(195 days)
No
The description focuses on standard medical device functionalities (blood pressure, weight, vision screening) and mentions validation against established standards and predicate devices, with no indication of AI/ML use.
No.
The SoloHealth Station is intended for screening and measurement, not for treatment or therapy. It explicitly states it does not provide diagnosis.
No
The "Intended Use / Indications for Use" section explicitly states, "SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease." While it measures vital signs and screens for clarity of central vision, it clearly disclaims diagnostic capability.
No
The device description explicitly states it is an "automated system for measuring blood pressure and pulse rate" and "measures weight, screens clarity of central vision". It also mentions "performance testing, safety testing, electromagnetic testing" and compliance with standards like IEC 60601-1-2 and IEC 60601-1, which are related to electrical and electromagnetic safety of medical equipment, indicating the presence of hardware components beyond just software.
Based on the provided information, the SoloHealth Station is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SoloHealth Station's Function: The SoloHealth Station measures physical parameters directly from the user (blood pressure, pulse rate, weight, and central vision clarity). It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for the general public to measure their own physical parameters and screen for central vision clarity. It explicitly states it does not provide a diagnosis of eye health or other disease.
Therefore, the SoloHealth Station falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXN, HOX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults (for vision screening)
Intended User / Care Setting
General public in indoor high-traffic commercial areas.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LifeClinic® 2400 (K040562), Computerized Screening, Inc CSI Model 5k Managed Health System Kiosk (K093389), Xperex Health Check Kiosk (K063008)
Reference Device(s)
Accutome Eye Charts, Vimetrics Central Vision Analyzer 1000, Optec 5000 Series Vision Tester
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
2
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
3
Indications for Use Statement
510(k) Number (if known): K113402
Device Name: SoloHealth Station
Indications for Use:
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.
| 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 |
|---|---|
| --------------- | --------- |
4
SoloHealth Station
K113402
MAY 3 0 2012
510(k) Summary SoloHealth Station K113402 May 18, 2012
| Company: | SoloHealth, Inc.
11555 Medlock Bridge, Suite 190
Duluth, GA 30097
Phone: (770) 622-4158
Fax: (770) 622-4122 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3007156596 |
| Primary Contact: | Kimberly Strohkirch
Memphis Regulatory Consulting, LLC
Phone: (901) 361-2037 |
| Company Contact: | Stephen Kendig
Chief 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:
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.
5
Indications for use:
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.
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).
6
:
:
| | SoloHealth
Station | LifeClinic® 2400
(K040562) | Computerized
Screening, Inc
CSI Model 5k
Managed
Health System
Kiosk
(K093389) | Xperex Inc.
Health Check
Kiosk
(K063008) | Comparison |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General public to
measure blood
pressure and
pulse rate;
Weight
measurement
and screen
clarity of central
vision | General public to
measure blood
pressure and
pulse rate; Not a
diagnostic device | General public
to measure
blood pressure
and pulse rate;
Not a
diagnostic
device | General public to
measure blood
pressure and
pulse rate; Not a
diagnostic device | Similar to LifeClinic
2400, CSI Model 5k
and Xperex Health
Check Kiosk |
| Indications
for Use | 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 | The Lifeclinic
2400 is intended
to be used by
the general
public so that a
user can
measure his/her
own blood
pressure and
pulse rate. It is
not a diagnostic
device, and only
furnished data
so that the users
can consult their
personal
physician. | The CSI Model
5K Managed
Health System
Kiosk is
intended for
use by the
general public
to measure
blood pressure,
pulse and
weight. It is not
intended to be
a diagnostic
device; it only
provides data
on blood
pressure, heart
rate and weight
and users are
advised to
consult a
physician. | The Health
Check Kiosk is
intended to be
used by the
general public so
that a user can
measure health
parameters such
as weight, body
fat, blood
pressure and
pulse rate in
public places
and/or
corporate
environments. It
is not for
diagnostic use. | Similar to LifeClinic
2400, CSI Model 5k
and Xperex Health
Check Kiosk |
| | SoloHealth
Station | LifeClinic® 2400
(K040562) | Computerized
Screening, Inc
CSI Model 5k
Managed
Health System
Kiosk
(K093389) | Xperex Inc.
Health Check
Kiosk
(K063008) | Comparison |
| | screens clarity of
central vision.
