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.

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 devices have 2 coin entries allowing the selection of two operation modes: partial or total cycle of measurements. Partial cycle measures weight, height, and estimation of body fat. Total cycle measures weight, height, blood pressure, pulse rate, and estimation of body fat.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that illustrate how the Keito K6, K7, and K8 multifunction devices meet these criteria, based on the provided text:

Acceptance Criteria and Device Performance

The provided document details the accuracy specifications of the Keito devices and presents comparative studies against predicate devices and observed/manual measurements to demonstrate substantial equivalence. The "acceptance criteria" here are implied by the comparison to established predicate devices and the accuracy claims.

Table 1: Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate/accuracy claim)	Keito K7 Reported Performance (Mean Difference vs. Observers)	Keito K5 Reported Performance (Mean Difference vs. Observers)	Keito K8 Reported Performance (Error Medium vs. Tanita)
Blood Pressure
Systolic Accuracy	1 mmHg (claimed)	-0.6 mmHg (K7-Observers)	1.0 mmHg (K5-Observers)	N/A
Diastolic Accuracy	1 mmHg (claimed)	0.4 mmHg (K7-Observers)	-0.7 mmHg (K5-Observers)	N/A
Pulse Accuracy	Not explicitly stated	0.9 bpm (K7-Observer)	-1.4 bpm (K5-Observer)	N/A
Weight	100 g (claimed)	N/A	N/A	N/A
Height	1 cm (claimed)	N/A	N/A	N/A
Body Fat	0.1% (claimed)	N/A	N/A	-0.4% (K8-Tanita TBF-300)

Note: The "Acceptance Criteria" column is derived from the stated accuracy of the devices and their predicates. The "Reported Device Performance" comes directly from the study results presented in the tables for K7 Blood Pressure and K8 Body Fat. The overall conclusion for blood pressure is that K7 performance is "very similar" to K5, implying K7 meets K5's established performance. For Body Fat, the results are considered "safe and accurate as TANITA TBF-300."

Study Details

2. Sample Sizes and Data Provenance

Blood Pressure Measurement (Multifunction K7 Test Results):
- Test Set Sample Size: 267 observations for Systolic, Diastolic, and Pulse measurements. 89 patients for Age, Wrist/Arm circumference, and Sex data.
- Data Provenance: Not explicitly stated, but the submission is from a Spanish company (Aguiflail Ibérica, S.L., Barcelona, Spain), suggesting the study was likely conducted in Spain. The data is presented as a "clinical test," implying prospective collection for the purpose of this submission.
Body Fat Measurement (Keito K8 vs. TANITA TBF-300):
- Test Set Sample Size: 177 observations.
- Data Provenance: Not explicitly stated, but similar to the blood pressure study, it's likely from Spain and prospectively collected for this comparative study.

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

Blood Pressure Measurement: The study compares the Keito K7 (and K5) devices against "Observers."
- Number of Experts: "Observer1" and "Observer2" are mentioned for inter-observer variability, and the device is compared against these "Observers." This implies at least two human observers.
- Qualifications: The qualifications of these observers are not specified in the provided document. It is not mentioned if they are medical professionals like cardiologists or nurses, nor is their experience level given.
Body Fat Measurement: The Keito K8 is compared against the TANITA TBF-300 device. The ground truth for body fat is not established by human experts but by an established predicate device.

4. Adjudication Method for the Test Set

Blood Pressure Measurement: For "Observer1 - Observer2" comparison, a simple comparison of their readings is used to assess inter-rater agreement. For "Keito K7 - Observers" (and K5), the device readings are compared directly against the readings of the human observers. No specific adjudication method (like 2+1 or 3+1 consensus) is described to resolve discrepancies between human observers or between the device and human observers. The "Mean Difference" and "SD of Differences" statistical metrics are used for comparison.
Body Fat Measurement: The Keito K8 device measurements are compared directly to the TANITA TBF-300 predicate device measurements. No human adjudication is involved as the predicate device serves as the reference.

