(209 days)
The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valve-regulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
This document describes the regulatory submission for the Intelli-Ox portable oxygen delivery system, not a study evaluating its performance against acceptance criteria in the context of an AI/human-in-the-loop system. The document focuses on demonstrating substantial equivalence to a predicate device (EZ-OX Plus) for FDA clearance. Therefore, many of the requested categories related to AI/human performance studies and ground truth establishment are not applicable.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it provide reported device performance in that sense. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristics and compliance with recognized industry standards. The key "performance" reported is compliance with these standards.
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Compliance) |
|---|---|---|
| Valve/Regulator Low Flow | Yes (≥ .5L) | Yes (≥ .5L) |
| Flow Between Settings | No | No |
| Cylinder on/off | No | No |
| Filling Port | Active | Active |
| Contents Gauge | Active | Active (Digital) |
| Filters | 3 | 3 |
| Pressure Design (max) | 3,000 psi | 3,000 psi |
| Single stage piston style | Yes | Yes |
| Guard Hand Grip | 1 grip | 1 grip |
| Access Ports | Yes | Yes |
| Flow selector/hose barb/gauge | Aligned | Aligned |
| Color | Green | Green |
| Height (guard + valve-regulator) | 7" | 7" |
| Cylinder Sizes | E | E |
| Weight (E) (product) | 950 gr | 950gr |
| Materials/construction | Aluminum | Aluminum |
| ISO 14971 Compliance | Yes | Yes |
| ISO 13485 Compliance | Yes | Yes |
| IEC 60513 Compliance | Yes | Yes |
| UN Manual of Tests & Criteria | Yes | Yes |
| IP Rating | IP55 | IP55 |
| IEC 61326-2-6-2 Compliance | Yes | Yes |
| ISO 21730 Compliance | Yes | Yes |
| IEC 61000-6-4 Compliance | Yes | Yes |
| IEC 60601-1-2 (various) | Yes | Yes |
| ISO 10651-3 Compliance | Yes | Yes |
| 21 CFR Parts 210/211 Compliance | Yes | Yes |
2. Sample size used for the test set and the data provenance
This is not applicable as the submission is for a medical device (oxygen delivery system) and not an AI algorithm evaluated on a typical "test set" of data. The "test" involved physical and engineering evaluations against standards and comparison to a predicate device. Data provenance (country of origin, retrospective/prospective) is not mentioned for such testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no concept of a "ground truth" established by experts in the context of an image or data interpretation for this device. The evaluation is based on engineering specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted device requiring a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is adherence to validated engineering specifications and recognized industry standards.
8. The sample size for the training set
Not applicable. No training set is involved for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study and Device Clearance:
The provided document (K143060) is an FDA 510(k) premarket notification for the "Intelli-Ox" portable oxygen delivery system. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device, the "EZ-OX Plus" (K053117).
The basis for substantial equivalence is primarily through:
- Comparison of technological characteristics: The Intelli-Ox is described as "very similar" to the EZ-OX Plus, with the main modification being the replacement of an analog gauge with a digital gauge. Both gauges serve informational purposes and do not control flow. The submission details a table (page 5) comparing various parameters (e.g., low flow settings, filters, pressure design, materials, dimensions) and states that the technological characteristics are the same.
- Compliance with recognized voluntary standards: The Intelli-Ox system complies with a list of industry and international standards applicable to medical gas regulators (listed on page 6). These include standards for risk management (ISO 14971), quality management (ISO 13485), electrical safety (IEC 60513, 60601-1-2), electromagnetic compatibility (IEC 61326-2-6-2, ISO 21730, IEC 61000-6-4, ISO 10651-3), and others like the United Nations Manual of tests and Criteria, IP rating, and 21 CFR regulations.
The ultimate conclusion is that "Based upon the performance testing and compliance with voluntary standards, the manufacturer believes that the Intelli-OX portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness."
This document does not describe a clinical trial or performance study against specific, quantified acceptance criteria in the manner one might find for a novel diagnostic or therapeutic device requiring clinical validation or an AI algorithm. Instead, it leverages the regulatory pathway of substantial equivalence based on established predicates and adherence to existing safety and performance standards for a well-understood type of medical device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
Air Liquide Healthcare Ms. Angie Beyer Compliance Specialist 2700 Post Oak Blvd., Suite 325 Houston, Texas 77056
Re: K143060
Trade/Device Name: Intelli-Ox Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: ECX Dated: April 20, 2015 Received: April 21, 2015
Dear Ms. Beyer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{1}------------------------------------------------
Page 2 - Ms. Beyer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Intelli-Ox
Indications For Use:
The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
Prescription Use _X AND/OR Over-The-Counter Use ________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Air Liquide. The logo consists of a teal square with a stylized "AL" inside, followed by the words "AIR LIQUIDE" in red. The logo is enclosed in a light blue rectangle.
510 (k) Summary Intelli-Ox Portable Oxygen System 510(k) Number: _K143060
Traditional 510(K): Premarket Notification: Intelli-Ox Portable Oxygen System
APPLICANT'S/SUBMITTER'S INFORMATION 1.