Users should
consult their
personal
physicians if they
have concerns
regarding their
eyesight. | | | | |
| Intended
Population | General Public | General Public | General Public | General Public | Identical |
| Human
Factors | Shock Hazard
tested per IEC
60601-1:1988
and IEC 60601-2-
30:1999; Blood
Pressure Risks
tested per AAMI
SP10 | Blood Pressure
Risks tested per
AAMI SP10 | Blood Pressure
Risks tested per
AAMI SP10 | Not available | Risks addressed
per current
industry standards |
| Hardware
Design | LCD Interface to
control blood
pressure and
pulse rate
measuring
device. A stop
button stops the
blood pressure
rate and
measuring
device. | Start/stop
button to control
blood pressure
and pulse rate
measuring
device | LCD Interface to
control blood
pressure and
pulse rate
measuring
device | Start/stop
button to control
blood pressure
and pulse rate
measuring
device | SoloHealth Kiosk
uses an LCD screen
as opposed to
directions on the
device for the user
to control the
device. A stop
button stops the
blood pressure
rate and measuring
device. No
additional risks for
control method. |
| Software
Design | The SoloHealth
Station uses
software as an
automated
system for
measuring
blood pressure
and pulse rate.
It is completely
automatic, and
measures blood
pressure by the | The Lifeclinic
2400 uses
software as an
automated
system for
measuring
blood pressure
and pulse rate.
It is completely
automatic, and
measures blood
pressure by the | The CSI 5k
Kiosk uses
software as an
automated
system for
measuring
blood pressure
and pulse rate.
It is completely
automatic, and
measures
blood pressure | Xperex Health
Check Kiosk uses
software as an
automated
system for
measuring
blood pressure
and pulse rate.
It is completely
automatic, and
measures blood
pressure by the | The software
program used by
the predicate is not
available for direct
comparison.
However, both
systems provide
blood pressure
measurements in
an automatic way
using software. |
| | SoloHealth
Station | LifeClinic® 2400
(K040562) | Computerized
Screening, Inc
CSI Model 5k
Managed
Health System
Kiosk
(K093389) | Xperex Inc.
Health Check
Kiosk
(K063008) | Comparison |
| | oscillometric
method. The
user is guided
by a series of
interactive
screens and
voice
instructions. | oscillometric
method. The
user is guided by
a series of
interactive
screens and
voice
instructions. | by the
oscillometric
method. The
user completes
functions by
pushing labeled
buttons. | oscillometric
method. The
user is guided by
a series of
interactive
screens and
voice
instructions. | |
| Dimensions
and Weight | 2 ft wide x 3 ft
deep x 5 feet tall | Not available | Not available | Not available | Dimensions of
predicate devices
are not available
for comparison. |
| Performance
Standards
Met | AAMI Standards
IEC Standards | AAMI Standards | AAMI Standard
IEC Standards | AAMI Standards | Identical AAMI
Standards.
SoloHealth Kiosk
also meets
Electrical Safety
Standards. |
| Materials | Commercially
available
materials
including soda
lime glass for
touchscreen,
metal housing,
and latex-free
polyester thread
for cuff | Not available | Not available | Latex-free
polyester thread
for cuff. The rest
of the material is
not available. | Materials of
predicate not
available for
comparison.
Materials of
SoloHealth Station
currently
commercially
available. |
| Cleaning/Disi
nfection/Ster
ilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Identical |
| Biocompatibi
lity | Commercially
available
materials
including soda
lime glass for
touchscreen,
metal housing,
and latex-free
polyester thread
for cuff. Blood
pressure cuff is
identical to cuff
used in Xperex | None listed in
510(k) Summary | None listed in
510(k)
Summary | None listed in
510(k) Summary | Materials of
SoloHealth are
widely available
commercially and
do not necessitate
biocompatibility
testing. |
| | SoloHealth
Station | LifeClinic® 2400
(K040562) | Computerized
Screening, Inc
CSI Model 5k
Managed
Health System
Kiosk
(K093389) | Xperex Inc.
