The SoloHealth Station is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision. SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.

Device Description

The SoloHealth Station is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in indoor high-traffic commercial areas. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series for interactive screen and voice instructions. Additionally, the SoloHealth Station measures weight, screens clarity of central vision, and does a risk factor analysis. Users are advised to consult a physician. Upon completion, data may be stored by the user and accessed via a website or sent via electronic mail to the user.

AI/ML Overview

The SoloHealth Station is an automated system intended for the general public to measure blood pressure and pulse rate, weight, and screen for clarity of central vision.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Component/Aspect	Acceptance Criteria (Standards Met)	Reported Device Performance
Blood Pressure	AAMI/ANSI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003 (Manual, electronic or automated sphygmomanometers)	Bench testing for AAMI SP10 was completed separately by the supplier of the blood pressure module. Verification testing performed by the supplier ensures compliance with AAMI SP10 for the blood pressure cuff. Both of these components are not altered when assembled in the SoloHealth Station. Clinical testing according to AAMI SP10 was completed by the supplier of the blood pressure module on the module itself. The module is not altered when assembled in the SoloHealth Station. Full AAMI SP10 testing protocol was executed in Duluth, GA on the final device design and has shown that the SoloHealth Station kiosk demonstrates compliance to AAMI SP10. Additionally, confirmatory testing was completed with the SoloHealth Station on a limited number of subjects to ensure that the use of an alternate cuff does not affect the results as compared to the AAMI SP10 testing on the module.
Electrical Safety	IEC 60601-1:1988+A1:1991+ A2:1995 (Medical Electrical Equipment Part 1-2: General Requirements for Safety) IEC 60601-2-30:1999 (Particular Requirements for Safety, including essential performance, of automatic cycling non-invasive blood pressure measuring equipment)	Electrical safety testing was completed in accordance with the specified standards. Several clauses indicated failures initially, but these were re-tested, resulting in satisfactory results, or justification was provided that the clauses were not applicable to the SoloHealth Station (located in an indoor environment).
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2001 (Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard: Electromagnetic Compatibility)	Electromagnetic compatibility testing was completed and passed in accordance with IEC 60601-1-2:2001.
Software Validation	"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) "Non-invasive Blood Pressure (NIBP) Monitor Guidance" (March 10, 1997) for a device of moderate concern.	Software validation has been satisfactorily completed according to the specified guidance documents. Device Risk Hazards Analysis, Software Requirements Specification Architecture Design Chart, Software Design Specifications, Traceability Analysis, Software Development Environment Description, and Revision History were completed.
Vision Screening	Similarity to a licensed Optometrist	Vision Screening Validation of the SoloHealth Station demonstrates that the screenings of the SoloHealth Station are similar to a licensed Optometrist.

2. Sample size used for the test set and the data provenance

Blood Pressure:
- The blood pressure module (component within the SoloHealth Station) underwent clinical testing according to AAMI SP10 by its supplier. The number of subjects for this initial testing is not specified in this document.
- Subsequently, "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects" in Duluth, GA. The exact number of subjects for this confirmatory study is not provided.
- Data Provenance: The confirmatory testing was done in Duluth, GA, presumably in the USA. It appears to be prospective data collection for the confirmatory study. The provenance of the supplier's clinical data is not specified.
Vision Screening: The document states that "confirmatory testing was completed with the SoloHealth Station on a limited number of subjects." The exact sample size is not provided.
- Data Provenance: Testing was done in Duluth, GA, presumably in the USA. This appears to be prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Blood Pressure: For the AAMI SP10 clinical testing, the standard requires specific expertise for ground truth measurements. While not explicitly stated in this document, AAMI SP10 typically necessitates trained observers for auscultatory reference measurements.
Vision Screening: The ground truth for vision screening was established by comparison to the "screenings of a licensed Optometrist." The number of optometrists is not specified.

4. Adjudication method for the test set

The document does not specify a formal adjudication method (e.g., 2+1, 3+1) for either the blood pressure or vision screening test sets.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned in the provided text. The device is a standalone kiosk for self-measurement and screening.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance testing for the SoloHealth Station (which includes the blood pressure and vision screening functions) appears to be focused on its standalone performance in comparison to established standards and human expert assessment. The device is an "automated system" for self-measurement by the general public.

