(124 days)
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
The device is to measure the heart rate with photoelectric measurement techniques. It is to be connected with a desktop PC or laptop PC. It is operated with a mouse or a keyboard of PC which is used to enter the patient information as well as to operate the system and review the resulting analysis.
The provided 510(k) summary for the Max Pulse System by Medicore Co., Ltd. indicates that no clinical data was needed for its clearance. Therefore, a study demonstrating the device meets acceptance criteria, as one might expect for a clinically validated device, is not present in this document. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.
Here's an analysis based on the information provided, outlining what is and isn't available regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Max Pulse System) |
|---|---|---|
| Intended Use | Measures pulse waveform; SpO2 and heart rate by photoelectric plethysmograph | Measures pulse waveform; SpO2 and heart rate by photoelectric plethysmograph |
| Intended Users | Professional use only | Professional use only |
| Mode | Non invasive | Non invasive |
| Heart Rate Range | 30-230 bpm | 30-240 bpm |
| Accuracy (SpO2 sensor) | ±2% (implicitly for predicate, stated for Max Pulse) | Accuracy ±2% (for MD-10 finger type reusable sensor) |
| Safety Features | Compliant with applicable safety standards | Compliant with applicable safety standards |
| Environmental Conditions (Operation) | Not specified in product labeling | Temperature 10-35°C; Relative humidity 20-95%RH; Atmospheric Pressure 700-1060hPa |
| Environmental Conditions (Storage) | Not specified in product labeling | -20 |
| Overall Performance | Substantially equivalent to predicate | Functions are substantially equivalent to the predicate. Meets the same safety and performance standards as the predicate. |
Missing Information Regarding Acceptance Criteria and Performance:
- Specific, quantifiable acceptance criteria for metrics like heart rate accuracy, pulse waveform fidelity, or SpO2 measurement accuracy (beyond the sensor's stated ±2%) are not detailed. The submission relies on claiming substantial equivalence to the predicate device, K023238 (McPulse by Meridian Co. Ltd.), which means the acceptance criteria are implicitly met if the device performs comparably to the predicate.
- The document does not provide a "study that proves the device meets the acceptance criteria" in terms of clinical trials or performance assessments with specific endpoints. Instead, it states that "The device has completed performance testing showing that the functions are substantially equivalent to the predicate." The details of this performance testing (e.g., methodology, sample size, results against specific thresholds) are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document explicitly states, "Clinical data is not needed for Max Pulse system or for most devices cleared by the 510(k) process." Therefore, there is no test set in the sense of patient data for a clinical study. The "performance testing" mentioned is non-clinical. The document does not specify the sample size or provenance of data used for this non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: Since no clinical data was required and no clinical "test set" was used, there were no experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: As no clinical test set requiring expert ground truth was utilized, no adjudication method was employed.
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:
- No: This is not an AI-assisted device, and no MRMC study was performed. The device is a direct measurement tool (plethysmograph) for heart rate and SpO2.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (Implicit, for technical performance): The device is a standalone measurement system. The "performance testing" mentioned, though not detailed, would likely assess the device's technical capabilities (e.g., accuracy of heart rate detection, signal quality) independent of human interpretation or assistance, comparing them to the predicate's technical specifications. However, the exact nature and results of this "standalone" technical performance testing are not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided for clinical ground truth: For a device measuring heart rate and SpO2, if clinical studies were done, ground truth would typically come from highly accurate reference devices (e.g., ECG for heart rate, co-oximetry for SpO2). However, as stated, no clinical data was required or submitted. For the non-clinical performance testing, the ground truth would have been based on established technical standards and the performance of the predicate device.
8. The sample size for the training set:
- Not Applicable / Not Provided: The Max Pulse System is not described as an AI/ML device that requires a "training set." It is a hardware device based on photoelectric measurement techniques.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: No training set was used for this type of device.
In summary:
The Max Pulse System gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (McPulse by Meridian Co. Ltd.) based on non-clinical performance testing and adherence to applicable safety and performance standards. The submission explicitly states that clinical data was not needed. Therefore, the detailed aspects of clinical studies, such as specific acceptance criteria derived from patient outcomes, sample sizes for clinical test sets, expert ground truth, or adjudication methods, are not present in this 510(k) summary. The "acceptance criteria" are effectively defined by the predicate device's established performance and the general regulatory requirements for this class of device.
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PI/CI
JUN 1 3 2011
510(k) Summary (21 CFR 807.92)
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
"The assigned 510(k) number is KIJ 0374 _" (applicant leave blank)
Premarket Notification [510(k)] Summary
[1]]. The summary contains the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared:
Submitter's Name: Medicore Co., Ltd.
