Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard physiological measurements using established technologies like bio impedance analysis.

Therapeutic

No
The device measures health parameters (weight, body fat, blood pressure, pulse rate) but does not provide therapy or treatment. It is explicitly stated that it is "not a diagnostic device, and only offers data that users can consult with their personal physicians."

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic device".

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical device that measures height, weight, blood pressure, pulse rate, and body fat using hardware components like a non-invasive bio impedance analyzer and likely a blood pressure cuff/sensor. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Keito Multifunction devices are not IVD (In Vitro Diagnostic) devices.

Here's why:

Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "It is not a diagnostic device, and only offers data that users can consult with their personal physicians." This is a clear declaration that the device is not intended for diagnostic purposes.
Nature of Measurements: The device measures physical parameters like weight, height, blood pressure, pulse rate, and estimates body fat. While these parameters can be used in a diagnostic process, the device itself is not performing a diagnostic test on a biological sample in vitro. IVD devices typically analyze biological samples (like blood, urine, tissue) to diagnose diseases or conditions.
User and Setting: The device is intended for use by the general public in public sites, not in a clinical laboratory setting where IVD tests are typically performed.

Therefore, the Keito Multifunction devices fall outside the definition of an In Vitro Diagnostic device. They are personal health monitoring devices that provide data for informational purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, height, estimation of body fat, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.

Product codes

DXN, MNW

Device Description

The Multifunction Keito K6, K7 & K8 are intended for public use to measure height, weight, systolic and diastolic blood pressures, to calculate pulse rate and body mass, and to estimate the percentage of body fat by using a non-invasive bio impedance analyzer.

The Multifunction Keito K6, K7 & K8 have got 2 coin entries allowing the selection of two operation modes: partial or total cycle of measurements:

Partial cycle: measure of weight, height and estimation of the body fat.
Total cycle: measure of weight, height, blood pressure, pulse rate and estimation of the body fat.

At the end of the measuring process, the Multifunction Keito K6, K7 & K8 prints the results in a ticket.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wrist/Forearm (for blood pressure measurement), Hands (for body fat estimation)

Indicated Patient Age Range

The Multifunction Keito K6, K7 & K8 calculates the body fat on people whose age is between 20 and 99 years old.

Intended User / Care Setting

general public without prescription, operated with coins, in pharmacies or in other public sites.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Blood Pressure Measurement (Multifunction K7 Test Results):

Sample Size: 267 observations (patients not specified for each observation, but 89 distinct patients)
Data Source: Clinical test comparing Keito K7 to observers' measurements.
Annotation Protocol: Not explicitly stated as annotation, but involves comparison of measurements from Keito K7 and two observers for Systolic, Diastolic, and Pulse.
Patient Demographics (for 89 patients):
- Age: Range 18-83 years, Average 46 years, SD 14.3
- Wrist circumference: Range 12-20 cm, Average 15.6 cm, SD 1.5
- Arm circumference: Range 21-36 cm, Average 25.9 cm, SD 2.6
- Height: Range 146-191 cm, Average 167.8 cm, SD 9.7
- Sex: 48 Male (53.9%), 41 Female (46.1%)

Body Fat Measurement Comparison (Keito K8 vs TANITA TBF-300):

Sample Size: 177 observations
Data Source: Comparative study between Keito K8 and TANITA TBF-300.
Annotation Protocol: Not explicitly stated as annotation, but involves comparison of % Fat measurements between the two devices.
Patient Demographics:
- Age: Range 18-82 years, Average 39 years, SD 14.7
- Stature: Range 145-194 cm, Average 167.2 cm, SD 9.3
- Weight: Range 43.3-110.8 kg, Average 68.7 kg, SD 13.3
- Sex: 79 Male (44.6%), 98 Female (55.4%)

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Blood Pressure Measurement (Multifunction K7):

Study Type: Clinical test comparing K7 to observers' measurements.
Sample Size: 267 observations (from 89 patients).
Key Results:
- Observer1 - Observer2: Systolic Mean Difference -0.4, SD 3.1; Diastolic Mean Difference -0.4, SD 3.0.
- Keito K7 - Observers: Systolic Mean Difference -0.6, SD 5.2 (50.6% > 5mmHg, 4.1% > 10mmHg, 0.0% > 15mmHg); Diastolic Mean Difference 0.4, SD 4.5 (38.2% > 5mmHg, 1.5% > 10mmHg, 0.0% > 15mmHg).
- Keito K7 - Observer (Pulse): Mean Difference 0.9, SD 4.1 (27.3% > 5%, 1.5% > 10%, 0.0% > 15%).
Conclusion: Results are very similar to the predicate Keito K5.

Blood Pressure Measurement (Multifunction K5 - predicate):

Study Type: Clinical test (submitted on K984083).
Sample Size: 267 observations (from 89 patients).
Key Results:
- Observer 1 - Observer 2: Systolic Mean Difference 0.1, SD 2.7; Diastolic Mean Difference -0.2, SD 2.3.
- Keito K5 - Observers: Systolic Mean Difference 1.0, SD 5.0 (30.7% > 5mmHg, 6.7% > 10mmHg, 1.5% > 15mmHg); Diastolic Mean Difference -0.7, SD 3.8 (23.6% > 5mmHg, 2.2% > 10mmHg, 0.0% > 15mmHg).
- Keito K5 - Observer (Pulse): Mean Difference -1.4, SD 4.7 (24.0% > 5%, 4.5% > 10%, 1.9% > 15%).

Body Fat Measurement (Keito K8 vs TANITA TBF-300):

Study Type: Comparative study.
Sample Size: 177 observations.
Key Metrics: Error Medium -0.4, Std. deviation 2.2 for % Fat Tanita; Error Medium Not Found, Std. deviation Not Found for % Fat Keito K8.
Key Results:
- % Of measures with a difference greater than: 2% (36.7%), 3% (17.5%), 4% (0.6%).
Conclusion: Effectiveness and data are considered as safe and accurate as TANITA TBF-300 due to proximity and low dispersion between measures.

Other Results:

Weight Accuracy: 100 g
Height Accuracy: 1 cm
Blood Pressure Accuracy: 1 mmHg
Body Fat Accuracy: 0.1%

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Blood Pressure (Keito K7 vs Observers):
- Systolic: Mean Difference -0.6, SD 5.2, %Exceeding 5 mmHg = 50.6%, %Exceeding 10 mmHg = 4.1%, %Exceeding 15 mmHg = 0.0%
- Diastolic: Mean Difference 0.4, SD 4.5, %Exceeding 5 mmHg = 38.2%, %Exceeding 10 mmHg = 1.5%, %Exceeding 15 mmHg = 0.0%
- Pulse: Mean Difference 0.9, SD 4.1, %Exceeding 5 mmHg = 27.3%, %Exceeding 10 mmHg = 1.5%, %Exceeding 15 mmHg = 0.0% (Note: "5 mmHg", "10 mmHg", "15 mmHg" are listed for pulse but the unit should be bpm)
Blood Pressure (Keito K5 vs Observers):
- Systolic: Mean Difference 1.0, SD 5.0, %Exceeding 5 mmHg = 30.7%, %Exceeding 10 mmHg = 6.7%, %Exceeding 15 mmHg = 1.5%
- Diastolic: Mean Difference -0.7, SD 3.8, %Exceeding 5 mmHg = 23.6%, %Exceeding 10 mmHg = 2.2%, %Exceeding 15 mmHg = 0.0%
- Pulse: Mean Difference -1.4, SD 4.7, %Exceeding 5 mmHg = 24.0%, %Exceeding 10 mmHg = 4.5%, %Exceeding 15 mmHg = 1.9% (Note: "5 mmHg", "10 mmHg", "15 mmHg" are listed for pulse but the unit should be bpm)
Body Fat (Keito K8 vs TANITA TBF-300):
- Error Medium: -0.4
- Std. deviation: 2.2
- % Of measures with a difference greater than 2: 36.7%
- % Of measures with a difference greater than 3: 17.5%
- % Of measures with a difference greater than 4: 0.6%