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

No MRMC study evaluating human reader improvement with AI assistance was explicitly performed or detailed. The studies here are focused on demonstrating the standalone performance of the device (Keito K7/K8) in comparison to either human observers (for BP) or a predicate device (for Body Fat), not on how AI (or the device's algorithms) assists human readers. The Keito devices are intended for public self-use and are not diagnostic tools requiring human interpretation of their output.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was assessed. The studies presented (7.1.1 and 7.1.2 for Blood Pressure, 7.2 for Body Fat) represent the standalone performance of the Keito K7, K5, and K8 devices, respectively. The data shows the device's measurements compared to a reference (human observers for BP, predicate device for Body Fat) without human intervention in the device's measurement process itself. The devices operate "without prescription" and provide results directly to the user.

7. Type of Ground Truth Used

Blood Pressure Measurement: The ground truth for blood pressure and pulse rate is established by human observers (referred to as "Observer1" and "Observer2") directly measuring the same parameters. This effectively serves as a "clinical reference standard" in this context.
Body Fat Measurement: The ground truth for body fat percentage is established by a predicate device, the TANITA TBF-300. This is a comparative study where the predicate device acts as the reference standard.

8. Sample Size for the Training Set

The document does not provide details on the sample size used for the training set for the algorithms within the Keito devices. The studies described are validation/testing studies for device performance. It states that the K6, K7, and K8 are an "evolution" of the K5 unit, implying that the underlying technology and software have a history of development, but the specifics of training data are not disclosed.

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

As the document does not specify a training set or its sample size, it also does not detail how the ground truth for any training set was established. We can infer that the original Keito K5, and presumably its predecessors or early development, would have been built and refined using data, likely compared against established measurement techniques or other reference devices, similar to the validation studies presented here. However, this is an inference and not explicitly stated in the provided text.

Summary

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

K10305-8

Image /page/0/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. Above the word is a circle that is slightly overlapping the letters "E" and "I". The letters are all capitalized and in black. The circle is a lighter shade, possibly white or gray.

Multifunction Keito K6,K 7 & K8

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

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

K103058

Image /page/1/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. Above the letters "EI" is a semi-circular shape. The text is black, and the background is white.

Section 05

510(K)SUMMARY Page 05-2

2/10

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 Height4.2-Blood Pressure4.3-Body fat4.4-Limitations of use:4.5-Physical Characteristics4.6-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

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

Image /page/2/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. Above the word, there is a partial image of a circle. The circle is white, and the word is black. The word is in all caps.

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}------------------------------------------------

Section 05 510(K)SUMMARY Page 05-4

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

Predicate name	Predicatereference	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 & K8Aguiflai Ibérica, SL510(k)P remarketN otification	Image: Keito logoSection 05510(K)SUMMARYPage 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
HeightWidthDepthWeight	2200 mm360 mm580 mm46 kg	2200 mm360 mm580 mm46 kg	2200 mm360 mm580 mm46 kg
Main SupplyConsumptionMain Fuse	100-240V 50Hz-60Hz0.160A @ 230V2A	100-240V 50Hz-60Hz0.160A @ 230V2A	100-240V 50Hz-60Hz0.160A @ 230V2A
Measurement rangesWeightHeightBlood pressureHeart rateFat	0 - 150 kg0 - 200 cm0 - 300 mm Hg38 - 176 bpm1 - 75 %	0 - 150 kg0 - 200 cm0 - 300 mmHg38 - 176 bpm1 - 75 %	0 - 150 kg0 - 200 cm0 - 300 mmHg38 - 176 bpm1 - 75 %

4.5-Physical Characteristics

Table 2-Keito k6, K7 & K8 physicalc haracteristics

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

K103058

Image /page/5/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. Above the letters, there is a partial shape that appears to be a semi-circle or an arch, possibly part of a logo or design element associated with the word.

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.

{6}------------------------------------------------

K.03058

Image /page/6/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. There is a partial circle above the "I" in the word. The text is black and the background is white.