7. The type of ground truth used

Blood Pressure: The ground truth for blood pressure measurements is based on compliance with the AAMI SP10 standard, which involves comparison to reference methods (typically auscultatory measurements by trained observers).
Vision Screening: The ground truth for vision screening is "similarity to a licensed Optometrist." This implies a comparison of the device's screening results to those obtained by a human optometrist.

8. The sample size for the training set

The document does not provide information on a specific training set or its sample size. The focus is on the performance testing against established standards and human expert equivalents.

9. How the ground truth for the training set was established

Given that no specific training set is outlined, information on how its ground truth was established is not provided. The development process would likely have involved data for algorithm development, but this document focuses on regulatory performance testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.

January 19, 2022

Solohealth, Inc. % Jeff Rongero Third Party Official Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle, North Carolina 27709

Re: K113402

Trade/Device Name: Solohealth Station Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, HOX

Dear Jeff Rongero:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 30, 2012. Specifically, FDA is updating this letter to reflect the correct product code.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, Jennifer.Shih(@fda.hhs.gov.

Sincerely,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

MAY 3 0 2012

SoloHealth, Inc. c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

Re: K113402

Trade Name: SoloHealth Station Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: DRG, HOX Dated: May 24, 2012 Received: May 25, 2012

Dear Mr. Rongero:

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. Ilsting 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.

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Page 2 – Mr. Jeff D. Rongero

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.

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 Statement

510(k) Number (if known): K113402

Device Name: SoloHealth Station

Indications for Use:

Prescription Use	No
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
---------------------

Division of Cardiovascular Devices

510(k) Number	K113402
---------------	---------

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SoloHealth Station

K113402

MAY 3 0 2012

510(k) Summary SoloHealth Station K113402 May 18, 2012

Company:	SoloHealth, Inc.11555 Medlock Bridge, Suite 190Duluth, GA 30097Phone: (770) 622-4158Fax: (770) 622-4122
EstablishmentRegistration:	3007156596
Primary Contact:	Kimberly StrohkirchMemphis Regulatory Consulting, LLCPhone: (901) 361-2037
Company Contact:	Stephen KendigChief Operating Officer
Trade Name:	Solo Health Station
Common Name:	Automated Blood Pressure Monitor
Classification:	Class II
Regulation Number:	870.1130 - Non-invasive blood pressure measurement system
Panel:	Cardiovascular
Product Code:	DXN

Device Description:

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Indications for use:

Substantial Equivalence:

The SoloHealth Station is substantially similar to predicate devices currently on the market. These devices are the LifeClinic® 2400 (K040562), Computerized Screening, Inc CSI Model 5k Managed Health System Kiosk (K093389) and Xperex Health Check Kiosk (K063008) as shown in Table 1. The central vision screening of the SoloHealth Station is similar to Accutome Eye Charts, Vimetrics Central Vision Analyzer 1000, and Optec 5000 Series Vision Tester shown in Table 2. The SoloHealth Station has the following main components: Blood Pressure Application, Weight Measuring Application, Vision Test, and Test Results. Biocompatibility for the blood pressure cuff is established utilizing Xperex's Health Check Kiosk (K063008).