Predicate Device(s)

K984083, K811146, K014009, K011652

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

K10305-8

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Multifunction Keito K6,K 7 & K8

Section 05 510(K) SUMMARY [21CFR § 807.92 (c)]

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Section 05

510(K)SUMMARY Page 05-2

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Table of contents
1-Submitter information. [21CFR§807.92(a)]
2-Name of the Device. [ 21 CFR§807.92(a) (1)]
3-Claiming equivalence with predicates. [21CFR§807.92(a)(3)]
4-Description of the Device [21CFR§ 807.92(a)(4)].
4. l-Weighta nd Height
4.2-Blood Pressure
4.3-Body fat
4.4-Limitations of use:
4.5-Physical Characteristics
4.6-Materials used (in contact with the user):
5-Statement of the Intended Use. {21CFR8807.92(a) (5)].
6-Comparison with the predicates. [21CFR§807.92(a) (6)].
7-Clinical tests: [21CFR8807.92(b) (2)]-
7. I-Blood Pressure Measurement:
7.1.1-Multifunction K7 Test Results. (See Section 18.2 of this 510(k) submission)
7.1.2-Multifunction K5 Test Results. (Submitted on K984083).
7.1.3-Conclusion
7.2-Body Fat Measurement comparison with TANITA TBF-300.
7.2.1-Conclusion

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Section 05 510(K)SUMMARY Page 05-3 1/12

1-Submitter information. [21CFR§807.92(a)]

Name:

Establishment Registration Number: Owner Operator Number:

Adress:

Contact:

Aguiflail bérica, S.L. 3003898938. 9039457.

La Pujada, 19 P.I. Els Garrofers. 08340 Vilassar de Mar ( Barcelona ). Spain.

Telephone Number: FAX Number:

Xavier Casals Quality Department.

+34.937540370.

+34.937540371.

E-mail: calidad@keito.com

2-Name of the Device. [21CFR§807.92(a) (1)]

Bundling considerations:

Because all the models submitted on this 510(k) are sharing the same technology and intended use, we declare that they do not differ significantly in purpose, software design, materials, energy source, function or any other feature. [21CFR § 860.3]. All the devices can be managed during one review because the only difference is on the externald esign, even some of them share the same labelling design.

Device Name and Classification:

Common Device Name:	Blood Pressure Monitoring System and Body FatA nalyzer Scales
Trade Names:	Keito K6, Keito K7,K eito K8.
Device Class:	Class II (Two).
Classification Name:	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, W EIGHT, HEIGHT, BODY FAT .
Class Code:	DXN:N on Invasive Blood Pressure Measurement [21CFR§ 870.1130]
MNW :body composition analyzer. [21CFR§ 870.2770].

3

1

Section 05 510(K)SUMMARY Page 05-4

3-Claiming equivalence with predicates. [21CFR§807.92(a)(3)].

| Predicate name | Predicate
reference | 510(k) code |
|---------------------|------------------------|-------------|
| Vita-Stat | 90550-03 | K811146 |
| Keito Multifunction | K5 | K984083 |
| Tanita corp. | TBF-300 | K014009 |
| Omron Health inc. | HBF-306 | K011652 |

Table 1-Predicates we consider equivalence

4-Description of the Device [21CFRS 807.92(a)(4)].

The Multifunction Keito K6, K7 & K8 arei ntended for public uset o measureh cight, weight, systolica nd diastolic blood pressures, to calculate pulse rate and body mass, and to estimate the percentage of body fat by using a non-invasive bio impedance analyzer.

The Multifunction Keito K6, K7 & K8 have got 2 coin entries allowing the selection of two operation modes: partialo r totalc ycle of measurements:

· Partial cycle:m easure of weight,h eight and estimation of the body fat.
· Totalc ycle: measure of weight, height, blood pressure,p ulse rate and estimation of the body fat.

4.1-Weight and Height

· If during the measurement theu ser moves, theM ultifunction Keito K6, K7 & K8 will not be able to measure his weight correctly.
· If during the measurementt he user is notu pright, the Multifunction Keito K6, K7 & K8 willn ot be able to measure his real height.T he system measures the total heighti ncluding the user's shoes.

