(352 days)
Not Found
No
The description focuses on mechanical components and user-selectable flow settings, with no mention of AI or ML capabilities.
Yes
The device is intended to provide supplemental oxygen to adults for medical applications, including oxygen deficiency and resuscitation, which constitutes a therapeutic use.
No
The device is a portable oxygen delivery system used for providing supplemental oxygen. It does not diagnose medical conditions.
No
The device description explicitly details hardware components such as an integrated valve-regulator, flow meter, medical aluminum cylinder, handle, and shroud. It is a physical oxygen delivery system, not a software-only device.
Based on the provided text, the Intelli-OX device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to adults." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering oxygen, including a valve-regulator, flow meter, and oxygen cylinder. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information.
The device is clearly described as a system for delivering oxygen directly to a patient.
N/A
Intended Use / Indications for Use
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
Product codes (comma separated list FDA assigned to the subject device)
ECX
Device Description
The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical 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 standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. 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 content gauge, indexed flow meter, and integrated valveregulator. 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. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
properly trained personnel / during MR imaging
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)
MRI performance testing was completed and documentation was provided to FDA in support of the substantial equivalence determination.
The Intelli-Ox systems are MR Conditional and comply with:
- ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- ISO TIR 10974, 2012, Clause 21, "Assessment of the Safety Magnetic ● Resonance Imaging for Patients with an Active Implantable Medical Device"
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2017
Air Liquide Healthcare America Corporation Steve Miller Director, Quality and Regulatory Affairs 12800 West Little York Road Houston, Texas 77041-2280
Re: K161179
Trade/Device Name: Intelli-OX Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: Class I Product Code: ECX Dated: February 13, 2017 Received: February 21, 2017
Dear Steve Miller:
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K161179
Device Name Intelli-OX
Indications for Use (Describe)
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a teal square with a stylized white "A" inside. To the right of the square is the company name "AIR LIQUIDE" in red, with a thin blue line above and below the text. The logo is simple and modern, with a focus on the company's name and a clean design.
510 (k) Summary Intelli-Ox 510(k) Number:
The following summary is provided in accordance with 21 CFR 807.92:
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: | Steven Miller |
| Contact's Phone: | 713-896-2280 |
| Contact's Fax: | 713-803-7427 |
-
- DATE April 20, 2016
3. DEVICE INFORMATION
Trade/Proprietary Name: Intelli-Ox (E cylinders)
| Common Name: | Portable Oxygen Delivery System |
|---|---|
| Device Name: | Cylinder, Compressed Gas, and Integrated Valve- |
| Regulator | |
| Classification Panel: | Anesthesiology |
| Classification Number: | Class 1 |
| Regulation: | 868.2700 |
| Product Code(s): | ECX |
Prior Submission: No prior submission for the subject device
4
AIR LIQUIDE
DEVICE CLASSIFICATION
Empty Compressed gas cylinders and compressed gas cylinder with valve assemblies are under product code ECX and reviewed by the Anesthesiology Devices Branch, Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices.
5. PREDICATE DEVICE(S)
The following device is the legally marketed device to which equivalence is being claimed:
- Intelli-Ox, K143060, Air Liquide Healthcare
DEVICE DESCRIPTION 6.
The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical 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 standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. 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 content gauge, indexed flow meter, and integrated valveregulator. 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. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
7. INDICATIONS FOR USE
The intended use for the proposed device, as described in its labeling, will include a statement that the device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. 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.
5
Image /page/5/Picture/0 description: The image shows the logo for Air Liquide. The logo consists of a blue square with a stylized "AL" in white, followed by the words "AIR LIQUIDE" in red. There are thin blue lines above and below the text.
8. COMPARISION WITH PREDICATE DEVICE
The Intelli-OX with MR Conditional Indication is the same unit as the predicate device. The fundamental scientific technology of the proposed device is unchanged from the legally marketed predicate devices. The Intelli-OX with MR Conditional Indication adds a new indication for use. The new indication for use reflects the device being MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device labeling for the Intelli-OX with MR Conditional Indication has been revised to reflect the additional indication for use. The change to the indications for use and device labeling does not raise any new questions of safety and effectiveness.
9. TESTING DATA
MRI performance testing was completed and documentation was provided to FDA in support of the substantial equivalence determination.
10. SUMMARY OF NON-CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The Intelli-Ox systems are MR Conditional and comply with:
- ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- ISO TIR 10974, 2012, Clause 21, "Assessment of the Safety Magnetic ● Resonance Imaging for Patients with an Active Implantable Medical Device"
STATEMENT OF SUBSTANTIAL EQUIVALENCE 11.
Based upon the MRI performance testing that is documented in this submission, the manufacturer believes that the proposed Intelli-Ox device is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness.