(274 days)
Not Found
No
The description focuses on the mechanical and performance characteristics of a gas blender, with no mention of AI or ML terms or functionalities.
Yes
The device is designed to dispense a continuous blend of medical air and oxygen to patients, which is a therapeutic intervention for respiratory support.
No
Explanation: The device is described as a "Medical Air/Oxygen Blender" designed to "dispense a continuous blend of Medical Air and Oxygen." Its function is to provide a mixture of gases, not to diagnose a condition or disease.
No
The device description clearly states it is a "Medical Air/Oxygen Blender" and describes physical components and testing against hardware standards like ISO 11195 and IEC 60601-1, indicating it is a hardware 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 "dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients." This describes a device that delivers gases directly to a patient for therapeutic purposes.
- Device Description: The description reinforces this by stating it's a "restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required." This again points to a device used in a clinical setting for patient treatment.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with patient specimens in this way.
The device is clearly a therapeutic medical device used for delivering respiratory support, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
Product codes
BZR
Device Description
The GMX Series Medical Air/Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. The GMX Series Medical Air/Oxygen blender includes two models: GMX30U-AIR/O2, GMX120U-AIR/O2. The GMX Series Medical Air/Oxygen blender is designed, tested, and will be manufactured in accordance with the following standard: ISO 11195 Gas mixers for medical use - Stand-alone gas mixers 1995.
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
infant, pediatric, and adult patients.
Intended User / Care Setting
qualified and trained personnel under the direction of a physician in institutional environments
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)
Summary of Non-Clinical Tests: The Medical Air/Oxygen Blender complies with voluntary standards: -ISO 11195 Gas mixers for medical use – Stand-alone gas mixers 1995; -USP :2012—Particulate Matter in Injections; ASTM D 5466-01(2007): Standard Test Method for - Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology); Mechanical Testing as per IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. Summary of Clinical Tests: The subject of this premarket submission, Medical Air/Oxygen Blender, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2015
Gentec (Shanghai) Corporation % Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd 7th Floor, 982 Congyun Road Baiyun District, 510420 China
Re: K142291
Trade/Device Name: GMX Series Medical Ait/oxygen Blender Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR Dated: February 13, 2015 Received: February 18, 2015
Dear Mr. Gu:
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.
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Page 2 - Mr. Mike Gu
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,
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) K142291
Device Name GMX Series Medical Air/Oxygen Blender
Indications for Use (Describe)
The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 18,2015 | ||||
|---|---|---|---|---|---|
| Submitter: | GENTEC (SHANGHAI) CORPORATION | ||||
| No. 1988 Yushu Road, Songjiang District, Shanghai, | |||||
| 201699 ,China | |||||
| Primary Contact Person: | Mike Gu | ||||
| Regulatory Manager | |||||
| Guangzhou Osmunda Medical Device Consulting Co., Ltd | |||||
| Tel: +86-20-62321333 | |||||
| Fax: +86-20-86330253 | |||||
| Secondary Contact | |||||
| Person: | Lifeng Miao | ||||
| Quality Engineer | |||||
| GENTEC (SHANGHAI) CORPORATION Technology Co., Ltd | |||||
| Tel: +86-21- 67727123-149 | |||||
| Fax: +86-21-67727176-1759 | |||||
| Device Trade Name: | GMX Series Medical Air/Oxygen Blender | ||||
| Common/Usual Name: | Oxygen Blender | ||||
| Classification Name: | |||||
| Product Code: | breathing | ||||
| BZR | gas | mixer | CFR | 868.5330 | |
| Predicate Device(s): | Precision Blender (K053232) | ||||
| Device Description: | The GMX Series Medical Air/Oxygen blender is a restricted | ||||
| medical device intended for use by qualified and trained | |||||
| personnel under the direction of a physician in institutional | |||||
| environments where delivery of air/oxygen mixtures is | |||||
| required. | |||||
| The GMX Series Medical Air/Oxygen blender includes two | |||||
| models: GMX30U-AIR/O2, GMX120U-AIR/O2. | |||||
| The GMX Series Medical Air/Oxygen blender is designed, | |||||
| tested, and will be manufactured in accordance with the | |||||
| following standard: | |||||
| ISO 11195 Gas mixers for medical use - Stand-alone gas | |||||
| mixers 1995. | |||||
| Intended Use: | GMX Series Medical Air/Oxygen Blender is designed to | ||||
| dispense a continuous blend of Medical Air and Oxygen via | |||||
| outlet ports to infant, pediatric, and adult patients. |
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- The medical oxygen/air enters the two-stage pressure Technology: balancing module through the inlet connectors, each containing a filter and check valves. In the balancing module, the pressures of both gas sources are adjusted and equalized. Then the gases flow into the proportioning module and are mixed according to the oxygen percentage selected.