4.2-Blood Pressure

· Before inserting the wristi n the cuff,t he user mustr emove the watch and any bracelet.
· The Multifunction Keito K6, K7 & K8 have got as ystem that detects automatically when the wrist is inserted and leanti n the cuff.
· If fora ny reason the system does not detect he presence of the wrist in the system can be manually activating by pressing the green key att he front of the unit.
· If the blood pressure measure has not started in 60 seconds, the system will cancel the process and will go to the estimation of the body fat .
· For a correctm easuring, the user mustr emain relaxed and mustn ot speak or make sudden movements.
· In case of emergency, by pressing the red key at the front of the process will be cancelled and the security system will deflate the cuff so that the user can remove his wrist from the cuff. In case of power fail,t he same process will occur automatically.
· If after three tries, the system cannotm easure the blood pressure, the system willg o to the estimation of the body fat .

4.3-Body fat

· Ift he user steps off the platform or does not indicate the age and gender, the measurement of the body fat will be cancelled.
. For ac orrect measurement, it is necessary to hold firmly the handles( that act like electrodes) with the hands bare and clean.
. A bad contact between the handles and the hands may lead to errors in the results of the measurement.

4

K103058

| Multifunction Keito K6,K 7 & K8
Aguiflai Ibérica, SL
510(k)P remarketN otification | Image: Keito logo
Section 05
510(K)SUMMARY
Page 05-5 |

------------------------------------------------------------------------------------------	---------------------------------------------------------------

· After a heavy meal or drink, the results may be faulty.

At the end of the measuring process, the Multifunction Keito K6, K7 & K8 prints the results in a ticket.

4.4-Limitations of use:

· If the measured weight is under 15 kg, the system understands that there is a baby on the platform and cancels the measurements of height, blood pressure and body fat .
· If the user's height is under 135 cm, the measurements of blood pressure and body fat will be cancelled.
· In those cases, if the selected measurement cycle was the complete one, the Multifunction Keito K6, K7 & K8 wills how on the tickett hatt he mewasuring process could not be completed.

The Multifunction Keito K6, K7 & K8 calculates the body fat on people whose age is between 20 and 99 years old.

	K8	K7	K6
Height
Width
Depth
Weight	2200 mm
360 mm
580 mm
46 kg	2200 mm
360 mm
580 mm
46 kg	2200 mm
360 mm
580 mm
46 kg
Main Supply
Consumption
Main Fuse	100-240V 50Hz-60Hz
0.160A @ 230V
2A	100-240V 50Hz-60Hz
0.160A @ 230V
2A	100-240V 50Hz-60Hz
0.160A @ 230V
2A
Measurement ranges
Weight
Height
Blood pressure
Heart rate
Fat	0 - 150 kg
0 - 200 cm
0 - 300 mm Hg
38 - 176 bpm
1 - 75 %	0 - 150 kg
0 - 200 cm
0 - 300 mmHg
38 - 176 bpm
1 - 75 %	0 - 150 kg
0 - 200 cm
0 - 300 mmHg
38 - 176 bpm
1 - 75 %

4.5-Physical Characteristics

Table 2-Keito k6, K7 & K8 physicalc haracteristics

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Section 05 510(K)SUMMARY Page 05-6 6/10

4.6-Materials used (in contact with the user):

· The body is made of Linear Polyethylene Plastic (PE-LLD).
The platform is covered by a rubber mat.
The handles for the body fate stimation are made of tin plated with chrome.
· The cuff used in the blood pressure measurement: 100% Polyesther horizontal plot.

5-Statement of the Intended Use. [21CFR§807.92(a) (5)].

The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, height, estimation of body fat , blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not ad iagnostic device, and only offers data thatu sers can consult with their personalp hysicians. The results are either printed on a ticket or saved on a card.

The differences between the predicates wich we are claiming equivalence are not critical to the intended use of the Keito devices. And these differences do not reduce the safety or the effectiveness of the is is being used as it is labelled, or while the voice instructions are being followed.

