MCPULSE

K023238 · Meridian Co., Ltd. · JOM · Feb 19, 2003 · Cardiovascular

Device Facts

• Record ID: K023238
• Device Name: MCPULSE
• Applicant: Meridian Co., Ltd.
• Product Code: JOM · Cardiovascular
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended Use

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

Device Story

McPulse Photoelectric Plethysmograph measures pulse waveform and heart rate via fingertip optoelectronic sensor. Sensor utilizes infrared LED and photodiode; LED light transmits through tissue; photodiode measures transmitted light to determine absorption. Microprocessor-based system converts light changes into pulse waveform; displays waveform on LCD screen; calculates heart rate based on time between successive pulses; displays digital heart rate values. Intended for professional use in clinical settings. Output assists healthcare providers in monitoring patient pulse characteristics and heart rate.

Clinical Evidence

Bench testing only. Testing included electrical safety, EMC, and user testing to verify performance against predicate device specifications.

Technological Characteristics

Optoelectronic sensor with infrared LED and photodiode. Microprocessor-based processing unit. Digital LCD display. Power source: AC (100-240Vac, 50/60Hz). Form factor: 305.5 x 296 x 92.5 mm; weight approx. 5.5 kg. Measurement range: 30-230 bpm.

Indications for Use

Indicated for non-invasive measurement of pulse waveform and heart rate in the finger for professional use.

Regulatory Classification

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.

Predicate Devices

• Novametrix Pulse Oximeter, Model 500 (K853124)

Submission Summary (Full Text)

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KO23238 0112

| EXHIBIT 2<br>510(k) Summary of Safety and Effectiveness<br>Meridian Co., Ltd..<br>9Fl., Seoul Bldg., 222 Jamsilbon-Dong, Songpa-Gu<br>Seoul, 138-863 Korea<br>Phone: [phone]<br>Fax: [phone]<br>September 18, 2002<br>Contact: 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
- 2. 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
- 3. Indications for Use (intended use) : The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.
- 4. 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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- 5. 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,<br>Model 500 (K853124) | McPulse |
|------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| INDICATION OF USE | measures pulse waveform, SaO2 and<br>heart rate by photoelectric<br>plethysmograph | measures pulse waveform and<br>heart rate by photoelectric<br>plethysmograph |
| MODE | Non invasive | Non Invasive |
| PRACTITIONER USE | Professional use only | Professional use only |
| DISPLAY | Digital LCD display<br>Analog display | Digital LCD Display |
| POWER SOURCE | AC(100/120/220/240Vac, 50/60Hz)/<br>DC(Portable rechargeable battery) | AC (100-240Vac, 50/60Hz) |
| TYPE OF SENSOR | LED-Photodiode /<br>finger, ear probe, flexible sensor | LED-Photodiode / finger<br>probe |
| ANATOMICAL SITE | Finger, ear, wrap around | Finger |
| RECORDER OUTPUTS | pulse waveform<br>Heart rate<br>SaO2% | pulse waveform<br>Heart rate |
| HEART RATE RANGE &<br>DISPLAY RESOULTION | 25-250bpm<br>1bpm | 30-230bpm<br>1bpm |
| 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 [phone]. 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 [phone] or [phone] 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