(374 days)
Not Found
No
The summary describes a standard oxygen concentrator based on pressure swing adsorption, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes.
The device is intended to be used by patients with respiratory disorders who require supplemental oxygen, which directly addresses a medical condition.
No
The device is an oxygen concentrator intended to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic function, not a diagnostic one. It does not perform any assessment, measurement, or analysis to identify or characterize a disease or condition.
No
The device description clearly describes a physical oxygen concentrator weighing 19kg and utilizing a pressure swing adsorption principle, indicating it is a hardware device. While software verification and validation are mentioned, this is standard for many medical devices and does not make it software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Owgels Oxygen Concentrator is a device that provides supplemental oxygen directly to a patient's respiratory system. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states it's for "patients with respiratory disorders who require supplemental oxygen." This is a therapeutic use, not a diagnostic one.
Therefore, based on the provided information, the Owgels Oxygen Concentrator is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
Owgels Oxygen Concentrator, Model : OZ-5-02TW0 adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. The concentrator can generate oxygen with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is around 19kg.
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
adults
Intended User / Care Setting
Home, institution 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)
The device has been evaluated the safety and performance by lab bench testing as following:
Biocompatibility testing: The biocompatibility evaluation for the Owgels Oxygen Concentrator, Model : OZ-5-02TW0 was conducted in accordance with the ISO18562-1, ISO 18562-3, ISO10993-5, ISO10993-5, ISO10993-10, ISO10993-17.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Owgen Concentrator, Model : OZ-5-02TW0. The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC60601-1-11, and ISO 80601-2-69 standards for electrical safety and the IEC60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Level of Concern: The software for this device was considered as a minor level of concern, because the subject device is a supplement to a patient's normal oxygen intake. A software failure will not result in injury to a patient or user. The device is not intended to be life-supporting or life sustaining.
Performance Bench Testing: The basic safety and essential performance Test was evaluated based on ISO 80601-2-69. And Oxygen concentration and maximum flow performance testing was also conducted to verify that oxygen production capacity of the oxygen generator can meet the design requirements after working continuously at the maximum output for 8 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Guangzhou Life Light Electronic Technology Co., Ltd. % Iris Fung Project Manager SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Guangzhou, 510060 Cn
Re: K191875
Trade/Device Name: Owgels Oxygen Concentrator, Model: OZ-5-02TW0 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: March 15, 2020 Received: April 7, 2020
Dear Iris Fung:
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 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191875
Device Name
Owgels Oxygen Concentrator, Model : OZ-5-02TW0
Indications for Use (Describe)
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life.
The device is intended for use in adults.
| 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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of the summary prepared: 2020-07-06 1.
2. Submitter's Information
Company Name: Guangzhou life light Electronic Technology Co.,Ltd. Address: No.A102,No.1 Kesheng Road,Baiyun District,Guangzhou,510540,P.R.China Phone: +86-20-87433122 or +86-20-87426280 URL: www.owgelsglobal.com Contact Person: Erika meng
E-mail: info@@owgels.com
Application response:
SGS-CSTC Standards Technical Services Co., Ltd. Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development District, Guangzhou, Guangdong, CHINA Contact Person: Ms. Iris Fung Tel: +86-20-32136908 Email: Iris.Fung@sgs.com
3. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Oxygen Concentrator Trade Name: Owgels Oxygen Concentrator, Model : OZ-5-02TW0 Classification Name: Generator, Oxygen, Portable Review Panel: Anesthesiology Product Code: CAW Regulation Number: 868.5440 Regulation Class: 2
4. Predicate Device Information
| Sponsor | LONGFIAN SCITECH CO., LTD. |
|---|---|
| Device Name | OXY.LIFE Oxygen Concentrator |
| 510(k) Number | K131968 |
| Product Code | CAW |
| Regulation Number | 868.5440 |
| Regulation Class | 2 |
4
Device Description 5.
