(258 days)
Not Found
No
The summary describes a kiosk for measuring basic health parameters and explicitly states it does not introduce novel modes of operational theory. There is no mention of AI, ML, or related concepts.
No
The device is described as furnishing data for users to consult physicians, not for treating or diagnosing conditions, and it explicitly states "It is not a diagnostic device."
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that the device is not a diagnostic device. It only provides data for users to consult healthcare professionals.
No
The device description explicitly states it is a "kiosk designed for use by the general adult public in public locations to measure the user's health parameters". It also mentions "Bench Testing was conducted on a unit with all design options (card reader, printer, etc.) per the requirements of IEC 60601-1", which is a standard for the safety and essential performance of medical electrical equipment, indicating a hardware component.
Based on the provided information, the HCK - 2000 (health station) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "It is not a diagnostic device..."
- Explicit Statement in Device Description: The "Device Description" section also explicitly states: "The HealthChek Network Health Station kiosk is not a diagnostic device."
- Purpose of Data: The intended use is to "furnish data so that users can consult their personal physicians or other healthcare professional." This indicates the device provides measurements, but the interpretation and diagnosis are left to a healthcare professional.
- Lack of Diagnostic Function: The device measures parameters like blood pressure, heart rate, BMI, and body weight. While these are health indicators, the device itself does not perform any diagnostic tests on biological samples (which is a key characteristic of IVDs).
Therefore, the HCK - 2000 is a health monitoring device that provides data for informational purposes, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
Product codes (comma separated list FDA assigned to the subject device)
DXN, FRW
Device Description
The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.
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
general adult public
Intended User / Care Setting
General Public / public environments
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)
Bench Testing was conducted on a unit with all design options (card reader, printer, etc.) per the requirements of IEC 60601-1 as well as the requirements for blood pressure units (per IEC 60101-2-30). Testing shows that the device is in compliance with the cited standards. Because of the long-established use of health monitoring kiosks, no clinical trial was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing right. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2016
HealthChek Network, LLC % John Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. Wisconsin 53066
Re: K152107
Trade/Device Name: Healthchek Network Health Station, Model HCK - 2000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, FRW Dated: March 3. 2016 Received: March 9, 2016
Dear John Ziobro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152107
Device Name
HealthChek Network Health Station, Model HCK - 2000
Indications for Use (Describe)
The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image contains the logo for HealthChek Network. The logo consists of a blue checkmark inside of a circle on the left. To the right of the checkmark is the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray.
VOLUME 2
SECTION 3
Traditional 510(k) Summary
-
- Summary Date 3/3/2016
| 2. Applicant Name: | HealthChek Network, LLC
135 West Sallier St.
Lake Charles, LA 70601
Ph 608-320-636
Establishment Registration Number: Pending |
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Submission Correspondent: On behalf of HealthChek Networks, LLC, the following consultant is assigned the responsibility of submission correspondence: John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922
-
- Trade Name: HealthChek Network Health Station, Model HCK - 2000
- న్. Common Name: Health Kiosk
- Description: Noninvasive blood pressure measurement system (Per FDA classification) 6.
The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.
7. Manufacturing Site: GMI Solutions 10202 North Enterprise Drive Mequon, WI 53092 USA (262) 242-8800 Establishment Registration Number: 2134848
Suggested Classification Regulation, Class & Product Code & Panel (NIBP unit): 8. 21 CFR 870.1130 Class II Product Code: DXN Panel: Cardiovascular
-
- Additional Suggested Classification Regulation, Class & Product Code & Panel (Patient scale): 21 CFR 880.2720 Class I Product Code: FRW Panel: General Hospital & Personal Use
10. Reason for Traditional 510(k): New submission
| 11. Predicate Device(s): | 510(k) Number: | K123539 |
|---|---|---|
| Manufacture: | StayHealthy | |
| Trade Name: | HealthCENTER Biometric Screening Kiosk | |
| Product Code: | DXN (Noninvasive blood pressure measurement system) | |
| HIT (Color vision tester) | ||
| MNW (Impedance plethysmograph) | ||
| Classification: | DXN: 21 CFR 870.1130 |
HealthChek Network Health Station Traditional 510(k) Submission
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Image /page/4/Picture/0 description: The image contains the logo for HealthChek Network. The logo features a blue checkmark inside of a circle on the left side of the image. To the right of the checkmark is the word "HealthChek" in gray and blue lettering, with "Network" in smaller gray lettering below it.
