The KP-7500 and KP-7500D are intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. It is indicated for use in adults.

The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

Device Description

The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the K-jump Health Co., Ltd.'s Arm Blood Pressure Monitor Models KP-7500 and KP-7500D, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary explicitly states that the device "complies with the following FDA recognized consensus standards...to the extent that these standards are applicable to this device: AAMI/ANSI SP10 (2002 / A1:2003); IEC 60601-1 (1988); and IEC 60601-1-2 (2002)." It also mentions compliance with EN61000-4-2 (1995) and EN61000-4-3 (2002).

For blood pressure monitors, AAMI/ANSI SP10 (2002 / A1:2003) is the key standard for accuracy. While the document doesn't provide a direct table of numerical "acceptance criteria" alongside specific device performance numbers (e.g., mean difference and standard deviation), compliance with AAMI/ANSI SP10 inherently means meeting its accuracy thresholds. The standard typically requires:

A mean difference between the device measurement and the reference measurement of ≤ ±5 mmHg.
A standard deviation of that difference of ≤ 8 mmHg.

Acceptance Criteria (Based on AAMI/ANSI SP10)	Reported Device Performance
Mean difference ≤ ±5 mmHg	"accurately measures the patient's blood pressure and pulse rate" (implied compliance with AAMI/ANSI SP10)
Standard deviation ≤ 8 mmHg	"accurately measures the patient's blood pressure and pulse rate" (implied compliance with AAMI/ANSI SP10)

The document states, "In accordance with AAMI/ANSI SP10, a clinical trial also was performed to verify the accuracy of in vivo measurement. The results demonstrate that the KP-7500 and KP-7500D accurately measures the patient's blood pressure and pulse rate." This statement is the "reported device performance," indicating it met the AAMI/ANSI SP10 criteria. Specific numerical values for mean difference and standard deviation are not provided in this summary.

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

Sample Size: Not specified in the provided text. The document only mentions "a clinical trial."
Data Provenance: Not specified, but generally, such clinical trials for device clearance are conducted in a controlled, prospective manner. The country of origin of the data is not mentioned. It is implied to be prospective as it's a "clinical trial performed to verify the accuracy of in vivo measurement."

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

For blood pressure monitor accuracy studies (like those compliant with AAMI/ANSI SP10), ground truth is established by trained observers (often physicians or nurses) using a reference sphygmomanometer and stethoscope, applying a standardized auscultatory method. The number and specific qualifications of these "experts" (trained observers) are not detailed in the provided 510(k) summary. However, AAMI/ANSI SP10 typically requires

three trained observers in its protocol to minimize observer bias.
These observers would be trained technicians or clinicians proficient in auscultatory blood pressure measurement, adhering to strict protocols.

4. Adjudication Method for the Test Set

The typical adjudication method for auscultatory blood pressure measurements in AAMI/ANSI SP10 compliant studies involves:

Multiple observers (usually three) taking independent measurements.
The average or consensus of these observers' measurements often serves as the reference (ground truth) against which the automated device is compared.
Discrepancies exceeding a certain threshold among observers would necessitate re-measurement or specific handling as per the protocol.

The specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated in the provided text, but it would have been part of the AAMI/ANSI SP10 protocol followed.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. Blood pressure monitors primarily measure a physiological parameter, and their accuracy is evaluated against a direct physiological reference, not by comparing human interpretation of device output with and without AI assistance.

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

Yes, the clinical trial described is a standalone performance study of the device. The device itself performs the measurement, and its output (algorithm only) is compared against the ground truth established by human observers using a reference method. There is no human-in-the-loop interacting with the device's measurement process; the device operates autonomously.

7. The Type of Ground Truth Used

Expert Consensus / Reference Auscultatory Measurement: For blood pressure monitors, the gold standard (ground truth) is always established using auscultatory measurements performed by trained human observers with a calibrated mercury or aneroid sphygmomanometer and stethoscope. This effectively represents "expert consensus" on the true blood pressure at the time of measurement.