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Section 05 510(K)SUMMARY Page 05-7

6-Comparison with the predicates. [21CFR§807.92(a) (6)].

| Specifications | MULTIFUNCTION
KEITO (K6, K7 &
K8) | Vita-Stat 90550-03 | Multifunction K5 | Tanita TBF-300 | Omron HBF-
306 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------|
| Accuracy | Weight: 100 g
Height: 1 cm
Blood pressure: 1
mmHg
Body fat: 0.1% | Blood pressure: 1
mmHg | Weight: 100 g
Height: 1 cm
Blood pressure: 1
mmHg | Weight: 100 g
Height: 1 cm
Body fat: 0.1 % | Body fat: 0.1 % |
| Digital
Displays | Weight, height, blood
pressure | blood pressure | Weight, height,b lood
pressure, pulse | Weight, body fat | Body fat |
| Measurement
range | Weight: 10 to 150 kg
Height: 0 to 200 cm
Bloodp ressure: 0 to
300 mmHg
Body fat: 1 to 75% | Blood pressure: 0 to
300 mmHg | Weight: 10 a 150 kg
Height: 0 to 200 cm
Blood pressure: 0 to
300 mmHg | Weight: 0 to 440 lb
Height: manual height
rod from 3' to 7'
Body fat: 1 to 75% | Body fat: 4 to
50% |
| Blood
pressure
measurement
method | Oscillometric | Oscillometric | Oscillometric | N/A | N/A |
| Overpressure
limit | 300 mmHg | 305 mmHg | 300 mmHg | N/A | N/A |
| Blood
pressure test
time | Tipically less than 50
seconds | Tipically less than 30
seconds | Tipically less than 50
seconds | N/A | N/A |
| Inflation | Compressor,
automatically
controlled | Compressor,
automatically
controlled | Compressor,
automatically
controlled | N/A | N/A |
| Deflation | Automatic deflation
and air exhaust | Automatic deflation
and air exhaust | Automatic deflation
and air exhaust | N/A | N/A |
| Rapid
pressure
release | Security valve.
Emergency stop
button at front of the
unit. | | Security valve.
Emergency stop
button at front of the
unit. | N/A | N/A |
| Pressure
detection | Differential pressure
sensor | | Absolute pressure
sensor | N/A | N/A |
| Cuff
dimensions | 99 mm diameter | | 99 mm diameter | N/A | N/A |
| Wrist / fore
arm
circumference
range | 140 to 210 mm
(wrist) | (fore arm) | 140 to 210 mm (wrist) | N/A | N/A |
| Body fat
measurement
method | Bio Impedance
Analysis (BIA) | N/A | N/A | Bio Impedance
Analysis (BIA) | Bio Impedance
Analysis (BIA) |
| Body fat test
time | Tipically less than 10
seconds | N/A | N/A | Tipically less than 10
seconds | Tipically less
than 10
seconds |
| Temperature
operating | 10°C to 40°C | 10°C to 40°C | 10°C to 40°C | 0°C to 35°C | 10°C to 40°C |
| Input Power
requirements | 200-240 Vac / 100-
120 Vac
50/60 Hz (automatic)
0.16A @ 200-240
Vac / 0.32A @ 100-
120 Vac | 120 Vac , 60 Hz.,
2.5A | 200-240 Vac / 100-
120 Vac
50/60 Hz (automatic)
0.6A @ 200-240 Vac /
1.2A @ 100-120 Vac | 100-240 Vac 50/60
Hz AC adapter | 2 "AAA" (R03)
batteries |
| Physical
height | | 1079 mm | 2330 mm | - | 127 mm |
| Width | | 647 mm | 540 mm | | 203 mm |
| Depth | | 927 mm | 590 mm | | 51 mm |
| Weight | | 40 kg | 60 kg | 19.3 kg | 0.248 kg |

Table 3-Comparison with predicates

$\frac{7}{10}$

7

K103058

$100

Multifunction Keito K6,K 7 & K8 Aguiflai Ibérica, SL 510(k)P remarketN otification

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7-Clinical tests. [21CFR§807.92(b) (2)].

