HealthChek Network Health Station by HEALTHCHEK NETWORK, LLC

The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.

Device Description

The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.

AI/ML Overview

The HealthChek Network Health Station, Model HCK-2000, is an automated system intended for use by the general adult public in public environments to measure health parameters such as blood pressure, heart rate, Body Mass Index (BMI), and body weight. It is not a diagnostic device and only provides data for users to consult with their personal physicians or other healthcare professionals.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance for each metric. Instead, it relies on a Substantial Equivalence Comparison to a predicate device (StayHealthy HealthCENTER Biometric Screening Kiosk) and compliance with recognized consensus standards.

However, based on the information provided, particularly for the regulated component (Noninvasive Blood Pressure Measurement System), the device's performance is expected to meet the requirements of relevant standards.

Implicit Acceptance Criteria (based on standards compliance and predicate comparison):

Feature/Parameter	Acceptance Criteria (Implicit)	Reported Device Performance/Compliance
Blood Pressure	Accuracy and safety as per IEC 80601-2-30 and AAMI/ANSI/ISO 81060-1	Compliant with IEC 80601-2-30:2009. Uses the SunTech Advantage Model 2 module (same as predicate). Capable of recording blood pressures from +40 to +260 mmHg Systolic and +20 to +200 mmHg Diastolic.
Heart Rate	Accuracy and safety as per relevant standards	Calculated via the BP module, capable of recording rates from 30 to 220 beats per minute.
Body Weight	Measurement up to 440 lbs / 200 kg with reasonable accuracy.	Tested at 440 lbs / 200 kg. Measured via a load cell imbedded in an ADA compliant seat (similar to predicate).
BMI	Calculation accuracy using NIH's algorithms.	Calculated using NIH's algorithms from user-entered height and measured weight.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-1-2.	Compliant with IEC 60601-1:2005 3rd edition and IEC 60601-1-2:2007 3rd edition (with immunity testing to IEC 60601-1-2:2014 4th edition).
Quality Management System	Compliance with 21 CFR Part 820 & ISO 13485:2003.	Compliant with 21 CFR 820 and ISO 13485:2003.
Risk Management	Compliance with ISO 14971:2007.	Compliant with ISO 14971:2007.

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

The document explicitly states: "Because of the long-established use of health monitoring kiosks, no clinical trial was performed." (Page 4). Therefore, there is no specific sample size for a test set involving human subjects for performance evaluation mentioned in this submission. The evaluation relies on bench testing and comparison to a predicate device.

The data provenance for the bench testing is not specified beyond "Bench Testing was conducted on a unit...". It's implied this was conducted in a laboratory setting by the manufacturer (GMI Solutions) or a testing facility working with them.

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

Since no clinical trial or test set involving human subjects for performance evaluation was conducted, there are no experts mentioned as establishing ground truth in this context. The "ground truth" for the device's technical specifications and safety is derived from compliance with recognized international and national standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed.

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

No. The document states "no clinical trial was performed." Therefore, there was no MRMC comparative effectiveness study to assess improvement with or without AI assistance. The device is a "health station" for self-measurement, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes the device as an "automated system" for self-measurement, which inherently functions in a standalone capacity without "human-in-the-loop" performance as typically understood in AI/imaging diagnostics. Its performance is demonstrated through compliance with technical standards and equivalence to a predicate device, rather than a standalone performance study as would be conducted for a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is established through:

Compliance with recognized consensus standards: (e.g., IEC 80601-2-30 for non-invasive sphygmomanometers, IEC 60601-1 for electrical safety).
Bench testing: Verifying the device's technical specifications against these standards.
Substantial equivalence to a legally marketed predicate device: Demonstrating that its design, intended use, and technological characteristics are similar to a device already cleared by the FDA.

8. Sample Size for the Training Set

Not applicable. This device is a measurement kiosk and does not involve AI or machine learning algorithms that require a "training set" in the context of diagnostic image analysis or similar applications. The BMI calculation uses "NIH's algorithms," which are established formulas, not a learned model requiring a training set.