Submitter's Address: 1F, Delice B/D B, 135-5, Sangdeawon-dong, Jungwon-gu, Sungnam-si, Gyunggi-do, Korea
Phone Number: 82-2-2056-2650
Fax Number: 82-2-2056-2688
Name of Contact Person: Mr. Byung-kuk Yoo
Date the Summary was prepared: November 8, 2010
[2]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if know.
Product Name: Max Pulse System
Common Name: Pneumatic Plethysmograph
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Classification: JOM; Class II;
Regulation Number: CFR 21 870.2780 [3]. An identification of the legally marketed device to which your firm is claiming substantial equivalence.
Predicate Device: McPulse by Meridian Co. Ltd.
[4] A description of the device
Description of Device: The device is to measure the heart rate with photoelectric measurement techniques. It is to be connected with a desktop PC or laptop PC. It is operated with a mouse or a keyboard of PC which is used to enter the patient information as well as to operate the system and review the resulting analysis.
| Predicate Device | Subject Device | |
|---|---|---|
| McPulseMeridian Co. Ltd | Max PulseMedicore, Co., Ltd. | |
| K023238 | ||
| Classification | Class II | Class II |
| Classification Code | JOM | JOM |
| Intended Use | Measures pulse waveform;SpO2 and heart rate byphotoelectric plethysmograph | Measures pulse waveform;SpO2 and heart rate byphotoelectricplethysmograph |
| Intended Users | Professional use only | Professional use only |
| Mode | Non invasive | Non invasive |
| Display | Digital LCD display | No |
| Power Source | AC (100-240Vac, 50/60 Hz) | 100-240VACPhase: SingleFrequency 50/60HzCurrent less than 1.0A |
| Type of Sensor | LED - photodiode/fingerprobe | LED - photodiode/fingerprobeMD-10 finger type reusablesensorAccuracy±2%Shape Clip typeLed specificationRed & infrared, nominalPhotodiode Active area :$5mm^2$Responsibility : 0.18Min |
| Recorder Outputs | Pulse waveformHeart rate | Pulse waveformHeart rate |
| Heart Rate Range | 30-230 bpm | 30-240 bpm |
| Size (unit:mm) | 305.5 W x 296 H x 92.5 D | 150x 130x 35 |
| Weight | Approx 5.5 kg | Approx. 650g |
| Safety features | Compliant with applicablesafety standards | Compliant with applicablesafety standards |
| EnvironmentalConditionsOperation | Not specified in productlabeling | Temperature 10-35°CRelative humidity 20-95%RHAtmospheric Pressure 700-1060hPa |
| EnvironmentalConditionsStorage | Not specified in productlabeling | -20 |
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[5]. The summary describes the intended use of the device.
Intended Use: The device provides noninvasive measurement of heart rate by photoelectric probe. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
[6] A brief discussion of the nonclinical submitted, reference, or relied on in the premaket notification submission for a determination of substantial equivalence.
Clinical data is not needed for Max Pulse system or for most devices cleared by the 510(k) process.
[7] Performance:
The device has completed performance testing showing that the functions are substantially equivalent to the predicate. In addition the device meets the same safety and performance standards as the predicate.
[8]The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The Medicore Max Pulse System is substantially equivalent1 to the McPulse device manufactured by Meridian Co. Ltd. that received clearance through 510(k) Premarket Notification K023238 and currently in commercial distribution.
1 The term "substantially equivalent" as used in this submission is intended to convey only a determination of substantial equivalence pursuant to the requirements of the FD&C Act. It is not intended to have any bearing whatsoever in determining what is patentable or on the resolution o patent infringement suits or any other patent matter.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medicore Co., Ltd. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25" Street NW Buffalo, MN 55313
JUN 1 3 2011
Re: K110374
Trade/Device Name: Max Pulse Regulation Number: 21 CFR 870.2780 Regulation Name: Photoelectric, Pneumatic, or Hydraulic Plethysmograph Regulatory Class: Class II (two) Product Codes: JOM Dated: May 27, 2011 Received: May 31, 2011
Dear Mr. Job:
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.
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
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Page 2 - Medicore Co., Ltd., c/o Mr. Mark Job
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 yours,
Bram D. Zuckerman, M.D.
$\beta$
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Max Pulse
Indications For Use:
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
Prescription Use
(Per 21CFR 801)
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| (ODE) | Concurrence Of CDRH, Office Of Device Evaluation |
|---|---|
| Division(Sign-Off) | Division of Cardiovascular Devices |
| 510(k) Number | K110374 |
§ 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).