(136 days)
No
The description details a standard pulse oximetry sensor and its function based on light absorption and a calculation algorithm, with no mention of AI or ML.
No.
The device is an accessory (sensor) for patient monitors, which are used for monitoring physiological parameters (SpO2 and pulse rate), not for providing therapy.
Yes
The device is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), which involves measuring and displaying physiological parameters to provide information about a patient's health status. This falls under the definition of a diagnostic device as it helps in assessing or detecting medical conditions.
No
The device description explicitly details hardware components (LEDs, photodiode, probe) and their function in acquiring physiological data, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of transplant tissues, organs, and blood.
- Device Function: The Reusable SpO2 Sensors described here are used for non-invasive monitoring of physiological parameters (oxygen saturation and pulse rate) by applying the sensor directly to the patient's finger. They do not involve the examination of specimens in vitro (outside the body).
- Intended Use: The intended use clearly states "continuous non-invasive monitoring."
- Device Description: The description details how light is passed through the finger and detected, which is a non-invasive method.
Therefore, based on the provided information, the Reusable SpO2 Sensors fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).
The sensor shall be connected with its corresponding monitor. 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 pulse rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. 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
Adult (> 40 kg) and pediatric (10-50 kg) patients.
Intended User / Care Setting
Not Found
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)
Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors 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.)
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.
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
§ 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).
0
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October 11, 2019
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: K191420
Trade/Device Name: Reusable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 9, 2019 Received: September 9, 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.
for 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 Ouality 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) K191420
Device Name Reusable SpO2 Sensor
Indications for Use (Describe)
The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2019/10/10
1. Submission sponsor
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 | Reusable SpO2 Sensor |
|---|---|
| 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 Changke Connect Electronics Co., Ltd. is requesting clearance for Reusable SpO2 Sensor. It is comparable to the following legally marketed system:
- UNIMED MEDICAL SUPPLIES INC. Unimed Reusable SpO2Sensors under K142832.
ട്. Device Description
The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).
The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by
4
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 pulse rate conditions.
Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. 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 Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.
| Features | Subject Device
Reusable SpO2 Sensors | Predicate Device K142832
Unimed Reusable SpO2
Sensors | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Applicant | Shenzhen Changke Connect
Electronics Co., Ltd. | Unimed Medical Supplies Inc. | / |
| 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 Reusable SpO2 Sensors are
indicated for continuous
non-invasive monitoring of
functional oxygen saturation of
arterial hemoglobin (SpO2) and
pulse rate (PR) for adult (> 40
kg) and pediatric (10-50 kg)
patients. | Unimed Disposable and Reusable
SPO2 Sensors are indicated for
continuous non-invasive
monitoring of functional oxygen
saturation of arterial hemoglobin
(SpO2) and pulse rate (PR) for
adult patients weighing greater
than40kg, pediatric patients
weighing 10 -50 kg, and neonatal
patients weighing no less than 3
Kg. | Different (1) |
| Principle of
operation | 2-wavelength Relative Optical
Absorption | 2-wavelength Relative Optical
Absorption | Same |
| Light | Red: 660-666nm | Red: 660-666nm | Same |
| Features | Subject Device
Reusable SpO2 Sensors | Predicate Device K142832
Unimed Reusable SpO2
Sensors | Comparison |
| Emitting
Signal
Detection
Method | Infrared: 880-950nm | Infrared: 880-950nm | Same |
| SpO2 Range | 70%-100% | 70%-100% | Same |
| SpO2
Accuracy | ±3% | ±3% | Same |
| PR Range | 30 bmp - 250 bmp | 30 bmp - 250 bmp | Same |
| PR Accuracy | ±3 | ±3 | Same |
| Sterile | No | No | Same |
| Usage | Reusable | Disposable, reusable | Same |
| Supplication
site | Finger | Finger or toes | Different (2) |
| Patient
contacting
Materials | Silica gel | Silica gel, Foam, 3M Textile | Different (3) |
| Cable length | 3000 mm | Finger clip: 1100 ± 100 mm | Different (4) |
| Patient end
design | finger clip, | finger clip, soft tip, Textile
Adhesive, and Non-Adhesive | Different (5) |
| Connector
design | 6 pin LEMO Connector | DB9M Connector
Masimo 6p Connector
Hypertronic 7pin Connector | Different (6) |
| 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 of proposed devices is within the range of predicate devices. This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 clinical accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness.
Different (2): The proposed devices are intended used on finger. This clinical use has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 clinical accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness.
Different (3): The predicate devices have 3 type of patient contacting materials and the proposed devices
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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 (4): 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.
Different (5): The predicate devices have 4 type of patient end design (finger clip, soft tip, Textile Adhesive, and Non-Adhesive). The proposed devices have 1 type of patient end which is finger clip. The proposed devices can meet the requirement of IEC 60601-1-2 and ISO 80601-2-61, so this difference does not raise different questions of safety and effectiveness.
Different (6): The connector design depends on the socket of the compatible patient monitor. The proposed devices can meet the requirement of IEC 60601-1-2 and ISO 80601-2-61 with the compatible patient monitor, so this difference does not raise different questions of safety and effectiveness.
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Changke Reusable 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 prolonged duration exceeding 24 hours but not 30 days.
Non-clinical data
The Changke Reusable 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: 2011 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
The tests accordance with IEC 60601-1. IEC 60601-1-2. ISO 80601-2-61 and ISO 10993 series are selected to show substantial equivalence between the subject device and the predicate.
7
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 Changke Reusable 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
Performance testing and compliance with voluntary standards demonstrate that the proposed devices are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.