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

Not applicable, as there is no training set for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing right. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 12, 2016

HealthChek Network, LLC % John Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. Wisconsin 53066

Re: K152107

Trade/Device Name: Healthchek Network Health Station, Model HCK - 2000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, FRW Dated: March 3. 2016 Received: March 9, 2016

Dear John Ziobro:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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

Enclosure

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Indications for Use

510(k) Number (if known) K152107

Device Name

HealthChek Network Health Station, Model HCK - 2000

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image contains the logo for HealthChek Network. The logo consists of a blue checkmark inside of a circle on the left. To the right of the checkmark is the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray.

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Traditional 510(k) Summary

1. Summary Date 3/3/2016

2. Applicant Name:	HealthChek Network, LLC135 West Sallier St.Lake Charles, LA 70601Ph 608-320-636Establishment Registration Number: Pending
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Submission Correspondent: On behalf of HealthChek Networks, LLC, the following consultant is assigned the responsibility of submission correspondence: John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922

1. Trade Name: HealthChek Network Health Station, Model HCK - 2000
న్. Common Name: Health Kiosk
Description: Noninvasive blood pressure measurement system (Per FDA classification) 6.

7. Manufacturing Site: GMI Solutions 10202 North Enterprise Drive Mequon, WI 53092 USA (262) 242-8800 Establishment Registration Number: 2134848

Suggested Classification Regulation, Class & Product Code & Panel (NIBP unit): 8. 21 CFR 870.1130 Class II Product Code: DXN Panel: Cardiovascular

1. Additional Suggested Classification Regulation, Class & Product Code & Panel (Patient scale): 21 CFR 880.2720 Class I Product Code: FRW Panel: General Hospital & Personal Use

10. Reason for Traditional 510(k): New submission

11. Predicate Device(s):	510(k) Number:	K123539
	Manufacture:	StayHealthy
	Trade Name:	HealthCENTER Biometric Screening Kiosk
	Product Code:	DXN (Noninvasive blood pressure measurement system)HIT (Color vision tester)MNW (Impedance plethysmograph)
	Classification:	DXN: 21 CFR 870.1130

HealthChek Network Health Station Traditional 510(k) Submission

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Image /page/4/Picture/0 description: The image contains the logo for HealthChek Network. The logo features a blue checkmark inside of a circle on the left side of the image. To the right of the checkmark is the word "HealthChek" in gray and blue lettering, with "Network" in smaller gray lettering below it.

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HIT: 21 CFR 886.1170 (510(k) Exempt) MNW: 21 CFR 870.2770 (510(k) Exempt)

1. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:

Quality System Standards.

CFR 21CFR820: Part 820 Quality System Regulations ●
. ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

Safety Standards / Testing Compliance:

IEC 60601-1:2005 3rd edition General requirements for basic safety and essential performance
. IEC 60601-1-2:2007 3rd edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (with immunity testing to IEC 60601-1-2:2014 4th edition)
. IEC 80601-2-30:2009 Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers

Design Standards

ISO 14971:2007 Medical devices Application of risk management to medical devices .
. 47CFR Part 15 Federal Communications Commission (FCC)
. 2002/95/EC Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS)
. HIPAA Compliant
1. Indication for Use

14. Technological Characteristics

The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system is combines the hardware and software platforms of the predicates and as such has it has identical technological characteristics.

1. Testing
  Bench Testing was conducted on a unit with all design options (card reader, printer, etc.) per the requirements of IEC 60601-1 as well as the requirements for blood pressure units (per IEC 60101-2-30). Testing shows that the device is in compliance with the cited standards. Because of the long-established use of health monitoring kiosks, no clinical trial was performed.
1. Comparison to Predicates
  The main difference between the proposed device and its predicate pertains to the physiological parameters that are measured. Both devices measure blood pressure and heart rate (using the same module supplied by Suntech), and both measure weight. However, the proposed device measures Body Mass Index (BMI) using the measured weight and a height value that the user manually enters. The predicate device instead presents three similar but distinct values, namely the Percent lean body mass, the Percent body fat and the Percent total body water. In addition, the predicate device tests for color blinded and has an option to present hydration. Of all of these parameters, Blood Pressure is regulated as a Class II device subject to 510(k) market clearance and the differences the alternative measured parameters in do not affect the relative safety and/or effectiveness. For additional information see Table 1.