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	SoloHealthStation	LifeClinic® 2400(K040562)	ComputerizedScreening, IncCSI Model 5kManagedHealth SystemKiosk(K093389)	Xperex Inc.Health CheckKiosk(K063008)	Comparison
Intended Use	General public tomeasure bloodpressure andpulse rate;Weightmeasurementand screenclarity of centralvision	General public tomeasure bloodpressure andpulse rate; Not adiagnostic device	General publicto measureblood pressureand pulse rate;Not adiagnosticdevice	General public tomeasure bloodpressure andpulse rate; Not adiagnostic device	Similar to LifeClinic2400, CSI Model 5kand Xperex HealthCheck Kiosk
Indicationsfor Use	The SoloHealthStation isintended to beused by thegeneral public sothat a user canmeasure his/herown bloodpressure andpulse rate andhis/her ownweight.Additionally, theSoloHealthStation isintended toscreen adults forclarity of centralvision.SoloHealthStation does notprovide ageneralscreening ofvisual functionand does notprovide adiagnosis of eyehealth or otherdisease. TheSoloHealthStation only	The Lifeclinic2400 is intendedto be used bythe generalpublic so that auser canmeasure his/herown bloodpressure andpulse rate. It isnot a diagnosticdevice, and onlyfurnished dataso that the userscan consult theirpersonalphysician.	The CSI Model5K ManagedHealth SystemKiosk isintended foruse by thegeneral publicto measureblood pressure,pulse andweight. It is notintended to bea diagnosticdevice; it onlyprovides dataon bloodpressure, heartrate and weightand users areadvised toconsult aphysician.	The HealthCheck Kiosk isintended to beused by thegeneral public sothat a user canmeasure healthparameters suchas weight, bodyfat, bloodpressure andpulse rate inpublic placesand/orcorporateenvironments. Itis not fordiagnostic use.	Similar to LifeClinic2400, CSI Model 5kand Xperex HealthCheck Kiosk
	SoloHealthStation	LifeClinic® 2400(K040562)	ComputerizedScreening, IncCSI Model 5kManagedHealth SystemKiosk(K093389)	Xperex Inc.Health CheckKiosk(K063008)	Comparison
	screens clarity ofcentral vision.Users shouldconsult theirpersonalphysicians if theyhave concernsregarding theireyesight.
IntendedPopulation	General Public	General Public	General Public	General Public	Identical
HumanFactors	Shock Hazardtested per IEC60601-1:1988and IEC 60601-2-30:1999; BloodPressure Riskstested per AAMISP10	Blood PressureRisks tested perAAMI SP10	Blood PressureRisks tested perAAMI SP10	Not available	Risks addressedper currentindustry standards
HardwareDesign	LCD Interface tocontrol bloodpressure andpulse ratemeasuringdevice. A stopbutton stops theblood pressurerate andmeasuringdevice.	Start/stopbutton to controlblood pressureand pulse ratemeasuringdevice	LCD Interface tocontrol bloodpressure andpulse ratemeasuringdevice	Start/stopbutton to controlblood pressureand pulse ratemeasuringdevice	SoloHealth Kioskuses an LCD screenas opposed todirections on thedevice for the userto control thedevice. A stopbutton stops theblood pressurerate and measuringdevice. Noadditional risks forcontrol method.
SoftwareDesign	The SoloHealthStation usessoftware as anautomatedsystem formeasuringblood pressureand pulse rate.It is completelyautomatic, andmeasures bloodpressure by the	The Lifeclinic2400 usessoftware as anautomatedsystem formeasuringblood pressureand pulse rate.It is completelyautomatic, andmeasures bloodpressure by the	The CSI 5kKiosk usessoftware as anautomatedsystem formeasuringblood pressureand pulse rate.It is completelyautomatic, andmeasuresblood pressure	Xperex HealthCheck Kiosk usessoftware as anautomatedsystem formeasuringblood pressureand pulse rate.It is completelyautomatic, andmeasures bloodpressure by the	The softwareprogram used bythe predicate is notavailable for directcomparison.However, bothsystems provideblood pressuremeasurements inan automatic wayusing software.
	SoloHealthStation	LifeClinic® 2400(K040562)	ComputerizedScreening, IncCSI Model 5kManagedHealth SystemKiosk(K093389)	Xperex Inc.Health CheckKiosk(K063008)	Comparison
	oscillometricmethod. Theuser is guidedby a series ofinteractivescreens andvoiceinstructions.	oscillometricmethod. Theuser is guided bya series ofinteractivescreens andvoiceinstructions.	by theoscillometricmethod. Theuser completesfunctions bypushing labeledbuttons.	oscillometricmethod. Theuser is guided bya series ofinteractivescreens andvoiceinstructions.
Dimensionsand Weight	2 ft wide x 3 ftdeep x 5 feet tall	Not available	Not available	Not available	Dimensions ofpredicate devicesare not availablefor comparison.
PerformanceStandardsMet	AAMI StandardsIEC Standards	AAMI Standards	AAMI StandardIEC Standards	AAMI Standards	Identical AAMIStandards.SoloHealth Kioskalso meetsElectrical SafetyStandards.
Materials	Commerciallyavailablematerialsincluding sodalime glass fortouchscreen,metal housing,and latex-freepolyester threadfor cuff	Not available	Not available	Latex-freepolyester threadfor cuff. The restof the material isnot available.	Materials ofpredicate notavailable forcomparison.Materials ofSoloHealth Stationcurrentlycommerciallyavailable.
Cleaning/Disinfection/Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Identical
Biocompatibility	Commerciallyavailablematerialsincluding sodalime glass fortouchscreen,metal housing,and latex-freepolyester threadfor cuff. Bloodpressure cuff isidentical to cuffused in Xperex	None listed in510(k) Summary	None listed in510(k)Summary	None listed in510(k) Summary	Materials ofSoloHealth arewidely availablecommercially anddo not necessitatebiocompatibilitytesting.
	SoloHealthStation	LifeClinic® 2400(K040562)	ComputerizedScreening, IncCSI Model 5kManagedHealth SystemKiosk(K093389)	Xperex Inc.Health CheckKiosk(K063008)	Comparison
	Corp's HealthCheck Kiosk.
ElectromagneticCompatibility	Meets IEC60601-1-2:2001	None listed in510(k) Summary	Meets IEC60601-1-2	None listed in510(k) Summary	The SoloHealthStation is tested tomeetelectromagneticcompatibilityrequirements.
Components	Blood Pressureand Pulse Rate;Weight; Vision	Blood Pressureand Pulse Rate	Blood Pressureand Pulse Rate;Weight	Blood Pressureand Pulse Rate	The SoloHealthStation hasadditionalfunctionality ofvision screening viastandard eye chart,which is not amedical device.
UserInteraction	Interactivescreens andvoiceinstructions	Interactivescreens andvoiceinstructions	Push buttons	Interactivescreens andvoiceinstructions	Identical toLifeClinic 2400