8. The Sample Size for the Training Set

The provided document is a 510(k) summary for a blood pressure monitor, which is typically a hardware and firmware device. While it mentions "Smartlogic" and "Fuzzylogic," referring to control algorithms, there is no mention of a "training set" in the context of machine learning for an algorithm that learns from data in the same way modern AI systems do. The "Smartlogic" or "Fuzzylogic" refers to the control logic for cuff inflation/deflation and signal processing, which is generally pre-programmed and validated, not "trained" on a large dataset in the sense of deep learning. Therefore, no training set size is specified or applicable in the modern AI sense.

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

As mentioned above, the concept of a "training set" and associated ground truth establishment for a learning algorithm is not applicable to this type of device as described in the 510(k) summary. The internal algorithms (Smartlogic/Fuzzylogic) are likely based on established signal processing techniques for oscillometric blood pressure measurement. Their performance is validated through the clinical trial described, not by training on a labeled dataset.

Summary

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Ko83753

510(k) Summary

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Mr. Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

JUN 19 2009

Name of Device

Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D

Name/Address of Sponsor

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person: Jason Cheng

Common or Usual Name

Arm Blood Pressure Monitor

Classification Name

Class II § 870.1130; System, Measurement, Blood Pressure, Non-Invasive

Predicate Device

I. K jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model KP-6210.
II. K-jump Health Co., Ltd.'s Arm BPM Blood Pressure Monitor Model KP-6821 and KP-6822.
III. MicroLife's Upper Arm Blood Pressure Monitor Model BP-3BT0-AP.

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Intended Use/Indications for Use

The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff. The device is indicated for use with adults.

The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

Technological Characteristics

Performance Data

The Arm Blood Pressure Monitor Model KP-7500 and KP-7500D complies with the following FDA recognized consensus standards, to the extent that these standards are applicable to this device:

AAMI/ANSI SP10 (2002 / A1:2003); .
IEC 60601-1 (1988); and �
IEC 60601-1-2 (2002). .

The KP-7500 and KP-7500D also complies with the following additional

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standards:

. EN61000-4-2 (1995); and
EN61000-4-3 (2002). .

In accordance with AAMI/ANSI SP10, a clinical trial also was performed to verify the accuracy of in vivo measurement. The results demonstrate that the KP-7500 and KP-7500D accurately measures the patient's blood pressure and pulse rate.

Substantial Equivalence

The KP-7500 and KP-7500D have the same intended use and indications for use as K-Jump's Arm Blood Pressure Monitor Model KP-6210, K-Jump's Wristwatch Blood Pressure Monitor Model KP-6821 and MicroLife's Model BP-3BT0-AP.

The KP-7500 has the same technological characteristics as the KP-6210 except: (1) that the KP-7500 uses a bellows sensor; and (2) the KP-7500 is used on the upper arm rather than on the wrist.

The KP-7500D has the same technological characteristics as the KP-6821 except: (1) that the KP-7500D uses a bellows sensor; and (2) the KP-7500D displays blood pressure and heart rate on the same screen simultaneously rather than on subsequent, alternating screens.

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Microlife's Model BP-3BT0-AP also uses a bellows sensor same as the KP-7500 and KP-7500D. Both devices include an irregular pulse detection function.

Thus, the minor differences between the KP-7500, KP-7500D and the predicate devices are not new technological characteristics for arm blood pressure monitors. The modification of the device's LCD display was made for user convenience. Therefore, these minor technological differences do not raise any new questions of safety or effectiveness. Accordingly, the KP-7500 and KP-7500D are substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2009

K-jump Health Co., Ltd. c/o Mr. Jason Cheng Regulatory Affairs No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien 248 Taiwan

Re: K083753

Trade/Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 12, 2009 Received: June 16, 2009

Dear Mr. Cheng:

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 - Mr. Jason Cheng

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

or 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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Indications for Use Statement

510(k) Number (if Known): K083753

Device Name: Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D

Indication for Use:

The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.

Prescription Use -------(Per 21 C.F.R. 801.109) -Over-The-Counter-Use-X-(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-OR-

of Cardiovascula

510(k) Number K 08373

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).