VOLUME 2
SECTION 3
HIT: 21 CFR 886.1170 (510(k) Exempt) MNW: 21 CFR 870.2770 (510(k) Exempt)
-
- Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
Quality System Standards.
- CFR 21CFR820: Part 820 Quality System Regulations ●
- . ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
Safety Standards / Testing Compliance:
- IEC 60601-1:2005 3rd edition General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 3rd edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (with immunity testing to IEC 60601-1-2:2014 4th edition)
- . IEC 80601-2-30:2009 Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
Design Standards
- ISO 14971:2007 Medical devices Application of risk management to medical devices .
- . 47CFR Part 15 Federal Communications Commission (FCC)
- . 2002/95/EC Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS)
- . HIPAA Compliant
-
- Indication for Use
The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
14. Technological Characteristics
The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system is combines the hardware and software platforms of the predicates and as such has it has identical technological characteristics.
-
- Testing
Bench Testing was conducted on a unit with all design options (card reader, printer, etc.) per the requirements of IEC 60601-1 as well as the requirements for blood pressure units (per IEC 60101-2-30). Testing shows that the device is in compliance with the cited standards. Because of the long-established use of health monitoring kiosks, no clinical trial was performed.
- Testing
-
- Comparison to Predicates
The main difference between the proposed device and its predicate pertains to the physiological parameters that are measured. Both devices measure blood pressure and heart rate (using the same module supplied by Suntech), and both measure weight. However, the proposed device measures Body Mass Index (BMI) using the measured weight and a height value that the user manually enters. The predicate device instead presents three similar but distinct values, namely the Percent lean body mass, the Percent body fat and the Percent total body water. In addition, the predicate device tests for color blinded and has an option to present hydration. Of all of these parameters, Blood Pressure is regulated as a Class II device subject to 510(k) market clearance and the differences the alternative measured parameters in do not affect the relative safety and/or effectiveness. For additional information see Table 1.
- Comparison to Predicates
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Image /page/5/Picture/0 description: The image shows the logo for HealthChek Network. The logo features a blue checkmark symbol on the left, followed by the text "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in a smaller, lighter gray font. The logo is simple and professional, conveying a sense of trust and reliability.
VOLUME 2
SECTION 3
-
- Conclusions
HealthChek believes proposed HealthChek Network Model HCK-2000 and its predicate, the StayHealthCENTER Biometric Screening Kiosk System, are substantially equivalent in their intended use, intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics and safety standards. The main difference that exists between the devices, relating to the measured physiological parameters do not affect the relative safety and/or effectiveness or the intended use/indication for use of the device
- Conclusions
Table 1: Substantial Equivalence Comparison
| | HealthChek Network
Model HCK - 2000
(Health Station System Under Review) | StayHealthy
HealthCENTER Biometric Screening
Kiosk (Cleared under K123539) | Substantial Equivalence
Comments |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | COMPARISON OF USES/INDICATIONS | |
| Intended Use /
Indication for
Use | The HCK - 2000 (health station) is an automated
system intended to be used by the general adult
public, in public environments, so that the user can
measure his/her own health parameters such as
blood pressure, heart rate, Body Mass Index (BMI)
and body weight. It is not a diagnostic device and
only furnishes data so that users can consult their
personal physicians or other healthcare professional.
