The MD300M122/MD300M222/MD300M322 handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

Device Description

The applicant device MD300M122 Handheld Pulse Oximeter is integrated with Bluetooth® technology allowing the user to transfer measurement data any time and anywhere. The oximeter is designed with the measurement, storage, review, visible and audible alarms and data transmission function. The MD300M122 Handheld Pulse Oximeter works by applying a external sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is infrared light. The applicant device of MD300M122 Handheld Pulse Oximeter is the handheld equipment, which mainly function are measurement, display, alarm, data storage & replay etc.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, K111494, focuses on the substantial equivalence of the Handheld Pulse Oximeter Model: MD300M122, MD300M222, MD300M322 to a predicate device, rather than explicitly stating acceptance criteria in a table format with specific performance metrics. However, it does imply acceptance criteria through its adherence to standards and the results of its clinical testing.

The primary acceptance criteria are derived from the applicable standard, ISO 9919:2005 Annex EE, which specifically addresses pulse oximeter accuracy. The study aimed to demonstrate compliance with the "specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter."

Here's a table based on the implicit criteria and the reported outcome:

Acceptance Criteria	Reported Device Performance
Accuracy of SpO2 and Pulse Rate measurement	The clinical study following ISO 9919:2005, Annex EE.2 determined that the "accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter."
Safety	The device passed bench tests according to IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for safety) and IEC 60601-1-2:2007 (Electromagnetic compatibility).
Functional Equivalence	The device was found to have the "same classification, same intended use, same design principle, similar specifications and same safety performance as the predicate device," with "no obvious differences to influence the effectiveness and safety."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document indicates that "The Clinical Tests following ISO 9919:2005, Annex EE.2 are conducted," and that "Procedures of testing required in EE.2 are adopted." ISO 9919:2005 Annex EE.2 typically outlines methodologies for clinical evaluation of pulse oximeter accuracy, which involves human subject testing over a range of oxygen saturation levels. The specific number of subjects and measurements within that framework is not detailed in this submission.
- Data Provenance: The study was conducted in a clinical lab in Beijing, China, specifically at the "Beijing Military General Hospital." The study is prospective in nature, as it is clinical testing for the purpose of demonstrating device performance and gaining regulatory clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to a "Golden Standard" Co-Oximeter for ground truth. This implies a gold standard instrument rather than expert consensus on subjective data. Therefore, the concept of "experts establishing ground truth" in the traditional sense of image interpretation or diagnosis is not directly applicable here. The accuracy of the Co-Oximeter itself is assumed to be established and validated. The individuals operating the Co-Oximeter and conducting the study would be trained clinical professionals, but their specific number and qualifications as "experts establishing ground truth" are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As the ground truth is established by an objective "Golden Standard" Co-Oximeter measurement, an adjudication method for reconciling differing human expert interpretations is not relevant or described. The comparison is between the device's SpO2 and PR readings and the Co-Oximeter's readings.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted. This device is a standalone pulse oximeter for measuring SpO2 and pulse rate. It does not involve human "readers" interpreting data or an AI component designed to assist human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance evaluation described, which compares the device's measurements directly against a "Golden Standard" Co-Oximeter, represents a standalone performance assessment of the oximeter's algorithm and sensing capabilities. There is no human-in-the-loop component in the accuracy validation described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was continuous physiological measurement from a "Golden Standard" Co-Oximeter. This is an objective, instrumental measurement considered highly accurate for blood oxygen saturation.
The sample size for the training set:
- The document does not provide information on a training set. Pulse oximeters typically rely on established physiological principles and sensor technology rather than machine learning algorithms that require extensive training data. If any internal algorithm optimization occurred during development, details about its data would not typically be included in a 510(k) summary focused on validation.
How the ground truth for the training set was established:
- As no training set is described for an algorithm in the machine learning sense, this question is not applicable based on the provided text. The device's design is based on established scientific principles of light absorption by oxygenated and deoxygenated hemoglobin.

Summary

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Additional Information K111494

Exhibit I 510(K) Summary

As required by 21 CFR 807.92 The Assigned 510(K) Number is: K111494

Date Prepared: December 16, 2011

2. Sponsor Information

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

Mr. Lei Chen North Building 3F, No.9 Shuangyuan Road, Bdachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone:+86-10-88790480-6018 Email:cc@choicemmed.com

3. Submission Correspondent

Ms. Sunny Wang Beijing Choice Electronic Technology Co., Ltd. Floor 4, Jingyang Building No. 15, Xijing Rd., Shijingshan District, Beijing 100041, P.R. China Phone: +86-10-88204630-8176 Fax: +86-10-88204632 Email: wangsuqin@choicemmed.com & cc@choicemmed.com