7.1-Blood Pressure Measurement:

We declare that we are the manufacturero f the predicate Keito K5 (K984083). Therefore, we can assert that the technology and the software on Multifunction Keito K6, K7 & K8 are an evolution of K5 unit. This evolution is not a great change wich can vary the effectiveness or the safety. Some components have been replaced by other technologically more advanced. In order to demonstrate and compare the same efficency, we have performed a clinical testa nd its results have been compared with the results obtained with Keito K5 (K984083).

7.1.1-Multifunction K7 Test Results. (See 18.2 of this Section 510(k) submission).

| Observations | Range | Difference | SD of
Differences | %Exceeding | |---------------------------|--- | | | Observer1 - Observer2 | | Systolic | 267 | Diastolic | 267 | Keito K7 - Observers | | Systolic | 267 | Diastolic | 267 | Observer | | Pulse | 267 | Keito K7 - Observer | | Pulse | 267 | Observations | Range | | Age | 89 | Wrist circumference in cm | 89 | Arm circumference in cm | 89 | Heigt in cm | 267 | Patients | Male | Female | %Male | Sex | 89 | Number of
| Mean
| |
------------------------|-------|--------|--------------------|----------------------|------------|---------|---------|
| Min | Max | | | 5 mmHg | 10 mmHg | 15 mmHg |
| | | | | | | |
| 93 | 176 | -0.4 | 3.1 | 7.1% | 0.0% | 0.0% |
| 53 | 98 | -0.4 | 3.0 | 8.2% | 0.0% | 0.0% |
| | | | | | | |
| 94 | 174 | -0.6 | 5.2 | 50.6% | 4.1% | 0.0% |
| 55 | 98 | 0.4 | 4.5 | 38.2% | 1.5% | 0.0% |
| | | | | | | |
| 51 | 113 | 0 | | | | |
| | | | | | | |
| 51 | 120 | 0.9 | 4.1 | 27.3% | 1.5% | 0.0% |
| Number of
| Average | SD | | | |
| 18 | 83 | 46 | 14.3 | | | |
| 12 | 20 | 15.6 | 1.5 | | | |
| 21 | 36 | 25.9 | 2.6 | | | |
| 146 | 191 | 167.8 | 9.7 | | | |
| Number of
| %Female | | | |
| 48 | 41 | 53.9% | 46.1% | | | |

Table 4-TestR esults K7 vs Patient.

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Section 05 510(K)SUMMARY Page 05-9

7.1.2-Multifunction K5 Test Results. (Submitted on K984083).

Sample Data Summary
	Number of
Observations	Range		Mean
Difference	SD of
Differences	% Exceeding
		Min	Max			5 mmHg	10 mmHg	15 mmHg
Observer 1 - Observer 2
Systolic	267	90	175	0.1	2.7	4.1%	1.9%	0.0%
Diastolic	267	60	105	-0.2	2.3	4.1%	0.0%	0.0%
Keito K5 - Observers
Systolic	267	90	175	1.0	5.0	30.7%	6.7%	1.5%
Diastolic	267	61	101	-0.7	3.8	23.6%	2.2%	0.0%
Observer
Pulse	267	57	122	0
Keito K5 - Observer
Pulse	267	56	125	-1.4	4.7	24.0%	4.5%	1.9%
	Number of
Observations	Range		Average	SD
Age	89	18	89	51	18.2
Wrist circumference in cm	89	13	23	17.2	2.0
Arm circumference in cm	89	21	40	29.0	3.5
Heigt in cm	267	145	191	170.4	10.4
	Number of
Patients	Male	Female	%Male	%Female
Sex	89	45	44	50.6%	49.4%

Table 5-TestR esults K5 vs Patient

7.1.3-Conclusion

After comparing both tables, particulary the Mean Difference and SD of Diferences where the Device's measurements were compared against the observer's measurements, we can affirm that the results obtained on the test performed in Multifunction Keito K7, are very similar. Therefore, from ourp ointo f view, we affirm that the comparation of the results have determined the substantial equivalence with the predicate Keito KS(K984083). The Multifunction Keito K6 and K8 have the same blood pressure modules as the Keito K7.

