(360 days)
Medke Oximetry Finger 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 than 40kg,
The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM). The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector. The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Parameter/Measurement | Acceptance Criteria (from Comparator) | Reported Device Performance (Medke Oximetry Finger Sensor) | Meets Criteria? |
|---|---|---|---|
| SpO2 Accuracy | ±2% (70-100%) | 1.37% (70-100%) for Model P91191.39% (70-100%) for Model P8119 | Y (per manufacturer's conclusion, as 1.37% and 1.39% are less than 2%) |
| Pulse Rate Accuracy | ±2 (30-250 bpm) | 1.63 (30-250 bpm) for Model P91191.67 (30-250 bpm) for Model P8119 | Y (per manufacturer's conclusion, as 1.63 and 1.67 are less than 2) |
Note on Acceptance Criteria: The document states the predicate device has a SpO2 Accuracy of "±2%(70-100%)" and Pulse Rate Accuracy of "±2(30-250bpm)". While the Medke device reports RMS values (Arms), the conclusion states they "meets the requirements of ISO80601-2-61," implying these results fall within acceptable limits based on that standard, and are presented as meeting the predicate's performance or being substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (SpO2 Accuracy): 12 healthy adults were selected as subjects. Each subject provided 25 data samples, resulting in a total of 300 data pairs (SpO2 vs. SaO2).
- Data Provenance: The study involved an "invasive 'breathe-down' test" on "healthy adult volunteers." The location or country of origin for these volunteers is not explicitly stated, but the company is based in Shenzhen, China. The study appears to be prospective as it involves active testing on human subjects.
- Sample Size for Test Set (PR Accuracy): Not explicitly stated, but tested using a "simulator."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for SpO2 accuracy was established through direct measurement of arterial blood SaO2 using a CO-Oximeter, which is a clinical reference method, not through expert interpretation of images or other subjective data.
- Qualifications of Experts: Not applicable for establishing ground truth as it was based on objective measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The SpO2 accuracy was determined by comparing the device's SpO2 readings directly with SaO2 measured by a CO-Oximeter from arterial blood samples. There was no mention of multiple reviewers or adjudication of subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on device accuracy against a reference standard in controlled conditions, not on how human readers perform with or without AI assistance. The device is an oximetry sensor, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in essence, the accuracy studies for both SpO2 and Pulse Rate represent the standalone performance of the device. The device's output (SpO2 and PR) was directly compared against established ground truth (CO-Oximeter for SpO2, simulator for PR). There is no "human-in-the-loop" interaction described that would affect the device's measurement performance for these parameters.
7. The Type of Ground Truth Used
- SpO2 Accuracy: The ground truth was outcomes data/physiological measurement (SaO2 measured directly from arterial blood samples using a CO-Oximeter). This is an objective, gold-standard method for determining true oxygen saturation.
- PR Accuracy: The ground truth was established by using a simulator with known pulse rates (30-250 BPM). This is also an objective, controlled method.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about a "training set" or "training data." This type of device (oximetry sensor) is based on fundamental biophysical principles and calibrated during manufacturing. It does not typically involve machine learning or AI models that require a separate training dataset for algorithm development in the way a diagnostic AI would. The studies described are for verification/validation of the finished product's performance.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/ML model for this device. The device's underlying measurement principles are well-established for pulse oximetry.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2016
Shenzhen Medke Technology Co., Ltd Lao Chengxin General Manager 4/F, Bldg. A1, Anle Ind. Zone, Hangcheng RD., Baoan Dist. Shenzhen , China 518126
Re: K152390
Trade/Device Name: Medke Oximetry Finger Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 15, 2016 Received: July 20, 2016
Dear Lao Chengxin:
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. 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 mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
James J.
