(195 days)
The Fingertip Pulse Oximeter is a reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. M230, M230A, M230B and M230C display the measuring results on 1.3" LED screen, and the screen of M130, M130A, M130B, M130C, M160A, M160C, M170A and M170C are 0.96" OLED.
Here’s a breakdown of the acceptance criteria and the study proving the device meets these criteria, based on the provided FDA 510(k) summary for the Fingertip Pulse Oximeter models:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary directly compares the proposed device to a predicate device, and indicates that the proposed device complies with specific standards. While it doesn't provide a direct "acceptance criteria" table in the format of a typical requirement specification with Pass/Fail, we can infer the acceptance criteria from the specified performance standards and comparisons.
| Acceptance Criteria (Inferred from Standard/Predicate Comparison) | Reported Device Performance (from "Proposed Device" column or compliance statements) |
|---|---|
| SpO2 Measurement Range: 0%~100% (from Predicate) | 0%~100% (Same as Predicate) |
| SpO2 Resolution: 1% (from Predicate) | 1% (Same as Predicate) |
| SpO2 Accuracy: | 80 to 100%: ±2% (Per ISO 80601-2-61, likely the maximum deviation from reference in this range) 70 to 80%: ±3% (Per ISO 80601-2-61, likely the maximum deviation from reference in this range) 0% to 69%: unspecified (Same as Predicate) |
| Pulse Rate Range: (Predicate: 25 bpm ~ 250 bpm) | 25 bpm ~ 254 bpm (Slight difference from Predicate, but within acceptable medical ranges) |
| Pulse Rate Accuracy: (Predicate: ±2 bpm) | ±3 bpm (Slight difference from Predicate, but deemed substantially equivalent) |
| Pulse Rate Resolution: 1% (from Predicate) | 1 bpm (Same as Predicate) |
| Biocompatibility: Complies with ISO 10993-1 | Cytotoxicity, Skin Sensitization, Skin Irritation tests passed, demonstrating compliance. |
| Electrical Safety: Complies with IEC 60601-1 | Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) |
| EMC: Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2: 2007 |
| Performance Standard: Complies with ISO 80601-2-61 | Complies with ISO 80601-2-61: 2011 |
| Software V&V: Complies with FDA Guidance | Software documentation including verification & validation provided, in accordance with FDA Guidance for moderate level of concern. |
| Cleaning Validation: Meets FDA guidance | Cleaning and disinfection validation testing conducted and device shows no degradation after repeated cleaning. |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Data (Human Subjects for SpO2 Accuracy): The document states: "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."
- Sample Size: The exact number of human subjects is not specified in this document. Annex EE of ISO 80601-2-61 typically requires a sufficient number of subjects (e.g., at least 10) to cover the specified SpO2 range.
- Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Shenzhen Raysintone Technology CO., Ltd, China, so it's highly probable the clinical study was conducted in China. It's a prospective study as it involves active testing on human subjects to determine accuracy.
-
Non-Clinical Data (Biocompatibility, Electrical Safety, EMC, Bench Testing, Software V&V, Cleaning Validation): These tests are typically performed on samples of the device and its components in a lab setting. The specific "sample size" for these physical or software tests is generally defined by the testing standards and protocols, rather than a "patient" sample size. The provenance for these tests is the manufacturer's testing facilities or contracted labs.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is primarily relevant for studies involving human interpretation (e.g., radiology for diagnostic AI). For a pulse oximeter, the ground truth for SpO2 accuracy is not established by human experts but by a co-oximeter (a laboratory device considered the gold standard for measuring fractional oxygen saturation in blood).
Therefore, this section is not applicable in the traditional sense for this device.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for pulse oximetry involves direct measurement of blood oxygen saturation, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating how AI assists human readers in diagnostic tasks, typically in imaging. This is a standalone medical device measuring physiological parameters, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The "Clinical data" section refers to testing the accuracy of the SpO2 measurement in human subjects according to ISO 80601-2-61. This standard outlines procedures for testing the accuracy of the pulse oximeter's algorithm/device output compared to a reference standard (co-oximeter), which is a "standalone" performance assessment of the device's core function.
