(142 days)
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in 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. YM101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of YM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on YM201 and YM301.
The provided document describes the FDA 510(k) clearance for Shenzhen Yimi Life Technology Co., Ltd.'s Pulse Oximeter, models YM101, YM201, YM301. The submission includes information on the device's acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Value) | Reported Device Performance (Target Value) |
|---|---|
| SpO2 Accuracy (70-100%) | ±2% |
| SpO2 Resolution | 1% |
| Pulse Rate Accuracy | ±2 bpm |
| Pulse Rate Range | 25 bpm ~ 250 bpm |
| Pulse Rate Resolution | 1 bpm |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (pass tests for Cytotoxicity, Skin Sensitization, Skin Irritation) |
| Electrical Safety | Complies with IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007)+AM1(2012) |
| EMC | Complies with IEC 60601-1-2:2007 (test results show compliance) |
| Pulse Oximeter Performance | Complies with ISO 80601-2-61:2011 |
| Cleaning/Disinfection Validation | No degradation after repeated cleaning and disinfection |
| Software Verification & Validation | Complies with FDA Guidance for software with moderate level of concern |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". However, it does not explicitly state the sample size used for the clinical test set (human subjects study). The data provenance is described as being from "human subjects," implying prospective data collection for the SpO2 accuracy study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly in relation to the clinical testing mentioned in Annex EE. For pulse oximetry, the "ground truth" (reference SpO2) in such studies is typically obtained from co-oximetry of arterial blood samples.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the clinical test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the testing described for the Pulse Oximeter's performance, particularly the "Clinical data" section for SpO2 accuracy, refers to the device's standalone performance in measuring oxygen saturation in human subjects. The device itself is an algorithm-driven measurement tool, operating without a human-in-the-loop for its direct measurement function.
7. The Type of Ground Truth Used:
For the "Clinical data" section relating to SpO2 accuracy, the ground truth is established by measuring arterial oxygen saturation directly from blood samples using a co-oximeter, which is the standard reference method for SpO2 accuracy studies as outlined in ISO 80601-2-61.
8. The Sample Size for the Training Set:
The document does not refer to a "training set" in the context of machine learning or AI. For a pulse oximeter, the core technology relies on established physiological principles and signal processing, rather than a machine learning model that requires a dedicated training set. The clinical data mentioned is for validation/performance testing, not training.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set in the context of typical machine learning, this information is not applicable and therefore not provided in the document.
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October 18, 2019
Shenzhen Yimi Life Technology Co.,Ltd. Shande Peng General Manager 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan District Shenzhen, 518118 CN
Re: K191430
Trade/Device Name: Pulse Oximeter, models YM101, YM201, YM301 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 10, 2019 Received: September 20, 2019
Dear Shande Peng:
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.
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
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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 (OS) 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,
for 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) K191430
Device Name Pulse Oximeter, models YM101, YM201, YM201, YM301
Indications for Use (Describe)
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in 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) |
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510(k) Summary
K191430
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen Yimi Life Technology Co., Ltd.305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village,Pingshan District, 518118, Shenzhen, P.R. ChinaTel.: +86 755- 86573112 |
|---|---|
| Contact Person: | Shande Peng |
| Prepare date: | 2019-10-17 |
| 2. Device nameand classification | Device Name: Pulse OximeterModels: YM101, YM201, YM301Classification Name: 21 CFR 870.2700 OximeterProduct code: DQARegulatory Class: Class II |
| 3. Reason forSubmission | New Application. No prior submission associated with the currentsubmission. |
| 4. PredicateDevice(s) | Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter /K173123 |
| 5. DeviceDescription | The oximeter consists of probe, electronic circuits, and display and plasticenclosures. And one side of probe is designed to locate light emitting diodesand a light detector (called a photo-detector). Red and Infrared lights areshone through the tissues from one side of the probe to the other. Then partsof the light emitted absorbed by blood and tissues. The light absorbed by theblood varies with the oxygen saturation of haemoglobin. After that, thephoto-detector detects the light volume transmitted through the tissues whichdepends on blood pulse, Hereafter, the microprocessor calculates a value forthe oxygen saturation (SpO2).The subject device is a reusable device, and need to reprocess assuggested in the user manual after each use. And the device is intended tobe used on the finger, and powered by 2*1.5V AAA battery.YM101 display the measuring results on 1.5' LED screen, and the backlightof the three models are red, white and green respectively. And the screen ofYM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, batteryindicator and pulse waveform can be displayed on YM201 and YM301. |
| 6. Indications forUse | The pulse oximeter is a reusable device and intended for spot-checking ofoxygen saturation and pulse rate for use with the finger of adult patients inhealthcare environments. And it is not intended to be used under motion orlow perfusion scenarios. |
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7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Proposed DeviceYM series Pulse Oximeter | Predicate DeviceC101H1/K173123 | Comparison Result |
|---|---|---|---|
| Manufacture | Shenzhen YimiLife Technology Co., Ltd. | Shenzhen Med-linkElectronics Tech Co., Ltd. | Different |
| Indications forUse | The pulse oximeter isintended for measureoxygen saturation and pulserate of adult patients inhealthcare environments. | Fingertip Pulse OximeterC101H1 is a non-invasivedevice intended for spotchecking of functional oxygensaturation of arterialhemoglobin (SpO2) and pulserate (PR). This portabledevice is indicated for usein adult patients in hospitals. | Different |
| Operational Specifications | |||
| Intended patientpopulation | Adult | Adult | Same |
| Intendedapplication site | Finger | Finger | Same |
| use under motionand low perfusionconditions | No | No | Same |
| MeasurementPrinciples | 2-wavelength RelativeOptical Absorption | 2-wavelength RelativeOptical Absorption | Same |
| Signal DetectionMethod | Photodetector | Photodetector | Same |
| SpO2 Range | 0~100% | 0~100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70~100%: ±2%0% to 69%: unspecified | 70~100%: ±3%0% to 69%: unspecified | Different |
| Pulse RateRange | 25 bpm ~ 250 bpm | 30 bpm ~ 240 bpm | Different |
| Pulse RateAccuracy | ±2 bpm | ±1 bpm or ±1%, whichever isgreater | |
| 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: 50kPa to 107.4 kPaRelative Humidity:10%-95% (nocondensation) | Temperature: -10°C to 40°CAtmospheric Pressure: 70kPa to 106 kPaRelative Humidity: 10%-80%(no condensation) | Different |
| Table 1 Comparison between main predicate C101H1 and the subject device | ||
|---|---|---|
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| OperatingEnvironment | Temperature: 15℃to 40℃Atmospheric Pressure: 70 kPa to 106 kPaRelative Humidity:15%-95% (nocondensation) | Temperature: 5℃to 40℃Atmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-80%(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 | 60mm×35mm×35 mm | Different |
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 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. 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.
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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 quidance "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 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).