all relevant requirements of the cited tests and guidelines, thus demonstrating substantial equivalence.

Acceptance Criterion (Referenced Standard/Guidance/Requirement)	Reported Device Performance
For Concentrator Unit (Innosan Travelair® "S" Plus Portable Oxygen Concentrator):
FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Electrical, Mechanical & Environmental)	All testing performed. None demonstrated design characteristics that violated requirements or resulted in safety hazards. CITECH concluded the Travelair® sample met all relevant requirements.
IEC-601-1 (1988) - Mechanical Vibration and Shock Resistance	Met all relevant requirements.
IEC-601-1 (1988), Clause 44.6 - Fluid Spill Resistance	Met all relevant requirements.
ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use"	All testing performed. Met all relevant requirements.
DCRND Reviewer's Guideline, November 1993 - Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing	All testing performed. Met all relevant requirements.
For AC Power Supply Accessory:
FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (active operating conditions)	All testing performed. None demonstrated design characteristics that violated requirements or resulted in safety hazards. CITECH concluded the AC Power Supply sample met all relevant requirements.
DCRND Reviewer's Guideline, November 1993 - Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing	All testing performed. Met all relevant requirements.
UL and TÜV Certification	Certified by UL and TÜV.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "the Travelair® sample tested" for the concentrator and "the AC Power Supply sample tested" for the accessory. This implies a small sample size, likely one unit of each, which is common for testing physical medical devices against engineering specifications.

Sample Size: Likely 1 unit for the concentrator, 1 unit for the AC power supply accessory.
Data Provenance: Not explicitly stated, but the testing was conducted by CITECH, an independent testing laboratory. The document is a 510(k) submission from Sim Italia s.r.l. (Italy), but the testing itself seems to be standard regulatory compliance testing, not a clinical data collection from patients or specific regions. It is retrospective in the sense that the testing was completed before the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" here is compliance with engineering standards and regulatory guidance, which is determined by objective measurements and testing protocols, not by expert interpretation of patient data or images. The "experts" would be the engineers and technicians at CITECH performing the tests, qualified in electrical, mechanical, and environmental testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This submission deals with objective engineering compliance testing, where results are typically binary (pass/fail against a specification).

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/ML-based diagnostic or therapeutic aid that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for demonstrating substantial equivalence is compliance with established engineering standards and regulatory guidance documents. This includes:

FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Electrical, Mechanical & Environmental Performance Requirements).
IEC-601-1 (1988) for specific tests like mechanical vibration/shock and fluid spill resistance.
ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use".
DCRND Reviewer's Guideline, November 1993 for electromagnetic compatibility.
UL and TÜV certification requirements for the AC power supply.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" as this is not an AI/ML device.

Summary of the Study:

The "study" or testing performed for this 510(k) submission was a series of non-clinical bench tests conducted by CITECH. These tests evaluated the electrical, mechanical, and environmental performance of the Innosan Travelair® "S" Plus Portable Oxygen Concentrator (and its AC power supply accessory) against recognized industry standards and FDA guidance documents. The purpose was to demonstrate that the expanded capabilities of the "Plus" model (namely, the AC power supply) did not introduce any new safety or effectiveness concerns compared to the predicate device and that the combined system met all relevant safety and performance requirements for oxygen concentrators. The conclusion of these tests was that the device met all relevant requirements and therefore was substantially equivalent to the predicate device.

Summary

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K971947

EXHIBIT #1 OCT - 3 1997 Page 1 of 4

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:_

1. Submitter's Identification:

Ms. Susan Muratori Sim Italia s.r.I. Surgical International Marketing Via S. Donato, 156 40127 Bologna, Italy Tel: (0039) 51/502439-519161-519255 Fax: (0039) 51/504453

Date Summary Prepared: May 23, 1997

2. Name of the Device:

ﺍﻟﻤﺘﺤﺪﺓ

ﻣﺴﺘﻘﺒﺔ

Innosan Travelair® "S" Plus Portable Oxygen Concentrator

Predicate Device Information: 3.

Innosan Travelair® "S" Portable Oxygen Concentrator, Code No. M407001853, K#963042.

4. Device Description:

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air inlet filter.

