MCPULSE by MERIDIAN CO., LTD. | FDA 510(k) Summary

The McPulse Photo-Plethysmograph is intended to be used to measure pulse waveform and heart rate in the finger by lighting a fingertip with combination of infrared LED and photodiode. The measurement probe is an optoelectronic sensor consisted of a light-emitting diode(infrared LED) and a photodiode placed on opposite side as a light receiver. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on LCD screen. Pulse rate is measured using the time between successive pulses and displayed digital values on LCD screen. The McPulse system consists of an optoelectronic sensor that is applied to the patient and a microprocessor-based system that processes and displays the measurement. The optoelectronic sensor contains a light-emitting diode(infrared LED) and one photodiode as a light receiver. The light from the LED is transmitted through the tissue at the sensor site. The photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on functional and safety aspects.

Here's a breakdown of the information that can be extracted or inferred, and points where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria or detailed performance results in the way one might expect for a clinical study comparing an AI system to a baseline. Instead, it offers a comparison of features to a predicate device.

Feature	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (McPulse)
Indication of Use	Measures pulse waveform and heart rate by photoelectric plethysmography	Measures pulse waveform and heart rate by photoelectric plethysmography
Mode	Non-invasive	Non Invasive
Practitioner Use	Professional use only	Professional use only
Display	Digital LCD display, Analog display	Digital LCD Display
Power Source	AC/DC (portable rechargeable battery)	AC (100-240Vac, 50/60Hz)
Type of Sensor	LED-Photodiode / finger, ear probe, flexible sensor	LED-Photodiode / finger probe
Anatomical Site	Finger, ear, wrap around	Finger
Recorder Outputs	Pulse waveform, Heart rate, SaO2%	Pulse waveform, Heart rate
Heart Rate Range & Display Resolution	25-250bpm, 1bpm	30-230bpm, 1bpm
Safety and Effectiveness	As safe and effective as predicate device	Bench and user testing indicates as safe and effective as predicate

Missing Information:

Specific numerical acceptance thresholds for pulse waveform accuracy, heart rate accuracy, signal-to-noise ratio, or other relevant performance metrics.
Quantitative results from "bench and user testing" that would show the McPulse's measured performance against these thresholds.

2. Sample size used for the test set and the data provenance:
The document mentions "bench and user testing." However, it does not specify:

The sample size of participants or data points used in these tests.
The provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "user testing" but does not provide any details about:

The number of experts involved.
Their qualifications.
How ground truth was established, if applicable, in the context of this device (which measures physiological signals rather than interpreting images or complex diagnostic data).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Provided. The nature of this device (photoelectric plethysmograph measuring pulse/heart rate) typically doesn't involve adjudication methods like those used for image interpretation in AI studies.

5. 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:
Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's a physiological monitoring device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measurement instrument. The "bench and user testing" would have evaluated its performance in this standalone capacity. However, no specific details or results of these tests are provided beyond a general statement of equivalency.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a device measuring pulse waveform and heart rate, ground truth would typically be established by:

Bench testing: Using calibrated signal generators or phantoms to simulate physiological signals with known characteristics.
User testing: Comparing the device's measurements to a gold standard reference device (e.g., an ECG for heart rate, or a highly accurate plethysmograph) on human subjects.
The document does not specify which methods were used for "bench and user testing" to establish ground truth for this device.

8. The sample size for the training set:
Not applicable. This device is a hardware-based physiological monitor, not a machine learning algorithm that requires a "training set" in the common sense of AI development.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for an AI model.

Summary of the Study:

The document describes a 510(k) submission for the "McPulse Photoelectric Plethysmograph" seeking substantial equivalence to the Novametrix Pulse Oximeter, Model 500 (K853124). The "study" proving the device meets its (largely inferred) acceptance criteria is described as "bench and user testing."

The conclusion is a qualitative statement: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." It further states that the McPulse is "as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

While the document confirms that testing was performed, it lacks the specific quantitative details regarding sample sizes, expert qualifications, ground truth methodology, and performance metrics that would typically be expected for a detailed description of acceptance criteria and a proving study in the context of more complex diagnostic devices or AI systems.

Summary

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KO23238 0112

EXHIBIT 2510(k) Summary of Safety and EffectivenessMeridian Co., Ltd..9Fl., Seoul Bldg., 222 Jamsilbon-Dong, Songpa-GuSeoul, 138-863 KoreaPhone: 82-2-2103-3320Fax: 82-2-2103-3333September 18, 2002Contact: Soorang Lee, R&D Director	FEB 1 9 2003
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1. Identification of the Device: Proprietary-Trade Name: McPulse Photoelectric Plethysmograph Classification Name: Plethysmograph, Photoelectric, Product code JOM Common/Usual Name: Photoelectric Plethysomograph
1. Equivalent legally marketed devices This product is similar in function to the Novametrix Pulse Oximeter, Model 500 510(k) No. : K853124 Applicant: NOVAMETRIX MEDICAL SYSTEMS INC
1. Indications for Use (intended use) : The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.
1. Description of the Device: The McPulse Photo-Plethysmograph is intended to be used to measure pulse waveform and heart rate in the finger by lighting a fingertip with combination of infrared LED and photodiode. The measurement probe is an optoelectronic sensor consisted of a light-emitting diode(infrared LED) and a photodiode placed on opposite side as a light receiver. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on LCD screen. Pulse rate is measured using the time between successive pulses and displayed digital values on LCD screen. The McPulse system consists of an optoelectronic sensor that is applied to the patient and a microprocessor-based system that processes and displays the measurement. The optoelectronic sensor contains a light-emitting diode(infrared LED) and one photodiode as a light receiver. The light from the LED is transmitted through the tissue at the sensor site. The photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed..

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1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

Feature	Novametrix Pulse Oximeter,Model 500 (K853124)	McPulse
INDICATION OF USE	measures pulse waveform, SaO2 andheart rate by photoelectricplethysmograph	measures pulse waveform andheart rate by photoelectricplethysmograph
MODE	Non invasive	Non Invasive
PRACTITIONER USE	Professional use only	Professional use only
DISPLAY	Digital LCD displayAnalog display	Digital LCD Display
POWER SOURCE	AC(100/120/220/240Vac, 50/60Hz)/DC(Portable rechargeable battery)	AC (100-240Vac, 50/60Hz)
TYPE OF SENSOR	LED-Photodiode /finger, ear probe, flexible sensor	LED-Photodiode / fingerprobe
ANATOMICAL SITE	Finger, ear, wrap around	Finger
RECORDER OUTPUTS	pulse waveformHeart rateSaO2%	pulse waveformHeart rate
HEART RATE RANGE &DISPLAY RESOULTION	25-250bpm1bpm	30-230bpm1bpm
SIZE (unit : mm)	228.6(W) × 92.08(H) ×254(D)	305.5(W) × 296(H) × 92.5(D)
WEIGHT	Approx. 3.6kg	Approx. 5.5 kg

6. Substantial Equivalence Chart

7. Conclusion

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Meridian Co. Ltd.. that the McPulse Photoelectric Plethysmograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Meridian Co., Ltd. c/o Mr. Daniel Kamm, P.E. Regulatory Associate Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K023238

Trade Name: McPulse Photoelectric Plethysmograph Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: January 14, 2003 Received: January 15, 2003

Dear Mr. Kamm:

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. Iisting 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 - Mr. Daniel Kamm, P.E.

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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Dell Tull

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

KOZ3238 510(k) Number_

Device Name: McPulse Photoelectric Plethysmograph

Indications for Use: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over the Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Per 21 CFR 801.109)

Delattre

of Cardiovascular Device

510(k) Number K023238

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).