For personal reference purposes, the user can also
choose to print or store their data on the HealthChek
network's database. | The Stayhealthy SH-650 is intended to be used
by the general public so that the user can measure
his/her own blood pressure, heart rate, percent
lean body mass, percent body fat, percent total
body water, body weight, and if the user may
have color blindness. It is not a diagnostic device
and only furnishes data so that users can consult
their personal physicians or other healthcare
professional. The user can also choose to print the
data or send the data to a personal physician or a
healthcare professional. | Both devices are for use by the
general public to monitor general
health parameters. Although the
devices measure different parameters,
neither device nor any of the
measured parameters are used for
diagnostic purposes. In addition, the
proposed device does not allow the
user to transmit their data to a
healthcare professional. Instead the
data is automatically stored on the
HealthChek's database and is made
available to the user for their
reference. This is a marketing feature
and does not affect the safety of the
user.
Therefore, Substantially Equivalent |
| Intended User | General Public | General Public | Both devices have identical intended
users.
Therefore, Substantially Equivalent |
| Intended Use
Environment | General Public Environments | From Website: Business, Government, Home,
Research, Health Clubs, Hospitality, Housing
Care Facilities, Schools, Retail | Both devices have similar intended
use environments.
Therefore, Substantially Equivalent |
| Target Patient
Population | General Public | General Public | Both devices have identical targeted
patient populations.
Therefore, Substantially Equivalent |
| Contraindicati
ons | None | None Stated | Both devices have no, or no known
contraindications.
Therefore, Substantially Equivalent. |
| Warnings | As it appears on the mandrel: WARNING This
cuff is not designed for very large arms. Your arm
should fit comfortably with your palm on the arm
rest. DO NOT FORCE YOUR ARM INTO THE
CUFF, AS DISCOMFORT OR INJURY MAY
OCCUR. TO RELEASE PRESS THE RED STOP
BUTTON
As it appears in the manual:
Warning, this machine may bruise you, and you
may faint while using it. Do not use it if you are
sensitive to pressure on your arm, or have
experienced fainting or dizziness. If the pressure on
your arm bothers you, or if unexpected readings are
obtained, immediately touch the 'STOP' button to
deflate the cuff. | Warning This cuff is not designed for very large
arms. DO NOT FORCE YOUR ARM INTO
THE CUFF, TEMPORARY DISCOMFORT OR
INJURY MAY OCCUR. Your arm should fit
comfortably, with your elbow and forearm on the
arm rest. TO RELEASE, PRESS THE STOP
BUTTON. | Because both devices use the same
blood pressure cuff mandrel, they
have identical warnings on it. The
predicate device manual does not
contain any cautions, warnings or
other use restrictions while the
proposed device does, including a
description of the circumferences that
the NIBP module and cuff were
designed to operate under. These
additional warnings can help aid
patient safety.
The manual of the proposed device
includes a section on Warnings,
Safety precautions and Restriction on
use. The predicate device does not.
The inclusion of a restriction for use
on neonatal, pregnant and pre- |
| Feature | HealthChek Network
Model HCK - 2000
(Health Station System Under Review) | StayHealthy
HealthCENTER Biometric Screening
Kiosk (Cleared under K123539) | Substantial Equivalence
Comments |
| Use
limitations
FDA Product
Code | administrator. If you are concerned about your
blood pressure, please discuss with a medical
professional
Warnings, Safety Precautions and Restrictions
on Use
WARNING, the blood pressure measurement is not
intended for use on neonatal, pregnant, or pre-
eclamptic patients.
When taking blood pressure. The recommended
position is comfortably seated, relaxed, legs
uncrossed, feet flat on the floor, middle of cuff at
level of heart right atrium. It is recommended that 5
minutes should elapse before the first reading is
taken. Any reading can be affected by the
measurement site, the position of the patient,
exercise, the patient's physiologic condition,
common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, arterial
sclerosis, poor perfusion, diabetes, age, pregnancy,
pre-eclampsia, renal diseases, patient motion,
trembling or shivering. Readings can also be
affected by extremes in temperature, humidity, and
altitude. If unexpected readings are obtained,
contact your physician immediately
As it appears in the manual and onscreen:
WARNING, the circumference of user's arm should
be within 24-38cm (9.5 to 15 inches) for best results
It is not a diagnostic device and only furnishes data
so that users can consult their personal physicians or
other healthcare professional.
