(173 days)
No
The description details a standard pulse oximetry sensor using LEDs, a photo-detector, and a microprocessor to calculate SpO2. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is strictly for monitoring and not for diagnosis or treatment.
Yes
The device continuously monitors and spot-checks functional oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device as it provides information for diagnosis.
No
The device description explicitly states it consists of hardware components including connectors, cable, patient side sensor with LEDs and a photo-detector, and a microprocessor. It also mentions electrical safety and EMC testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This SpO2 sensor measures oxygen saturation and pulse rate by shining light through the finger and detecting the light transmitted. This is a non-invasive measurement taken directly from the patient's body, not from a specimen taken from the body.
- Intended Use: The intended use clearly states "continuous monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR...)" using a sensor on the finger. This is a direct physiological measurement.
Therefore, based on the provided information, this device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This SpO2 Sensor is intended for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And one side of sensor is designed to locate light emitting diodes (LEDs) and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2).
The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000 Express Patient Monitor, which has been cleared by K070791. And the function alarms and interface accessories are controlled by the monitor, and such information is not available in this submission.
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 and pediatric 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)
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
Biocompatibility testing: The biocompatibility evaluation for the SpO2 Sensor was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests: Cytotoxicity, Skin Sensitization, Skin Irritation.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing: Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard for performance effectiveness.
Software Verification and Validation Testing: Not applicable, no software is embedded.
Clinical data: Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-6:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The SpQ2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations and per FDA's guidance for Pulse Oximeters, darkly pigmented subjects are included in the desaturation study is three.
Summary: Based on the non-clinical performance and clinical data as documented in the device development, the subject devices were found to be as safe and as effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: ±2%
Pulse Rate Accuracy: ±2 bpm
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.
Not Found
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
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Upnmed Equipment Co., Ltd. Fu Jian Management Representative 4th Floor, Building #1 East, Huihuang Industrial Area Xitian Community, Gongming Town. Guangming District Shenzhen, 518107 Cn
Re: K183277
Trade/Device Name: SpO2 Sensor U401-A, U401-B, U401-C, U401-D Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: April 8, 2019 Received: April 16, 2019
Dear Fu Jian:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Michael Ryan 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
Indications for Use
510(k) Number (if known) K183277
Device Name
SpO2 Sensor, models U401-A, U401-B, U401-C, U401-D
Indications for Use (Describe)
This SpO2 Sensor is intended for the continuous nonitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.
| 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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3
510(k) Summary
K183277
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Upnmed Equipment Co., Ltd.
4th Floor, Building #1 East, Huihuang Industrial Area, Xitian Community,
Gongming Town, Guangming District, 518107, Shenzhen, P.R. China
Tel.: +86 -755-29728789
Fax: +86 -755-29423789 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fu Jian |
| Prepare date: | 2019-04-08 |
| 2. Device name
and classification: | Device Name: SpO2 Sensor
Models: U401-A, U401-B, U401-C, U401-D
Classification Name: 21 CFR 870.2700 Oximeter
Product code: DQA
Regulatory Class: Class II |
| 3. Reason for
Submission | New Application. |
| 4. Predicate
Device(s): | Shenzhen Med-link Electronics Tech Co., Ltd., Shenzhen Med-Link Pulse Oximeter
Probe, model S0136J-L/ K113727 |
| 5. Device
Description: | The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And
one side of sensor is designed to locate light emitting diodes (LEDs) and a light
detector (called a photo-detector). Red and Infrared lights are shone through the
tissues from one side of the probe to the other. Then parts of the light emitted
absorbed by blood and tissues. The light absorbed by the blood varies with the
oxygen saturation of haemoglobin. After that, the photo-detector detects the light
volume transmitted through the tissues which depends on blood pulse, Hereafter, the
microprocessor calculates a value for the oxygen saturation (SpO2).
The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000
Express Patient Monitor, which has been cleared by K070791. And the function
alarms and interface accessories are controlled by the monitor, and such information
is not available in this submission. |
4
This SpO2 Sensor is intended for the continuous noninvasive monitoring and 6. Indications for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and Use: pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.
7. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness as the predicate device.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness of the subject device. And the differences do not raise different questions of safety of effectiveness.
| ITEM | Proposed Device
U401 Series SpO2 Sensor | Predicate Device
S0136J-L/K113727 | Comparison
Result |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Upnmed Equipment
Co., Ltd. | Shenzhen Med-link Electronics
Tech Co., Ltd. | --- |
| Indications for Use | This SpO2 Sensor is intended
for the continuous noninvasive
monitoring and spot-checking
of functional oxygen saturation
of arterial hemoglobin (SpO2)
and pulse rate (PR, measured
by an SpO2 sensor) for use
with adult and pediatric
patients. | Shenzhen Med-link disposable
probe, model S0136J-L, is
indicated for single patient use
when continuous, non-invasive
arterial oxygen saturation and
pulse rate monitoring are
required for adult patients or
pediatric patients weighing more
than 30 kg. The S0136J-L is
contraindicated for use with
patients during motion
condition. | Different 1 |
| Intended patient
population | Pediatric, Adult | Pediatric, Adult | Same |
| Intended
application site | Finger | Finger | Same |
| use under motion
and low perfusion
conditions | No | No | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Light Emitting
Diodes (LEDs)
wavelengths | RED: 660 nm, nominal
IRED: 905nm, nominal | RED: 660 nm, nominal
IRED: 905 nm, nominal | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| SpO2 Range | 70% -100% | 70%-100% | Same |
| SpO2 Accuracy | ±2% | ±3% | Different 2 |
| Pulse Rate Range | 20 bpm - 250 bpm | 20 bpm – 250 bpm | Same |
| Pulse Rate
Accuracy | ±2 bpm | ±3 bpm | Different |
| Measuring Mode | spot-checking or continuous
monitoring | spot-checking or continuous
monitoring | Same |
| Shipped Sterile | No | No | Same |
| Storage and
Transport | Temperature: -10℃to 50°C
Atmospheric Pressure: 50 kPa
to 106 kPa
Relative Humidity: ≤93% (no
condensation) | Temperature: -10℃to 40°C
Atmospheric Pressure: 86 kPa to
106 kPa
Relative Humidity: 0%-80% (no
condensation) | Different 3 |
| Operating
Temperature | Temperature: 5°C to 40°C
Atmospheric Pressure: 50 kPa
to 106 kPa
Relative Humidity: ≤85% (no
condensation) | Temperature: -10℃to 40°C
Atmospheric Pressure: 86 kPa to
106 kPa
Relative Humidity: 0%-80% (no
condensation) | |
| Physical Specifications | | | |
| Cable Length | 1.0 m | 0.9 m | Different 4 |
Table 1 Comparison between main predicate S0136J-L and the subject device
5
Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the difference of indications for Use is caused by different language, so the difference do not raise different questions of safety and effectiveness.
- Different Indications for Use
-
- Different SpO2 Accuracy
The accuracy of the subject device is ±2%, which of the predicate is ±3%, which means the performance of the subject is better, and such specification is verified per the international standard ISO 80601-2-61, so the different accuracy will be acceptable for the subject probe.
- Different SpO2 Accuracy
-
- Different Storage and Transport
Minor difference to Storage & Transport and operation environments (including Temperature, Atmospheric Pressure and Relative Humidity) for the subject device, but the system has been proved to be safe and effective since the testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes do not raise different questions of safety and effectiveness.
- Different Storage and Transport
-
- Different Physical Specifications
The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor differences do not raise different questions of safety and effectiveness.
- Different Physical Specifications
As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The main differences between the subject and predicate devices are minor, including only the operating/storage environment, cable length which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical, the different technological characteristics do not raise different questions of safety and effectiveness.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
6
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the SpO2 Sensor was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard for performance effectiveness.
Software Verification and Validation Testing
Not applicable, no software is embedded.
Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-6:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The SpQ2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations and per FDA's guidance for Pulse Oximeters, darkly pigmented subjects are included in the desaturation study is three.
Summary
Based on the non-clinical performance and clinical data as documented in the device development, the subject devices were found to be as safe and as effective as the predicate device.
9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.