AC Power Supply Accessory Description:

The Innosan Travelair® "S" Plus Portable Oxygen Concentrator AC Power Supply Accessory, called the "Switching Power Supply for Travelair® "S" Plus Portable Oxygen Concentrator", is manufactured by an OEM vendor and packaged by Sim Italia s.r.l. specifically for the Travelair® Portable Oxygen Concentrator. The power supply has UL and TÜV certification. The code number for the power supply is 032228000. The AC power supply is housed in a plastic enclosure with approximate maximum dimensions of 10.5" x 6.25" x 4.73" high. The input power is supplied via a three-wire power cord connected to an input IEC-type receptacle. The output panel includes an ON-OFF switch and 6.5' input power cable that terminates in a connector intended for the Innosan Travelair® "S" Plus Portable Oxygen Concentrator. The input power requirements are 110/240 VAC, 50/60 Hz.

Intended Use: 5.

ﻟﻌﻘﺎﺑﺔ

ﻣﺘﻌﺪﻫﻪ

6. Comparison to Predicate Devices:

The Innosan Travelair® "S" Plus Portable Oxygen Concentrator, Code No. M407001853, is identical to our original 510(k) cleared device, K#963042, except for the addition of an AC power supply accessory.

The only difference between the Travelair® "S" device and the Travelair® "S" Plus device is that, in addition to the use of an automobile battery, it can now be line-powered with a standard power supply functioning off of a mains current (110 VAC 60 Hz/220 VAC/50 Hz).

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EXHIBIT #1 Page 3 of 4

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Innosan Travelair® "S" Plus Portable Oxygen Concentrator with an AC Power Supply Accessory in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

The following testing was conducted by CITECH:

Input Voltage Variation a.
Overcurrent Protection b.
C. Controls Protection
Connector Protective Incompatibility d.
Mechanical Safety e.

ﺮ ﺍﻟﻤﺴﺎ

Mechanical Vibration and Shock Resistance (IEC-601-1 (1988) f.
Fluid Spill Resistance (IEC-601-1, Clause 44.6) g.
Extreme Operating and Storage Temperature/Humidity h.
Surface Temperatures ..

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was CITECH's conclusion that the Travelair® sample tested met all relevant requirements of the aforementioned test.

In addition, the following testing was conducted by CITECH:

Radiated and Conducted Electromagnetic Energy and Magnetic Field a. Testing on the Travelair® device. Testing was conducted per the DCRND Reviewer's Guideline, November 1993.
b. Testing was also conducted per ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use".

Regarding the AC Power Supply:

The AC Power Supply Accessory for the Innosan Travelair® "S" Plus Portable Oxygen Concentrator was tested for compliance to electrical safety and environmental criteria when connected to a Travelair® Portable Oxygen

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EXHIBIT #1 Page 4 of 4

Concentrator to simulate active operating conditions in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. The following testing was conducted by CITECH:

Overcurrent protection a.
Electrical leakage current b.
Mechanical shock resistance C.
Extreme storage and operating environments d.
Sinusoidal vibration e.
Surface temperatures f.
Spill resistance . g.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was CITECH's conclusions that the AC Power Supply sample tested met all relevant requirements of the aforementioned test.

In addition, the following testing was conducted by CITECH:

Radiated and Conducted Electromagnetic Energy and Magnetic Field a. Testing on the AC Power Supply. Testing was conducted per the DCRND Reviewer's Guideline, November 1993.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

Status

We have demonstrated that the Innosan Travelair® "S" Plus Portable Oxygen Concentrator with an AC Power Supply Accessory is identical to the predicate device presently on the market, with the addition of an AC Power Supply, based on electrical, mechanical and environmental results as well as ASTM F1464-93, "Standard Specification For Domiciliary Use". We also adhered to FDA's Reviewer Guidance for Oxygen Concentrators (1991).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Ms. Susan D. Goldstein-Falk SIM Italia s.r.l. c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

K971947 Re: Innosan Travelair "S" Plus Requlatory Class: II (two) 73 CAW Product Code: Dated: September 11, 1997 Received: September 15, 1997

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan D. Goldstein-Falk

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT B Page 1 of of 1 1

510(k) Number (if known):

Device Name: Innosan Travelair(R) "S" Plus Portable Oxygen Concentrator, Code No. M407001853 (with AC Power Supply Accessory) Indications For Use:

The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use with a power supply accessory (off of a mains current - 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	__________________________

Prescription Use	✓
(Per 21 CFR 801.109)

	Over-The-Counter Use__________
	(Optional Format 1-2-96)

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).