DXN (Noninvasive blood pressure measurement
system)
FRW (Weight) | It is not a diagnostic device and only furnishes
data so that users can consult their personal
physicians or other healthcare professional
• DXN (Noninvasive blood pressure
measurement system)
• HIT (Color vision tester)
• MNW (Impedance plethysmograph) | eclamptic patients is in compliance
with IEC 80601-2-30 clause
201.7.9.2.1 2. These additional
restrictions on use can help aid patient
safety
Therefore, Substantially Equivalent
Both devices have identical use
limitations.
Therefore, Substantially Equivalent
Both devices use the same FDA
product code for the regulated aspect
of blood pressure measuring. The
predicate device did not list product
code FRW even though it measures
weight; their omission does not have
an impact on the substantial
equivalence determination. The
predicate device includes alternative
features and therefore cites additional
FDA product codes. However, the
additional features do not substantially
deviate from either device's intended
use as a general health and well-being
monitoring system and do not raise
any concerns for safety and
effectiveness.
Therefore, Substantially Equivalent |
| Measured
Physiological
Parameters –
From 510(k) | Blood pressure, BP (uses the SunTech Advantage
Model 2 module, containing the ct3.39.0
firmware and equipped with the SunTech Kiosk
Cuff (part # 98-0231-00-AD. REV B); capable of
recording blood pressures from +40 to +260 mm
Hg Systolic and +20 to +200 mmHg Diastolic
• Heart rate (calculated via the BP module) capable
of recording rates from 30 to 220 beats per minute
• BMI (Body Mass Index) (via a calculated value
using the NIH's algorithms using a height value | • Blood pressure, BP (uses the SunTech
Advantage Model 2 module, containing the
ct3.39.0 firmware and equipped with the
SunTech Kiosk Cuff (part # 98-0231-00-AD.
REV B); capable of recording blood pressures
from +40 to +260 mm Hg Systolic and +20 to
+200 mm Hg Diastolic
• Heart rate (calculated via the BP module)
capable of recording rates from 30 to 220 beats
per minute | Both devices measure blood pressure
and heart rate using the same third
party blood pressure module. Both
devices measure weight using a load
cell. The proposed device measure BMI
while the predicate device measures
percent lean & fat mass. The
predicate device also tests for color
blindness which the proposed device
does not do. However, these features
do not substantially change the overall |
| | HealthChek Network Health Station
Traditional 510(k) Submission | 005_VOL_002_003_Traditional 510(k) Summary - REVISED.docx
Confidential | Page 002/003-4 |
| | HealthChek Network
Model HCK - 2000
(Health Station System Under Review) | StayHealthy
HealthCENTER Biometric Screening
Kiosk (Cleared under K123539) | Substantial Equivalence
Comments |
| Feature | entered by the user) No indicated range as this is
a function of height and weight
• Body weight, (tested at 440 lbs / 200 kg) (as
measured via a load cell imbedded in an ADA
compliant seat) | • Percent lean body mass (via bioimpedance)
• Percent body fat (via bioimpedance)
• Percent total body water (via bioimpedance)
• Body weight, (up to 500 pounds / 227 kg) (via
a load cell imbedded in an ADA compliant
seat)
• If the user may have color blindness | design intention of the device and the
differences in parameters can be
considered to be "marketing" features |
| Additional /
Alternative
Measured
Physiological
Parameters –
From Website | None | • Hydration-The Stayhealthy Hydration Index
(SHI), which calculates on an individual basis,
your specific hydration status based on broad
population averages and studies.
• On the graph showing your hydration results is
a line marked with zero. This represents the
threshold for acceptable hydration, and should
be considered the minimum level of hydration
your body needs. A measurement above zero is
desirable.
• Each person's zero point is calculated by
determining the hydration of their lean mass
(everything except fat), plus the water
contained in their body fat. Just as physical
makeup varies from person to person, so does
the zero point | The predicate device offers the
measurement of "hydration" as an
additional/alternative physiological
parameter. However, this feature does
not substantially change the overall
design intention of the device and can
be considered to be a "marketing"
feature.
