(335 days)
No
The summary describes standard pulse oximetry technology and mentions no AI/ML components or related performance metrics.
No
The device is described as non-invasive, intended for monitoring non-invasive oxygen saturation and pulse rate. Monitoring devices typically do not actively treat a condition, which is the primary function of a therapeutic device.
Yes
The device is described as a Pulse Oximeter intended for "spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate." Monitoring these physiological parameters to assess a patient's health status falls under the definition of a diagnostic purpose, as it helps in identifying or assessing a medical condition.
No
The device description explicitly states it is a "battery powered fingertip device" composed of hardware modules (power, signal acquisition, control and signal processing) and includes a sensor for oximetry. It is not solely software.
No, 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 Pulse Oximeter CMS50EW measures oxygen saturation and pulse rate non-invasively through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, based on the provided information, the Pulse Oximeter CMS50EW is a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.
Product codes
DQA
Device Description
The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology.
The proposed device is composed of power module, signal acquisition module, control and signal processing module. The power source of it is a built-in rechargeable lithium battery. And it has alarm function, to raise the user's attention for exceeding of physiological limit and device error via visual and audio alarming indicator. And the pulse oximeter can communicate with computer by USB data wire and Bluetooth.
The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry technology including the sensor was unchanged.
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 patients
Intended User / Care Setting
home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings).
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 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.
- A IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
- A ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
In addition, wireless transmission function test, including wireless transmission performance, data integrity, wireless coexistence, and security of wireless data, was conducted per the FDA guidance, Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued on January 3, 2007. The test results complied with the acceptance criteria.
Clinical testing was not necessary in this submission to support the device modification because the oximetry technology including the sensor is unchanged from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 70%100%:±2%, 069%,unspecified
PR accuracy: ±2bpm or ±2% (select the larger)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Contec Medical Systems Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China
Re: K141362
Trade/Device Name: Pulse Oximeter CMS50EW Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 18, 2015 Received: March 23, 2015
Dear Ms. Hong:
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 may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Hong
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 the quality systems (QS) 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,
Tejashri Purohit-Sheth, M.D. Tejash
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division 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) K141362
Device Name Pulse Oximeter CMS50EW
Indications for Use (Describe)
The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of noninvasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.
| 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)
ing the
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Tab #1 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K141362
-
- Date of Submission: 04/20/2015
-
- Sponsor Identification
Contec Medical Systems Co., Ltd No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.
Establishment Registration Number: 3006979678
Contact Person: Xueyong Li Position: Quality Manager Tel: 86 355 8015489 Fax: 86 355 8015490 Email: lxy1011@163.com
-
- Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
4
-
- Proposed Device Identification
Proposed Device Name: Pulse Oximeter CMS50EW Proposed Device Model: CMS50EW Proposed Device Common Name: Pulse Oximeter
- Proposed Device Identification
Regulatory Information: Classification Name: Oximeter; Classification: 2; Product Code: DQA; Regulation Number: 870.2700; Review Panel: Anesthesiology;
Intended Use Statement:
The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.
న్. Predicate Device Identification
510(k) Number: K090671 Product Name: Pulse Oximeter CMS50E Manufacturer: Contec Medical Systems Co., Ltd
-
- Device Description
The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology.
- Device Description
The proposed device is composed of power module, signal acquisition module, control and signal processing module. The power source of it is a built-in rechargeable lithium battery. And it has alarm function, to raise the user's attention for exceeding of physiological limit and device error via visual and audio alarming indicator. And the pulse oximeter can communicate with computer by USB data wire and Bluetooth.
The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry
5
technology including the sensor was unchanged.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
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.
-
A IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
-
A ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
In addition, wireless transmission function test, including wireless transmission performance, data integrity, wireless coexistence, and security of wireless data, was conducted per the FDA guidance, Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued on January 3, 2007. The test results complied with the acceptance criteria.
-
- Clinical Test
Clinical testing was not necessary in this submission to support the device modification because the oximetry technology including the sensor is unchanged from the predicate device.
- Clinical Test
-
Substantially Equivalent (SE) Conclusion 9.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | DQA | Same |
| Regulation No. | 21 CFR 870.2700 | Same |
| Class | 2 | Same |
| Intended Use | The Pulse Oximeter CMS50EW is a non-invasive device | |
| intended for spot-check or continuous monitoring of | ||
| non-invasive oxygen saturation of arterial hemoglobin | Same | |
| (SpO2) and the pulse rate through the finger of adult | ||
| patients in home and hospital environments (including | ||
| clinical use internist/surgery, anesthesia, and intensive | ||
| care settings). The device is reusable and not intended for | ||
| out-of-hospital transport use. | ||
| Features | %SpO2 and PR measurement, | |
| Pulse bar, Alarm function, | ||
| Bluetooth | %SpO2 and PR | |
| measurement, | ||
| Pulse bar, Alarm | ||
| function, no Bluetooth | ||
| function. | ||
| Principles of operation | An experience formula of data process is established | |
| taking use of Lambert Beer Law according to Spectrum | ||
| Absorption Characteristics of Reductive Hemoglobin | ||
| (Hb) and Oxyhemoglobin (HbO2) in glow & | ||
| near-infrared zones. Operation principle of the device is: | ||
| Photoelectric Oxyhemoglobin Inspection Technology is | ||
| adopted in accordance with Capacity Pulse Scanning & | ||
| Recording Technology, so that two beams of different | ||
| wavelength of lights can be focused onto human nail tip | ||
| through perspective clamp finger-type sensor. Then | ||
| measured signal can be obtained by a photosensitive | ||
| element, information acquired through which will be | ||
| shown on screen through treatment in electronic circuits | ||
| and microprocessor. | Same | |
| Measurement wavelength | Red: 660nm | |
| Infrared: 880nm | Same | |
| SpO2 range | 0%-100% | Same |
| SpO2 accuracy | 70% | Same |
| PR measurement range | 30bpm~250bpm | Same |
| PR accuracy | $±2bpm$ or $±2%$ (select the larger) | Same |
| Patient Contact | Silicone | Same |
| Material | ||
| Electrical Safety | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Same |
| Label and Labeling | Meet FDA's Requirements | Same |
Table 1 Comparison of Technology Characteristics
6
The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry technology including the sensor was unchanged.
7
Based on the comparison above, the proposed device, Pulse Oximeter CMS50EW, is determined to be Substantially Equivalent (SE) to the predicate device, Pulse Oximeter CMS50E (K090671).