(147 days)
Not Found
No
The summary describes a standard pulse oximeter that measures SpO2 and pulse rate using traditional methods and does not mention any AI or ML components.
No.
The device is a non-invasive monitor intended for the spot-check of physiological parameters (oxygen saturation and pulse rate), not for providing therapy or treatment.
Yes
The device measures oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are bio-parameters used to monitor and detect hypoxemia, a condition that can result from various respiration diseases. The "Intended Use" explicitly states it's for "spot-check of oxygen saturation... and the pulse rate of adult and pediatric patients in home and hospital environments," and the "Device Description" explains its role in "monitoring the SpO2... in the clinical rescuing" of patients with respiration diseases. These measurements provide information crucial for diagnosing or assessing specific medical conditions, particularly those related to respiratory function.
No
The device description explicitly details hardware components such as a sensor, screen, and power source (2 AAA alkaline batteries), and mentions electrical safety and electromagnetic compatibility testing, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, 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 CMS-50C is described as a "non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate". It measures these parameters by placing a sensor on the patient's finger.
- Method of measurement: The text explicitly contrasts the device's method with the "traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpQ2 by use the blood-gas analyzer." This highlights that the Pulse Oximeter does not analyze a sample taken from the body.
Therefore, since the device measures physiological parameters directly from the body without analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pulse Oximeter CMS-50C is a non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.
The Pulse Oximeter CMS-50C is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). This device is not intended for continuous monitoring.
Product codes
DQA
Device Description
The pulse oxygen saturation is the percentage of HbO2 in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient's life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpQ2 by use the blood-gas analyzer. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Pulse Oximeter. The device can measure the pulse rate simultaneously.
Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. The You just need to put the into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
The applicant device has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline.
The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products.
The device is electrically operated and the Electrical Safety Test and Electromagnetic Compatibility Test following IEC 60601-1 and IEC60601-1-2 were conducted.
The device is not kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
Home, hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc).
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)
The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital. The accuracy of CMS-50C pulse oximeter equipment is compliance to the requirement, and the product is safe during the use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) Number is:
1. Applicant Device Information
Trade/Proprietary Name: Pulse Oximeter CMS-50C Common Name: Oximeter Classification Name: Oximeter Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology Intended Use:
Pulse Oximeter CMS-50C is a non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.
2. Submitter Information
Manufacturer Name:
Contec Medical System Co., LTD. No.2-1 Hengshan Road, Economic and Technical Development Zone Oinghuangdao , Hebei,China, 066000
Contact Person of the Submission:
Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong(@mid-link.net eric.chen@mid-link.net
1
3. Predicate Device
Fingertip pulse Oximeter MD300C (K070371)
K-number: K070371
Product Code: DQA
Intended Use:
Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.
Manufactured by:
Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B 1126-1127, Fuxing Road A36, Beijing , P.R.China, 100039
4. Device Description
The pulse oxygen saturation is the percentage of HbO2 in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient's life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpQ2 by use the blood-gas analyzer. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Pulse Oximeter. The device can measure the pulse rate simultaneously.
Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. The You just need to put the into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
The applicant device has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline.
The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products.
The device is electrically operated and the Electrical Safety Test and Electromagnetic Compatibility Test following IEC 60601-1 and IEC60601-1-2 were conducted. Please see the
2
Attachment 2 Electrical Safety and EMC Test.
The Performance Test reports Low-Voltage Alarm System are presented in Attachment 3 Performance Bench Test.
The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital provided in Attachment 4 Clinical Test Reports.
All applicable standards are listed in Chapter II Standards.
The device is not kit.
3
5. Effectiveness and Safety Considerations
Effectiveness:
The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the safety and essential performance of pulse oximeter
The accuracy of CMS-50C pulse oximeter equipment is compliance to the requirement, and the product is safe during the use. It can be used in the clinical environment. It is substantially equivalent to other pulse oximeter product with the same effectiveness and safety.
Safety Considerations:
The Performance Test reports Low-Voltage Alarm System are presented in Attachment 3 Performance Bench Test.
The test results of biocompatibility of all the skin-contacting material are presented as Table IV-2 for the consideration of Biological Specifications. Please see Appendix 1 Biocompatibility Reports.
The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility.
The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -. Requirements and tests
The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
4
6. Substantially Equivalence Determination
Comparison Analysis
The applicant device has same classification informations and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The only difference is working time Operating temperature, PR display range, Relative humidity, Atmosphere pressure. These differences are slight and do not effluence the effectiveness and safety of the device and don't raise new question of effectiveness and safety.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using a black and white color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2008
Contec Medical System Company, Limited C/O Ms. Diana Hong Official Correspondent Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999, Zhong Shan No.2 Road(S) Shanghai CHINA 200030
Re: K073454
Trade/Device Name: Pulse Oximeter CMS-50C Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 29, 2008 Received: April 29, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
6
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K073454
Device Name: Pulse Oximeter CMS-50C
Indications for Use:
The Pulse Oximeter CMS-50C is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). This device is not intended for continuous monitoring.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nini Ch
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
| 510(k) Number: | K073454 |
|---|---|
| ---------------- | --------- |