(286 days)
Not Found
No
The description focuses on standard oxygen concentration technology (PSA) and mentions basic control modules (MCU, pressure detection, oxygen concentration detection, etc.) without any indication of learning or adaptive algorithms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to provide supplemental oxygen, which directly treats a medical condition (lack of sufficient oxygen).
No
The device is an oxygen concentrator, which provides supplemental oxygen. It does not perform any diagnostic functions or analyze medical conditions.
No
The device description explicitly lists hardware components such as an air compressor, adsorption tower, oxygen sensor, flow meter, and various modules (power, MCU control, pressure detection, etc.). This indicates it is a physical medical device with integrated software, not a software-only 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 "provide supplemental oxygen in a home, institutional environment." This describes a therapeutic or life-support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the components and function of an oxygen concentrator, which physically separates oxygen from the air for breathing. This is a medical device, but not one used for in vitro diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the CONTEC™ Oxygen Concentrator, OC3D, is a medical device used for oxygen therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONTECTM Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.
Product codes
CAW
Device Description
The Oxygen Concentrator is a small and portable oxygen concentrator. It consisted of air compressor, adsorption tower of molecular sieve, oxygen sensor and flow meter. It adopts pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air.
The machine takes the advantages of small in volume, light in weight, convenient in moving (as it has turning truckle), stable in performance, easy in operating, low in noise, which complies with requirements of medical device.
The OC3D is divided into power module, MCU control module, Pressure detection module, Oxygen concentration detection module, alarm module, Compressor and fan drive module, Solenoid valve drive module, Display driver module, Work indication module, button detection module.
Power module: provide power supply for each system module;12V/3A power is supplied by the power board, MCP1702-5002E/M supplies 5.0V for oxygen concentration collection, L7805CV 5.0V is the system power, which form two 3.3V power supply through the two TLV70033DDCR , used to be compatible with the system and screen voltage.
MCU control module: MCU is to detect the status of pressure, oxygen concentration and buttons, and to control the drives of compressors, fans, solenoid valves, displays, and indicators as required
Pressure detection module: MCU collects the pressure value at a certain frequency through the AD. When the detected pressure exceeds the maximum limit and the minimum limit, the alarm signal is triggered and displayed on the screen.
Oxygen concentration detection module: MCU collects the oxygen concentration and the flow value at a certain frequency. When the detected oxygen concentration and the flow value exceeds the maximum limit and the minimum limit, the alarm signal is triggered and displayed on the screen.
Alarm module: If the device detects the alarm trigger signal in working status, such as high system pressure, low system pressure, low flow rate, the oxygen concentration is below 82%, MCU will drive alarm circuit, to send sound alarm and light alarm. If the power supply is interrupted in the running status of the device, electrical energy stored in the board card and the logic circuit will drive the buzzer to send the sound alarm.
Compressor and fan drive module: After receiving the signal of starting to make oxygen, the MCU turns on the electric relay and turns on the compressor, and the fan to work.
Solenoid valve drive module: After receiving the signal of starting to make oxygen, and after the compressor and the fan is opened ,then delay for a period of time, and then switch on the solenoid valve
Display driver module: MCU drive display module to display the system running information, running total time etc. on the screen.
Work indication module: After MCU worked, the green light of drive is on; after making oxygen for 20min, if the oxygen concentration is less than 82% but not less than 60%, the yellow light will be lit, if the oxygen concentration is below 60%, then the red light will be lit; if system works abnormally and alarms, the red light will be lit.
Button detection module: When MCU detects a button input, the MCU performs key handling operations
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
Adult
Intended User / Care Setting
home, institutional environment.
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)
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:
- IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for a. basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment Part 1-2: General b. Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment Part 2-69: c. Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment
- IEC 60601-1-8 Edition 2.1 2012-11, Medical Electrical Equipment Part 1-8: General d. Requirements For Basic Safety And Essential Performance - Collateral Standard: General
Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems.
- IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: General e. Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment .
- f. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and g. delay-type hypersensitivity
- Testing for Ozone concentration, TVOC, PM2.5, CO, NO2 Criteria is Ozone concentration
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Contec Medical System Co., Ltd. % Ray Wang General Manager Beijing Believe-med Technology Service Co., Ltd. Rm.912, Building #15, Xiyuehui, No.5, YiHe North Rd., FangShan District. Beijing, China, 102401
Re: K180837
Trade/Device Name: ContecTM Oxygen Concentrator OC3D Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: December 11, 2018 Received: December 14, 2018
Dear Ray Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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, Todd D. Courtney -S
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below
510(k) Number (if known) K180837
Device Name CONTEC ™ Oxygen Concentrator Model OC3D
Indications for Use (Describe)
CONTEC™ Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.
Type of Use (Select one or both as applicable)
Z 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 instructionssearch 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 sponsorand a person is not required to respond to a collection of information unless it displays a currently valid OMB number."
