Who is the manufacturer of MULTIFUNCTION KEITO?

Aguiflai Iberica S.L. filed the 510(k) submission for MULTIFUNCTION KEITO (K103058).

What is the FDA product code for MULTIFUNCTION KEITO?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MULTIFUNCTION KEITO?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MULTIFUNCTION KEITO?

Vita-Stat 90550-03 (K811146); Keito Multifunction K5 (K984083); Tanita TBF-300 (K014009); Omron HBF-306 (K011652).

Who can help prepare an FDA 510(k) submission like MULTIFUNCTION KEITO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTIFUNCTION KEITO

K103058 · Aguiflai Iberica S.L. · DXN · Nov 10, 2011 · Cardiovascular

Device Facts

Record ID	K103058
Device Name	MULTIFUNCTION KEITO
Applicant	Aguiflai Iberica S.L.
Product Code	DXN · Cardiovascular
Decision Date	Nov 10, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended 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.

Device Story

Multifunction Keito K6, K7, and K8 are coin-operated, public-access kiosks installed in pharmacies or similar sites. Inputs include user weight (platform), height (sensor), blood pressure (oscillometric cuff), and body fat (bio-impedance analysis via hand-held electrodes). Device automatically detects wrist insertion for blood pressure; provides emergency deflation/stop buttons. Outputs are printed tickets or card-saved data. Device is non-diagnostic; intended for personal health monitoring to be reviewed by a physician. Benefits include convenient, self-service access to health metrics. Operation requires user to remain upright and still; system cancels measurements if movement is detected or if user is outside specified height/weight thresholds.

Clinical Evidence

Bench testing and comparative clinical studies performed. Blood pressure accuracy (systolic/diastolic) compared against observer measurements (n=267) for K7 vs K5, showing mean differences of -0.6/-0.4 mmHg (K7) vs 1.0/-0.7 mmHg (K5). Body fat estimation compared against Tanita TBF-300 (n=177), showing mean error of -0.4% and SD of 2.2%. Results demonstrate substantial equivalence in accuracy and performance to predicate devices.

Technological Characteristics

Materials: Linear Polyethylene Plastic (PE-LLD) body, rubber platform mat, chrome-plated tin handles, 100% polyester cuff. Sensing: Oscillometric blood pressure (differential pressure sensor), bio-impedance analysis (BIA) for body fat. Power: 100-240V AC. Dimensions: 2200mm x 360mm x 580mm. Connectivity: Ticket printer/card output. Standalone kiosk form factor.

Indications for Use

Indicated for general public use (OTC) to measure weight, height, systolic/diastolic blood pressure, pulse rate, and estimate body fat percentage. Intended for individuals aged 20-99 for body fat estimation. Contraindicated for users under 15 kg (weight) or under 135 cm (height).

Regulatory Classification

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.

Predicate Devices

Vita-Stat 90550-03 (K811146)
Keito Multifunction K5 (K984083)
Tanita TBF-300 (K014009)
Omron HBF-306 (K011652)

Related Devices

K984083 — MULTIFUNCTION KEITO K5 · Bumedco Intl., Inc. · Jan 18, 2000
K063008 — HEALTH CHECK KIOSK · Xperex Corporation · Jun 7, 2007
K093389 — CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK · Computerized Screening, Inc. · Nov 17, 2009
K152107 — HealthChek Network Health Station · Healthchek Network, LLC · Apr 12, 2016
K172739 — higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) · Higi Sh, LLC · Oct 10, 2017

Submission Summary (Full Text)

{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 | 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 | | {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}------------------------------------------------ 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 {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 | 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 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 of Observations | Range | | Mean Difference | SD of Differences | %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 of Observations | 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 of Patients | 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 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. {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 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. {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: 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. ## 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