Disposable SpO2 Sensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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" in blue, and "ADMINISTRATION" in a smaller font size below. Shenzhen Caremed Medical Technology 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: K191279 Trade/Device Name: Disposable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 8, 2019 Received: November 8, 2019 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. {1}------------------------------------------------ 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) 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) Device Name Disposable SpO2 Sensors ### Indications for Use (Describe) Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations. 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) # 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 instructions, search 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 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 ## Prepared Date: 2019/11/25 #### Submission sponsor 1. Name: Shenzhen Caremed Medical Technology Co., Ltd. Address: East Side, 3/F, C Building, Kelunte Low-Carbon Industries, Gaofeng Community, Dalang Office, Longhua District, Shenzhen, Guangdong, China Contact person: Alan Xie Title: Quality Manager E-mail: cm003@szcaremed.com Tel: +86-755-36560977-889 #### 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 | |-------------------|------------------------------------| | Model | C543-16, C533-16, C523-16, C503-16 | | Common Name | Oximeter (Accessory-sensor) | | Regulatory Class | Class II | | Classification | 21CFR 870.2700 / Oximeter / DQA | | Submission type | Traditional 510(K) | #### 3. Subiect Device Information #### 4. Predicate Device By submission of the Traditional 510(k), Shenzhen Caremed Medical Technology Co., Ltd. is requesting clearance for Disposable SpO2 Sensor. It is comparable to the following legally marketed system: - 1. UNIMED MEDICAL SUPPLIES INC. Unimed Disposable and Reusable SpO2Sensors under K142832. #### 5. Device Description The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. {4}------------------------------------------------ The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. 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 lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, 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). | Model | Measurement site | Intended population | |---------|------------------|------------------------------------| | C503-16 | Fingers | Adult (>40 kg) | | C523-16 | Fingers | Pediatric (10 kg < weight < 40 kg) | | C533-16 | Fingers | Infant (3 kg < weight < 15 kg) | | C543-16 | Finger | Adult (> 40 kg) | #### 6. Intended use & Indication for use Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations. | Features | Subject Device | Predicate Device K142832 | Comparison | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | Caremed Disposable SpO2 | Unimed Disposable and | | | | Sensors | Reusable SpO2 Sensors | | | Applicant | Shenzhen Caremed Medical<br>Technology Co., Ltd. | Unimed Medical Supplies Inc. | / | | Classification<br>Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same | | Classification<br>and Code | Class II, DQA | Class II, DQA | Same | | Common<br>name | Oximeter (Accessory-sensor) | Oximeter (Accessory-sensor) | Same | | Features | Subject Device<br>Caremed Disposable SpO2<br>Sensors | Predicate Device K142832<br>Unimed Disposable and<br>Reusable SpO2 Sensors | Comparison | | Intended use | Caremed Disposable SpO2<br>Sensors are indicated for<br>continuous non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate (PR) for<br>adult, pediatric and infant patient<br>populations. | Unimed Disposable and Reusable<br>SPO2 Sensors are indicated for<br>continuous non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate (PR) for<br>adult patients weighing greater<br>than40kg, pediatric patients<br>weighing 10 -50 kg, and neonatal<br>patients weighing no less than 3<br>Kg. | Different (1) | | Principle of<br>operation | 2-wavelength Relative Optical<br>Absorption | 2-wavelength Relative Optical<br>Absorption | Same | | Light Emitting | Red: 660-666nm<br>Infrared: 880-950nm | Red: 660-666nm<br>Infrared: 880-950nm | Same | | Signal<br>Detection<br>Method | Photodetector | Photodetector | Same | | SpO2 Range | 70%-100% | 70%-100% | Same | | SpO2<br>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<br>site | Finger or toes | Finger or toes | Same | | Patient<br>contacting<br>Materials | Non-woven | Silica gel, Foam, 3M Textile | Different (2) | | Cable length | 900 $\pm$ 50 mm | Finger clip: 1100 $\pm$ 100 mm | Different (3) | | Patient end<br>design | Textile Adhesive | finger clip, soft tip, Textile<br>Adhesive, and Non-Adhesive | Same | | Connector<br>design | DB9M Connector | DB9M Connector<br>Masimo 6p Connector<br>Hypertronic 7pin Connector | Same | | Usage | Disposable | Disposable, reusable | Same | | Electrical<br>Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same | | Features | Subject Device<br>Caremed Disposable SpO2<br>Sensors | Predicate Device K142832<br>Unimed Disposable and<br>Reusable SpO2 Sensors | Comparison | | 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}------------------------------------------------ {6}------------------------------------------------ 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 difference is the addition of infant (3 kg < weight < 15 kg). 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 predicate devices have 3 type of patient contacting materials and the proposed devices have 1 type. The proposed devices can meet the requirement of ISO 10993-5/-10, so this difference does not raise different questions of safety and effectiveness. Different (3): The cable length is different. However, the proposed devices can meet the requirement of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-61, so this difference does not raise different questions of safety and effectiveness. #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility testing The biocompatibility evaluation for the Caremed Disposable SpO2 Sensors 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 Caremed 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 {7}------------------------------------------------ - . 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 Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range. #### 9. Conclusion It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, of operation, biocompatibility, performance characteristics, and intended use.