Section 05 510(K)SUMMARY Page 05-7

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

Specifications	MULTIFUNCTIONKEITO (K6, K7 &K8)	Vita-Stat 90550-03	Multifunction K5	Tanita TBF-300	Omron HBF-306
Accuracy	Weight: 100 gHeight: 1 cmBlood pressure: 1mmHgBody fat: 0.1%	Blood pressure: 1mmHg	Weight: 100 gHeight: 1 cmBlood pressure: 1mmHg	Weight: 100 gHeight: 1 cmBody fat: 0.1 %	Body fat: 0.1 %
DigitalDisplays	Weight, height, bloodpressure	blood pressure	Weight, height,b loodpressure, pulse	Weight, body fat	Body fat
Measurementrange	Weight: 10 to 150 kgHeight: 0 to 200 cmBloodp ressure: 0 to300 mmHgBody fat: 1 to 75%	Blood pressure: 0 to300 mmHg	Weight: 10 a 150 kgHeight: 0 to 200 cmBlood pressure: 0 to300 mmHg	Weight: 0 to 440 lbHeight: manual heightrod from 3' to 7'Body fat: 1 to 75%	Body fat: 4 to50%
Bloodpressuremeasurementmethod	Oscillometric	Oscillometric	Oscillometric	N/A	N/A
Overpressurelimit	300 mmHg	305 mmHg	300 mmHg	N/A	N/A
Bloodpressure testtime	Tipically less than 50seconds	Tipically less than 30seconds	Tipically less than 50seconds	N/A	N/A
Inflation	Compressor,automaticallycontrolled	Compressor,automaticallycontrolled	Compressor,automaticallycontrolled	N/A	N/A
Deflation	Automatic deflationand air exhaust	Automatic deflationand air exhaust	Automatic deflationand air exhaust	N/A	N/A
Rapidpressurerelease	Security valve.Emergency stopbutton at front of theunit.		Security valve.Emergency stopbutton at front of theunit.	N/A	N/A
Pressuredetection	Differential pressuresensor		Absolute pressuresensor	N/A	N/A
Cuffdimensions	99 mm diameter		99 mm diameter	N/A	N/A
Wrist / forearmcircumferencerange	140 to 210 mm(wrist)	(fore arm)	140 to 210 mm (wrist)	N/A	N/A
Body fatmeasurementmethod	Bio ImpedanceAnalysis (BIA)	N/A	N/A	Bio ImpedanceAnalysis (BIA)	Bio ImpedanceAnalysis (BIA)
Body fat testtime	Tipically less than 10seconds	N/A	N/A	Tipically less than 10seconds	Tipically lessthan 10seconds
Temperatureoperating	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 Powerrequirements	200-240 Vac / 100-120 Vac50/60 Hz (automatic)0.16A @ 200-240Vac / 0.32A @ 100-120 Vac	120 Vac , 60 Hz.,2.5A	200-240 Vac / 100-120 Vac50/60 Hz (automatic)0.6A @ 200-240 Vac /1.2A @ 100-120 Vac	100-240 Vac 50/60Hz AC adapter	2 "AAA" (R03)batteries
Physicalheight		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

Image /page/7/Picture/2 description: The image shows the word "KEITO" in a bold, sans-serif font. There is a curved line above the "I" in "KEITO", which may be part of a logo or design element. The text is black and the background is white, creating a high contrast image. The image appears to be a logo or brand name.

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).

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

Table 4-TestR esults K7 vs Patient.

{8}------------------------------------------------

K103058

9/10

Image /page/8/Picture/3 description: The image shows a logo with the text "KEITC" in bold, black letters. The letters are large and fill most of the frame. Above the letters, there is a faint, incomplete circular shape, possibly part of a larger design element. The overall impression is a simple, high-contrast logo.

Section 05 510(K)SUMMARY Page 05-9

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

Sample Data Summary
	Number ofObservations	Range		MeanDifference	SD ofDifferences	% 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 ofObservations	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 ofPatients	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.

{9}------------------------------------------------

10/10

Image /page/9/Picture/3 description: The image shows the word "KEITO" in a bold, sans-serif font. Above the word, there is a graphic that appears to be a stylized image of a head or a plant. The text is in black, and the background is white, creating a high-contrast image.

Krosob8

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

Summary of measurements
Device	Number ofObservations	Range		ErrorMedium	Std.deviation	% Of measures with a differencegreater 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.

{10}------------------------------------------------

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

{12}------------------------------------------------

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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 口

Over-The-Counter Use ☑

n of Cardiovascular Devil for

510(k) Number K103058

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).

Acceptance Criteria and Device Performance

Study Details

2. Sample Sizes and Data Provenance

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

4. Adjudication Method for the Test Set

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

6. Standalone (Algorithm Only) Performance

7. Type of Ground Truth Used

8. Sample Size for the Training Set

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

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:

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

§ 870.1130 Noninvasive blood pressure measurement system.