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Image /page/5/Picture/0 description: The image shows the logo for HealthChek Network. The logo features a blue checkmark symbol on the left, followed by the text "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in a smaller, lighter gray font. The logo is simple and professional, conveying a sense of trust and reliability.

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1. Conclusions
  HealthChek believes proposed HealthChek Network Model HCK-2000 and its predicate, the StayHealthCENTER Biometric Screening Kiosk System, are substantially equivalent in their intended use, intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics and safety standards. The main difference that exists between the devices, relating to the measured physiological parameters do not affect the relative safety and/or effectiveness or the intended use/indication for use of the device

Table 1: Substantial Equivalence Comparison

	HealthChek NetworkModel HCK - 2000(Health Station System Under Review)	StayHealthyHealthCENTER Biometric ScreeningKiosk (Cleared under K123539)	Substantial EquivalenceComments
Feature		COMPARISON OF USES/INDICATIONS
Intended Use /Indication forUse	The HCK - 2000 (health station) is an automatedsystem intended to be used by the general adultpublic, in public environments, so that the user canmeasure his/her own health parameters such asblood pressure, heart rate, Body Mass Index (BMI)and body weight. It is not a diagnostic device andonly furnishes data so that users can consult theirpersonal physicians or other healthcare professional.For personal reference purposes, the user can alsochoose to print or store their data on the HealthCheknetwork's database.	The Stayhealthy SH-650 is intended to be usedby the general public so that the user can measurehis/her own blood pressure, heart rate, percentlean body mass, percent body fat, percent totalbody water, body weight, and if the user mayhave color blindness. It is not a diagnostic deviceand only furnishes data so that users can consulttheir personal physicians or other healthcareprofessional. The user can also choose to print thedata or send the data to a personal physician or ahealthcare professional.	Both devices are for use by thegeneral public to monitor generalhealth parameters. Although thedevices measure different parameters,neither device nor any of themeasured parameters are used fordiagnostic purposes. In addition, theproposed device does not allow theuser to transmit their data to ahealthcare professional. Instead thedata is automatically stored on theHealthChek's database and is madeavailable to the user for theirreference. This is a marketing featureand does not affect the safety of theuser.Therefore, Substantially Equivalent
Intended User	General Public	General Public	Both devices have identical intendedusers.Therefore, Substantially Equivalent
Intended UseEnvironment	General Public Environments	From Website: Business, Government, Home,Research, Health Clubs, Hospitality, HousingCare Facilities, Schools, Retail	Both devices have similar intendeduse environments.Therefore, Substantially Equivalent
Target PatientPopulation	General Public	General Public	Both devices have identical targetedpatient populations.Therefore, Substantially Equivalent
Contraindications	None	None Stated	Both devices have no, or no knowncontraindications.Therefore, Substantially Equivalent.
