(360 days)
No
The description focuses on the hardware components and optical principles of operation, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies described are standard accuracy tests using human subjects and simulators, not AI/ML model validation.
No.
The device is indicated for monitoring vital signs (SpO2 and pulse rate), not for treatment or therapy.
Yes
The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)," which are measurements used for diagnostic purposes.
No
The device description explicitly states that the sensors are made up of hardware components including a connector, cable, LEDs, a photo detector, and a sensor housing. It is a physical sensor, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medke Oximetry Finger Sensors are used for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate) directly on the patient's body (finger). They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous non-invasive monitoring," which is characteristic of a patient monitoring device, not an IVD.
Therefore, the Medke Oximetry Finger Sensors fall under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers or toes
Indicated Patient Age Range
adult patients weighing greater than 40kg
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
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.
PR Accuracy:
Use the simulator with patient monitor(NPB40) to test the PR Accuracy in the range of 30-250BPM.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SP02 Accuracy:
- Study type: Invasive "breathe-down" test
- Sample size: 12 healthy adults, 300 data pairs (25 data samples per subject)
- Key results:
- P9119 with NPB-40: Root Mean Square (Arms) for 60-100% range is 1.39, for 70-100% range is 1.37.
- P8119 with NPB-40: Root Mean Square (Arms) for 60-100% range is 1.40, for 70-100% range is 1.39.
- Conclusion: Pass for all ranges (60-79, 80-100, 60-100, 70-100, 60-69, 70-79, 80-89, 90-100).
PR Accuracy:
- Study type: Simulator test
- Sample size: Not explicitly stated, tested with simulator device.
- Key results:
- P9119 with NBP-40: Arms for 70-100% is 1.63.
- P8119 with NBP-40: Arms for 70-100% is 1.67.
- Conclusion: Pass for all ranges (77-70, 84-78, 92-85, 97-92, 100-97).
Overall Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SPO2 Accuracy: ±3%(70-100%)
Pulse Rate Accuracy: ±3(30-250bpm)
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 for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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
2
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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Type of Use (Select one or both, as applicable)
3
Image /page/3/Picture/0 description: The image shows the logo for Medke. The logo is blue with an orange accent. The logo is stylized and appears to be in a sans-serif font.
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.,Baoan |
| Dist.,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.,Baoan |
| Dist.,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:
| Comparison
item | Subject Device
Medke Oximetry
Finger Sensor (Model:
P9119& P8119) | Predicate Device
Reusable and disposable SPO2 sensor
compatibility with Nellcor
(model:T100A-090103 soft sensor)
K100077 | Note | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Intended use&
Indications for
Use | Medke Oximetry
Finger Sensor are
indicated for continuous
non-invasive monitoring
of functional oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate(PR) for adult | When used with a compatible patient
monitor or a pulse oximeter device, Solaris
Medical Technology, Inc. reusable &
disposable SpO2 sensors are intended to be
used for continuous, non-invasive functional
arterial oxygen saturation (SpO2)
and pulse rate monitoring.
Solaris Medical Technology, Inc. reusable | same | |
| | patients weighing
greater than40kg,. | multi-patient use SpO2 Soft Sensors,
reusable multi-patient use SpO2 Finger
Sensors, and disposable single patient use
SpO2 Soft-finger Sensors are for use with
adult/pedliatric patients weighing greater
than 40kg.
Solaris Medical Technology, Inc. disposable
single patient use SpO2 Adhesive
Sensors are for use with adult patients
weighing greater than 40kg, pediatric
patients weighing 10 - 40 kg, and infant
(non-neonatal) patients weighing 3 - 15kg.
Prescription device. | | |
| Measurement
Method | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative Optical Absorption | Same | |
| Light Emitting | Red:660-666nm,
Ired:880-950nm | Red:660-666nm,
Ired:880-950nm | same | |
| Signal
Detection
Method | Photodetector | Photodetector | Same | |
| SPO2 Accuracy | $\pm3%(70-100%)$ | $\pm2%(70-100%)$ | Similar | |
| Pulse Rate
Accuracy | $\pm3(30-250bpm)$ | $\pm2(30-250bpm)$ | Simiar | |
| Applied
population | Adult( $\ge40Kg$ ) | Adult( $\ge40Kg$ ) | same | |
| Measurement
part | Fingers or toes | Fingers or toes | Same | |
| compatible
monitor | 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 | |
| Proximal
connector
Design | DB9 9pin | DB9 7pin | Similar | |
| Distal
connector
Design | finger clip , soft tip, | soft tip | Similar | |
| Conformance
standard | 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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Image /page/7/Picture/0 description: The image shows a logo for a company or organization. The logo is composed of stylized text in blue, with a small orange accent on one of the letters. The text appears to be a brand name or acronym, designed with a modern and bold font style. The overall design is clean and professional, suggesting a corporate identity.
| 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 | Sensor | |||||||
| model | Monitor | |||||||
| model | Arms | |||||||
| 70-100 | 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.