Table 1. Detailed comparison of the subject and predicate devices.

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SoloHealth Station

Table 2. Similar Vision Screening Devices

	Subject Device		Similar Vision Screening Devices
	SoloHealth Station	Eye Chart	Vimetrics Central VisionAnalyzer 1000 (CVA-1000)	Optec 5000 SeriesVision Tester	Detailed Comparison
510(k)	Subject Device K113402	None	K100095	None located	Comparison not applicable.
ManufacturerEstablishmentRegistration	SoloHealth	Accutome	Vimetrics, LLC	Stereo Optical
	3007156596	2521877	None found in FDA database	1419226
Primary DeviceListing	DXN, Automated BloodPressure MonitorHOX, Chart, VisualAcuity	HOX, Chart,Visual Acuity	HOX, Chart, Visual Acuity	HOX, Chart, VisualAcuity; HIT, Tester,Vision Color	The SoloHealth Stationcentral vision screening issimilar to the visual acuitychart of the Eye chart,Central Vision Analyzer andOptec 5000.
Classification	Class II	Class I Exempt	Class I, requiring premarketnotification	Class I Exempt	The SoloHealth Station isClass II and is subject to510(k) clearance. The visionscreening component of theSoloHealth Station is similarto the Eye Chart, CentralVision Analyzer, and Optec5000 that are Class I.
Intended Use	General public tomeasure blood pressureand pulse rate; Weightmeasurement andscreen clarity of centralvision	To test visualacuity	The CVA-1000 is intended foruse under the directsupervisionof an ophthalmologist oroptometrist in themeasurement of vision atfixation in oneor both eyes, with or withoutoptical correction.	To test visualacuity	The SoloHealth Station issimilar to all similar devicesand is intended to screen forclarity of central vision.
Indications	The SoloHealth Station	No labeling	The OVA-1000 is intended	No labeling	The indication for screening
	Intended Population	Subject Device	Similar Vision Screening Devices
		SoloHealth Station	Eye Chart	Vimetrics Central Vision Analyzer 1000 (CVA-1000)	Optec 5000 Series Vision Tester	Detailed Comparison
	General Public	is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision.SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.	available	for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.	available	for clarity of central vision is the same intent and is similar to the indications statement by Central Vision Analyzer. The SoloHealth Station does measure vision at fixation in one or both eyes with or without optical correction in central vision as does the predicate Central Vision Analyzer.
	General public				General Public	Similar to the Optec 5000, the SoloHealth Station is intended for the general public use. The Optec 5000 is used by department of transportation to test visual
					General Public with supervision of ophthalmologist or optometrist
Subject Device	Similar Vision Screening Devices
	SoloHealth Station	Eye Chart	Vimetrics Central VisionAnalyzer 1000 (CVA-1000)	Optec 5000 SeriesVision Tester	Detailed Comparison
Near DistanceScreening	Yes; Screeningsimulated at 17 inches	Yes	Yes	Yes; Screeningsimulated 16 in.	All devices are used for neardistance screening.
Far DistanceScreening	Yes; Screeningsimulated at 11 feet	Yes	Yes	Yes; Screeningsimulated 20 feet	All devices are used for fardistance screening.
Display/Technology	LCD computer monitor,UL 60950Interactive CentralVision Panel	Plastic chart	Yes, LCD computer monitorand interactive central visionpanel	LED lighted films	The SoloHealth Station usesan LCD computer monitorand interactive central visionpanel which is substantiallyequivalent to the predicateof Central Vision Analyzer.
					acuity by the general public.The kiosk predicates are alsointended for the generalpublic.

