(92 days)
The CARE ZY5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
The CARE ZY5BA is an AC power electrically operated device. The unit separates oxygen from room air (ambient air), which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room. It will not affect the normal amount of oxygen in user's room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized valve and protected from over pressurization by the compressor's pressure relief valve. Oxygen provided by the CARE ZYSBA Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or oxygen mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the CARE ZY5BA contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operate the device conveniently according the instructions.
Acceptance Criteria and Device Performance Study (CARE ZY5BA Oxygen Concentrator)
This medical device submission is for an oxygen concentrator, not an AI-powered diagnostic device. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to the evaluation of algorithms for diagnostic accuracy.
The acceptance criteria for this device are based on its substantial equivalence to a predicate device and compliance with relevant performance and safety standards.
1. Acceptance Criteria and Reported Device Performance
The key "performance" for an oxygen concentrator relates to its ability to reliably produce oxygen and meet safety standards. The document outlines these by demonstrating compliance with established standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Equivalence to predicate device (A&J-POCA01 Oxygen Concentrator K071608) in technological characteristics and intended use. | "Bench performance testing has demonstrated that the CARE ZY5BA Oxygen Concentrator is substantially equivalent to the predicate device." |
| Environmental Testing | All environmental testing identified in FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". | Device met all design specifications and was verified to be substantially equivalent. |
| Oxygen Concentrator Performance | Compliance with ASTM F1464 and ISO 8359 standards. | Testing demonstrated compliance with these standards. |
| Electrical Safety | Compliance with IEC60601-1, IEC60601-1-2, IEC60601-1-4 standards. | Testing assured compliance with these standards. |
| Risk Management | Compliance with ISO14971 (Hazard Analysis). | A hazard analysis was performed, and testing was conducted to validate overall operation. |
| General Device Operation | Meets all design specifications. | Testing was conducted to validate and verify that the CARE ZY5BA Oxygen Concentrator met all design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission focuses on the performance and safety of a medical device (oxygen concentrator), not on the evaluation of a diagnostic algorithm or AI model requiring a "test set" in the context of image analysis or similar diagnostic applications. The testing involved physical device performance and compliance with engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no diagnostic "ground truth" to be established by experts for this type of device. The "ground truth" is defined by the technical specifications and performance standards for oxygen concentrators.
4. Adjudication Method for the Test Set
Not applicable. As there is no "test set" in the diagnostic sense, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is for evaluating the comparative effectiveness of human readers, often aided by AI, in diagnostic tasks. For an oxygen concentrator, this is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an oxygen concentrator, a physical piece of medical equipment, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established by:
- Engineering Specifications and Design Requirements: The device must meet its intended design specifications for oxygen purity, flow rate, pressure, and operational parameters.
- International and Industry Standards: Compliance with standards such as ASTM F1464, ISO 8359 (for oxygen concentrators), IEC 60601-1 series (for electrical safety), and ISO 14971 (for risk management) defines the acceptable performance and safety.
- Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML algorithm requiring training data, there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is:
Submitter:
KIDSSAR
Foshan Care Medical Technology Co., Ltd
Address:
No.1 HuaBao South Road, Foshan, Guangdong, China
Contact Person:
Polo Chen R&D Manager Email: polochen888@hotmail.com Tel: 0086-757-88023253 Fax: 0086-757-83828996
Applicant:
Foshan Care Medical Technology Co., Ltd
Address:
No.1 HuaBao South Road, Foshan, Guangdong, China
Date of the summary prepared:
June 15.2010
Name of the device:
Trade/Proprietary Name: CARE ZY5BA Oxygen Concentrator Common Name: Oxygen Concentrator
Classification:
Class II as per 21 CFR 868.5440, Portable Oxygen Generator
Legally Marketed Predicate Device:
A&J-POCA01 Oxygen Concentrator K071608
Intended Use:
1
Chapter 4
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The CARE ZY 5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
Description:
The CARE ZY5BA is an AC power electrically operated device. The unit separates oxygen from room air (ambient air), which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room. It will not affect the normal amount of oxygen in user's room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized valve and protected from over pressurization by the compressor's pressure relief valve.
Oxygen provided by the CARE ZYSBA Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or oxygen mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.
The front panel of the CARE ZY5BA contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operate the device conveniently according the instructions.
Technological Characteristics:
Technologies utilized by the CARE ZY5BA Oxygen Concentrator bring forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.
Bench performance testing has demonstrated that the CARE ZY5BA Oxygen
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Concentrator is substantially equivalent to the predicate device.
Testing:
Laboratory testing was conducted to validate and verify that the CARE ZYSBA Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device. This testing consisted of all environmental testing identified in the FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". Additional testing was performed to demonstrate compliance with the standards of ASTM F1464 and ISO 8359. Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation. The CARE ZY5BA Oxygen Concentrator has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-1-2, IEC60601-1-4, and ISO14971.
Conclusion:
The conclusions drawn from the testing of the CARE ZY5BA Oxygen Concentrator demonstrates that the device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Foshan Care Medical Technology Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526
NOV - 9 2010
Re: K102245
Trade/Device Name: CARE ZY5BA Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 28, 2010 Received: November 4, 2010
Dear Mr. Mouser:
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. Mouser
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Pease
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
NOV - 9 2010
510(k) Number (if known): 长/ロフ24/5 Device Name: CARE ZY5BA Oxygen Concentrator Indications for Use:
The CARE ZY5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schult
Page 1 of 1
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102245
§ 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).