3
Tab #8 510(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: K180837
-
- Date of Preparation: 12/08/2018
-
- Sponsor Identification
Contec Medical System Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China. Establishment Registration Number: 3006979678
Contact Person: Xueyong Li Position: Quality Manager Tel: 86-355-8015490 Fax: 86-355-8015490 Email: lxy1011@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
-
- Identification of Predicate Device(s)
Predicate Device: 510(k) Number: K162433 Product Name: GCE Zen-O™ Portable Oxygen Concentrator Model Name:RS-00500 Manufacturer: Oxus Inc.
- Identification of Predicate Device(s)
-
Identification of Proposed Device న్.
Trade Name: CONTEC™ Oxygen Concentrator Model OC3D Common Name: Generator, Oxygen, Portable Model(s): OC3D
Regulatory Information Classification Name: Portable oxygen generator Classification: II Product Code: CAW Regulation Number: CFR 868.5440 Review Panel: Anesthesiology
Device Description
The Oxygen Concentrator is a small and portable oxygen concentrator. It consisted of air compressor, adsorption tower of molecular sieve, oxygen sensor and flow meter. It adopts pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air.
The machine takes the advantages of small in volume, light in weight, convenient in moving (as it has turning truckle), stable in performance, easy in operating, low in noise, which complies with requirements of medical device.
5
Image /page/5/Figure/1 description: This image is a block diagram of a system with several components. The system includes a power module that provides 3.3V, 5V, and 12V power. The 3.3V power is used to power the display driver, while the 5V power is used to power the MCU control module. The 12V power is used to power the solenoid drive and the compressor and fan drive.
Fig 7-1 Working Frame of OC3D
The OC3D is divided into power module, MCU control module, Pressure detection module, Oxygen concentration detection module, alarm module, Compressor and fan drive module, Solenoid valve drive module, Display driver module, Work indication module, button detection module.
Power module: provide power supply for each system module;12V/3A power is supplied by the power board, MCP1702-5002E/M supplies 5.0V for oxygen concentration collection, L7805CV 5.0V is the system power, which form two 3.3V power supply through the two TLV70033DDCR , used to be compatible with the system and screen voltage.
MCU control module: MCU is to detect the status of pressure, oxygen concentration and buttons, and to control the drives of compressors, fans, solenoid valves, displays, and indicators as required Pressure detection module: MCU collects the pressure value at a certain frequency through the AD. When the detected pressure exceeds the maximum limit and the minimum limit, the alarm signal is triggered and displayed on the screen.
Oxygen concentration detection module: MCU collects the oxygen concentration and the flow value at a certain frequency. When the detected oxygen concentration and the flow value exceeds the maximum limit and the minimum limit, the alarm signal is triggered and displayed on the screen.
Alarm module: If the device detects the alarm trigger signal in working status, such as high system pressure, low system pressure, low flow rate, the oxygen concentration is below 82%, MCU will drive alarm circuit, to send sound alarm and light alarm. If the power supply is
6
interrupted in the running status of the device, electrical energy stored in the board card and the logic circuit will drive the buzzer to send the sound alarm.
Compressor and fan drive module: After receiving the signal of starting to make oxygen, the MCU turns on the electric relay and turns on the compressor, and the fan to work.
Solenoid valve drive module: After receiving the signal of starting to make oxygen, and after the compressor and the fan is opened ,then delay for a period of time, and then switch on the solenoid valve Display driver module: MCU drive display module to display the system running information, running total time etc. on the screen.
Work indication module: After MCU worked, the green light of drive is on; after making oxygen for 20min, if the oxygen concentration is less than 82% but not less than 60%, the yellow light will be lit, if the oxygen concentration is below 60%, then the red light will be lit; if system works abnormally and alarms, the red light will be lit.
Button detection module: When MCU detects a button input, the MCU performs key handling operations
Intended Use Statement:
CONTECTM Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.