Warnings	As it appears on the mandrel: WARNING Thiscuff is not designed for very large arms. Your armshould fit comfortably with your palm on the armrest. DO NOT FORCE YOUR ARM INTO THECUFF, AS DISCOMFORT OR INJURY MAYOCCUR. TO RELEASE PRESS THE RED STOPBUTTONAs it appears in the manual:Warning, this machine may bruise you, and youmay faint while using it. Do not use it if you aresensitive to pressure on your arm, or haveexperienced fainting or dizziness. If the pressure onyour arm bothers you, or if unexpected readings areobtained, immediately touch the 'STOP' button todeflate the cuff.	Warning This cuff is not designed for very largearms. DO NOT FORCE YOUR ARM INTOTHE CUFF, TEMPORARY DISCOMFORT ORINJURY MAY OCCUR. Your arm should fitcomfortably, with your elbow and forearm on thearm rest. TO RELEASE, PRESS THE STOPBUTTON.	Because both devices use the sameblood pressure cuff mandrel, theyhave identical warnings on it. Thepredicate device manual does notcontain any cautions, warnings orother use restrictions while theproposed device does, including adescription of the circumferences thatthe NIBP module and cuff weredesigned to operate under. Theseadditional warnings can help aidpatient safety.The manual of the proposed deviceincludes a section on Warnings,Safety precautions and Restriction onuse. The predicate device does not.The inclusion of a restriction for useon neonatal, pregnant and pre-
Feature	HealthChek NetworkModel HCK - 2000(Health Station System Under Review)	StayHealthyHealthCENTER Biometric ScreeningKiosk (Cleared under K123539)	Substantial EquivalenceComments
UselimitationsFDA ProductCode	administrator. If you are concerned about yourblood pressure, please discuss with a medicalprofessionalWarnings, Safety Precautions and Restrictionson UseWARNING, the blood pressure measurement is notintended for use on neonatal, pregnant, or pre-eclamptic patients.When taking blood pressure. The recommendedposition is comfortably seated, relaxed, legsuncrossed, feet flat on the floor, middle of cuff atlevel of heart right atrium. It is recommended that 5minutes should elapse before the first reading istaken. Any reading can be affected by themeasurement site, the position of the patient,exercise, the patient's physiologic condition,common arrhythmias such as atrial or ventricularpremature beats or atrial fibrillation, arterialsclerosis, poor perfusion, diabetes, age, pregnancy,pre-eclampsia, renal diseases, patient motion,trembling or shivering. Readings can also beaffected by extremes in temperature, humidity, andaltitude. If unexpected readings are obtained,contact your physician immediatelyAs it appears in the manual and onscreen:WARNING, the circumference of user's arm shouldbe within 24-38cm (9.5 to 15 inches) for best resultsIt is not a diagnostic device and only furnishes dataso that users can consult their personal physicians orother healthcare professional.DXN (Noninvasive blood pressure measurementsystem)FRW (Weight)	It is not a diagnostic device and only furnishesdata so that users can consult their personalphysicians or other healthcare professional• DXN (Noninvasive blood pressuremeasurement system)• HIT (Color vision tester)• MNW (Impedance plethysmograph)	eclamptic patients is in compliancewith IEC 80601-2-30 clause201.7.9.2.1 2. These additionalrestrictions on use can help aid patientsafetyTherefore, Substantially EquivalentBoth devices have identical uselimitations.Therefore, Substantially EquivalentBoth devices use the same FDAproduct code for the regulated aspectof blood pressure measuring. Thepredicate device did not list productcode FRW even though it measuresweight; their omission does not havean impact on the substantialequivalence determination. Thepredicate device includes alternativefeatures and therefore cites additionalFDA product codes. However, theadditional features do not substantiallydeviate from either device's intendeduse as a general health and well-beingmonitoring system and do not raiseany concerns for safety andeffectiveness.Therefore, Substantially Equivalent