Health Check
Kiosk
(K063008) | Comparison |
| | Corp's Health
Check Kiosk. | | | | |
| Electromagne
tic
Compatibility | Meets IEC
60601-1-2:2001 | None listed in
510(k) Summary | Meets IEC
60601-1-2 | None listed in
510(k) Summary | The SoloHealth
Station is tested to
meet
electromagnetic
compatibility
requirements. |
| Components | Blood Pressure
and Pulse Rate;
Weight; Vision | Blood Pressure
and Pulse Rate | Blood Pressure
and Pulse Rate;
Weight | Blood Pressure
and Pulse Rate | The SoloHealth
Station has
additional
functionality of
vision screening via
standard eye chart,
which is not a
medical device. |
| User
Interaction | Interactive
screens and
voice
instructions | Interactive
screens and
voice
instructions | Push buttons | Interactive
screens and
voice
instructions | Identical to
LifeClinic 2400 |
Table 1. Detailed comparison of the subject and predicate devices.
7
.
.
.
ﺘ
8
:
9
:
.
.
,
10
SoloHealth Station
Table 2. Similar Vision Screening Devices
| Subject Device | Similar Vision Screening Devices | |||||
|---|---|---|---|---|---|---|
| SoloHealth Station | Eye Chart | Vimetrics Central Vision | ||||
| Analyzer 1000 (CVA-1000) | Optec 5000 Series | |||||
| Vision Tester | Detailed Comparison | |||||
| 510(k) | Subject Device K113402 | None | K100095 | None located | Comparison not applicable. | |
| Manufacturer | ||||||
| Establishment | ||||||
| Registration | SoloHealth | Accutome | Vimetrics, LLC | Stereo Optical | ||
| 3007156596 | 2521877 | None found in FDA database | 1419226 | |||
| Primary Device | ||||||
| Listing | DXN, Automated Blood | |||||
| Pressure Monitor | ||||||
| HOX, Chart, Visual | ||||||
| Acuity | HOX, Chart, | |||||
| Visual Acuity | HOX, Chart, Visual Acuity | HOX, Chart, Visual | ||||
| Acuity; HIT, Tester, | ||||||
| Vision Color | The SoloHealth Station | |||||
| central vision screening is | ||||||
| similar to the visual acuity | ||||||
| chart of the Eye chart, | ||||||
| Central Vision Analyzer and | ||||||
| Optec 5000. | ||||||
| Classification | Class II | Class I Exempt | Class I, requiring premarket | |||
| notification | Class I Exempt | The SoloHealth Station is | ||||
| Class II and is subject to | ||||||
| 510(k) clearance. The vision | ||||||
| screening component of the | ||||||
| SoloHealth Station is similar | ||||||
| to the Eye Chart, Central | ||||||
| Vision Analyzer, and Optec | ||||||
| 5000 that are Class I. | ||||||
| Intended Use | General public to | |||||
| measure blood pressure | ||||||
| and pulse rate; Weight | ||||||
| measurement and | ||||||
| screen clarity of central | ||||||
| vision | To test visual | |||||
| acuity | The CVA-1000 is intended 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. | To test visual | |||||
| acuity | The SoloHealth Station is | |||||
| similar to all similar devices | ||||||
| and is intended to screen for | ||||||
| clarity 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 Vision | ||||
| Analyzer 1000 (CVA-1000) | Optec 5000 Series | |||||
| Vision Tester | Detailed Comparison | |||||
| Near Distance | ||||||
| Screening | Yes; Screening | |||||
| simulated at 17 inches | Yes | Yes | Yes; Screening | |||
| simulated 16 in. | All devices are used for near | |||||
| distance screening. | ||||||
| Far Distance | ||||||
| Screening | Yes; Screening | |||||
| simulated at 11 feet | Yes | Yes | Yes; Screening | |||
| simulated 20 feet | All devices are used for far | |||||
| distance screening. | ||||||
| Display/Technology | LCD computer monitor, | |||||
| UL 60950 | ||||||
| Interactive Central | ||||||
| Vision Panel | Plastic chart | Yes, LCD computer monitor | ||||
| and interactive central vision | ||||||
| panel | LED lighted films | The SoloHealth Station uses | ||||
| an LCD computer monitor | ||||||
| and interactive central vision | ||||||
| panel which is substantially | ||||||
| equivalent to the predicate | ||||||
| of Central Vision Analyzer. | ||||||
| acuity by the general public. | ||||||
| The kiosk predicates are also | ||||||
| intended for the general | ||||||
| public. |
Page 7 of 11
11
SoloHealth Station
Page 8 of 11
12
SoloHealth Stațion
Page 9 of 11
·
13
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.
14
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.