(60 days)
No
The description details a standard pulse oximetry sensor and its connection to a patient monitor, relying on established algorithms for calculating SpO2 and pulse rate based on light absorption. There is no mention of AI or ML techniques.
No
The device is described as a non-invasive monitor for measuring SpO2 and pulse rate, which are diagnostic/monitoring functions, not therapeutic. It does not actively treat or ameliorate a condition.
Yes
Explanation: The device measures and monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), which provides physiological information used to diagnose and monitor patient health conditions.
No
The device description clearly outlines hardware components (LEDs, photodiode, sensor attached to the finger) and their function in measuring SpO2, indicating it is a hardware device with associated software for calculation and display.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The description clearly states that the Disposable SpO2 Sensor is a non-invasive device that measures oxygen saturation and pulse rate by detecting light absorption through the patient's finger. It does not involve the analysis of blood, urine, tissue, or any other sample removed from the body.
- The measurement is performed in vivo. The device is applied directly to the patient's finger to obtain the measurement. This is an in vivo measurement, not an in vitro (in glass/outside the body) measurement.
The device is a medical device used for physiological monitoring, specifically pulse oximetry.
N/A
Intended Use / Indications 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.
Product codes
DQA
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Range: 70%-100%
SpO2 Accuracy: ± 3%
PR Range: 30 bmp - 250 bmp
PR Accuracy: ± 3
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Disposable SpO2 Sensor | Predicate Device K191279
Caremed Disposable SpO2
Sensors | Comparison | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------|
| Applicant | Shenzhen Changke
Connect Electronics Co.,
Ltd. | Shenzhen Caremed Medical
Technology Co., Ltd. | / | |
| Classification
Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same | |
| Classification and Code | Class II, DQA | Class II, DQA | Same | |
| Common name | Oximeter (Accessory-
sensor) | Oximeter (Accessory-sensor) | Same | |
| Intended 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. | 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. | Different (1) | |
| Principle of operation | 2-wavelength Relative | 2-wavelength Relative Optical | Same | |
| Features | Subject Device
Disposable SpO2 Sensor | Predicate Device K191279
Caremed Disposable SpO2
Sensors | Comparison | |
| | Optical Absorption | Absorption | | |
| Light Emitting | Red: 660-666nm
Infrared: 880-950nm | Red: 660-666nm
Infrared: 880-950nm | Same | |
| Signal Detection
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
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
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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.
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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