Disposable SpO2 Sensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". The logo is simple and professional, reflecting the FDA's role in regulating food and drugs. Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District, Shenzhen, 518067 Cn Re: K200069 Trade/Device Name: Disposable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 10, 2020 Received: January 13, 2020 Dear Kevin 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K200069 Device Name Disposable SpO2 Sensor Indications for Use (Describe) The Disposable SpO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults in hospital environment. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------|----------------------------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary # Prepared in accordance with the requirements of 21 CFR Part 807.92 # K200069 # Prepared Date: 2020/03/07 ### Submission sponsor 1. Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General Manager E-mail: zhouyahui@szcklt.com Tel: +86 136 1301 2560 ## 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Disposable SpO2 Sensor | |-------------------|---------------------------------| | Common Name | Oximeter (Accessory-sensor) | | Regulatory Class | Class II | | Classification | 21CFR 870.2700 / Oximeter / DQA | | Submission type | Traditional 510(K) | ### Subject Device Information 3. ### 4. Predicate Device Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd. Device name: Disposable SpO2 Sensor 510(K) Number: K191279 ## 5. Device Description The proposed device, Disposable SpO2 Sensor is an accessory to the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 cleared in K113623. {4}------------------------------------------------ The sensor shall be connected to its corresponding monitor through adapter cable model CK-03-452. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light are emitted through fingertips and received by a photodiode can be induced to change with pulse light intensity; the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb). ### 6. Intended use & Indication for use The Disposable SpO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults in hospital environment. | Features | Subject Device<br>Disposable SpO2 Sensor | Predicate Device K191279<br>Caremed Disposable SpO2<br>Sensors | Comparison | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------| | Applicant | Shenzhen Changke<br>Connect Electronics Co.,<br>Ltd. | Shenzhen Caremed Medical<br>Technology Co., Ltd. | / | | | Classification<br>Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same | | | Classification and Code | Class II, DQA | Class II, DQA | Same | | | Common name | Oximeter (Accessory-<br>sensor) | Oximeter (Accessory-sensor) | Same | | | Intended use | The Disposable SpO2<br>Sensor is indicated for<br>continuous non-invasive<br>monitoring of functional<br>oxygen saturation of<br>arterial hemoglobin (SpO2)<br>and pulse rate (PR) for<br>adults in hospital<br>environment. | Caremed Disposable SpO2<br>Sensors are indicated for<br>continuous non-invasive<br>monitoring of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR) for adult, pediatric<br>and infant patient populations. | Different (1) | | | Principle of operation | 2-wavelength Relative | 2-wavelength Relative Optical | Same | | | Features | Subject Device<br>Disposable SpO2 Sensor | Predicate Device K191279<br>Caremed Disposable SpO2<br>Sensors | Comparison | | | | Optical Absorption | Absorption | | | | Light Emitting | Red: 660-666nm<br>Infrared: 880-950nm | Red: 660-666nm<br>Infrared: 880-950nm | Same | | | Signal Detection<br>Method | Photodetector | Photodetector | Same | | | SpO2 Range | 70%-100% | 70%-100% | Same | | | SpO2 Accuracy | $\pm$ 3% | $\pm$ 3% | Same | | | PR Range | 30 bmp - 250 bmp | 30 bmp - 250 bmp | Same | | | PR Accuracy | $\pm$ 3 | $\pm$ 3 | Same | | | Sterile | No | No | Same | | | Application site | Finger | Finger or toes | Different (2) | | | Patient contacting<br>Materials | Non-woven | Non-woven | Same | | | Cable length | 900 $\pm$ 50 mm | 900 $\pm$ 50 mm | Same | | | Patient end design | Textile Adhesive | Textile Adhesive | Same | | | Connector design | DB9M Connector | DB9M Connector | Same | | | Usage | Disposable | Disposable | Same | | | Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same | | | EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same | | | Performance | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 | Same | | | Biocompatibility | Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same | | | Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same | | | Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same | ### 7. Comparison to the Predicate Device {5}------------------------------------------------ Justifications for differences between proposed device and the predicate device are shown as below: Different (1): The intended population between proposed device and predicate device is different. The subject device is only for adult and the predicate device has pediatric models. This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness. Different (2): The application site is different because of the patient population. Compare to adult model in predicate device, they are same. Thus, this difference does not raise different questions of safety and effectiveness. {6}------------------------------------------------ ## 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the Disposable SpO2 Sensor was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: - . Cytotoxicity - . Sensitization - Irritation . The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days. # Non-clinical data The Disposable SpO2 Sensors have been tested according to the following standards: - IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-. Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests - ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment. The test was selected to show substantial equivalence between the subject device and the predicate. # Clinical data Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards: - . ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment. - . Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range. ## 9. Conclusion Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device. The subject device has the same intended use as {7}------------------------------------------------ the predicate device, and the technological differences do not raise different questions of safety and effectiveness