The Multifunction KEITO K5 is intended to be used by adults in order to measure height, weight, systolic and diastolic blood pressures, and to calculate pulse rate.

Device Description

The Multifunction KEITO K5 (K5) is designed to provide the user with measurements of blood pressure, height, and weight, as well as to calculate the Body Mass Index (BMI) and pulse rate. The user is prompted to select a measurement cycle, step onto the K5 platform, and wait momentarily while the measurements and calculations are performed. After the measurements have been taken, the K5 provides the user with the results. To operate the K5 the user inserts a coin into the coin slot, and steps onto the platform. The user has the option of selecting a partial measuring cycle or a complete cycle. In a partial cycle, weight and height measurements are taken and Body Mass Index calculations are performed in the partial cycle. In a complete cycle, weight, height, blood pressure, and pulse measurements are taken. Body Mass Index is calculated and the W.H.O. blood pressure recommendations are provided. The K5 prints out a ticket containing the results of the measurements and the recommended ranges for both BMI and blood pressure.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Multifunction KEITO K5, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Blood Pressure Accuracy	Met the acceptance requirements of German regulations (BGBI.IS.759, 771 and 1667) for clinical testing of blood pressure systems.	"The results were evaluated in accordance with the acceptance requirements of the regulation (BGBI.IS.759, 771 and 1667) and found to be acceptable."
Height Compensation	Developed a formula to compensate for user height during wrist cuff blood pressure measurements based on statistical methodologies.	"Based on the results, a formula was developed to compensate for user height during wrist cuff blood pressure measurements."

2. Sample Size and Data Provenance for Test Set

Blood Pressure Accuracy Test:
- Sample Size: Not explicitly stated, but the test compared the K5 to a manual sphygmomanometer.
- Data Provenance: The testing was conducted by Physikalisch-Technische Bundesanstalt (a German national metrology institute), implying the data was collected in Germany. It is implied to be prospective testing for regulatory approval.
Height Compensation Test:
- Sample Size: "multiple users of different heights, ages and sex." The exact number is not specified.
- Data Provenance: Not explicitly stated, but likely conducted by the manufacturer or a third-party testing facility. It is implied to be prospective.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Blood Pressure Accuracy Test:
- The "ground truth" was established by a manual sphygmomanometer, which is the gold standard for clinical blood pressure measurement.
- The document does not specify the number or qualifications of clinicians/technicians operating the manual sphygmomanometer, but it's implied they were trained professionals given the regulatory context.
Height Compensation Test:
- The ground truth for blood pressure measurements in this test would also be the manual sphygmomanometer.
- No specific experts mentioned for validating the compensatory formula itself, beyond the statistical methodologies applied.

4. Adjudication Method for the Test Set

No specific adjudication method (like 2+1, 3+1 consensus) is described.
For the blood pressure accuracy, the comparison was directly between the device and the manual sphygmomanometer, with results being "evaluated in accordance with the acceptance requirements of the regulation." This suggests a direct comparison against a standard rather than expert adjudication of AI outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a standalone measurement system, not an AI assisting human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done.
- The pressure system of the Multifunction KEITO K5 was tested by Physikalisch-Technische Bundesanstalt to verify its accuracy against a manual sphygmomanometer.
- Additional testing was conducted on the K5 to determine correct user height compensation.

7. Type of Ground Truth Used (Test Set)

Blood Pressure Accuracy Test: Comparison against a gold standard (manual sphygmomanometer).
Height Compensation Test: Comparison against a gold standard (manual sphygmomanometer), along with objective measurements of height, age, and sex.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an AI/machine learning model. The K5 is described as a non-invasive blood pressure measurement system, not an AI-driven diagnostic or image analysis tool that would typically have a distinct training set.
The "formula was developed to compensate for user height" based on testing "multiple users of different heights, ages and sex." This process of developing the formula might be considered analogous to a training phase, but the sample size is not specified beyond "multiple users."

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

As above, the concept of a "training set" for an AI model isn't directly applicable here.
If we consider the development of the height compensation formula as an analogous process, the "ground truth" for developing this formula was established by using manual sphygmomanometer readings and objective user height measurements from "multiple users of different heights, ages and sex." The formula was then derived using "statistical methodologies" to correlate these measurements and compensate for variations.

Summary

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

JAN 1 8 2000

K981/083

Multifunction K5 Bumedco International Inc. 510(k) Premarket Notification

Appendix VIII. 510(k) Summary of Safety and Effectiveness Data Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. General Information

A.	Submitted By:	Bumedco International Inc.
		725 Timber Lane
		Shoreview, MN 55126
	Tel:	(612) 787-0625
	Fax:	(612) 765-0186
	Contact Person:	Darrold L. Glanville
B.	Device Trade Name:	Multifunction K5
	Common Name:	Blood Pressure Monitoring System
	Classification Name:	Non-invasive Blood-Pressure Measurement System
C.	Predicate Device:	Omron Portable Wrist Blood Pressure Kit,
		Model HEM-608

D. Device Description:

Vita-Stat Model 8000-C

To operate the K5 the user inserts a coin into the coin slot, and steps onto the platform. The user has the option of selecting a partial measuring cycle or a complete cycle. In a partial cycle, weight and height measurements are taken and Body Mass Index calculations are performed in the partial cycle. In a complete cycle, weight, height, blood pressure, and pulse measurements are taken. Body Mass Index is calculated and the W.H.O. blood pressure recommendations are provided. The K5 prints out a ticket containing the results

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

of the measurements and the recommended ranges for both BMI and blood pressure.

E. Indications for Use:
The Multifunction KEITO K5 is intended to measure height, weight, and blood pressure and to calculate pulse rate.
F. Technological Comparison:
The Multifunction KEITO K5, Vita-Stat Model 8000-C and the Omron Portable Wrist Blood Pressure Monitor have the same type of measurement method as well as provide systolic, diastolic, and pulse measurements.

II. Testing

The pressure system was tested by Physikalisch-Technische Bundesanstalt, to verify the accuracy of the pressure system as compared to a manual sphygmomanometer in accordance with the German's regulations for clinical testing of blood pressure systems (BGBI.IS. 759,771 and 1667). The results were evaluated in accordance with the acceptance requirements of the regulation (BGBI.IS.759,771 and 1667) and found to be acceptable.

Additional testing was conducted to determine the correct user height compensation for the K5. The procedure involved testing multiple users of different heights, ages and sex with a manual sphygmomanometer and the K5. The results were computed using statistical methodologies. Based on the results, a formula was developed to compensate for user height during wrist cuff blood pressure measurements.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2000

Darrold Glanville President Bumedco International, Inc. 725 Timber Lane Shoreview, Minnesota 55126

K984083 Re: Trade Name: Multifunction Keito K5, Non-Invasive Blood Pressure System Regulatory Class: II (two) Product Code: DXN Dated: November 5, 1999 November 8, 1999 Received:

Dear Mr. Glanville:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Darrold Glanville

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Soff. Sore R. Samperlee

Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Multifunction KEITO K5

Bumedco International Inc. Sponsor Name:

Indications for Use

The Multifunction KEITO K5 is intended to be used by adults in order to measure height, weight, systolic and diastolic blood pressures, and to calculate pulse rate.

Beue Q. Bamperski
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number 1< 984083

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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).