(178 days)
No
The summary describes a mechanical oxygen delivery system with no mention of AI or ML capabilities.
Yes.
The device's intended use is to provide "supplemental oxygen... to neonates, pediatrics, and adults," which is a therapeutic intervention.
No
Explanation: The Medipure Oxygen-LC System is described as an "integrated delivery system" intended to "provide supplemental oxygen." Its function is to deliver oxygen, not to identify, monitor, or analyze a medical condition or disease.
No
The device description explicitly states it is comprised of a physical valve, regulator, and steel cylinder, which are hardware components.
Based on the provided information, the Medipure Oxygen-LC System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen...to neonates, pediatrics, and adults." This is a therapeutic intervention, delivering a substance to the patient's body.
- Device Description: The device is described as an "integrated medical gas delivery system" comprised of a valve, regulator, and cylinder. This is consistent with a device used for delivering a gas for medical treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Medipure Oxygen-LC System does not involve any such activities.
Therefore, the Medipure Oxygen-LC System is a medical device used for delivering oxygen directly to a patient, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
Product codes
ECX
Device Description
The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).
The Cavagna MVA2 series VIPR is currently used on the Grab 'n Go Plus predicate device. It is compliant with CGA E-18. The plastic shroud is a new design and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3).
The modified design of the Medipure Oxygen-LC System is intended to satisfy customers with high oxygen demands who may not have access to a medical pipeline. The all-in-one concept of the VIPR (used in both the modified and unmodified predicate devices) provides ease of use and convenience over the traditional setup of separate regulator and flow meter.
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
neonates, pediatrics, and adults.
Intended User / Care Setting
Not Found
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
Internal verification and validation testing confirms that product specifications of the Medipure Oxygen-LC System are met. These are equivalent to those of the predicate device. The testing results support that the device's design changes do not affect the safe and effective use of the device as compared to the unmodified predicate device. Verification testing of the Medipure Oxygen-LC System, in accordance with design controls, demonstrated the device meets the specifications for its intended use. Verification testing was performed as follows:
- ISO 11117:2008 Gas cylinders Valve protection caps and valve guards-Design, construction and tests
- ISO 10524-3, Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves
- 49 CFR §173.301(h)(3) DOT Cylinder valve protection
- Total Suspended Particulate, Odor and Oxygen Analysis
The device passed all testing and is determined to be substantially equivalent to the unmodified Grab 'n Go Plus device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Praxair Distribution, Incorporated % Ms. Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 816 Congress Avenue Suite 1400 Austin, TX 78701
Re: K153518
Trade/Device Name: Medipure Oxygen-LC System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: ECX Dated: May 5, 2016 Received: May 5, 2016
Dear Ms. Swearingen:
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
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.
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,
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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
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Indications for Use
510(k) Number (if known) K153518
Device Name Medipure Oxygen-LC System
Indications for Use (Describe)
The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
| 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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Section 5 – 510(k) Summary (Special 510(k))
Medipure Oxygen-LC System
K
1. Submission Sponsor
Praxair Distribution, Incorporated 175 East Park Drive Tonawanda, New York 14150 U.S.A. Phone number: (330) 949-3324 Contact: Mr. Mike Skrjanc Title: Director FDA Compliance and Project Safety
2. Submission Correspondent
Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (512) 818.3811 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com
3. Date Prepared
May 5, 2016
4. Device Identification
| Trade/Proprietary Name: | Medipure Oxygen-LC System |
|---|---|
| Common/Usual Name: | Medical Gas Delivery System |
| Classification Name: | N/A - Unclassified |
| Regulation Number: | N/A - Unclassified |
| Product Code: | ECX - Cylinder, compressed gas, and valve |
| Device Class: | Unclassified (pre-amendment) |
| Classification Panel: | Anesthesiology |
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5. Legally Marketed Predicate Device
K132778, Grab 'n Go Plus, Praxair Healthcare Services.
6. Device Description
The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).
The Cavagna MVA2 series VIPR is currently used on the Grab 'n Go Plus predicate device. It is compliant with CGA E-18. The plastic shroud is a new design and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3).
