Intelli-Ox
Device Facts
| Record ID | K161179 |
|---|---|
| Device Name | Intelli-Ox |
| Applicant | Air Liquide Healthcare America Corporation |
| Product Code | ECX · Anesthesiology |
| Decision Date | Apr 13, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2700 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
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 emergency use only. For all other medical applications, the device is Rx only.
Device Story
Intelli-OX is a portable oxygen delivery system supplying USP oxygen; consists of integrated valve-regulator, flow meter, medical aluminum cylinder, handle, and protective shroud. Device provides user-selectable flow rates via indexed flow meter; includes DISS-1240 connection for high-flow delivery. Used in clinical settings by medical personnel to provide oxygen therapy; MR Conditional design allows use during MRI procedures up to 3.0 Tesla. Integrated unit eliminates need to mount separate regulators, facilitating faster patient care. Benefits include portability and compatibility with MRI environments.
Clinical Evidence
Bench testing only. MRI performance testing conducted per ASTM F2052-15 and ISO TIR 10974 (2012) to validate MR Conditional status.
Technological Characteristics
Integrated valve-regulator, flow meter, and medical aluminum cylinder. Features include hose barb connection, protective shroud, carrying handle, and content gauge. MR Conditional up to 3.0 Tesla. Complies with ASTM F2052-15 and ISO TIR 10974.
Indications for Use
Indicated for adults requiring supplemental oxygen; suitable for use during MR imaging up to 3.0 Tesla; emergency use for oxygen deficiency and resuscitation by trained personnel; Rx only for other medical applications.
Regulatory Classification
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.
Predicate Devices
- Intelli-Ox (K143060)
Submission Summary (Full Text)
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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.
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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
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## 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)
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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 |
- 2. 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-<br>Regulator |
| Classification Panel: | Anesthesiology |
| Classification Number: | Class 1 |
| Regulation: | 868.2700 |
| Product Code(s): | ECX |
Prior Submission: No prior submission for the subject device
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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.
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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.