4. US Agent

Wei Huang Mid-Link International INC 307 Eagle Heights Apt E, Madison, Wisconsin, 53705, United States Phone: 608-3355979 Fax: 760-4665084 Email:info@mid-link.net

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5. Proposed Device Information

Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Handheld Pulse Oximeter Model: MD300M122, MD300M222, MD300M322 Classification Name: Oximeter Regulation Number: 21 CFR 870.2700 Product Code: DQA Panel: Anesthesiology

6. Predicate Device

Fingertip Pulse Oximeter MD300C318 (K092620) Beijing Choice Electronic Technology Co., Ltd. Room 1127-1128 Building B, Bailangyuan Fuxing Road, No.A36 Beijing, CHINA 10039

7. Device Description

● MD300M122 Handheld Pulse Oximeter

The MD300M122 Handheld Pulse Oximeter works by applying a external sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is infrared light.

The applicant device of MD300M122 Handheld Pulse Oximeter is the handheld equipment, which mainly function are measurement, display, alarm, data storage & replay etc.

Measurement function

That's the mainly function of the device, which use the method described above to measure the SpO2 value and Pulse Rate value of user.

Display function

The display function of the device display the SpO2&PR value, waveform synchronously, battery capacity indicator, alarm state indication and time.

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Additional Information K111494

Alarm function

The applicant device has physiological alarm function as SpO2 and PR parameter and technology alarm function as Low Battery Voltage, probe off and Finger out.

Each alarm of device contains VISUAL and AUDIBLE alarm. And you can turn on or off the alarm and set the alarm limits.

There are three-level alarm priorities in Oximeter. All the three priorities divided by built-in module and can't be changed by user.()High priority: "Di- Di ----- Di - Di" indicates the patient is in the very dangerous situation. @Medium priority: "Di - Di" indicates the warning-attention should be paid.(3)Low priority: "Di" indicates the technical alarm caused by the device itself.

Data storage, replay & transmission function

The measured record is stored automatically every four seconds. The monitor can store 72 hours records.

The device includes the function as "record review" on the Oximeter equipment. And you can review "Data Browse", "SpO2 Trend", "PR Trend" and "Data Clear" by this function. The data stored in the device can be transmitted through Bluetooth or USB cable.

Power

The applicant device uses three AA alkaline batteries or rechargeable batteries for power supply. The device has charge function by AC/DC power adapter, the specification of which is: 100-240 (VAC), 47/63 (Hz) input; 5Vd.c. output.

The device can measure normally during the process of charging, but we won't recommend to do so.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological product.

The device is software-driven and the software validation is provided in Section 10 Software.

. MD300M222 Handheld Pulse Oximeter

MD300M222 is the same as MD300M122 except the appearance.

● MD300M222 Handheld Pulse Oximeter

MD300M322 is the same as MD300M122 except the appearance.

8. Intended use

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Additional Information K111494

9. Substantial Equivalence

The applicant devices MD300M222/MD300M222/MD300M322 Handheld Pulse Oximeter have the same classification, same intended use, same design principle, similar specifications and same safety performance as the predicate device. These are no obvious differences to influence the effectiveness and safety of the device.

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

10. Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The proposed device was performed the tests according to the following standards:

IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Partl: General requirements for safety.

IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

FCC PART 15, SUBPART C: 2008 (Senction 15.249)

The Clinical Tests following ISO 9919:2005, Annex EE.2 are conducted in the lab of Beijing Military General Hospital. The study protocol is subjected to ISO 9919:2005 Annex EE. Procedures of testing required in EE.2 are adopted. It can be determined from the result of the study that the accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with "Golden Standard" Co-Oximeter.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Sunny Wang Correspondent Beijing Choice Electronic Technology Company, Limited Floor 4. Jungyang Bldg, No.15 Xiiing Road Shijingshan District, Beijing CHINA 100041

JAN 1 8 2012

Re: K111494

Trade/Device Name: Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 16, 2011 Received: December 19, 2011

Dear Ms. 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. 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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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 /ucm 1 1 5809.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.

Anthony D. Watson, B.S., M.S., M.B.A.

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 (if known): pending

Device Name: Handheld Pulse Oximeter_

Indications for Use:

The MD300M122/MD300M222/MD300M322 handheld pulse oximeter is intended The MD300M122/MD300MZ22/MD300M222 fitunctional pulse oxygen saturation
for continuous monitoring, spot-checking of functional pulse oxygens in hospitals and for continuous monitoring, spot-checking of functions. Partin and provins and home care.

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 IF NEEDED)

Moll J. Ward br Lester Schultheis

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

510(k) Number:

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).