The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. The device is indicated for use in adults.

The K-Jump Arm Blood Pressure Monitor, Model KP-6821 AND KP-6822 are intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Device Description

The Arm BPM is designed to measure the systolic, diastolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the arm and held in place with Velcro™, an LCD display, a semiconductor sensor, an internal air pump, a battery power source, and keys for operation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the K-Jump Arm Blood Pressure Monitor, Models KP-6821 and KP-6822:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on compliance with standards rather than specific numerical performance metrics. The key standard referenced is ANSI/AAMI SP10A-1996. While the text states the device "complies" with this standard, it does not explicitly list the numerical acceptance criteria from that standard or specific numerical results for K-Jump's device beyond "tested with."

Therefore, based only on the provided text:

Acceptance Criterion (Standard)	Reported Device Performance
ANSI/AAMI SP10A-1996 "Electronic or Automatic Sphygmomanometer"	Complies with the standard.

To provide a complete table with numerical acceptance criteria, one would need to refer to the ANSI/AAMI SP10A-1996 standard itself. Generally, this standard specifies accuracy requirements such as:

Mean difference: The mean difference between the device readings and reference readings (e.g., mercurial sphygmomanometer) should be within ±5 mmHg.
Standard deviation: The standard deviation of the differences should be 8 mmHg or less.

However, since these specific numerical values are not in the provided text, they are not included in the table above.

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

Sample Size: One hundred patients.
Data Provenance: The text does not specify the country of origin of the data. It also does not explicitly state whether it was retrospective or prospective, but clinical trials are generally prospective. Given the nature of a clinical trial for device validation, it is highly likely to be prospective.

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

The text states that the blood pressure and heart rate were "tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM." The mercurial sphygmomanometer is the reference standard (ground truth). It is implied that a trained human operator (likely a medical professional) would be performing the auscultatory measurements. However:

Number of Experts: Not specified. It's typically one per patient measurement for the reference, but the text doesn't indicate if multiple independent experts were involved for comparison purposes on the same patient.
Qualifications of Experts: Not explicitly stated. For auscultatory measurements using a mercurial sphygmomanometer, the operator would need to be trained in proper blood pressure measurement techniques (e.g., a nurse, physician, or trained technician).

4. Adjudication Method for the Test Set

The text describes a direct comparison: "One hundred patients had their blood pressure and heart rate tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM." This implies a comparison between the device's reading and the singular reading from the reference standard. There is no mention of multiple expert readings that would require an adjudication method (like 2+1 or 3+1 concensus).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This was not an MRMC comparative effectiveness study. The study described compares a device's performance to a reference standard, not the improvement of human readers with AI assistance.

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

Yes. The study described is a standalone performance test of the Arm BPM device against a reference standard. The device operates automatically to measure blood pressure and heart rate.

7. The Type of Ground Truth Used

Expert Reference Standard: The ground truth was established by an "Ausculatory Mercurial Sphygmomanometer." This is considered the clinical gold standard for non-invasive blood pressure measurement, requiring a trained human operator (expert) for its use.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The document describes the validation study (test set) for regulatory submission. It does not provide information about a "training set" for an algorithm. Blood pressure monitors like this typically rely on established physiological principles and signal processing, rather than machine learning models that require a separate training set.

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

Not Applicable / Not Provided. As no training set information is given, this question is not relevant based on the provided text.

Summary

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510(k) SUMMARY

K-Jump's Arm Blood Pressure Monitor, Models KP-6821 and KP-6822 series

K014204

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

MAR 5 2002

Daniel 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 22331386

Date Prepared: November 5, 2001

Name of Device and Name/Address of Sponsor

Arm Blood Pressure Monitor, Model KP-6821 and KP-6822

K-Jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: 011 886 2 22991378 Facsimile: 011 886 2 22331386 Contact Person: Daniel Tseng

Common or Usual Name	Blood Pressure Monitor
Classification Name	System, Measurement, Blood Pressure, Non-Invasive
Predicate Device	I. A & D Engineering Inc.
	Arm Blood Pressure Monitor Model UA-779
	II. K-Jump Health Co., Ltd.
	Wristwatch Blood Pressure Monitor Model KP-6120

Intended Use

The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. The device is indicated for use in adults.

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Technological Characteristics

1014204 p. 2/2

Performance Data

The Arm BPM complies with EN 60601-1-2 (1993); EN 55011 (1991), IEC 801-2 (1991); IEC 801-3; EN 1060-1 and EN 1060-3 and the AAMI/ANSI SP10A-1996 standard. "Electronic or Automatic Sphygmomanometer."

K-Jump conducted a clinical trial in accordance with the ANSI/AAMI SP10A-1996 "Electronic or Automatic Sphygmomanometer" standard. One hundred patients had their blood pressure and heart rate tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM.

Substantial Equivalence

The Arm BPM is substantially equivalent to the A & D Engineering Inc.'s Arm BPM Model UA-779 and K-Jump's WristWatch BPM Model 6120. The Arm BPM and its predicate device are all noninvasive blood pressure monitors. Both the Arm BPM and A & D's Arm BPM take readings from the Upper Arm using the oscillometric method. The Arm BPM and A & D UA-779 have the same intended use, principles of operation and virtually identical technological characteristics. With the exception of minor variations in pressure measurement ranges, minimum operational relative humidity, minimum storage temperature and memory capacity, the devices are technologically identical. These minor differences do not raise any new issues of safety or effectiveness because both devices comply with the AAMI/ANSI SP10A-1996 standard "Electronic or Automated Sphygmomanometer".". Thus, the Arm BPM is substantially equivalent to the A & D's UA-779 and the WristWatch BPM. Further, the Arm BPM substantial equivalence is demonstrated by conformance to the ANSI/AAMI SP10A-1996 standard.

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Image /page/2/Picture/1 description: The image shows a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 5 2002

K-Jump Health Co., Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004

Re: K014204

Trade Name: Arm Blood Pressure Monitor, Models KP-6821, KP-6822 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 21, 2001 Received: December 21, 2001

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 2017, 11:24 accordance with the provisions of the Federal Food, Drug, de rices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, maxis of the Act include requirements for annual registration, listing of general controlly profices of tactice, 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 If your device is classified (600 a00 royals. 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. Jonathan S. Kahan

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 that i Drines Internations administered by other Federal agencies. You must or any I catal button and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fat 607); adoning (21 OFF 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) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promative noticated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 301) 594-4646. Additionally, for questions on the promotion and advertising of Compinance at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general millimantes turers, 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,

signature

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

Enclosure

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Indications for Use Form

510(k) Number (if known): _

Device Name: K-JUMP Health Co., Ltd. Arm Blood Pressure Monitor, Models KP-6821 and KP-6822 series

Indication for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) N:
2014 207

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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).