Air Liquide Healthcare America Corporation 12800 West Little York Road Houston, TX 77041
| Direct Phone: | 800-624-8000 |
|---|---|
| Internet: | www.us.airliquide.com |
| Establishment Registration No: | 3003764448 |
| Contact: | Angie Beyer |
| Contact's Phone: | 713-624-8268 |
| Contact's Fax: | 713-803-1246 |
2. DATE
May 12, 2015
DEVICE INFORMATION 3.
Trade/Proprietary Name: Intelli-Ox
| Common Name: | Portable Oxygen Delivery System |
|---|---|
| Device Name: | Cylinder, Compressed Gas, and Integrated Valve-Regulator |
| Classification Panel: | Anesthesiology |
| Classification Number: | Unclassified |
| Product Nomenclature: | Cylinder, Compressed Gas, and Integrated Valve-Regulator |
| Product Code(s): | ECX |
| Prior Submission : | No prior submission for the subject device. |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a blue square with a white lambda symbol inside, followed by the words "AIR LIQUIDE" in red, sans-serif font. The logo is enclosed in a light blue box.
DEVICE CLASSIFICATION 4.
Empty Compressed gas cylinders and compressed gas cylinder with valve assemblies are unclassified devices under product code ECX and reviewed by the Anesthesiology Branch, Division of Anesthesiology and Respiratory, General Hospital, Infection Control, and Dental Devices.
Individually, gas cylinder pressure regulators and gas pressure gauges are Class 1 devices and exempted from pre-market notification, but are part of the above mentioned assembly.
5. PREDICATE DEVICE(s)
The predicate device for the Intelli-Ox is the EZ-OX Plus, which was cleared under 510(k) K053117.
DEVICE DESCRIPTION 6.
The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valveregulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a blue square with a white lambda symbol inside, followed by the words "AIR LIQUIDE" in red. The logo is surrounded by a thin blue border.
7. INDICATIONS FOR USE
The intended use for the modified device, as described in its labeling, has not changed as a result of the modification.
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
COMPARISON WITH PREDICATE DEVICE 8.
Very similar to the original EZ-OX Plus, the newly designed Intelli-Ox has been modified by replacing the analog gauge with a digital gauge. The gauge in both devices does not control the administration of flow, but rather is for information purposes. Both the Indications for Use and the Fundamental scientific technology of the proposed device are unchanged from the legally marketed device (predicate). A summary comparison of technological characteristics, including design and materials is provided in the table below:
| Parameter | EZ-OX Plus | Intelli-Ox |
|---|---|---|
| Valve/Regulator | ||
| Low Flow Settings | Yes (≥ .5L) | Yes (≥ .5L) |
| Flow Between Settings | No | No |
| Cylinder on/off | No | No |
| Filling Port | Active | Active |
| Contents Gauge | Active | Active |
| Filters | 3 | 3 |
| Pressure Design | 3,000 psi (max) | 3,000 psi (max) |
| Single stage piston style | Yes | Yes |
| Guard | ||
| Hand Grip | 1 grip | 1 grip |
| Access Ports | Yes | Yes |
| Flow selector/ hose barb/ | Yes | Yes |
| gauge aligned | ||
| Color | Green | Green |
| Height (guard and | 7" | 7" |
| integrated valve-regulator) | ||
| Cylinder | ||
| Cylinder Sizes | E | E |
| Weight (E) (product) | 950 gr | 950gr |
| Materials/construction | Aluminum | Aluminum |
The technological characteristics of the EZ-OX Plus (predicate device) and the Intelli-Ox (modified device) are the same.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the logo for Air Liquide. The logo consists of a blue square with a white lambda symbol inside, followed by the words "AIR LIQUIDE" in red, uppercase letters. The logo is enclosed in a thin blue rectangle.
SUMMARY OF NON-CLINICAL TESTING AS BASIS FOR 9. SUBSTANTIAL EQUIVALENCE
The Intelli-Ox system complies with the following industry and international standards that are applicable to medical gas regulators:
- · ISO 14971: Medical Device Risk Management
- · ISO 13485: Medical Device Quality Management System
- · IEC 60513 ed. 2.0 (1994-01): Fundamental Aspects of Safety Standards for Medical Electrical Equipment
- · United Nations Manual of tests and Criteria, 4th Edition revised with Amendment 2, Part III, Classification Procedures, Test Methods, and Criteria Relating to Class 3, Class 4 Division 5.1 and Class 9, Section 38.3, Lithium Batteries
- · International Protection Rating (IP) of IP55
- · IEC 61326-2-6-2 2nd Ed. 2012, EMC requirements, Medical Equipment
- · ISO 21730 2nd Ed. 2007, Recommendations for Electromagnetic Compatiblity
- · IEC 61000-6-4 2nd Ed. 2006-07, Electromagnetic Compatibility
- · IEC 60601-1-2 Electrical Equipment Healthcare Application
- · IEC 60601-1-2 Ed. 4.0. Medical Electrical Equipment
- · ISO 10651-3 Electromagnetic Compatibility
- · Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 210 and 211
10. STATEMENT OF SUBSTANTIAL EQUIVALENCE
Based upon the performance testing and compliance with voluntary standards, the manufacturer believes that the Intelli-OX portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness.
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.