The MD300C318 Fingertip Pulse Oximeter is intended for continuous use or spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick.

Device Description

The applicant device MD300C318 is a Finger Pulse Oximeter, which designed with the measurement, storage, review, audible alarms, visible alarms, vibration alert for finger-out, low battery voltage alarm function, and data transmission (optional) functions. The power source of the applicant device is 2*AAA Typical lithium ion batteries. The Pulse Oximeter consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit, and with Bluetooth® communication which is integrated into a telemedicine system or other health data collection system through the wireless connection. 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 nm, which is red light; the other is 940 nm, which is ultra red 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. The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

AI/ML Overview

The provided 510(k) summary for the MD300C318 Fingertip Pulse Oximeter describes the device, its intended use, and claims substantial equivalence to a predicate device, but it does not explicitly detail specific acceptance criteria or a dedicated study proving these criteria were met in the way typically expected for a detailed performance study with defined metrics.

Instead, the submission states that the device is compliant with several standards and has undergone "human testing." The "Clinical Test reports following ISO 9919:2005" is mentioned, which is the most relevant piece of information pointing to how performance was assessed. ISO 9919:2005 specifies requirements for the safety and essential performance of pulse oximeters, and typically includes accuracy requirements for SpO2 and pulse rate.

Here's an attempt to extract and infer the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a table with pass/fail values. It only refers to compliance with ISO 9919:2005.

Inferred from ISO 9919:2005 (General Requirements for Pulse Oximeters):

Acceptance Criterion (Inferred from ISO 9919:2005)	Reported Device Performance
*SpO2 Accuracy (Arms):**	"Successfully undergone ... human testing to support the determination of substantial equivalence."
- For SpO2 range 70-100%	(Not explicitly stated in numbers, but implied to meet ISO standard requirements)
*Pulse Rate Accuracy:	"Successfully undergone ... human testing to support the determination of substantial equivalence."
- For specified pulse rate range	(Not explicitly stated in numbers, but implied to meet ISO standard requirements)
Electrical Safety (IEC60601-1)	In compliance
EMC (IEC60601-1-2)	In compliance
Software Validation (FDA Guidance)	In compliance
Biocompatibility (ISO 10993)	Meets requirements

Note: ISO 9919:2005 typically requires SpO2 accuracy (Arms, root mean square difference) to be within a certain limit (e.g., ±2% for adults/pediatrics) in the 70-100% saturation range, often evaluated through human desaturation studies. Pulse rate accuracy also has specific limits, often within ±1 or ±2 beats per minute. These specific numerical results are not provided in the given text.

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

The document states: "The applicant device has successfully undergone both bench and human testing to support the determination of substantial equivalence." and "The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the safety and essential performance of pulse oximeter."

Sample Size for Test Set: Not explicitly stated. Clinical tests for pulse oximeters following ISO 9919 often involve a minimum number of healthy volunteers (e.g., 10-15 subjects) for induced hypoxia studies to cover the full SpO2 range.
Data Provenance: Not explicitly stated. Given the manufacturer is based in Beijing, China, it's plausible the human testing was conducted in China, but this is an inference, not a stated fact in the document.
Retrospective or Prospective: Not explicitly stated. Human desaturation studies for pulse oximeter accuracy are typically prospective.

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

Number of Experts: Not applicable/Not stated. For pulse oximeter accuracy studies, the "ground truth" for arterial oxygen saturation (SaO2) is typically established by co-oximetry measurements from arterial blood samples taken by trained medical professionals, not by "experts" reviewing images or data for consensus. For pulse rate, the ground truth is often established by ECG or direct arterial pressure monitoring.
Qualifications of Experts: Not applicable/Not stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not stated. This concept (e.g., 2+1, 3+1) is typically used for subjective assessments where multiple readers interpret data and discrepancies are resolved. Pulse oximeter accuracy studies rely on objective measurements from reference devices (co-oximeter, ECG), not adjudicated interpretations.

