Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard signal processing and calculation by a microprocessor, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No

The device is intended for "spot checking" of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.

Diagnostic

Yes
The device is described as a "reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate". Checking these physiological parameters to monitor a patient's condition or health status is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components including a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and is powered by batteries. It also mentions reprocessing instructions, indicating a physical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
Device Function: The Fingertip Pulse Oximeter described here is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's finger. It does not analyze any specimens taken from the body.

Therefore, based on the provided information, the device is a non-invasive medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQA

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. 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 the models is shown in the table below.

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

Intended User / Care Setting

Hospital and other 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)

Non-Clinical Testing:
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. Testing included Cytotoxicity, Skin Sensitization, and Skin Irritation. Results demonstrate biocompatibility.
Electrical safety and electromagnetic compatibility (EMC): Testing conducted, and results show compliance with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) and IEC 60601-1-2: 2007.
Bench Testing: Conducted in compliance with ISO 80601-2-61: 2011. Pulse Rate Accuracy meets requirements defined in ISO 80601-2-61, Clause 201.12.1.104.
Software Verification and Validation Testing: Software documentation provided in accordance with FDA Guidance for software with a moderate level of concern.
Cleaning Validation: Cleaning and disinfection validation testing conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17, 2015. Performance shows no degradation after repeated cleaning and disinfection.

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.

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.

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

SpO2 Accuracy: 80 to 100%: ±2%, 70 to 80%: ±3%, 0% to 69%: unspecified.
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 shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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

2

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. China
TEL: +86 755 27407409 | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------|
| Contact Person: | Xingbao Yang | | |
| Prepare date: | 2020-11-01 | | |
| 2. Device name
and 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 for
Submission | New Application. No prior submission associated with the current
submission. | | |
| 4. Predicate
Device(s) | Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201 Pulse
Oximeter / 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.
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 the
models 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

4

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 Device
YM 101/YM201 Pulse
Oximeter
K191430 | Proposed Device
M130, M130A, M130B, M130C,
M160A, M160C M170A,
M170C,M230, M230A, M230B,
M230C | Comparison
Result |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Manufacture | Shenzhen Yimi
Life Technology Co., Ltd. | Shenzhen Raysintone
Technology Co., Ltd. | --- |
| 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 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. | Different |
| Contraindications | Not intended to be used
under motion or low
perfusion scenarios. | 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 |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| Display content | YM101:
SpO2%, PR, battery
indicator, Pulse rate bar
graph

YM201:
SpO2%, PR, battery
indicator, Pulse rate
bar graph, pulse waveform | M230/M230A/M230B/M230C:
SpO2%, PR, battery indicator,
Pulse rate, bar graph

M130/M130A/M130B/M130C/M
160A/M160C/M170A/M170C:
SpO2%, PR, battery indicator,
Pulse rate, bar graph, pulse
waveform, Setting item, Data
Graphic | Same