The modified design of the Medipure Oxygen-LC System is intended to satisfy customers with high oxygen demands who may not have access to a medical pipeline. The all-in-one concept of the VIPR (used in both the modified and unmodified predicate devices) provides ease of use and convenience over the traditional setup of separate regulator and flow meter.
7. Indications for Use Statement
The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
8. Substantial Equivalence Discussion
The following table compares the Medipure Oxygen-LC System to the unmodified predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence, and supports that the subject device, as modified, does not raise any new issues of safety or effectiveness than the predicate device.
| Manufacturer | Praxair Distribution, Inc.
(previously Praxair
Healthcare Services) | Praxair Healthcare
Services | Significant Differences |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Medipure Oxygen-LC
System | Grab 'n Go Plus System | |
| 510(k) Number | - | K132778 | N/A |
| Product Code | ECX | ECX | Same |
| Regulation Number | unclassified | unclassified | Same |
| Intended Use | Medical gas providing
supplemental oxygen, by
Rx only, to neonates, | Medical gas providing
supplemental oxygen,
by Rx only, to neonates, | Same |
| | pediatrics, and adults. | pediatrics, and adults. | |
| Indications for Use | The Medipure Oxygen-LC
System is an integrated
delivery system intended to
provide supplemental
oxygen, by Rx only, to
neonates, pediatrics, and
adults. The device is
intended for limited
duration use, such as would
be necessary during patient
transport. | The Grab 'n Go Plus
System is an integrated
delivery system intended
to provide supplemental
oxygen, by Rx only, to
neonates, pediatrics, and
adults. The device is MR
Conditional, and suitable
for use during MR
imaging for MRI systems
up to 3.0 Tesla.
The device is intended for
limited duration use, such
as would be necessary
during patient transport. | Similar. The unsuitability
of the Medipure Oxygen-
LC steel cylinder for use
in an MRI environment is
a restriction of the use
environment, but does
not change the intended
use of the device to
provide supplemental
oxygen, by Rx only, to
neonates, pediatrics, and
adults. |
| Medical Gas | Oxygen | Oxygen | Same |
| Low Flow Setting | Yes | Yes | Same |
| Contents Gauge Type | Bourdon Tube | Bourdon Tube | Same |
| Filters | 4 | 4 | Same |
| Service Pressure Max. | 3335 psi | 3335 psi | Same |
| Regulator Style | Single Stage Piston | Single Stage Piston | Same |
| Cylinder Material | High strength Steel | Aluminum | The larger capacity
Medipure Oxygen-LC
cylinders utilize high
strength Cr Mo steel to
accommodate the higher
stresses. The steel
cylinders are industry
standard and commonly
used for medical gases,
thereby raising no new
questions of safety and
effectiveness. |
| Cylinder Sizes | K, T | D, E | Medipure Oxygen-LC has
larger cylinders to
provide a larger oxygen
capacity during use.
Verification testing shows
the larger volume raises
no new questions of
safety and effectiveness. |
| Access Ports | Yes | Yes | Same |
| Flow Selector | Yes | Yes | Same |
Table 5A – Comparison of Characteristics
5
9. Non-Clinical Performance Data
Internal verification and validation testing confirms that product specifications of the Medipure Oxygen-LC System are met. These are equivalent to those of the predicate device. The testing results support that the device's design changes do not affect the safe and effective use of the device as compared to the unmodified predicate device. Verification testing of the Medipure Oxygen-LC System, in accordance
6
with design controls, demonstrated the device meets the specifications for its intended use. Verification testing was performed as follows:
- ISO 11117:2008 Gas cylinders Valve protection caps and valve guards-Design, construction and tests
- ISO 10524-3, Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves
- · 49 CFR §173.301(h)(3) DOT Cylinder valve protection
- Total Suspended Particulate, Odor and Oxygen Analysis
The device passed all testing and is determined to be substantially equivalent to the unmodified Grab 'n Go Plus device.
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics, but can be demonstrated to be substantially equivalent to the predicate device, and does not raise additional questions regarding its safety and effectiveness.
As such, the Medipure Oxygen-LC System, as modified, is determined to be substantially equivalent to the Grab 'n Go Plus predicate device.