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

Was an MRMC study done? No. This type of study is not relevant for evaluating the standalone accuracy of a pulse oximeter. MRMC studies assess how human readers' diagnostic performance changes with and without AI assistance, which is not the purpose of this device's evaluation.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The "human testing" or "clinical test reports following ISO 9919:2005" specifically evaluates the device's (algorithm + sensor) ability to accurately measure SpO2 and pulse rate against a reference standard. This is a standalone performance evaluation by nature.

7. Type of Ground Truth Used

Type of Ground Truth: Clinical Reference Standard. For SpO2, the ground truth is established using arterial blood gas analysis with a co-oximeter (SaO2). For pulse rate, the ground truth is typically obtained from an electrocardiogram (ECG) or arterial line. This is implied by adherence to ISO 9919:2005 standards.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not stated. Pulse oximeters typically use established physics-based algorithms and lookup tables, rather than machine learning models that require large training datasets in the conventional sense. The device's algorithm would be developed based on physiological models and potentially validated with internal data, but the concept of a "training set" as used in AI/ML is not directly applicable here.

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

How Ground Truth for Training Set Was Established: Not applicable. As noted above, the device likely uses a physics-based algorithm. If any initial calibration or look-up table generation involved human data, the ground truth would similarly be established by a clinical reference standard (e.g., co-oximetry), but the document does not provide details on this development process.

In summary: The provided 510(k) summary confirms the device underwent human testing in compliance with ISO 9919:2005, which is the standard for pulse oximeter accuracy. However, it lacks specific numerical performance data, sample sizes for the clinical study, and explicit details on the ground truth establishment for that study, beyond stating compliance with the standard.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The Assigned 510(k) Number is: ___K092620

1. Submitter Information

Manufacturer Name and Address: .

Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B, Rm. 1127-1128, Fuxing Road, A36 Beijing, China 100039

Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Rd., Badachu Hi-tech Zone, Shijingshan District Beijing, China 100041

. Contact Person:

Ms. Yajing Li North Building 3F, No. 9 Shuangyuan Rd., Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88790480 Ext.6046 Fax:+86-10-88798860 Email: liyajing@choicemmed.com & cc@choicemmed.com

. Date prepared: March 12, 2009

2. Applicant Device Information

Trade/Proprietary Name: MD300C318 Fingertip Pulse Oximeter ●
Common Name: Pulse Oximeter ●
Classification: 21CFR 870.2700 Oximeter Class: II .

3. Legally Marketed Predicate Device

Finger Pulse Oximeter model 9560 K-number: K081285 NONIN MEDICAL, INC.

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4. Device Description

The Pulse Oximeter consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit, and with Bluetooth® communication which is integrated into a telemedicine system or other health data collection system through the wireless connection.

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 nm, which is red light; the other is 940 nm, which is ultra red 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.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

5. Intended use

6. Effectiveness and Safety Considerations

The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1 : General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -.

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Requirements and tests.

The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".

The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the safety and essential performance of pulse oximeter.

The applicant device has successfully undergone both bench and human testing to support the determination of substantial equivalence.

7. Substantially Equivalence Determination

The applicant device MD300C318 Fingertip Pulse Oximeter has same classification information, same intended use, same design principle, same specifications, same product materials and performance effectiveness as the predicate device. These are no obvious differences to influence the effectiveness and safety of the device.

8. Conclusion

The applicant device MD300C318 Fingertip Pulse Oximeter is Substantially Equivalent (SE) to the predicate device which is US legally market device. Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices. Therefore, the applicant device is determined as safe and effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of a circular seal that contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Yajing Li Beijing Choice Electronic Technology Company, Limited North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing CHINA 100041

DEC - 4 2009

Re: K092620

Trade/Device Name: MD300C318 Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 1, 2009 Received: December 1, 2009

Dear Ms. Li:

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. 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.

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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Page 2- Ms. Li

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

ph for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name: __ MD300C318 Fingertip Pulse Oximeter

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEÉDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schutte

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K092620

II-2

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).