Therefore, Substantially Equivalent |
| Device
Options | • Printer for results
• Barcode scanner (2D)
• Data Ports for Personal Health Devices:-USB:
Used for pedometer download.,
• Ethernet Connection: Ability to connect to the
HealthChek database though built-in Ethernet port | • Printer for results / incentives / coupons
• Barcode scanner (2D)
• Personal health device upload ports: IR, USB
mini, micro, Type A (Download stations for
Omron Pedometers and for blood glucose
meters)
• 32-inch LCD HD display screen (for
Advertising, Information and Store messaging)
• Wi-Fi or cellular connectivity
• Loyalty Card reader - so customer can access
an online account | In regards to device options, the
predicate device allows for the use of
a 32" LCD screen which is used for
advertising purposes as well as the use
of a "loyalty card" which is also a
brand-identification feature that does
not change the overall indication for
use.
The proposed device does not include
WiFi or cellular connectivity, but does
include an Ethernet connection that is
used to store patient-data. Unlike the
predicate wherein their WiFi / cellular
connection is used to transmit data to
the personal physician. Allowing the
user to conveniently store and retrieve
their data is a marketing feature and
does not affect patient safety.
Therefore, Substantially Equivalent |
| | | COMPARISON OF ERGONOMICS/HUMAN FACTORS | |
| | | | |
| User Input
Mechanism | Touch screen interface | 17 inch LCD touch screen user navigationBP
"Express" feature | Both devices use a touch screen; the
size of the screen is immaterial.
Therefore, Substantially Equivalent |
| Data Output /
Display
Mechanisms | • On-Screen Display
• Built-in 200 dpi Printer | • On-Screen Display
• Built-in Laser Printer
• Loyalty Card reader – so customer can access
an online account | Both devices have on-screen displays
and the ability to print out the data.
The type of printer and the ability to
access the user's information via a
"loyalty card" is immaterial.
Therefore, Substantially Equivalent |
| Data Storage | No data is saved directly on the kiosk. All data is
stored remotely. | No data is saved directly on the kiosk. All data is
stored remotely | Neither device stores personal data on
the kiosk itself although the proposed
device is not designed to forward the
information on to a personal health
care practitioner.
Therefore, Substantially Equivalent |
| COMPARISON OF PATIENT CONTACT MECHANISMS & MATERIALS | | | |
| Patient
Contact/Interf | Blood pressure cuff is in compliance with ISO
10993 | Blood pressure cuff is in compliance with ISO
10993 | Both devices are in compliance with
the same standard. |
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Image /page/6/Picture/0 description: The image is a logo for HealthChek Network. The logo consists of a blue circle with a white checkmark inside, followed by the words "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray.
VOLUME 2
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Image /page/7/Picture/0 description: The image contains the logo for HealthChek Network. The logo features a blue checkmark symbol on the left, followed by the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in a smaller, gray font.
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005 VOL 002 003 Traditional 510(k) Summary - REVISED.docx Confidential Page 002/003-5
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Image /page/8/Picture/0 description: The image contains the logo for HealthChek Network. The logo consists of a blue checkmark inside of a circle on the left. To the right of the checkmark is the word "HealthChek" in gray and blue. Below "HealthChek" is the word "Network" in gray.
