(88 days)
K#933081, K#9555549, K#952650
Not Found
No
The description focuses on physical means of oxygen concentration and standard electrical/mechanical safety testing, with no mention of AI/ML terms or data processing beyond basic alarms.
Yes
The device is described as "intended to provide a patient with supplemental oxygen" and "delivers oxygen to patients by physical means," which explicitly states its therapeutic purpose.
No
The device is an oxygen concentrator, which provides supplemental oxygen to patients. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly outlines physical components like molecular sieves, wheels, a caster, a handle, and a hinged cover. The performance studies also detail testing related to electrical, mechanical, and environmental performance, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to a patient by physical means (molecular sieve bed oxygen concentrator). This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electrical aspects of oxygen concentration and delivery. 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 device is clearly described as a medical device used for treatment (providing oxygen), not for diagnosis.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
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
automobile
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)
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.
Testing information demonstrating safety and effectiveness of the Innosan Travelaire "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:
- Input Voltage Variation
- Overcurrent Protection
- Controls Protection
- Connector Protective Incompatibility
- Mechanical Safety
- Mechanical Vibration and Shock Resistance (IEC-601-1 (1988)
- Fluid Spill Resistance (IEC-601-1, Clause 44.6)
- Extreme Operating and Storage Temperature/Humidity
- 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 Testing on the Travelair® device. Testing was conducted per the DCRND Reviewer's Guideline, November 1993.
- Testing was also conducted per ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use".
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.
K#933081, K#9555549, K#952650
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
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
Image /page/0/Picture/0 description: The image shows a logo with the text "italia s.r.l." in a outlined font. Below the text, there is the phrase "SURGICAL INTERNATIONAL MARKETING" in a smaller, sans-serif font. To the left of the text, there is a graphic element that appears to be a stylized representation of mountains or a waveform.
NOV - 1 1996
EXHIBIT #2 Page 1 of 3
510(K) SUMMARY
This summary of 5/0(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: K9030Y2
Submitter's Identification: 1.
Ms. Susan Muratori Sim Italia s.r.l. Surgical International Marketing Via S. Donato, 156 40127 Bologna, Italy Tel: (0039) 51/502439-519161-519255 Fax: (0039) 51/504453
Date Summary Prepared: July 25, 1996
2. Name of the Device:
Innosan Travelair® "S" Portable Oxygen Concentrator
Predicate Device Information: 3.
- a) OxLife Traveler L3, K#933081; K#9555549
- b) Chad Therapeutics Oxymatic™ Electronic Oxygen Conserver, K#952650
Device Description: 4.
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.J.A.A. 242165 ISCRIZIONE TRIBUNALE BOLOGNA 25741
1
EXHIBIT #2 Page 2 of 3
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.
Companison 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
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are las follows:
Testing information demonstrating safety and effectiveness of the Innosan Travelaire "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:
- Input Voltage Variation a.
Overcurrent Protection 0.
Controls Protection
- Connector Protective Incompatibility d.
- Mechanical Safety a.
C.
2
EXHIBIT #2 Page 3 of 3
- 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.
- j, 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.
- Testing was also conducted per ASTM F1464-93, "Standard b. 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).