Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pulse oximetry process using light absorption and a microprocessor for calculation, with no mention of AI or ML terms or concepts.

Therapeutic

No.
The device is a pulse oximeter intended for spot-checking of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.

Diagnostic

Yes

The device measures oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status and aid in clinical decision-making. This falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It also mentions being powered by batteries.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
Device Function: The description clearly states the pulse oximeter measures oxygen saturation and pulse rate by shining light through the finger and detecting the transmitted light. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
Intended Use: The intended use is for "spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients." This aligns with a non-invasive physiological measurement device, not an IVD.

Therefore, the device described is a medical device, but it falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DOA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger

Indicated Patient Age Range

adult patients

Intended User / Care Setting

healthcare environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data includes "Non-Clinical Data" and "Clinical Data".

Non-Clinical Testing:

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: 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SpO2 Accuracy: 70~100%: ±2% 0% to 69%: undefined
Pulse Rate Accuracy: ±3 bpm

Predicate Device(s)

K191430

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

2

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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, China
TEL:+86 755-89369909 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shande Peng |
| Prepare date: | 2024-08-26 |
| 2. Device name and
classification | 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 Oximeter
Product code: DQA
Regulatory Class: Class II |
| 3. Reason for
Submission | Submission for the significant changes to the previous cleared devices. |
| 4. Predicate
Device(s) | Shenzhen Yimi Life Technology Co., Ltd. , YM101, YM201, YM301 Pulse Oximeter
cleared under K191430 |
| 5. 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. |
| 6. Indications for Use | 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. |

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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 Device
YM series Pulse Oximeter | Predicate Device
YM101, YM201, YM301 | Comparison
Result |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Yimi Life Technology
Co., Ltd. | Shenzhen Yimi Life Technology
Co., Ltd. | Same |
| Indications for Use | 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 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. | Same |
| Operational Specifications | | | |
| Intended patient
population | Adult | Adult | Same |
| Intended
application site | Finger | Finger | Same |
| use under motion
and low perfusion
conditions | No | No | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| SpO2 Range | 35100% | 0100% | Different¹ |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70100%: ±2%
0% to 69%: undefined | 70100%: ±2%
0% to 69%: unspecified | Same |
| Pulse Rate Range | 30 bpm ~ 250 bpm | 25 bpm ~ 250 bpm | Different² |
| Pulse Rate
Accuracy | ±3 bpm | ±2 bpm | Same |
| Pulse
Rate Resolution | 1 bpm | 1 bpm | Same |
| Shipped Sterile | No | No | Same |
| Power suppler | 21.5V AAA alkaline battery | 21.5V AAA alkaline battery | Same |
| Storage and
Transport
Environment | Temperature: -20°C to 60°C
Relative Humidity: 10%-95%
(no condensation)
Atmospheric Pressure: 50 kPa
to 107.4 kPa | Temperature: -20°C to 60°C
Atmospheric Pressure: 50 kPa
to 107.4 kPa
Relative Humidity:
10%-95% (no condensation) | Same |
| Operating
Environment | Temperature: 10 °C to 40 °C
Atmospheric Pressure: 70 kPa
to 106 kPa
Relative Humidity: 15%-95%
(no condensation) | Temperature: 15 °C to 40 °C
Atmospheric Pressure: 70 kPa
to 106 kPa
Relative Humidity:
15%-95% (no condensation) | Different3 |
| Compliance Standards | | | |
| Bio-compatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1
IEC 60601-1-11 | IEC 60601-1
IEC 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:
$57 \times 30 \times 31$ mm
Appearance YM03: $62 \times 34 \times 35$ mm
Appearance YM04: $63 \times 36 \times 37$ mm | $57 \text{mm} \times 30 \text{mm} \times 30 \text{mm}$ | Different4 |
| Data Transmission | | | |
| Data
transmission | Has wireless function with
Bluetooth and available for
YM401, YM402, YM403,
YM501, YM502, YM503 and
YM504 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.