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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) summary for the Shenzhen Yimi Life Technology Co., Ltd. Pulse Oximeter (various models). It details the device's characteristics and its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly refers to acceptance criteria for SpO2 accuracy and Pulse Rate accuracy based on the ISO 80601-2-61 standard.

Acceptance Criteria (from ISO 80601-2-61)	Reported Device Performance
SpO2 Accuracy
70-100%: ±2%	70-100%: ±2%
0-69%: Undefined	0-69%: Undefined
Pulse Rate Accuracy
Not explicitly stated in the document, but the device "meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104"	±3 bpm (This is the predicate's declared accuracy, and the subject device's declared accuracy is ±2 bpm, which is better and thus meets or exceeds the predicate's and implied standard.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the clinical test set. It only states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". Annex EE of ISO 80601-2-61 generally recommends a minimum of 10 healthy subjects for SpO2 accuracy testing, though more may be required depending on the specific design of the study and the range of SpO2 values assessed.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a Chinese manufacturer, the clinical testing was likely conducted in China or a similar jurisdiction following international standards. The nature of SpO2 accuracy testing typically involves prospective studies where subjects are intentionally desaturated under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical test set. For pulse oximetry, the ground truth for SpO2 accuracy is typically established by co-oximetry measurements from arterial blood samples, which does not directly involve "experts" in the sense of clinical reviewers for image analysis. The "ground truth" (reference standard) in this context is the quantitative co-oximetry reading.

4. Adjudication Method for the Test Set

Not applicable in the context of pulse oximetry SpO2 accuracy testing. Ground truth is established by objective co-oximetry measurements, not through expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. Pulse oximeters provide a direct numerical output (SpO2 and pulse rate), so MRMC studies are not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The entire premise of the SpO2 accuracy testing described (clinical data per ISO 80601-2-61 Annex EE) is to evaluate the device's ability to accurately measure oxygen saturation and pulse rate independently, without human interpretation influencing the measurement. The device's output is compared directly against the reference standard (co-oximetry).

7. Type of Ground Truth Used

The ground truth used for SpO2 accuracy testing is co-oximetry measurements from arterial blood samples. This is the gold standard for determining actual arterial oxygen saturation. For pulse rate, the ground truth would typically be from an ECG monitor or a reference pulse rate measurement device.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. Pulse oximeters traditionally rely on established physiological principles and algorithms (e.g., Beer-Lambert law and pulsatile blood flow), rather than machine learning models that require extensive training data in the same way an AI image analysis algorithm would. Therefore, a distinct "training set" as understood in AI/ML development is not typically applicable for this type of device.

9. How the Ground Truth for the Training Set was Established

As no training set is described, this question is not applicable. The device's underlying principles are physics-based, and its performance is validated against physiological standards with direct measurements.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a bold, sans-serif font. Below that is the word "ADMINISTRATION" in a smaller, sans-serif font.

October 25, 2024

Shenzhen Yimi Life Technology Co., Ltd. Peng Shande General Manager 302 Building C, YouLiTong Technology Industrial Plant, No.56 Qingsong Road, Laokeng Community, Longtian Street Shenzhen, 518118 China

Re: K240092

Trade/Device Name: Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 6, 2024 Received: February 6, 2024

Dear Peng Shande:

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 (the 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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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 Anesthesia, Respiratory, and Sleep 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240092

Device Name

Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)

Indications for Use (Describe)

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen Yimi Life Technology Co., P.R. Ltd.302 Building C, YouLiTong Technology Industrial Plant, No.56 Qingsong Road,Laokeng Community, Longtian Street, Pingshan District, 518118 Shenzhen, ChinaTEL:+86 755-89369909
Contact Person:	Shande Peng
Prepare date:	2024-08-26
2. Device name andclassification	Device Name: Pulse Oximeter
	Models: YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111,YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402,YM403, YM501, YM502, YM503 and YM504
	Classification Name: 21 CFR 870.2700 OximeterProduct code: DQARegulatory Class: Class II
3. Reason forSubmission	Submission for the significant changes to the previous cleared devices.
4. PredicateDevice(s)	Shenzhen Yimi Life Technology Co., Ltd. , YM101, YM201, YM301 Pulse Oximetercleared under K191430
5. Device Description	The oximeter consists of probe, electronic circuits, and display and plasticenclosures. And one side of probe is designed to locate light emitting diodes and alight detector (called a photo-detector). Red and Infrared lights are shone throughthe tissues from one side of the probe to the other. Then parts of the light emittedabsorbed by blood and tissues. The light absorbed by the blood varies with theoxygen saturation 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 oxygen saturation (SpO2).The subject device is a reusable device, and need to reprocess as suggested in theuser manual after each use. And the device is intended to be used on the finger,and powered by 2*1.5V AAA battery.
6. Indications for Use	The pulse oximeter is a reusable device and intended for spot-checking of oxygensaturation and pulse rate for use with the finger of adult patients in healthcareenvironments. And it is not intended to be used under motion or low perfusionscenarios.