MeasuredPhysiologicalParameters –From 510(k)	Blood pressure, BP (uses the SunTech AdvantageModel 2 module, containing the ct3.39.0firmware and equipped with the SunTech KioskCuff (part # 98-0231-00-AD. REV B); capable ofrecording blood pressures from +40 to +260 mmHg Systolic and +20 to +200 mmHg Diastolic• Heart rate (calculated via the BP module) capableof recording rates from 30 to 220 beats per minute• BMI (Body Mass Index) (via a calculated valueusing the NIH's algorithms using a height value	• Blood pressure, BP (uses the SunTechAdvantage Model 2 module, containing thect3.39.0 firmware and equipped with theSunTech Kiosk Cuff (part # 98-0231-00-AD.REV B); capable of recording blood pressuresfrom +40 to +260 mm Hg Systolic and +20 to+200 mm Hg Diastolic• Heart rate (calculated via the BP module)capable of recording rates from 30 to 220 beatsper minute	Both devices measure blood pressureand heart rate using the same thirdparty blood pressure module. Bothdevices measure weight using a loadcell. The proposed device measure BMIwhile the predicate device measurespercent lean & fat mass. Thepredicate device also tests for colorblindness which the proposed devicedoes not do. However, these featuresdo not substantially change the overall
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	HealthChek NetworkModel HCK - 2000(Health Station System Under Review)	StayHealthyHealthCENTER Biometric ScreeningKiosk (Cleared under K123539)	Substantial EquivalenceComments
Feature	entered by the user) No indicated range as this isa function of height and weight• Body weight, (tested at 440 lbs / 200 kg) (asmeasured via a load cell imbedded in an ADAcompliant seat)	• Percent lean body mass (via bioimpedance)• Percent body fat (via bioimpedance)• Percent total body water (via bioimpedance)• Body weight, (up to 500 pounds / 227 kg) (viaa load cell imbedded in an ADA compliantseat)• If the user may have color blindness	design intention of the device and thedifferences in parameters can beconsidered to be "marketing" features
Additional /AlternativeMeasuredPhysiologicalParameters –From Website	None	• Hydration-The Stayhealthy Hydration Index(SHI), which calculates on an individual basis,your specific hydration status based on broadpopulation averages and studies.• On the graph showing your hydration results isa line marked with zero. This represents thethreshold for acceptable hydration, and shouldbe considered the minimum level of hydrationyour body needs. A measurement above zero isdesirable.• Each person's zero point is calculated bydetermining the hydration of their lean mass(everything except fat), plus the watercontained in their body fat. Just as physicalmakeup varies from person to person, so doesthe zero point	The predicate device offers themeasurement of "hydration" as anadditional/alternative physiologicalparameter. However, this feature doesnot substantially change the overalldesign intention of the device and canbe considered to be a "marketing"feature.Therefore, Substantially Equivalent
DeviceOptions	• Printer for results• Barcode scanner (2D)• Data Ports for Personal Health Devices:-USB:Used for pedometer download.,• Ethernet Connection: Ability to connect to theHealthChek database though built-in Ethernet port	• Printer for results / incentives / coupons• Barcode scanner (2D)• Personal health device upload ports: IR, USBmini, micro, Type A (Download stations forOmron Pedometers and for blood glucosemeters)• 32-inch LCD HD display screen (forAdvertising, Information and Store messaging)• Wi-Fi or cellular connectivity• Loyalty Card reader - so customer can accessan online account	In regards to device options, thepredicate device allows for the use ofa 32" LCD screen which is used foradvertising purposes as well as the useof a "loyalty card" which is also abrand-identification feature that doesnot change the overall indication foruse.The proposed device does not includeWiFi or cellular connectivity, but doesinclude an Ethernet connection that isused to store patient-data. Unlike thepredicate wherein their WiFi / cellularconnection is used to transmit data tothe personal physician. Allowing theuser to conveniently store and retrievetheir data is a marketing feature anddoes not affect patient safety.Therefore, Substantially Equivalent
		COMPARISON OF ERGONOMICS/HUMAN FACTORS