VOLUME 2
SECTION 3
| HealthChek Network | StayHealthy | ||
|---|---|---|---|
| Model HCK - 2000 | HealthCENTER Biometric Screening | Substantial Equivalence | |
| Feature | (Health Station System Under Review) | Kiosk (Cleared under K123539) | Comments |
| ace Materials | Therefore, Substantially Equivalent | ||
| COMPARISON OF POWER REQUIREMENTS / COMPUTER INTERFACE | |||
| Operating | |||
| System | Windows Seven | Windows seven (embedded) | Both devices operate on the same |
| Windows platform. The issue of | |||
| "embeddedness" is immaterial. | |||
| Therefore, Substantially Equivalent | |||
| User Input | |||
| Mechanism | Touch screen interface | Touch screen user navigationBP "Express" | |
| feature | Both devices use a touch screen for | ||
| ser input. | |||
| Therefore, Substantially Equivalent | |||
| Power Source | Single phase 110/220 VAC, 2A 50 or 60 Hz | 120V, 60Hz, 2.0A | Both devices can operate on standard |
| USA power inputs. | |||
| Therefore, Substantially Equivalent | |||
| COMPARISON OF DIMENSIONAL SPECIFICATIONS | |||
| Dimensions | 32" W x 27.5 " L x 62" H | 27.5" W x 39.6" L x 44.2" H (80" H with | |
| optional LCD display) | Both devices have similar dimensions | ||
| suitable for use as a public-accessible | |||
| heath kiosk. | |||
| Therefore, Substantially Equivalent | |||
| Weight | 230 lbs | 200 lbs / 90 KG | Both devices have similar weights that |
| are needed to create a public- | |||
| accessible heath kiosk. | |||
| Therefore, Substantially Equivalent | |||
| COMPARISON OF ENVIRONMENT SPECIFICATIONS | |||
| Operating | |||
| Environment | |||
| (overall | |||
| system) | 15° C to +50° C | ||
| 15 to 95% (Non-Condensing) | 41 - 95 °F (5 to 35 °C) | ||
| 10 - 80% (non-condensing) | Both devices are designed to operate | ||
| in similar "office-based" | |||
| environments. | |||
| Therefore, Substantially Equivalent | |||
| Storage | |||
| Environment | -20° C to +50° C | ||
| 10 to 90% (Non-Condensing) | Not specified | While not stated/known for the | |
| predicate, it is reasonable to assume | |||
| that both devices have similar storage | |||
| conditions. | |||
| Therefore, Substantially Equivalent | |||
| COMPARISON OF APPLICABLE STANDARDS | |||
| Quality | |||
| System | |||
| Standards | |||
| Compliance | • CFR 21CFR820: Part 820 - Quality System | ||
| Regulations | |||
| • ISO 13485:2003 Medical devices - Quality | |||
| management systems - Requirements for | |||
| regulatory purposes | FDA-cleared class II medical devices | Both devices claim compliance with | |
| similar quality system standards. | |||
| Therefore, Substantially Equivalent | |||
| Safety | |||
| Standards / | |||
| Testing | |||
| Compliance | |||
| (3rd party | |||
| testing | |||
| conducted) | • IEC 60601-1:2005 3rd edition General | ||
| requirements for basic safety and essential | |||
| performance | |||
| • IEC 60601-1-2:2007 Medical electrical | |||
| equipment - Part 1-2: General requirements for | |||
| basic safety and essential performance - | |||
| Collateral Standard: Electromagnetic | |||
| disturbances - Requirements and tests (with | |||
| immunity testing to 60601-1-2:2014) | |||
| • IEC 80601-2-30:2000 Particular requirements for | |||
| basic safety and essential performance of | |||
| automated non-invasive sphygmomanometers | |||
| • AAMI/ANSI/ISO 81060-1:2013 Non-invasive | |||
| sphygmomanometers - Part 2: Clinical investigation | |||
| of automated measurement type (via OEM) | • UL/IEC 60601-1/2 certified | ||
| • CAN/CSA-C22.2 certified | |||
| • ISO 81060-1:2002 compliant blood pressure | |||
| device (via OEM) | Both devices claim compliance with | ||
| similar safety standards. | |||
| Therefore, Substantially Equivalent | |||
| Design | |||
| Standards | |||
| Compliance | |||
| (Used | |||
| internally | |||
| during the | |||
| design | |||
| process) | • ISO 14971:2007 Medical devices - Application | ||
| of risk management to medical devices | |||
| • 47CFR Part 15 Federal Communications | |||
| Commission (FCC) | |||
| • 2002/95/EC Restriction of the Use of Certain | |||
| Hazardous Substances in Electrical and | |||
| Electronic Equipment (RoHS) | |||
| • HIPAA compliant | • American Disabilities Act (ADA) compliant | ||
| • HIPAA compliant | |||
| • RoHS compliant | Both devices claim compliance with | ||
| similar design standards. | |||
| Therefore, Substantially Equivalent |