Who is the manufacturer of SOLOHEALTH STATION?

Solohealth, Inc. filed the 510(k) submission for SOLOHEALTH STATION (K113402).

What is the FDA product code for SOLOHEALTH STATION?

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

What is the regulatory pathway for SOLOHEALTH STATION?

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

Who can help prepare an FDA 510(k) submission like SOLOHEALTH STATION?

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

SOLOHEALTH STATION

Q: What are the predicate devices for SOLOHEALTH STATION?

LifeClinic 2400 (K040562); Computerized Screening, Inc CSI Model 5k Managed Health System Kiosk (K093389); Xperex Health Check Kiosk (K063008).

K113402 · Solohealth, Inc. · DXN · May 30, 2012 · Cardiovascular

Device Facts

Record ID	K113402
Device Name	SOLOHEALTH STATION
Applicant	Solohealth, Inc.
Product Code	DXN · Cardiovascular
Decision Date	May 30, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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.

Device Story

SoloHealth Station is an automated, kiosk-based system for use in high-traffic indoor commercial areas. It measures blood pressure and pulse rate via an oscillometric cuff, weight via a scale, and screens central vision clarity. The user interacts with the device via an LCD touchscreen and voice instructions. Data can be stored, accessed via a website, or emailed to the user. The device provides health data to the user, who is advised to consult a physician for interpretation or concerns. It serves as a point-of-care screening tool for the general public to monitor health parameters.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI SP10:2002/(R)2008 and A1:2003 for blood pressure measurement was verified via the module supplier and confirmed on the final kiosk design. Limited confirmatory testing on human subjects ensured the alternate cuff did not affect results. Vision screening validation demonstrated similarity to licensed optometrist screening methods.

Technological Characteristics

Kiosk-based system with LCD touchscreen, metal housing, and latex-free polyester cuff. Measures blood pressure (oscillometric), weight, and central vision. Connectivity includes web-based data storage and email. Electrical safety per IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-2-30:1999. EMC per IEC 60601-1-2:2001. Software is automated, rule-based system for data acquisition and user guidance.

Indications for Use

Indicated for general public use to measure blood pressure, pulse rate, and weight, and to screen adults for clarity of central vision. Not for general visual function screening or diagnosis of eye health/disease. Users advised to consult physicians for eyesight concerns.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

LifeClinic 2400 (K040562)
Computerized Screening, Inc CSI Model 5k Managed Health System Kiosk (K093389)
Xperex Health Check Kiosk (K063008)

Reference Devices

Accutome Eye Charts
Vimetrics Central Vision Analyzer 1000 (K100095)
Optec 5000 Series Vision Tester

Related Devices

K101198 — CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K · Computerized Screening, Inc. · Aug 4, 2010
K140360 — HEALTH KIOSK · Engagementhealth, LLC · Apr 10, 2015
K151127 — higi Station · Higi Sh, LLC · Dec 8, 2015
K123539 — STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK · Stayhealthy, Inc. · Apr 22, 2013
K172739 — higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) · Higi Sh, LLC · Oct 10, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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. |…