When the difference in pressure between the two inlet gasses exceeds the prescribed value ( or one gas source is disconnected), the bypass poppet which blocks the flow of both gases will move to one side and create a path for the high pressure gas to flow into the alarm channel and generate the audible alarm. Meanwhile, the gas with the higher pressure will flow directly to the outlet port.
When the desired output flow is below the specified range, the bleed valve needs to be activated to ensure the accuracy of oxygen concentration.
Determination of The proposed device has the same technological Substantial Equivalence: characteristics (i.e. design, energy source) as the predicate device. Both devices accept room air and 100% oxygen gas and, via mechanical means, adjust the molar fraction of oxygen gas in the room air, and blended gas is delivered to the patient, they have identical specifications for the delivery of blended gas and similar specifications for the audible alarm (the pressure differential specification is identical). Both devices are pneumatically powered (supply source, not included) and they produce an audible alarm when the difference in pressure between the two inlet gasses exceeds the prescribed value, or one gas source is disconnected. Neither device is intended to be used sterile, nor do either device contain electrical components.
Please see Table below for more details.
| Item | Precision Blender | GMX Series
Air/Oxygen
Blender |
|------------|----------------------------------|-------------------------------------|
| Dimensions | 4.9"2.3"4.1"
(12557104mm) | 137.5140165mm |
| Weight | 1.34 kg | 1.5Kg |
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| Oxygen %
| Range | 21-100% | 21-100% |
|---|---|---|
| Accuracy | $\pm$ 3% | $\pm$ 3% |
| Energy Source | Air Supply | Air Supply |
| Supply | ||
| Pressure | 30-75 Psi | 30-72.5 psi |
| Max Flow | ||
| (GMX120U- | ||
| AIR/O2) | ≥120 LPM | ≥120 LPM |
| Pressure Drop | ||
| (GMX120U- | ||
| AIR/O2) | ≤6psi at 50Psi | |
| inlet | ||
| Pressure and | ||
| 40lpm flow | ≤6psi at 50Psi | |
| inlet pressure and | ||
| 40lpm flow | ||
| Alarm/Bypass | ||
| Reset | ≤6psi | ≤6psi |
| Alarm | ||
| Intensity | 0.3meter≥80db | 1foot≥80db |
| Operating | ||
| Temperature | 15°C-40°C | 10°C-40°C |
| Connector | NIST or DISS | NIST or DISS |
| Max Flow | ||
| (GMX30U- | ||
| AIR/O2) | ≥30 LPM | ≥30LPM |
| Pressure Drop | ||
| (GMX30U- | ||
| AIR/O2) | ≤6psi at 50Psi | |
| inlet | ||
| Pressure and | ||
| 10lpm flow | ≤6psi at 50Psi | |
| inlet pressure and | ||
| 10lpm flow |
The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews
- Design Reviews
- . Raw materials verification
- Final acceptance testing (Validation) .
- Performance testing (Verification) ●
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Summary of Non-Clinical Tests:
The Medical Air/Oxygen Blender complies with voluntary standards :
- -ISO 11195 Gas mixers for medical use – Stand-alone gas mixers 1995;
- -USP :2012—Particulate Matter in Injections;
- ASTM D 5466-01(2007): Standard Test Method for - Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology);
- Mechanical Testing as per IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
Summary of Clinical Tests:
The subject of this premarket submission, Medical Air/Oxygen Blender, did not require clinical studies to support substantial equivalence.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
- GENTEC (SHANGHAI) CORPORATION considers the GMX Conclusion: Series Medical Air/Oxygen Blender to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).