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SoloHealth Station

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SoloHealth Stațion

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K113402

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K113402

Performance Testing:

Performance testing of the SoloHealth Station consists of performance testing, safety testing, electromagnetic testing, and software validations.

Software validation has been satisfactorily completed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and "Non-invasive Blood Pressure (NIBP) Monitor Guidance" (March 10, 1997) for a device of moderate concern. Hardware of the SoloHealth Station includes a computer with Microsoft Windows 7 Operating system with 4 GB RAM, Intel i5 650 Processor, and a 20 GB Hard Drive. Software requires the following applications: .Net framework v4.0, Logmein Pro2 v4.1 or higher, ELO Touch screen drivers, Apache Server, MySql, and Firefox portable. Device Risk Hazards Analysis, Software Requirements Specification Architecture Design Chart, Software Design Specifications, Traceability Analysis, Software Development Environment Description, and Revision History were completed in accordance with the guidance documents.

Electromagnetic compatibility testing was completed and passed in accordance with IEC 60601-1-2:2001. Electrical safety testing was completed in accordance with IEC 60601-1:1988 and IEC60601-2-30:1999. Several clauses indicated failures initially. These clauses were re-tested resulting in satisfactory results or justification that the clauses were not applicable to the SoloHealth Station, which is located in an indoor environment.

Electromagnetic testing was performed on the SoloHealth Station and passed per the following standards:

. IEC 60601-1-2:2001, 200 Ed Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard: Electromagnetic Compatibility
Safety testing was performed on the SoloHealth Station and passed per the following standards:
. IEC 60601-1:1988+A1:1991+ A2:1995 Medical Electrical Equipment Part 1-2: General Requirements for Safety
. IEC 60601-2-30:1999, Particular Requirements for Safety, including essential performance, of automatic cycling non-invasive blood pressure measuring equipment

Performance testing was performed on the SoloHealth station and passed per the following standards:

AAMI/ANSI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic ● or automated sphygmomanometers
Bench testing for AAMI SP10 was completed separately by the supplier of the blood pressure module. Verification testing performed by the supplier ensures compliance with AAMI SP10 for the blood pressure cuff. Both of these components are not altered when assembled in the SoloHealth Station.

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K113402

SoloHealth Station

Clinical testing according to AAMI SP10 was completed by the supplier of the blood pressure module on the module itself. The module is not altered when assembled in the SoloHealth Station. Full AAM SP10 testing protocol was executed in Duluth, GA on the final device design and has shown that the SoloHealth Station kiosk demonstrates compliance to AAMI SP10. Additionally, confirmatory testing was completed with the SoloHealth Station on a limited number of subjects to ensure that the use of an alternate cuff does not affect the results as compared to the AAMI SP10 testing on the module.

Vision Screening Validation of the SoloHealth Station demonstrates that the screenings of the SoloHealth Station are similar to a licensed Optometrist.

In conclusion, the performance testing, safety testing, electromagnetic testing, and software validations according to the industry standard shows that the SoloHealth Station is substantial equivalent to the predicate devices and assures that the SoloHealth Station is as safe and effective as the predicate devices.

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).