Lee -S
Digitally signed by James J. Lee -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=James J. Lee -S,
0.9.2342.19200300.100.1.1=2000954859
Date: 2016.08.18 17:22:19 -04'00'
For Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation 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)
Device Name
Medke Oximetry Finger Sensor
Indications for Use (Describe)
Medke Oximetry Finger 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 than 40kg,
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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Section 5
510(K) Summary
1. Prepared Date: 2016-8-16
2. Submitter Information
| Name | Shenzhen Medke Technology Co.,LTD |
|---|---|
| Address | 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.,BaoanDist.,Shenzhen,China |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |
3. Contact Person
| Contact person | LAO CHENGXIN |
|---|---|
| Title | General Manager |
| Address | 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.,BaoanDist.,Shenzhen,China |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |
| info@medke.com |
4. Proposed Device Information
| Trade Name | Medke Oximetry Finger Sensor |
|---|---|
| Model | P9119& P8119 |
| Common name | Oximeter |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |
5. Predicate Device Information
| 510(K)No. | Trade Name/model | Submitter |
|---|---|---|
| K100077 | Solaris Medical Technology, Inc.Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. |
6. Device description
The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM).
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Image /page/4/Picture/0 description: The image shows the word "Medke" in a stylized, modern font. The word is primarily blue, with a small orange rectangle above the "d" and another above the "e". The font is bold and angular, giving the word a strong, technological feel.
The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector.
The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.
7. Intended use
Medke Oximetry Finger 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 than 40kg.
8. Comparison to predicate device
The Medke Oximetry Finger Sensors utilize the same measurement principles as the listed predicate devices: two wavelengths of light (red, infrared) from light emitting diodes (LED's) illuminate the patients arterial tissue; and the light transmission through the tissue is measured using a photodiode light detector. The transmission properties vary with the patient's arterial blood saturation and pulse rate.This method is fundamental to all pulse oximeter sensors and monitors for the non-invasive measurement of functional oxygen saturation (SpO2). Please see the comparison list:
| Comparisonitem | Subject DeviceMedke OximetryFinger Sensor (Model:P9119& P8119) | Predicate DeviceReusable and disposable SPO2 sensorcompatibility with Nellcor(model:T100A-090103 soft sensor)K100077 | Note | |
|---|---|---|---|---|
| Intended use&Indications forUse | Medke OximetryFinger Sensor areindicated for continuousnon-invasive monitoringof functional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate(PR) for adult | When used with a compatible patientmonitor or a pulse oximeter device, SolarisMedical Technology, Inc. reusable &disposable SpO2 sensors are intended to beused for continuous, non-invasive functionalarterial oxygen saturation (SpO2)and pulse rate monitoring.Solaris Medical Technology, Inc. reusable | same | |
| patients weighinggreater than40kg,. | multi-patient use SpO2 Soft Sensors,reusable multi-patient use SpO2 FingerSensors, and disposable single patient useSpO2 Soft-finger Sensors are for use withadult/pedliatric patients weighing greaterthan 40kg.Solaris Medical Technology, Inc. disposablesingle patient use SpO2 AdhesiveSensors are for use with adult patientsweighing greater than 40kg, pediatricpatients weighing 10 - 40 kg, and infant(non-neonatal) patients weighing 3 - 15kg.Prescription device. | |||
| MeasurementMethod | 2-wavelength RelativeOptical Absorption | 2-wavelength Relative Optical Absorption | Same | |
| Light Emitting | Red:660-666nm,Ired:880-950nm | Red:660-666nm,Ired:880-950nm | same | |
| SignalDetectionMethod | Photodetector | Photodetector | Same | |
| SPO2 Accuracy | $\pm3%(70-100%)$ | $\pm2%(70-100%)$ | Similar | |
| Pulse RateAccuracy | $\pm3(30-250bpm)$ | $\pm2(30-250bpm)$ | Simiar | |
| Appliedpopulation | Adult( $\ge40Kg$ ) | Adult( $\ge40Kg$ ) | same | |
| Measurementpart | Fingers or toes | Fingers or toes | Same | |
| compatiblemonitor | Nellcor(N395) | Nellcor(N395) | Same | |
| Sterility | No | No | Same | |
| Usage | Reusable | Reusable | Same | |
| Material | ABS,PVC,TPU,Silicone | ABS,PVC,Silicone | Similar | |
| Cable Length | 1.0 | 0.9 | Similar | |
| ProximalconnectorDesign | DB9 9pin | DB9 7pin | Similar | |
| DistalconnectorDesign | finger clip , soft tip, | soft tip | Similar | |
| Conformancestandard | IEC60601-1,IEC60601-1-2.ISO80601-2-61.ISO | IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10 | Same | |
| 10993-5/10 |
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Image /page/5/Picture/0 description: The image shows a logo with the word "Medke" in a stylized font. The letters are primarily blue, with orange accents on the top right of the "e" and the "k". The font is bold and slanted, giving the logo a dynamic and modern appearance.
