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.

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

The provided document indicates that the Wristwatch Blood Pressure Monitor Model KP-7000 was evaluated for performance against the AAMI/ANSI SP10 standard.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from AAMI/ANSI SP10)	Reported Device Performance
Accuracy of in-vivo blood pressure measurement for systolic and diastolic blood pressure.	"The results demonstrate that the KP-7000 accurately measures the patient's blood pressure and pulse rate."

Note: The document states compliance with AAMI/ANSI SP10 (1992 / A1:1996), which outlines specific accuracy requirements for blood pressure monitors. However, the exact numerical accuracy performance (e.g., mean difference and standard deviation of differences between the device and a reference measurement) is not explicitly detailed in this summary. The summary only provides a high-level statement of accuracy.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance:
- Country of origin: Not specified.
- Retrospective or prospective: The phrase "a clinical trial also was performed" suggests a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (For blood pressure monitor validation, this typically refers to trained observers following a standardized protocol, often with mercury sphygmomanometers)

4. Adjudication method for the test set

Adjudication Method: Not specified. For blood pressure clinical trials, this usually involves a specific protocol for how multiple observers take and compare readings to establish a reference, but details are not provided here.

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

MRMC Study: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the reported performance is for the device operating as a standalone blood pressure monitor, without human intervention in the measurement process itself, beyond initiation and placement. The AAMI/ANSI SP10 standard requires clinical validation of the device's accuracy against a reference method.

7. The type of ground truth used

Type of Ground Truth: Clinical reference measurements, presumably obtained by trained observers using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer as per AAMI/ANSI SP10 guidelines).

8. The sample size for the training set

Sample Size: Not applicable. This device is a traditional blood pressure monitor, not a machine learning or AI-based device that typically has a "training set." Its calibration and accuracy are based on engineering design and validation against standards rather than data-driven training.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

SEP = 9 2003

510(k) Summary

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

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

Date Prepared: August 11, 2003

Name of Device

Wristwatch Blood Pressure Monitor Model KP-7000

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: T.T. Lin

Common or Usual Name

Wrist Blood Pressure Monitor

Classification Name

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

Predicate Device

K-jump Health Co., Ltd.'s Wristwatch BPM Blood Pressure Monitor Model I. KP-6120.
II. MicroLife's Wrist Watch Blood Pressure Monitor Model BP-3BU1-3.

{1}------------------------------------------------

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.

Technological Characteristics

Performance Data

The Wristwatch Blood Pressure Monitor Model KP-7000 complies with the following FDA-recognized consensus standards, to the extent that these standards are applicable to this device:

AAMI/ANSI SP10 (1992 / A1:1996); ●
IEC 60601-1-1 (2000); and .
IEC 60601-1-2 (2002). ●

The KP-7000 also complies with the following additional 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-7000 accurately measures the patient's blood pressure and pulse rate.

Substantial Equivalence

The KP-7000 has the same intended use and indications for use as K-Jump's Wristwatch Blood Pressure Monitor Model KP-6120 and MicroLife's Model BP-3BU1. The KP-7000 has the same technological characteristics as the the KP6120 except: (1) that the KP-7000 uses a bellows sensor; (2) the KP-7000 has a lower maximum storage temperature; and (3) the KP-7000 displays blood pressure

{2}------------------------------------------------

and heart rate on the same screen simultaneously rather than on subsequent, alternating screens. Microlife's Model BP-3BU1 also uses a bellows sensor and has the same maximum storage temperature as the KP-7000. Thus, the minor differences between the KP-7000 and the predicate devices are not new technological characteristics for wrist watch 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-7000 is substantially equivalent to its predicate devices.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

K-Jump Health Co., Ltd c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteen Street, N.W. Washington, D.C. 20004-1109

Re: K032492

Trade Name: Wristwatch Blood Pressure Monitor Model KP-7000 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure monitor Regulatory Class: Class II (two) Product Code: DXN Dated: August 12, 2003 Received: August 12, 2003

Dear Mr. Kahan:

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.

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

{4}------------------------------------------------

Page 2 - Mr. Jonathan S. Kahan

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 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,

K. Dalton Tull

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

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if Known):

K432492 ______________________________________________________________________________________________________________________________________________________________________

Device Name: KP-7000

Wristwatch Blood Pressure Monitor Model

Indication for Use:

The KP-7000 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff which is wrapped around the wrist. It is indicated for use in adults.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use X (Optional Format 1-2-96)

N. Deaton

510(k) Number K032492

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).