Pulse Oximeter MD3001 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

Device Description

The applicant device of Pulse Oximeter MD3001 is a device, which can display % SpO2, pulse rate value and vertical bar graph pulse amplitude. The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. The Pulse oximetry 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 fingersensor 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 has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries.

AI/ML Overview

Acceptance Criteria and Device Performance for Pulse Oximeter MD300I

1. Table of Acceptance Criteria and Reported Device Performance

The provided document K072825 for the Pulse Oximeter MD300I references compliance with ISO 9919:2005 for effectiveness and safety. However, specific numerical acceptance criteria and corresponding reported device performance values (e.g., accuracy ranges for SpO2 and pulse rate) are not explicitly detailed within the provided text.

The document states:

"The accuracy of MD300I pulse oximeter equipment is compliance to the requirement, and the product is safe during the use."
"The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital provided in Attachment 4 Clinical Test Reports."

To fully answer this question with a table of specific numerical acceptance criteria and reported device performance, the Attachment 4 Clinical Test Reports referenced in the submission would be necessary. Without this attachment, only a generic statement of compliance can be made.

Based on the available information, the table would look like this (with placeholders for specific numerical values):

Acceptance Criteria (from ISO 9919:2005, e.g.)	Reported Device Performance (MD300I)
SpO2 Accuracy (e.g., ±X% over Y-Z% SpO2 range)	Not specified in provided summary (Stated as compliant with ISO 9919:2005 requirements)
Pulse Rate Accuracy (e.g., ±W bpm)	Not specified in provided summary (Stated as compliant with ISO 9919:2005 requirements)
Alarm Functions (e.g., Low-Voltage Alarm System performance)	Compliant with requirements (Report No. MD300I-01-003)
Biocompatibility (skin-contacting materials)	Compliant with ISO 10993 (Presented in Table IV-2)
Electrical Safety	Compliant with IEC60601-1
Electromagnetic Compatibility (EMC)	Compliant with IEC60601-1-2

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

Sample Size for Test Set: Not specified in the provided summary. The document mentions "clinical test reports" but does not give the number of subjects or data points.
Data Provenance:
- Country of Origin: China ("Beijing Military General Hospital").
- Retrospective or Prospective: Not explicitly stated, but clinical tests are typically prospective to evaluate device performance on live subjects according to a protocol.

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

This information is not provided in the given text. While clinical tests were conducted at a hospital, there is no mention of a ground truth established by experts for the purpose of validating the oximeter's readings against a reference standard. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements or a CO-oximeter, where the ABG result itself is considered the ground truth, not an expert consensus on a reading.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers provide interpretations. For pulse oximetry, the ground truth is usually derived from objective measurements (e.g., CO-oximetry of arterial blood gas). Therefore, an adjudication method in the traditional sense is not applicable or mentioned in the context of this device. The device's SpO2 and pulse rate readings would be compared directly against the reference standard.

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

No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is more common for diagnostic imaging AI systems where human readers interpret images with and without AI assistance. A pulse oximeter is a direct measurement device, not an interpretive one.

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

Yes, a standalone performance assessment was done. The clinical tests described (compliance with ISO 9919:2005) assess the device's ability to accurately measure SpO2 and pulse rate independently. The device itself is designed to provide readings directly to the user (human-in-the-loop interpretation of the measurement, but not the algorithm itself).

7. The Type of Ground Truth Used

The type of ground truth used for pulse oximeters in clinical studies according to ISO 9919:2005 typically involves simultaneous measurements with a reference CO-oximeter on arterial blood samples. This provides a highly accurate and objective measure of arterial oxygen saturation (SaO2) against which the pulse oximeter's SpO2 readings are compared. While not explicitly stated to be CO-oximetry in the provided summary, it is the standard for such clinical performance evaluations.

8. The Sample Size for the Training Set

Not applicable/Not provided. The MD300I is a traditional hardware-based pulse oximeter, not an AI/machine learning algorithm that requires a training set in the typical sense. Its underlying physics and signal processing are deterministic.

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

Not applicable/Not provided. As explained above, this device does not utilize a training set in the way AI/ML algorithms do.

Summary

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K072825

510(k) Summary JAN 1 4 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

1. Statement

This is a special 510(k) report for Pulse Oximeter MD3001, which is a modification device to Fingertip Pulse Oximeter MD300C(K070371). The modification does not change intended use. And the new device has different trade name to predicate device.

The main modifications between applicant device and Fingertip Pulse Oximeter MD300C (K070371) are listed below:

Item	MD300I	MD300C
Storage Disk	EEPROM (AT24C256)	None Storage Disk
Data Transfer	Data can be transferred to PC	No Transfer Function
Sensor	Three separate sensors	One Fixed Sensor

2. Applicant Device Information

Trade/Proprietary Name: Pulse Oximeter MD300I Common Name: Oximeter Classification Name: Oximeter Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology Intended Use:

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3. Submitter Information

Manufacturer Name:

Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B 1126-1127, Fuxing Road A36, Beijing , P.R.China, 100039

Contact Person of the Submission:

Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net

4. Predicate Device

Fingertip Oximeter MD300C K-number: K070371 Product Code: DQA Intended Use:\

Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

Manufactured bv:

Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B 1126-1127, Fuxing Road A36, Beijing , P.R.China, 100039

5. Device Description

The applicant device of Pulse Oximeter MD3001 is a device, which can display % SpO2, pulse rate value and vertical bar graph pulse amplitude.

The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit.

The Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The

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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 fingersensor 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 has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries.

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 contain drug or biological products.

The device is electrically operated and the Electrical Safety Test and Electromagnetic Compatibility Test following IEC 60601-1 and IEC60601-1-2 were conducted. Please see the Attachment 2 Electrical Safety and EMC Test.

The device is software-driven and the software validation is provided in Chapter VIII Software Validation.

The Performance Test reports Low-Voltage Alarm System (Report No. MD300I -01-003) are presented in Attachment 3 Performance Bench Test.

The Clinical Test reports following ISO 9919:2005, Medical electrical equipment -Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital provided in Attachment 4 Clinical Test Reports.

All applicable standards are listed in Chapter II Standards.

The device is not kit.

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6. Effectiveness and Safety Considerations

Effectiveness:

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

The accuracy of MD300I pulse oximeter equipment is compliance to the requirement, and the product is safe during the use. It can be used in the clinical environment. It is substantially equivalent to other pulse oximeter product with the same effectiveness and safety.

Safety Considerations:

The Performance Test reports Low-Voltage Alarm System (Report No. MD3001 -01-003) are presented in Attachment 3 Performance Bench Test.

The test results of biocompatibility of all the skin-contacting material are presented as Table IV-2 for the consideration of Biological Specifications. Please see Appendix 1 Biocompatibility Reports.

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

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 -. 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.

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7. Substantially Equivalence Determination

Comparison Analysis

The applicant device has same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The only difference is working time and Relative humidity. These differences are slight and do not effluence the effectiveness and safety of the device and don't raise new question of effectiveness and safety.

Conclusion:

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

JAN 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Beijing Choice Electronic Technology Company, Limited C/O Ms. Diana Hong Report Correspondent Shanghai Midlink Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan No19, LN999, Zhong Shan Nan ER Shanghai, China 200030

Re: K072825

Trade/Device Name: Pulse Oximeter MD300I Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 28, 2007 Received: January 2, 2008

Dear Ms. Hong:

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 such 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. Hong

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number:

Device Name: _Pulse Oximeter MD3001

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 NEEDED)

Concurrence of CDRH, Office vice Evaluation (ODE)

Mait Threhnt

1. A.J., S.M., and G.M.R.

K072825

Page l of

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).