The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

Device Description

The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 mm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

AI/ML Overview

The provided text details the 510(k) summary for a Pulse Oximeter (K190869). While it doesn't use the exact term "acceptance criteria" for all performance aspects, it does specify accuracy requirements and the study conducted to demonstrate compliance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Required Performance)	Reported Device Performance
SpO2 Accuracy (70-100%)	±3% (Per ISO 80601-2-61)	Root-mean-squared (Arms) value of ±3% with saturations from 70% to 100%.
SpO2 Measuring Range	N/A (Compared to predicate, which was 0-100%)	35%-100%
SpO2 Resolution	N/A (Compared to predicate, which was 1%)	1%
PR Accuracy	N/A (Improved compared to predicate's variable accuracy)	±2 bpm (across the entire range)
PR Measuring Range	N/A (Compared to predicate, which was 30-235 bpm)	30-250 bpm
PR Resolution	N/A (Compared to predicate, which was 1 bpm)	1 bpm
Home-Used Compliance	Compliance with IEC 60601-1-11	Performance testing shows compliance.
Biocompatibility	Compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Testing conducted in accordance with the standard.
Electrical Safety/EMC	Compliance with IEC 60601-1, IEC 60601-1-2	Testing conducted successfully.

Note: The document explicitly states the SpO2 accuracy and lists successful compliance with relevant standards. For other parameters like SpO2/PR range and resolution, the reported performance matches or exceeds that of the predicate device, implicitly meaning they meet the "acceptance criteria" of being comparable or better.

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

Sample Size for Physiological (Clinical) Test Set (SpO2 Accuracy): 12 healthy adult volunteers (4 men and 8 women).
Data Points Collected: Total 1440 data points were sampled for analysis.
Data Provenance: The study was clinical testing of human subjects. The document does not specify the country of origin for the clinical study, but the submitting company and correspondent are based in Shenzhen, China. It was a prospective study involving human subjects for direct measurement.

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

The ground truth for SpO2 accuracy was established against a laboratory CO-Oximeter, which is an objective, gold-standard laboratory instrument for measuring arterial blood gas saturation (SaO2). Therefore, "experts" in the sense of human readers interpreting data were not used for the primary SpO2 accuracy ground truth. The expertise would lie in the accurate operation and calibration of the CO-Oximeter and the proper execution of the clinical trial protocol.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established using a laboratory CO-Oximeter, which provides a direct, objective measurement (SaO2) from blood samples. This does not involve human interpretation or subjective assessment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document describes a clinical study to assess the device's accuracy against a laboratory reference standard (CO-Oximeter), not a comparative effectiveness study involving multiple human readers with and without AI assistance (as this is a standalone measurement device, not an AI interpretation tool).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, for its primary function (SpO2 and PR measurement), the device operates in a standalone manner. The clinical study described evaluates the device's direct measurement performance (algorithm only) against a gold standard, without human interpretation in the loop influencing the measurement itself.

7. The Type of Ground Truth Used

The primary ground truth for the clinical accuracy study was objective laboratory measurement data: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This is a medical device (pulse oximeter) that performs real-time physiological measurements based on established physical principles of light absorption, rather than an AI/machine learning algorithm that requires a distinct training phase on a large dataset. The device's underlying principles (e.g., Beer-Lambert Law principles applied to pulsatile blood flow) are physics-based, not learned from a training dataset in the AI sense.

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

Not applicable. As explained in point 8, this is not an AI/machine learning device requiring a training set and associated ground truth establishment in that context. The device's operation is based on fundamental optical and physiological principles. The "training" for such devices typically involves extensive engineering, calibration, and verification against physical models and known physiological responses, rather than data-driven learning from a labeled training set.

Summary

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September 13, 2019

Shenzhen Aeon Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District Shenzhen, 518067 Cn

Re: K190869

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 5, 2019 Received: August 5, 2019

Dear Kevin Wang:

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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Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Pulse Oximeter

K190869

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

K190869

Prepared Date: 2019/03/29

Submission sponsor 1.

Name: Shenzhen Aeon Technology Co., Ltd.

Address: RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong, No.133 of Yiyuan road, Nantou Street, Nanshan District, Shenzhen, P.R China.

Contact person: Xie Hua

Title: General Manager

E-mail: Raymond@aeon-med.com

Tel: +86-755-86182140

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A. NanShan Medical devices Industrial Park Nanshan District, Shenzhen,

Guangdong, P.R. China 518067

Contact person: Kevin Wang

E-mail: kevin@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Pulse Oximeter
Model	A310, A310L, A320, A330, A330N, A340, A340L, A350
Common Name	Fingertip Pulse Oximeter
Regulatory Class	Class II
Classification	21CFR 870.2700 / Oximeter / DQA
Submission type	Traditional 510(K)

3. Subject Device Information

Predicate Device 4.

