INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853

K963042 · Sim Italia S.R.L. · CAW · Nov 1, 1996 · Anesthesiology

Device Facts

• Record ID: K963042
• Device Name: INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
• Applicant: Sim Italia S.R.L.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innosan Travelair® "S" Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery, 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 Story

Mobile oxygen concentrator; extracts oxygen from ambient air via two molecular sieves; powered by automobile battery. Provides continuous (approx. 1.2 L/min) and demand (approx. 2.6 L/min) flow modes. Demand mode utilizes a valve to deliver oxygen only during patient inhalation. Features include maneuverability via wheels/handle, fluid-resistant cover, and alarms for low oxygen, high temperature, blocked filter, and power loss. Operated by patient in an automobile. Output is supplemental oxygen; assists in respiratory support. Benefits include portability and oxygen conservation during delivery.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including electrical, mechanical, and environmental performance, electromagnetic compatibility, and adherence to ASTM F1464-93.

Technological Characteristics

Molecular sieve bed oxygen concentrator; automobile battery powered (not line-powered). Features demand valve for oxygen conservation. Dimensions include wheels and adjustable handle. Fluid-resistant design. Tested per IEC-601-1 (1988) for mechanical safety, vibration, shock, and fluid spill resistance. Tested per ASTM F1464-93 for domiciliary oxygen concentrators.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy, specifically designed for use in an automobile environment.

Regulatory Classification

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).

Predicate Devices

• OxLife Traveler L3 (K933081, K955549)
• Chad Therapeutics Oxymatic™ Electronic Oxygen Conserver (K952650)

Submission Summary (Full Text)

{0}

Italia s.r.l.
SURGICAL INTERNATIONAL MARKETING
K963042

NOV - 1 1996

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## 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: K963042

1. **Submitter’s Identification:**

Ms. Susan Muratori
Sim Italia s.r.l.
Surgical International Marketing
Via S. Donato, 156
40127 Bologna, Italy
Tel: [phone]
Fax: [phone]

Date Summary Prepared: July 25, 1996

2. **Name of the Device:**

Innosan Travelair® "S" Portable Oxygen Concentrator

3. **Predicate Device Information:**

a) OxLife Traveler L3, K#933081; K#955549
b) Chad Therapeutics Oxymatic™ Electronic Oxygen Conserver, K#952650

4. **Device Description:**

The Travelair® is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile’s battery. 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, blocked air inlet filter, and loss of power.

40127 BOLOGNA - ITALIA VIA S DONATO 156 TEL. 051 / 50 24 39 - 50 44 53 - 51 92 55 - 51 91 61 - FAX (G3) 051 / 50 44 53 COD. FISC./PART. IVA 01228210371
C.C.I.A.A. 242165 ISCRIZIONE TRIBUNALE BOLOGNA 25741
Banca Commerciale Italiana - Sede di Bologna - Via Rizzoli, 5 • Credito Italiano - Ag. 3 - Via Ferrarese, 12 • Cassa di Risparmio di Bologna - Sede - Via Farini, 22
Cassa di Risparmio di Modena - Filiale Bologna B - Via Dagnini, 48/D • Banca Popolare di Milano - Sede di Bologna - Via Carbonesi, 11
® TRADE MARK

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10-28-1996 03:32PM FROM mdl CONSULTANTS
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5. Intended Use:

The Innosan Travelair® "S" Portable Oxygen Concentrator is a mobile oxygen
concentrator for use in an automobile, with power from the automobile's
battery, 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.

6. Comparison to Predicate Devices:

The Travelair® does not employ rechargeable batteries; only an automobile
battery. It is not line-powered. The Travelair® is an oxygen concentrator which
is mechanically similar to the predicate devices, with the addition of the demand
valve which allows oxygen to flow only when the patient breathes. This
conserving feature is similar to the CHAD Oxymatic device.

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

Testing information demonstrating safety and effectiveness of the Innosan
Travelair® "S" Portable Oxygen Concentrator 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:

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

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

a. Radiated and Conducted Electromagnetic Energy and Magnetic Field 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".

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

We have demonstrated that the Innosan Travelair® "S" Portable Oxygen Concentrator is as safe and effective as predicate devices presently on the market, 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).