7. The Type of Ground Truth Used
The ground truth used for the SpO2 accuracy assessment is co-oximetry (laboratory or arterial blood gas analysis), which directly measures arterial oxygen saturation (SaO2). This is considered the physiological gold standard for oxygen saturation. The document explicitly references ISO 80601-2-61, Annex EE, which details the methodology for this, involving inducing stable levels of desaturation in human subjects and comparing the device's SpO2 readings to co-oximeter SaO2 readings taken from arterial blood samples.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional medical device (hardware with embedded firmware/algorithm) and not an AI/ML model that undergoes a discrete "training set" process in the context of deep learning. Its internal algorithms for calculating SpO2 and pulse rate are based on established physiological principles and signal processing, not on iterative learning from a large training dataset like a neural network.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no traditional "training set" for an AI/ML model in this context. The core algorithms would have been developed and validated against known physiological models, engineering principles, and potentially smaller datasets from research and development, but not in the sense of a large, labeled training dataset for an AI algorithm seeking regulatory clearance.
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December 7, 2020
Shenzhen Raysintone Technology CO., Ltd Xingbao Yang General Manager Zone C, 4th Floor, F Building, Xinwei Second Industrial Zone Guangming District Shenzhen, Guangdong 518106 China
Re: K201384
Trade/Device Name: Fingertip Pulse Oximeter - models M130, M130A, M130B, M130C, M160A, M160C M170A, M170C, M230, M230A, M230B and M230C Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 1, 2020 Received: November 9, 2020
Dear Xingbao Yang:
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. 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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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. 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.
Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K201384
Device Name
Fingertip Pulse Oximeter, models M130A, M130C, M160A, M160C M170A, M170C, M230, M230A, M230B and M230C
Indications for Use (Describe)
The Fingertip Pulse Oximeter is a reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Raysintone Technology Co., Ltd.Zone C, 4th Floor, F Building, Xinwei Second Industrial Zone,Guangming New District, Shenzhen, 518106, P.R. ChinaTEL: +86 755 27407409 | ||
|---|---|---|---|
| Contact Person: | Xingbao Yang | ||
| Prepare date: | 2020-11-01 | ||
| 2. Device nameand classification | Device Name: Fingertip Pulse Oximeter | ||
| Models: M130, M130A, M130B, M130C, M160A, M160C, M170A,M170C, M230, M230A, M230B and M230C | |||
| Classification Name: 21 CFR 870.2700 Oximeter | |||
| Product code: DQA | |||
| Regulatory Class: Class II | |||
| 3. Reason forSubmission | New Application. No prior submission associated with the currentsubmission. | ||
| 4. PredicateDevice(s) | Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201 PulseOximeter / K191430 | ||
| 5. DeviceDescription | The oximeter consists of probe, electronic circuits, and display andplastic enclosures. And one side of probe is designed to locate lightemitting diodes and a light detector (called a photo-detector). Red andInfrared lights are shone through the tissues from one side of the probeto the other. Then parts of the light emitted absorbed by blood andtissues. The light absorbed by the blood varies with the oxygensaturation of haemoglobin. After that, the photo-detector detects the lightvolume transmitted through the tissues which depends on blood pulse,Hereafter, the microprocessor calculates a value for the oxygensaturation (SpO2).The subject device is a reusable device, and need to reprocess assuggested in the user manual after each use. And the device is intendedto be used on the finger, and powered by 2*1.5V AAA battery.M230, M230A, M230B and M230C display the measuring results on 1.3"LED screen, and the screen of M130, M130A, M130B, M130C, M160A,M160C, M170A and M170C are 0.96" OLED. The configuration of themodels is shown in the table below. | ||
| Function | M230, M230A,M230B, M230C | M130, M130A,M130B, M130C,M160A, M160C,M170A, M170C | |
| Display | LED | OLED | |
| measurement | |||
| Pulse rate measurement | Yes | Yes | |
| Bar graph display | Yes | Yes | |
| Battery display | Yes | Yes | |
| Automatic power-off function | Yes | Yes | |
| Pulse beat sound | No | Yes | |
| Sound On/Off function | No | Yes | |
| Pulse waveform display | No | Yes | |
| Direction display | 2 | 4 | |
| Data Record | No | Yes |
Yes
Spo2 parameter
Yes
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Scientific concepts that form the basis for the device
Pulse oximeter sensors have red and infrared low voltage light emitting diodes which serve as light sources. The emitted light is transmitted through the tissue, then detected by the photodetector and sent to the microprocessor of the pulse oximeter. All constituents of the human body, venous and arterial blood, and tissue absorb light. The pulsating of arterial blood results in changes in the absorption to added hemoglobin (Hb) and oxygenated hemoglobin (HbO2) in the path of the light. Since HbO2 and Hb absorb light to varving degrees, this varying absorption is translated into plethysmographic waveforms at both red and infrared wavelengths. The relationship of red and infrared plethysmographic signal amplitude can be directly related to arterial oxygen saturation.