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Krosob8

7.2-Body Fat Measurement comparison with TANITA TBF-300.

Summary of measurements
Device	Number of
Observations	Range		Error
Medium	Std.
deviation	% Of measures with a difference
greater than
		Min	Max			2	3	4
% Fat Tanita	177	8.4	44.7	-0.4	2.2	36.7%	17.5%	0.6%
% Fat Keito K8	177	10.2	45.8
Stadistics				Average	Std.
deviation
Age	177	18	82	39	14.7
Starure (cm)	177	145	194	167.2	9.3
Weight in kg	177	43.3	110.8	68.7	13.3
		Male	Female	%Male	%Female
Sex	177	79	98	44.6%	55.4%

Table 6- BIA Test Keito K8 vs TANITA TBF-300

7.2.1-Conclusion

We conducted a comparative study to demonstrate that the results obtained by TANITA and Multifunction Keito device are very similar, without great differences. Not finding a standard that fixes the allowed parameters where both devices could be compared with, we have only to contrast the results and establish a comparative table to specify the differences between them. From our understanding, the effectiveness and data collected in Multifunction Keito device can be considered as safe and accurate as TANITA TBF-300 because the error Medium and the calculated Standard Deviation give us and idea of proximity and few dispersion between the measures obtained. The Multifunction Keito K6 and K7 have the same BIA modules as the Keito K8.

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Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 0 2011

Aguiflai Iberica, S.L. c/o Mr. Xavier Casals Administrative Quality Department C/ De La Pujada, 19 Poligono Industrial Els Garrofers Vilassar de Mar, Barcelona 08340 SPAIN

Re: K103058

Trade/Device Names: Multifunction Keito, with models Keito K6, Keito K7 and Keito K8 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, MNW Dated: October 20, 2011 Received: October 31, 2011

Dear Mr. Casals:

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.

11

Page 2 - Mr. Xavier Casals

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); 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,

Brapi D. Zuckerman, M.D. 10. Director . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10305f

Image /page/12/Picture/2 description: The image shows the word "KEITO" in bold, black letters. Above the "I" is a solid black circle. A horizontal line is below the word "KEITO".

Section 04 Indications for Use Statement Page 04-2

510(K) Number (if known): 《103058

Device Name: MULTIFUNCTION KEITO K6, K7 & K8

Sponsor's Name: Aguiflai Ibérica s.l.

Indications for use:

The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, estimation of body fat index, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 口

Over-The-Counter Use ☑

n of Cardiovascular Devil for

510(k) Number K103058

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 870.1130 Noninvasive blood pressure measurement system.

Multifunction Keito K6,K 7 & K8

Section 05

Table of contents

1-Submitter information. [21CFR§807.92(a)]

Name:

2-Name of the Device. [21CFR§807.92(a) (1)]

Bundling considerations:

Device Name and Classification:

3-Claiming equivalence with predicates. [21CFR§807.92(a)(3)].

4-Description of the Device [21CFRS 807.92(a)(4)].

4.1-Weight and Height

4.2-Blood Pressure

4.3-Body fat

4.4-Limitations of use:

4.5-Physical Characteristics

4.6-Materials used (in contact with the user):

5-Statement of the Intended Use. [21CFR§807.92(a) (5)].

6-Comparison with the predicates. [21CFR§807.92(a) (6)].

7-Clinical tests. [21CFR§807.92(b) (2)].

7.1-Blood Pressure Measurement:

7.1.1-Multifunction K7 Test Results. (See 18.2 of this Section 510(k) submission).

Section 05 510(K)SUMMARY Page 05-9

7.1.2-Multifunction K5 Test Results. (Submitted on K984083).

Table 5-TestR esults K5 vs Patient

7.1.3-Conclusion

7.2-Body Fat Measurement comparison with TANITA TBF-300.

7.2.1-Conclusion

DEPARTMENT OF HEALTH & HUMAN SERVICES

Indications for use:

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