(408 days)
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.
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.
The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Guidance) | Reported Device Performance (Mecun SpO2 sensor) | Comment |
|---|---|---|
| ISO 80601-2-61: 2017 SpO2 Accuracy (70-80% SpO2) | ±3% | Meets requirement. The predicate device's accuracy was ±3% for 70-100%, implying the subject device also meets this, specifically within this range. |
| ISO 80601-2-61: 2017 SpO2 Accuracy (80-100% SpO2) | ±2% | Meets requirement. Better accuracy in this range compared to the predicate device's ±3% for 70-100%, but still within acceptable limits as per ISO 80601-2-61 and FDA guidance. |
| ISO 80601-2-61: 2017 SpO2 Accuracy (< 70% SpO2) | Undefined | Consistent with the predicate device and standard practice for pulse oximeters, which typically do not define accuracy below 70%. |
| Pulse Rate Accuracy | ±3 (20-250bpm) | Similar to predicate device (±3 for 30-250bpm). The subject device's lower limit for pulse rate accuracy is better (20bpm vs 30bpm), indicating no new safety or effectiveness issues. |
| Biocompatibility Testing (ISO 10993-1) | Cytotoxicity, Skin Sensitization, Skin Irritation | Performed and passed. This demonstrates the device's materials are safe for patient contact. |
| Electrical Safety (IEC 60601-1) | Compliant | Indicates the device meets general requirements for basic safety and essential performance of medical electrical equipment. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant | Ensures the device operates safely in its electromagnetic environment without causing or being susceptible to undue electromagnetic disturbances. |
| Performance Effectiveness (ISO 80601-2-61) | Compliant | Comprehensive compliance with this standard indicates the device meets particular requirements for basic safety and essential performance of pulse oximeter equipment, which includes SpO2 and PR accuracy. |
| Guidance: "Pulse Oximeters - Premarket Notification Submissions" | Clinical testing performed | Clinical studies were conducted according to this FDA guidance, ensuring the rigor and relevance of the clinical performance evaluation for market approval. |
2. Sample size used for the test set and data provenance
- Sample Size for Test Set: The document states that "Clinical studies were conducted to verify the accuracy of subject device" but does not specify the exact sample size used for the clinical test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of clinical studies for SpO2 accuracy (desaturation studies involving human subjects) strongly suggests a prospective design where subjects are enrolled and monitored specifically for the study.
3. Number of experts used to establish the ground truth for the test set and their qualifications
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. For SpO2 accuracy studies, the "ground truth" is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual interpretation. However, medical personnel would be extensively involved in performing the study according to protocol and ensuring data quality.
4. Adjudication method for the test set
The document does not specify an adjudication method. For pulse oximetry accuracy studies using arterial blood gas analysis, an adjudication method in the traditional sense (e.g., 2+1 reader consensus) is generally not applicable, as ground truth (SaO2 from co-oximetry) is a direct physiological measurement, not an interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
This is a standalone device (SpO2 sensor), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for the Mecun SpO2 sensor is standalone (device-only performance). The clinical study evaluated the direct accuracy of the SpO2 sensor in comparison to a reference standard (arterial blood gas analysis/co-oximetry) without human interpretation being a variable in the device's output.
7. The type of ground truth used
The ground truth for the SpO2 accuracy validation in clinical studies is typically established by arterial blood gas analysis (co-oximetry). This is the physiological reference standard for measuring functional oxygen saturation (SaO2).
8. The sample size for the training set
This device is a hardware sensor, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a training set sample size is not applicable. The device's internal algorithms for processing optical signals to derive SpO2 and PR are designed and validated through engineering principles and testing against physiological models and clinical data, distinguishing it from adaptive AI models that train on vast datasets.
9. How the ground truth for the training set was established
As mentioned, a "training set" is not applicable for this type of hardware device. The internal algorithms and calibration are established through engineering design, physiological modeling, and validation against known physical and physiological parameters, rather than based on labeled training data as used in machine learning.
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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 (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
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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 AilianIndustrial Park, Zhugushi, Wulian Community, LonggangStreet, 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
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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:
| Comparisonitem | Subject Device | Predicate Device (K201360) | Remark |
|---|---|---|---|
| Manufacturer | Shenzhen Mecun MedicalSupply Co., Ltd. | Xinkang Medical InstrumentCo., Ltd. | / |
| Product name | Mecun SpO2 sensor | Reusable and DisposableSpO2 Sensors | / |
| Model | Adult/disposable: MC-FN011M | Adult/disposable: XDANAdult/reusable: XSAE3 | Same(onlydisposabletypeincluded) |
| Product Code | DQA | DQA | Same |
| RegulationNumber | 870.2700 | 870.2700 | Same |
| Classification | II | II | Same |
| Intendeduse&Indications for Use | Mecun SpO2 sensor isindicated for continuous non-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate (PR) for adultpatients weighing greater than40kg. The sensor is intended tobe used in hospital settingswhere patient care is offered byqualified healthcare personnel. | The Reusable & DisposableSPO2 Sensors are indicated forcontinuous non-invasivemonitoring of functional oxygensaturation of arterialhemoglobin (SpO2) and pulserate (PR) for adult patientsweighing greater than 40kg.The sensors are intended to beused in hospital settings wherepatient care is offered byqualified healthcare personnel. | Same |
| MeasurementMethod | 2-wavelength RelativeOptical Absorption | 2-wavelength RelativeOptical Absorption | Same |
| LightEmitting | Red: 660nmInfrared: 940nm | Red: 660nm±3nmInfrared: 880-950nm | Similar |
| SignalDetection | Photodetector | Photodetector | Same |
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| Method | |||
|---|---|---|---|
| SpO2Accuracy | ±3% (70-80%)±2% (80-100%)Undefined ( < 70%) | ±3% (70-100%)Undefined ( < 70%) | Note 1 |
| PulseRateAccuracy | ±3(20-250bpm) | ±3(30-250bpm) | Similar |
| Appliedpopulation | Adult (≥40Kg) | Adult (≥40Kg) | Same |
| Cable length | MC-FN011M: 900±50mm | XDAN: 1m | Similar |
| Measurementpart | Finger | Finger | Same |
| Sensorterminal | Non-woven | Non-woven | Same |
| Sterility status | Non-sterile | Non-sterile | Same |
| Compatiblemonitor | Nellcor | Nellcor | Same |
| Sterile | No | No | Same |
| Materialcontacted withpatient | Sensor housing: non-wovenCable: PVC | Sensor housing: non-wovenCable: PVC | Same |
| Biocompatibility | CytotoxicitySkin irritationSkin sensitization | CytotoxicitySkin irritationSkin sensitization | Same |
| ElectricalPerformanceand Safety | IEC60601-1, IEC60601-1-2,ISO80601-2-61 | IEC60601-1, IEC60601-1-2,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.
§ 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).