7
6. Substantially Equivalent (SE) Comparison
Table 7-1 Comparison of Technology Characteristics
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Device name | OC3D CONTECT™ Oxygen concentrator | RS-00500 GCE Zen-O™ Portable Oxygen Concentrator |
| Classification Name | Portable oxygen generator | Portable oxygen generator |
| Product Code | CAW | CAW |
| Regulation Number | CFR 868.5440 | CFR 868.5440 |
| Comparison Statement | The proposed device has same classification information as the predicate device. | |
| Intended Use | CONTECT™ Oxygen concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional, or travel environment. | The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment. |
| Patient Population | Adult | Adult |
| Single Patient, multi-use | Yes | Yes |
| Comparison Statement | The proposed device has similar intended use as the predicate device. | |
| Main Unit Technical Specifications | ||
| Technology | Pressure Swing Adsorption with molecular sieve | Pressure Swing Adsorption with molecular sieve |
| Dimensions | 508(L) × 260(W) × 530(H) mm (20" L x 10.2" W x20.8" Η) | 6.6" H x 8.3" W x 12.3" L |
| Weight | 21Kg(46.30lbs) | 10.25 lbs |
| Oxygen | ||
| Concentration | 93%±3% | 87% - 96% |
| Equivalent Flow | ||
| Rates | 0.5~3LPM | 1-6 LPM, increments of 0.5 LPM |
| 0.5 - 2 LPM, increments of 0.5 L (Continuous mode) | ||
| User Interface | Buttons | |
| LCD Display | Buttons | |
| LCD Display | ||
| Power supply | AC110V±10%, 60Hz±1Hz | 100-240VAC, 50/60 Hz, 2.5A |
| 24VDC, 6.25A | ||
| Software | Embedded | Embedded |
| Acoustic Noise | ≤55dB(A) | 42 dB(A) at 2 LPM |
| Alarms | power failure | Battery empty |
| high pressure | Low Pressure | |
| low pressure | Motor communication | |
| low flowrate | No pulse | |
| high temperature | Skipped Breaths | |
| Low oxygen concentration | High temp | |
| Motor stall | RAM failure | |
| Compressor failure | Motor stall | |
| Compressor failure | ||
| Fan failure | ||
| Invalid Battery | ||
| Low Flow | ||
| Low Battery | ||
| No Breath Detected | ||
| uC timeput | ||
| EEPROM failure | ||
| EEPROM error | ||
| Status | ||
| Indicators | Flowrates | Flowrates |
| Alarms | Battery Condition | |
| Power | Alarms | |
| Failure indication | History Log | |
| Diagnostics | ||
| Operating | Temperature: 10°C~40°C | Temperature: 5 °C~40°C |
| Environment | Relative humidity: ≤80% | |
| Atmospheric pressure: 860hPa~1060hPa | ||
| Altitude: it can work normally from the altitude range 0 to 1900m,its | ||
| efficiency is lower than 90% from the distance of 1900m to 4000m. | Relative humidity:5 – 93 % | |
| Altitude: 0-9000 ft(0-2743.2m) | ||
| Shipping / | ||
| Storage | ||
| Conditions | Temperature: -20°C~+60°C; | |
| Relative Humidity: ≤95%. | Temperature: -20 to 60oC, Keep Dry, | |
| Humidity: 0 - 93 % RH | ||
| Sterile | No | No |
| Single Use | No | No |
| Comparison Statement: | The proposed device has the similar main unit specifications with the predicate device. | |
| Applied Standards: | ||
| Biocompatibility | ISO10993-5&ISO10993-10 | |
| 4 VOC's less than ambient | 4 VOC's less than ambient | |
| Electrical Safety | IEC60601-1 | |
| IEC 60601-1-11 | IEC60601-1 | |
| IEC 60601-1-11 | ||
| EMC | IEC60601-1-2 | IEC60601-1-2 |
| Performance | ISO 80601-2-69 | ISO 80601-2-69 |
| alarm | IEC 60601-1-8 | IEC 60601-1-8 |
| Comparison Statement | The proposed probe has same applied Standards with the predicate device. |
8
510(k) Summary
9
10
7. Substantially Equivalent (SE) Conclusion
SE Analysis:
The subject device has same classification information, same intended use, same indication for use, similar product design, similar specification, similar applied Standards as predicate device. The differences are included as followings:
Analysis 1 : Although the Dimensions and Power supply specifications, Operating and Storage Environment Conditions of OC3D is different from the predicate device, but both the predicate device and the proposed device has passed the IEC60601-1 test. Hence, there are no different questions of safety and effectiveness questions pertaining to Electrical Safety.
Analysis 2: The device and predicate device have difference in alarms, but they have same alarms relating to the basic function of safety and performance, such as pressure, flowrate, oxygen concentration, motor and compressor. Hence, there are no different questions of safety and effectiveness questions pertaining to alarms.
Analysis 3: The device and predicate device have difference in flow rate accuracy, but the proposed device meets the requirements of the standard ISO80601-2-69 and IEC60601-1-8. Hence, there are no different questions of safety and effectiveness questions pertaining to Performance of the subject device.
Analysis 4: The subject device and the predicate device have differences in Acoustic Noise, Alarms information displayed, Status Indicators. However, the proposed device meets the requirements of the standard ISO80601-2-69 and IEC60601-1-8. In addition, performance testing, human factors study, risk analysis has been conducted on the subject device. Hence, there are no different questions of safety and effectiveness questions pertaining to Performance of the subject device.
8. Non-Clinical Test Conclusion
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:
- IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for a. basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment Part 1-2: General b. Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
- ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment Part 2-69: c. Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment
- IEC 60601-1-8 Edition 2.1 2012-11, Medical Electrical Equipment Part 1-8: General d. Requirements For Basic Safety And Essential Performance - Collateral Standard: General
11
Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems.
- IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: General e. Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment .
- f. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and g. delay-type hypersensitivity
- Testing for Ozone concentration, TVOC, PM2.5, CO, NO2 Criteria is Ozone concentration