(408 days)
No
The document describes a standard pulse oximeter sensor that uses optical absorption to measure SpO2 and pulse rate. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a sensor for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate), which are diagnostic in nature, not therapeutic. It states it is intended to be connected to an oximeter for monitoring, not for delivering therapy.
Yes
The device is indicated for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)". Monitoring biological parameters to assess a patient's physiological state is a diagnostic function.
No
The device description explicitly states it consists of hardware components: a connector, cable, patient sensor terminal, LED emitter, and LED detector.
Based on the provided information, the Mecun SpO2 sensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc.
- The Mecun SpO2 sensor is a non-invasive device. It measures oxygen saturation and pulse rate directly from the patient's finger using optical means. It does not require the collection or analysis of any bodily fluids or tissues.
The device description and intended use clearly indicate that it is a sensor that attaches to the patient's body to monitor physiological parameters, which is characteristic of a non-invasive medical device, not an IVD.
N/A
Intended Use / Indications for Use
Mecun SpO2 sensor is 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 sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.
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 weighing greater than 40kg.
Intended User / Care Setting
qualified healthcare personnel / hospital 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)
Biocompatibility testing: The biocompatibility evaluation for Mecun 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 terminal sensor and cable are considered to be contacted with patient's intact skin for duration of less than 24 hours. The biocompatibility testing includes the following: 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 following standards: IEC 60601-1: 2005 + A1:2012 + A2:2020, IEC 60601-1-2: 2014 + A1:2020, ISO 80601-2-61: 2017.
Clinical study: Clinical studies were conducted to verify the accuracy of subject device. The clinical studies were conducted per following standards: ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment and Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff Clinical testing has been performed under an approved protocol with subject informed consent.
Summary: Based on the non-clinical performance and clinical data as documented in the device development, the subject device has a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: ±3% (70-80%), ±2% (80-100%), Undefined (
§ 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
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August 16, 2024
Shenzhen Mecun Medical Supply Co., Ltd. Zheng Bo General Manager 2nd Level, 2nd Building, Fuqiang S&T Park, 6 Ailian Industrial Park, Zhugushi, Wulian Community Shenzhen, Guangdong province 518000 China
Re: K231979
Trade/Device Name: Mecun SpO2 sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 8, 2024 Received: April 8, 2024
Dear Zheng Bo:
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 (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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of 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
3
Indications for Use
510(k) Number (if known) K231979
Device Name Mecun SpO2 sensor
Indications for Use (Describe)
Mecun SpO2 sensor is 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 sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
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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510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Submitter
| Submitter's Name | Shenzhen Mecun Medical Supply Co., Ltd. |
|---|---|
| Contact Person | Zheng Bo |
| Address | 2nd Level, 2nd Building, Fuqiang S&T Park, 6 Ailian |
| Industrial Park, Zhugushi, Wulian Community, Longgang | |
| Street, Longgang District, Shenzhen City, China | |
| Telephone | +86-755-86062204 |
| Fax number | +86-755-86062204 |
| james@szcsqy.com; manager@mecun.com | |
| Data preparation | April 8th, 2024 |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Mecun SpO2 sensor |
| Classification name: | Oximeter |
| Classification: | II |
| Review Panel: | Cardiovascular devices |
| Product Code: | DQA |
| Regulation Number: | 870.2700 |
3. Predicate Device Information
| Trade Name | Reusable and Disposable SpO2 Sensors |
|---|---|
| 510(k) Number | K201360 |
| Classification name | Oximeter |
| Classification: | II |
| Review Panel: | Cardiovascular devices |
| Product code | DQA |
| Regulation No. | 870.2700 |
4. Device Descriptions
Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven
5
housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.
5. Intended Use/Indications for Use
Mecun SpO2 sensor is 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 sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
6. Comparisons of technological characteristics with the predicate device
Mecun SpO2 sensor and Xinkang SpO2 sensors (K201360) are similar in intended use, compositions, functions, scientific technology, materials and method of operation, the following table provides a comparison summary:
| Comparison
| item | Subject Device | Predicate Device (K201360) | Remark |
|---|---|---|---|
| Manufacturer | Shenzhen Mecun Medical | ||
| Supply Co., Ltd. | Xinkang Medical Instrument | ||
| Co., Ltd. | / | ||
| Product name | Mecun SpO2 sensor | Reusable and Disposable | |
| SpO2 Sensors | / | ||
| Model | Adult/disposable: MC-FN011M | Adult/disposable: XDAN | |
| Adult/reusable: XSAE3 | Same | ||
| (only | |||
| disposable | |||
| type | |||
| included) | |||
| Product Code | DQA | DQA | Same |
| Regulation | |||
| Number | 870.2700 | 870.2700 | Same |
| Classification | II | II | Same |
| Intended | |||
| use& | |||
| Indication | |||
| s for Use | Mecun SpO2 sensor is | ||
| 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 sensor is intended to | |||
| be used in hospital settings | |||
| where patient care is offered by | |||
| qualified healthcare personnel. | The Reusable & Disposable | ||
| SPO2 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 sensors are intended to be | |||
| used in hospital settings where | |||
| patient care is offered by | |||
| qualified healthcare personnel. | Same | ||
| Measurement | |||
| Method | 2-wavelength Relative | ||
| Optical Absorption | 2-wavelength Relative | ||
| Optical Absorption | Same | ||
| Light | |||
| Emitting | Red: 660nm | ||
| Infrared: 940nm | Red: 660nm±3nm | ||
| Infrared: 880-950nm | Similar | ||
| Signal | |||
| Detection | Photodetector | Photodetector | Same |
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| Method | |||
|---|---|---|---|
| SpO2 | |||
| Accuracy | ±3% (70-80%) | ||
| ±2% (80-100%) | |||
| Undefined ( |