Owgels Oxygen Concentrator, Model : OZ-5-02TW0 adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. The concentrator can generate oxygen with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is around 19kg.
6. Intended Use / Indications for Use
Intended Use
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home. institution environments. The Owgen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.
Indications for use
The Owgels Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Owgels Oxygen Concentrator can be used in a home, institution environments. The Owgels Oxygen Concentrator does not nor is it intended to sustain or support life. The device is intended for use in adults.
7. Test Summary
The device has been evaluated the safety and performance by lab bench testing as following:
Biocompatibility testing
The biocompatibility evaluation for the Owgels Oxygen Concentrator, Model : OZ-5-02TW0 was conducted in accordance with the ISO18562-1,ISO 18562-3,ISO10993-5 ,ISO10993-5 ,ISO10993-10, ISO10993-17.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Owgen Concentrator, Model : OZ-5-02TW0 . The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC60601-1-11, and ISO 80601-2-69 standards for electrical safety and the IEC60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Level of Concern: The software for this device was considered as a minor level of concern,because the subject device is a supplement to a patient's normal oxygen intake. A software failure will not result in injury to a patient or user. The device is not intended to be lifesupporting or life sustaining.
Performance Bench Testing
5
The basic safety and essential performance Test was evaluated based on ISO 80601-2-69. And Oxygen concentration and maximum flow performance testing was also conducted to verify that oxygen production capacity of the oxygen generator can meet the design requirements after working continuously at the maximum output for 8 hours
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Owgels Oxygen Concentrator, Model : OZ-5-02TW0 is substantially equivalent to the predicate devices quoted above.
| Elements of
Comparison | Subject Device | Predicate
Device(Primary) | Remark | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------|
| Device Name and
Model | Owgels Oxygen
Concentrator, Model :
OZ-5-02TWO | JAY-5 Medical
Molecular Sieve Oxygen
Concentrator | -- | |
| 510 (K) Number | Applying | K131968 | -- | |
| Product Code | CAW | CAW | SE | |
| Regulation
Number | 21 CFR868.5440 | 21 CFR868.5440 | SE | |
| Indications for use | The Owgels Oxygen
Concentrator is intended
to be used by patients
with respiratory
disorders who require
supplemental oxygen. A
high concentration of
supplemental oxygen is
supplied and a nasal
cannula is used to
channel oxygen from the
concentrator to the
patient. The Owgels
Oxygen Concentrator
can be used in a home,
institution environments.
The Owgels Oxygen
Concentrator does not
nor is it intended to
sustain or support life. | The Longfian Oxygen
Concentrator, Model
Jay-5 is intended to be
used by patients with
respiratory disorders
who require
supplemental oxygen. A
high concentration of
supplemental oxygen is
supplied and a nasal
cannula is used to
channel oxygen from
the concentrator to the
patient. The Longfian
Oxygen Concentrator,
Model Jay-5 can be
used in a home,
institution, vehicle, and
various mobile
environments. The
Longfian Oxygen
Concentrator, Model | SE, Note 1 | |
| | | The device is intended
for use in adults. | Jay-5 does not nor is it
intended to sustain or
support life. | |
| Principles of
operation | | Pressure Swing
Adsorption with
molecular sieve | Pressure Swing
Adsorption with
molecular sieve | SE |
| Operating system | | Time cycle/ Pressure
Swing Adsorption | Time cycle/ Pressure
Swing Adsorption | SE |
| Electronic safety | | Electrical Safety per
IEC-60601 | Electrical Safety per
IEC-60601 | SE |
| | Software/Hardware | Analog and digital
electronics
with microprocessor | Analog and digital
electronics
with microprocessor | SE |
| Feature | | | | |
| Oxygen
Concentration | | 93% ±3% | 93% ± 3% | SE |
| Flow Specifications | | 0 LPM-5 LPM | 0 LPM-5 LPM | SE |
| Acoustic Noise | |