User InputMechanism	Touch screen interface	17 inch LCD touch screen user navigationBP"Express" feature	Both devices use a touch screen; thesize of the screen is immaterial.Therefore, Substantially Equivalent
Data Output /DisplayMechanisms	• On-Screen Display• Built-in 200 dpi Printer	• On-Screen Display• Built-in Laser Printer• Loyalty Card reader – so customer can accessan online account	Both devices have on-screen displaysand the ability to print out the data.The type of printer and the ability toaccess the user's information via a"loyalty card" is immaterial.Therefore, Substantially Equivalent
Data Storage	No data is saved directly on the kiosk. All data isstored remotely.	No data is saved directly on the kiosk. All data isstored remotely	Neither device stores personal data onthe kiosk itself although the proposeddevice is not designed to forward theinformation on to a personal healthcare practitioner.Therefore, Substantially Equivalent
COMPARISON OF PATIENT CONTACT MECHANISMS & MATERIALS
PatientContact/Interf	Blood pressure cuff is in compliance with ISO10993	Blood pressure cuff is in compliance with ISO10993	Both devices are in compliance withthe same standard.

HealthChek Network Health Station Traditional 510(k) Submission

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Image /page/7/Picture/0 description: The image contains the logo for HealthChek Network. The logo features a blue checkmark symbol on the left, followed by the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in a smaller, gray font.

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HealthChek Network Health Station Traditional 510(k) Submission

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Image /page/8/Picture/0 description: The image contains the logo for HealthChek Network. The logo consists of a blue checkmark inside of a circle on the left. To the right of the checkmark is the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray.

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	HealthChek Network	StayHealthy
	Model HCK - 2000	HealthCENTER Biometric Screening	Substantial Equivalence
Feature	(Health Station System Under Review)	Kiosk (Cleared under K123539)	Comments
ace Materials			Therefore, Substantially Equivalent
		COMPARISON OF POWER REQUIREMENTS / COMPUTER INTERFACE
OperatingSystem	Windows Seven	Windows seven (embedded)	Both devices operate on the sameWindows platform. The issue of"embeddedness" is immaterial.Therefore, Substantially Equivalent
User InputMechanism	Touch screen interface	Touch screen user navigationBP "Express"feature	Both devices use a touch screen forser input.Therefore, Substantially Equivalent
Power Source	Single phase 110/220 VAC, 2A 50 or 60 Hz	120V, 60Hz, 2.0A	Both devices can operate on standardUSA power inputs.Therefore, Substantially Equivalent
COMPARISON OF DIMENSIONAL SPECIFICATIONS
Dimensions	32" W x 27.5 " L x 62" H	27.5" W x 39.6" L x 44.2" H (80" H withoptional LCD display)	Both devices have similar dimensionssuitable for use as a public-accessibleheath kiosk.Therefore, Substantially Equivalent
Weight	230 lbs	200 lbs / 90 KG	Both devices have similar weights thatare needed to create a public-accessible heath kiosk.Therefore, Substantially Equivalent
COMPARISON OF ENVIRONMENT SPECIFICATIONS
OperatingEnvironment(overallsystem)	15° C to +50° C15 to 95% (Non-Condensing)	41 - 95 °F (5 to 35 °C)10 - 80% (non-condensing)	Both devices are designed to operatein similar "office-based"environments.Therefore, Substantially Equivalent
StorageEnvironment	-20° C to +50° C10 to 90% (Non-Condensing)	Not specified	While not stated/known for thepredicate, it is reasonable to assumethat both devices have similar storageconditions.Therefore, Substantially Equivalent
COMPARISON OF APPLICABLE STANDARDS
QualitySystemStandardsCompliance	• CFR 21CFR820: Part 820 - Quality SystemRegulations• ISO 13485:2003 Medical devices - Qualitymanagement systems - Requirements forregulatory purposes	FDA-cleared class II medical devices	Both devices claim compliance withsimilar quality system standards.Therefore, Substantially Equivalent
SafetyStandards /TestingCompliance(3rd partytestingconducted)	• IEC 60601-1:2005 3rd edition Generalrequirements for basic safety and essentialperformance• IEC 60601-1-2:2007 Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements and tests (withimmunity testing to 60601-1-2:2014)• IEC 80601-2-30:2000 Particular requirements forbasic safety and essential performance ofautomated non-invasive sphygmomanometers• AAMI/ANSI/ISO 81060-1:2013 Non-invasivesphygmomanometers - Part 2: Clinical investigationof automated measurement type (via OEM)	• UL/IEC 60601-1/2 certified• CAN/CSA-C22.2 certified• ISO 81060-1:2002 compliant blood pressuredevice (via OEM)	Both devices claim compliance withsimilar safety standards.Therefore, Substantially Equivalent
DesignStandardsCompliance(Usedinternallyduring thedesignprocess)	• ISO 14971:2007 Medical devices - Applicationof risk management to medical devices• 47CFR Part 15 Federal CommunicationsCommission (FCC)• 2002/95/EC Restriction of the Use of CertainHazardous Substances in Electrical andElectronic Equipment (RoHS)• HIPAA compliant	• American Disabilities Act (ADA) compliant• HIPAA compliant• RoHS compliant	Both devices claim compliance withsimilar design standards.Therefore, Substantially Equivalent

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).