By submission of the Traditional 510(k), Shenzhen Aeon Technology Co., Ltd. is requesting clearance for Pulse Oximeter. It is comparable to the following legally marketed system:

1. AMEMO INC. Fingertip Pulse Oximeter under K153021.

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5. Device Description

The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 mm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell.

The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

6. Intended use & Indication for use

Features	Subject DevicePulse Oximeter	Predicate Device K153021Fingertip Pulse Oximeter	Remark
Applicant	Shenzhen Aeon Technology Co., Ltd.	AMEMO INC	/
ClassificationRegulation	21 CFR 870.2700	21 CFR 870.2700	Same
Classificationand Code	Class II,DQA	Class II,DQA	Same
Commonname	Fingertip Pulse Oximeter	Fingertip Pulse Oximeter	Same
Intended use	The Pulse Oximeter is anon-invasive device intended forspot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate (PR). This portable device isindicated for use in adult patientsin clinical institution and home	Fingertip Pulse Oximeter A310 isa non-invasive device intendedfor spot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulse rate(PR). This portable device isindicated for use in adult patientsin hospitals.	Different 1)
Features	Subject DevicePulse Oximeterenvironments.	Predicate Device K153021Fingertip Pulse Oximeter	Remark
PatientPopulations	Adults	Adults	Same
Principle	The device displays numericalvalues for functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate bymeasuring the absorption of redand infrared (IR) light passingthrough perfused tissue. Changesin the absorption caused by thepulsation of blood in the vascularbed are used to determine oxygensaturation and pulse rate.	The device displays numericalvalues for functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate bymeasuring the absorption of redand infrared (IR) light passingthrough perfused tissue. Changesin the absorption caused by thepulsation of blood in the vascularbed are used to determine oxygensaturation and pulse rate.	Same
LEDwavelength	Red=660 nm;Infrared=905 nm;	Red= 660 nm;Infrared=905 nm;	Same
Power source	2 AAA alkaline batteries	2 AAA alkaline batteries	Same
Display data	SpO2%, PR	SpO2%, PR	Same
SpO2MeasuringRange	35%-100%	0%-100%	Similar
SpO2Resolution	1%	1%	Same
SpO2 Accuracy	70~100%, ±3%;0-69%, unspecified;	70~100%, ±3%;0-69%, unspecified;	Same
PR MeasuringRange	30-250 bpm	30-235 bpm	Similar
PR Resolution	1 bpm	1 bpm	Same
PR Accuracy	± 2 bpm	30-99 bmp, ± 2 bpm100-235 bmp, ± 2%	Different 2)
Standard	IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-61ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-61ISO 10993-5ISO 10993-10	Same

7. Comparison to the Predicate Device

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Justification of difference:

Different 1): The subject device is intended for use in hospital and home environments. The performance testing shows that the subject device complies with home-used standard IEC 60601-1-11. This difference does not raise any different questions of safety or effectiveness.

Different 2): The subject device is more accurate than predicate over the declared pulse rate range. According to pulse rate testing results, the subject device is demonstrated compliant with the declared range and accuracy.

Performance Data 8.

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 FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

. Cytotoxicity
. Sensitization
Irritation ●

The Pulse Oximeter is considered surface contacting for a prolonged duration (24 hours to 30 days).

Non-clinical data

The Pulse Oximeter has been tested according to the following standards and guidance documents:

IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 80601-2-61: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
IEC 60601-1-11: Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
FDA Guidance for Pulse Oximeters - Premarket Notification Submissions [510(k)s]

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Clinical data

The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult volunteers (4 men and 8 women) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The subjects include 3 people with medium skin, and 3 with dark skin pigmentation. Total 1440 data points were sampled for analysis.

The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range 70%-100%.

Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the standard; and the Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement.

The SpO2 accuracy result showed that the root-mean-square (Arms) value of the Fingertip Pulse Oximeter is ±3% with the saturations from 70% to 100%.

9. Conclusion

It has been shown in this 510(k) submission that the subject device and the predicate device have the same intended use, and the difference in technological characteristics do not raise different questions regarding safety or effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the predicate device in terms of design, components, materials, principals of operation, biocompatibility, and performance characteristics.

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).