Significant physical and performance characteristics of the device, please refer to the column Proposed Device in Table 1 for details.
6. Indications for The Fingertip Pulse Oximeter is a reusable non-invasive device intended Use for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Predicate DeviceYM 101/YM201 PulseOximeterK191430 | Proposed DeviceM130, M130A, M130B, M130C,M160A, M160C M170A,M170C,M230, M230A, M230B,M230C | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen YimiLife Technology Co., Ltd. | Shenzhen RaysintoneTechnology Co., Ltd. | --- |
| Indications forUse | The pulse oximeter is areusable device andintended for spot-checkingof oxygen saturation andpulse rate for use with thefinger of adult patients inhealthcare environments.And it is not intended to beused under motion or lowperfusion scenarios. | The Fingertip Pulse Oximeter isa reusable non-invasive deviceintended for the spot checkingof oxygen saturation of arterialhemoglobin (SpO2) and thepulse rate of adult patients inhospital and other healthcareenvironments. And it is notintended to be used undermotion or low perfusionscenarios. | Different |
| Contraindications | Not intended to be usedunder motion or lowperfusion scenarios. | Not intended to be used undermotion or low perfusionscenarios. | Same |
| Operational Specifications | |||
| Intended patientpopulation | Adult | Adult | Same |
| Intendedapplication site | Finger | Finger | Same |
| MeasurementPrinciples | 2-wavelength RelativeOptical Absorption | 2-wavelength RelativeOptical Absorption | Same |
| Signal DetectionMethod | Photodetector | Photodetector | Same |
| Display content | YM101:SpO2%, PR, batteryindicator, Pulse rate bargraphYM201:SpO2%, PR, batteryindicator, Pulse ratebar graph, pulse waveform | M230/M230A/M230B/M230C:SpO2%, PR, battery indicator,Pulse rate, bar graphM130/M130A/M130B/M130C/M160A/M160C/M170A/M170C:SpO2%, PR, battery indicator,Pulse rate, bar graph, pulsewaveform, Setting item, DataGraphic | SameDifferent |
| SpO2MeasurementRange | 0%~100% | 0%~100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70~100%: ±2%0% to 69%: unspecified | 80 to 100%: ±2%70 to 80%: ±3%0% to 69%: unspecified. | Different |
| Pulse RateRange | 25 bpm ~ 250 bpm | 25 bpm ~ 254 bpm | Different |
| Pulse RateAccuracy | ±2 bpm | ±3 bpm | Same |
| PulseRate Resolution | 1 bpm | 1 bpm | Same |
| Shipped Sterile | No | No | Same |
| Power suppler | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | Same |
| Storage andTransportEnvironment | Temperature: -20 °C to 60 °CAtmospheric Pressure: 50 kPa to 107.4 kPaRelative Humidity:10%-95% (no condensation) | Temperature: -20 °C to 60 °CAtmospheric Pressure: 50 kPa to 107.4 kPaRelative Humidity: 10%-95% (no condensation) | Same |
| OperatingEnvironment | Temperature: 15 °C to 40 °CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity:15%-95% (no condensation) | Temperature: 15 °C to 40 °CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-95% (no condensation) | |
| Compliance Standards | |||
| Bio-compatibility | ISO 10993-1ISO 109903-5ISO 10993-10 | ISO 10993-1ISO 109903-5ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | |
| Physical Specifications | |||
| Dimension(WidthHeightDepth) | 57mm×30mm×30 mm | M230,M230A,M230B,M230C,M130,M130A,M130B,M130C:57.5mm×32.5mm×32mmM160A,M160C,M170A,M170C:64mm×38.5mm×36.5mm | Different |
| Weight | <28 g (without the batteries) | M230,M230A,M230B,M230C,M130,M130A,M130B,M130C:Approx: 49g (including thebatteries)M160A,M160C,M170A,M170C:Approx: 62g (including thebatteries) |
Table 1 Comparison between the predicate and the subject devices
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As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness.
8. Performance Testing
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Fingertip Pulse Oximeter 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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours.
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And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- 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 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 for safety and the IEC 60601-1-2: 2007 Medical electrical equipment --Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
Cleaning Validation
Cleaning and disinfection validation testing was conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.
Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
9. Conclusion
Verification and validation testing was conducted on the subject device Fingertip Pulse Oximeter and all testing passed pre-specified criteria. This premarket notification submission demonstrates that 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).