Mecun SpO2 sensor

K231979 · Shenzhen Mecun Medical Supply Co., Ltd. · DQA · Aug 16, 2024 · Cardiovascular

Device Facts

• Record ID: K231979
• Device Name: Mecun SpO2 sensor
• Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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.

Device Story

Mecun SpO2 sensor is a reusable/disposable patient-contact accessory; connects to compatible Nellcor monitors (e.g., N-600x). Device uses optical plethysmography; LED emitter (red 660nm, infrared 940nm) and photodetector measure light absorption of arterial hemoglobin in finger. Output is processed by the host monitor to display SpO2 and pulse rate. Used in hospital settings by qualified healthcare personnel for continuous monitoring. Benefits include non-invasive, real-time assessment of patient oxygenation and heart rate, aiding clinical decision-making regarding respiratory status.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61:2017 and FDA pulse oximeter guidance. Testing verified SpO2 and pulse rate accuracy in adult subjects. Results demonstrated SpO2 accuracy of ±3% (70-80%) and ±2% (80-100%), and pulse rate accuracy of ±3 bpm (20-250 bpm).

Technological Characteristics

Sensor housing (non-woven), cable (PVC). Sensing principle: 2-wavelength optical absorption (660nm/940nm). Connectivity: wired connection to Nellcor-compatible monitors. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1. Non-sterile.

Indications for Use

Indicated for continuous non-invasive monitoring of SpO2 and pulse rate in adult patients weighing >40kg in hospital settings.

Regulatory Classification

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.

Predicate Devices

• Reusable and Disposable SpO2 Sensors (K201360)

Reference Devices

• Nellcor N-600x (K060576)

Submission Summary (Full Text)

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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.

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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<br>Industrial Park, Zhugushi, Wulian Community, Longgang<br>Street, Longgang District, Shenzhen City, China |
| Telephone | [phone] |
| Fax number | [phone] |
| E-mail | [e-mail]; [e-mail] |
| 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

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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<br>item | Subject Device | Predicate Device (K201360) | Remark |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Manufacturer | Shenzhen Mecun Medical<br>Supply Co., Ltd. | Xinkang Medical Instrument<br>Co., Ltd. | / |
| Product name | Mecun SpO2 sensor | Reusable and Disposable<br>SpO2 Sensors | / |
| Model | Adult/disposable: MC-FN011M | Adult/disposable: XDAN<br>Adult/reusable: XSAE3 | Same<br>(only<br>disposable<br>type<br>included) |
| Product Code | DQA | DQA | Same |
| Regulation<br>Number | 870.2700 | 870.2700 | Same |
| Classification | II | II | Same |
| Intended<br>use&<br>Indication<br>s for Use | Mecun SpO2 sensor is<br>indicated for continuous non-<br>invasive monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate (PR) for adult<br>patients weighing greater than<br>40kg. The sensor is intended to<br>be used in hospital settings<br>where patient care is offered by<br>qualified healthcare personnel. | The Reusable & Disposable<br>SPO2 Sensors are indicated for<br>continuous non-invasive<br>monitoring of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR) for adult patients<br>weighing greater than 40kg.<br>The sensors are intended to be<br>used in hospital settings where<br>patient care is offered by<br>qualified healthcare personnel. | Same |
| Measurement<br>Method | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption | Same |
| Light<br>Emitting | Red: 660nm<br>Infrared: 940nm | Red: 660nm±3nm<br>Infrared: 880-950nm | Similar |
| Signal<br>Detection | Photodetector | Photodetector | Same |

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| Method | | | |
|-----------------------------------------|-------------------------------------------------------|-------------------------------------------------------|---------|
| SpO2<br>Accuracy | ±3% (70-80%)<br>±2% (80-100%)<br>Undefined ( < 70%) | ±3% (70-100%)<br>Undefined ( < 70%) | Note 1 |
| Pulse<br>Rate<br>Accuracy | ±3(20-250bpm) | ±3(30-250bpm) | Similar |
| Applied<br>population | Adult (≥40Kg) | Adult (≥40Kg) | Same |
| Cable length | MC-FN011M: 900±50mm | XDAN: 1m | Similar |
| Measurement<br>part | Finger | Finger | Same |
| Sensor<br>terminal | Non-woven | Non-woven | Same |
| Sterility status | Non-sterile | Non-sterile | Same |
| Compatible<br>monitor | Nellcor | Nellcor | Same |
| Sterile | No | No | Same |
| Material<br>contacted with<br>patient | Sensor housing: non-woven<br>Cable: PVC | Sensor housing: non-woven<br>Cable: PVC | Same |
| Biocompatibilit<br>y | Cytotoxicity<br>Skin irritation<br>Skin sensitization | Cytotoxicity<br>Skin irritation<br>Skin sensitization | Same |
| Electrical<br>Performance<br>and Safety | IEC60601-1, IEC60601-1-2,<br>ISO80601-2-61 | IEC60601-1, IEC60601-1-2,<br>ISO80601-2-61 | Same |

#### Note 1:

The SpO2 Accuracy of subject device has slightly difference from the predicate device. But the subject device's SpO2 Accuracy meets the requirement of ISO80601-2-61 as well as the requirements of FDA guidance of pulse oximeters, so this difference also does not raise any safety and effectiveness issue.

#### 7. Performance data

The subject device conforms to the following standards:

#### 7.1 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

7.2 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:

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- . IEC 60601-1: 2005 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014 + A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC
- . ISO 80601-2-61: 2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard for performance effectiveness

### 7.3 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
- . 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

## 7.4 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.

## 8. Conclusions

Based on device comparison information and performance data, the subject device is as safety and effectiveness as predicate device, and the differences in technological characteristics do not raise any new issue of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.