(311 days)
No
The summary describes a standard oxygen concentrator using pressure swing adsorption technology with basic alarms. There is no mention of AI, ML, or any features that would suggest their use.
Yes
The device is intended for the administration of supplemental oxygen, which is a therapeutic intervention, even though it's not life-supporting.
No.
The Oxygen Concentrator is intended for the administration of supplemental oxygen and its main function is to supply oxygen. The Intended Use explicitly states, "This device is not intended for life supporting nor does it provide any patient monitoring capabilities," which would typically be associated with diagnostic devices.
No
The device description clearly outlines a physical oxygen concentrator that uses pressure swing adsorption technology and includes hardware components like alarms and different flow rate models. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of supplemental oxygen. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device description focuses on the mechanism of generating oxygen from ambient air (pressure swing adsorption) and its function of supplying supplemental oxygen. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly described as a medical device for delivering oxygen to a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.
Product codes
CAW
Device Description
The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%).
The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power.
The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.
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
Not Found
Intended User / Care Setting
will be operated by trained personnel, at home, in community health care and medical institutions.
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
- ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment - Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment.
- ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- A VOCs and PM2.5 test per EPA TO 15 andIP-10 method
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
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June 1, 2018
SysMed (China) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K172234
Trade/Device Name: Oxygen Concentrator, Models M30, M40, and M50 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: April 26, 2018 Received: April 30, 2018
Dear Diana Hong:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K172234
Device Name Oxygen Concentrator Models M30, M40, and M50
Indications for Use (Describe)
The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.
| 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172234
-
- Date of Preparation: 05/31/2018
-
- Sponsor Identification
SysMed (China) Co., Ltd
11-2-3 No. 17 Wensu Str., Hunnan New Dis., Shenyang, 110171, China
Establishment Registration Number: Not yet registered
Contact Person: Jian Yue Position: Quality Manager Tel: +86-24-24696136 Fax: +86-24-24696137 Email: office02@sysmed.cn
-
- Designated Submission Correspondent Ms.
Diana Hong (Primary Contact Person) Betty Xiao (Alternative Contact Person)
- Designated Submission Correspondent Ms.
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Oxygen Concentrator Common Name: Portable Oxygen Generator Models: M30, M40, M50
Regulatory Information Classification Name: Generator, Oxygen, Portable Classification: 2 Product Code: CAW Regulation Number: 21CFR 868.5440 Review Panel: Anesthesiology
Intended Use Statement:
The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.
Device Description
The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%).
The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power.
The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.
-
- Identification of Predicate Devices
510(k) Number: K150930 Product Name: Deployable Oxygen Generator System - Small (DOGS-S)
- Identification of Predicate Devices
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
5
-
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- ♪ IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
-
ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment - Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment.
- ♪ ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ♪ ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- A VOCs and PM2.5 test per EPA TO 15 andIP-10 method
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | |
| M30, M40, M50 | Predicate Device | |
| K150930 | ||
| Classification | 2 | 2 |
| Product Code | CAW | CAW |
| Regulation Number | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Intended Use | The Oxygen Concentrator is intended | |
| for the administration of | ||
| supplemental oxygen. This device is | ||
| not intended for life supporting nor | ||
| does it provide any patient | ||
| monitoring capabilities. The system | ||
| will be operated by trained personnel, | ||
| at home, in community health care | ||
| and medical institutions. | The Deployable Oxygen Generator | |
| System – Small (DOGS-S) is | ||
| intended for the administration of | ||
| supplemental oxygen. This device | ||
| is not intended for life support nor | ||
| does it provide any patient | ||
| monitoring capabilities. The | ||
| system will be operated by trained | ||
| personnel. | ||
| Use environment | home, community health care and | |
| medical institutions | Home, hospital and medical | |
| facility | ||
| Operation principle | pressure swing adsorption technology | |
| (PSA) | pressure swing adsorption | |
| technology (PSA) | ||
| Oxygen purity | 93% +/- 3% | 93% +/- 3% |
Table 1 Comparison of Technology Characteristics
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| Flow type | Continuous flow | Continuous flow |
|---|---|---|
| Flow rate | M30: 0-3 L/min | |
| M40: 0-4 L/min | ||
| M50: 0-5 L/min | 0.5 - 15 L/min | |
| Sound level | ≤45 dBA |