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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 DeviceYM101, YM201, YM301	ComparisonResult
Manufacture	Shenzhen Yimi Life TechnologyCo., Ltd.	Shenzhen Yimi Life TechnologyCo., Ltd.	Same
Indications for Use	The pulse oximeter is areusable device and intendedfor spot-checking of oxygensaturation and pulse rate foruse with the finger of adultpatients in healthcareenvironments. And it is notintended to be used undermotion or low perfusionscenarios.	The pulse oximeter is a reusabledevice and intended forspot-checking of oxygensaturation and pulse rate foruse with the finger of adultpatients in healthcareenvironments. And it is notintended to be used undermotion or low perfusionscenarios.	Same
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	35~100%	0~100%	Different¹
SpO2 Resolution	1%	1%	Same
SpO2 Accuracy	70~100%: ±2%0% to 69%: undefined	70~100%: ±2%0% to 69%: unspecified	Same
Pulse Rate Range	30 bpm ~ 250 bpm	25 bpm ~ 250 bpm	Different²
Pulse RateAccuracy	±3 bpm	±2 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°CRelative Humidity: 10%-95%(no condensation)Atmospheric Pressure: 50 kPato 107.4 kPa	Temperature: -20°C to 60°CAtmospheric Pressure: 50 kPato 107.4 kPaRelative Humidity:10%-95% (no condensation)	Same
OperatingEnvironment	Temperature: 10 °C to 40 °CAtmospheric Pressure: 70 kPato 106 kPaRelative Humidity: 15%-95%(no condensation)	Temperature: 15 °C to 40 °CAtmospheric Pressure: 70 kPato 106 kPaRelative Humidity:15%-95% (no condensation)	Different3
Compliance Standards
Bio-compatibility	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 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)	Appearance YM01 and YM02:$57 \times 30 \times 31$ mmAppearance YM03: $62 \times 34 \times 35$ mmAppearance YM04: $63 \times 36 \times 37$ mm	$57 \text{mm} \times 30 \text{mm} \times 30 \text{mm}$	Different4
Data Transmission
Datatransmission	Has wireless function withBluetooth and available forYM401, YM402, YM403,YM501, YM502, YM503 andYM504 only	Not available	Different5

Table 1 Comparison between the predicate and the subject device

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Justification for the differences:

1. Different SpO2 Range
  The measuring range of the predicate is 0~~100%, while that of the subject is 35~~100%, and such specification is verified per the international standard ISO 80601-2-61, same as the standard complied with of the predicate, so the different range will be acceptable for the subject device.
1. Different Pulse Rate Range and Pulse Rate Accuracy
  The measuring range of the predicate is 25 bpm ~ 250 bpm and the accuracy is ±3 bpm, while that of the subject is 30 bpm ~ 250 bpm and the accuracy is ±2 bpm, and such specification is verified per the international standard ISO 80601-2-61, same as the standard complied with of the predicate, so the different range and accuracy will be acceptable for the subject device.
1. Different Operating Environment
  Minor difference to operation environment for the subject device, but the system has been proved to be safe and effective since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes will not cause any safety and effectiveness problem.
1. Different Physical Specifications

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The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different will not raise any safety and effectiveness questions.

1. Different data transmission function
  The data transmission function with Bluetooth is available for YM401, YM402, YM403, YM501, YM502, YM503 and YM504 , and the wireless function has been verified to assure its data transmission and cybersecurity. No new safety and effectiveness questions raised.

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 as demonstrated in the non-clinical and clinical evidence.

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 prolonged contact duration of longer than 24 hours but less than 30 days. 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

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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.

Clinical data:

Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2ACCURACY 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. The subject device and the predicate device have intended use and the differences in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).