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Image /page/6/Picture/0 description: The image shows the word "Medke" in a stylized font. The word is written in blue, with the exception of the top part of the letters "e" and "k", which are orange. The font is bold and slanted to the right, giving the word a sense of movement. The background of the image is white.
From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method , Measurement part , compatible monitor , Sterility, Usage & Conformance standard.
Regarding SPO2 & Pulse Rate Accuracy, Material, Distal connector design, both devices have some difference, but the subject devices have passed the ISO80601-2-61, IEC60601-1,IEC60601-1-2,and ISO10993-5/10 testing.
According to contrast and analysis, So, the differences between subject device and predicate device do not raise different questions of safety or effectiveness.
9. Non-clinical test data
The subject device meets the following the recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
10. Clinical data summary
1) SP02 Accuracy
According to IEC80601-2-61, Invasive "breathe-down" test refers to compare SpO2 which was measured from subject devices and CO-Oximeter of measured standard arterial blood SaO2, that is, through comparing and observing the SpO2 which was obtained from five oxygen saturation stable stages by inhaling different FiO2 by volunteers and SaO2 which was measured by extract radial artery blood sample periodically through arterial duct on a group of healthy adult volunteers within the scope of the oximeter accuracy specification.
12 healthy adults were selected as subjects for this accuracy trial. One subject can acquired 25 data samples, and 300 data pairs were obtained. Compare and analyze these data pairs (SPO2VSSaO2), the result is as follows:
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| Model | Monitor | Root Mean Square(Arms) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 60-79 | 80-100 | 60-100 | 70-100 | 60-69 | 70-79 | 80-89 | 90-100 | ||
| P9119 | NPB-40 | 1.57 | 1.31 | 1.39 | 1.37 | 2.6 | 1.52 | 1.38 | 1.26 |
| P8119 | NPB-40 | 1.61 | 1.31 | 1.40 | 1.39 | 1.62 | 1.61 | 1.38 | 1.24 |
| Conclusion | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Table 1 SPO2 Accuracy
2) PR Accuracy
Use the simulator with patient monitor(NPB40) to test the PR Accuracy in the range of 30-250BPM, the testing result is as follows:
| Table 2 Pulse Rate Accuracy | ||||||||
|---|---|---|---|---|---|---|---|---|
| Item | Sensormodel | Monitormodel | Arms70-100 | 77-70 | 84-78 | 92-85 | 97-92 | 100-97 |
| 1 | P9119 | NBP-40 | 1.63 | 1.17 | 0.67 | 1.83 | 2.00 | 2.50 |
| 2 | P8119 | NBP-40 | 1.67 | 0.67 | 2.00 | 1.83 | 2.00 | 1.83 |
| Conclusion | Pass | Pass | Pass | Pass | Pass | Pass |
Table 2 Pulse Rate Accuracy
From the test result above,the SPO2 accuracy of Medke Oximetry Finger Sensor (P9119&P8119) is 1.371.39 in range 70-100%, and the PR accuracy is 1.631.67 in range 30~250 BPM, which meets the requirements of ISO80601-2-61.
11. Substantial Equivalence Statement
Based on the comparison ,analysis, and the submitted performance data, Medke Oximetry Finger Sensors are as safe and effective and are substantially equivalent to the predicate devices.
§ 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).