(299 days)
KOREBALANCE TM, K070676
No
The summary describes "Motion Intelligence developed algorithms" for analyzing sway data, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The performance studies focus on correlation and equivalence with a predicate device, not on training or validation of an AI/ML model.
No
The device is intended to assess balance, not to provide therapy or treatment.
Yes
The device "analyzes balance through measurements of postural sway," and provides reports for "clinician's review" indicating changes in balance scores. It is "intended for use to assess sway as an indicator of balance," which directly aligns with the definition of a diagnostic device (assessing a physiological state).
No
The device description explicitly states that the system is comprised of application software and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad.
Based on the provided information, the ClearEdge® Balance System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ClearEdge® Balance System assesses balance by measuring postural sway using external sensors and software. It does not analyze blood, urine, tissue, or any other biological sample.
- The intended use is to assess balance as an indicator of sway. This is a functional assessment of a physiological state, not a diagnostic test performed on a biological sample.
- The device description focuses on software analysis of sensor data. It describes a system comprised of software, a mobile device, a sensor, and pads, all used to measure and analyze physical movement.
Therefore, the ClearEdge® Balance System falls outside the definition of an In Vitro Diagnostic device. It is a medical device used for functional assessment.
N/A
Intended Use / Indications for Use
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
Product codes (comma separated list FDA assigned to the subject device)
LXV
Device Description
The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor.
Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Located at a person's center of mass, midline at approximately L5.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Certified athletic trainers, physical therapists, chiropractors, nurses and physicians.
The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
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
Supplemental human performance testing summary:
Supplemental human performance testing consisted of using Sway and CE Balance simultaneously to generate balance scores on 34 subjects who were tested on the five Sway balance stances. 29 subjects were healthy and 5 had some neurologic condition.
The balance scores generated by Sway and ClearEdge on all five Svar stances were combined for comparison.
MDC Development:
144 subjects were tested on two occasions separated by short periods of time (most time intervals between the two test were less than 50 days). 109 subjects were healthy and 35 had time study only if the study only if they had no injury or change in symptoms between the two tests.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Laboratory Testing and supplemental human performance testing.
Sample Size:
Laboratory Testing: Not Applicable (inverted pendulum)
Supplemental human performance testing: 34 subjects
MDC Development: 144 subjects
Key Results:
Laboratory Testing Summary:
Correlation of ClearEdge Balance and Sway Balance scores were evaluated using regression. Linear regression: r values for all tests were greater than 97, and the slopes of the liners regression in the tests ranged between 92 and 1.05 (p
N/A
0
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October 22, 2019
Quadrant Biosciences Bryan Greene Vice President - Operations 505 Irving Avenue Syracuse, New York 13210
Re: K183661
Trade/Device Name: ClearEdge Balance System Regulation Number: 21 CFR Regulation Name: N/A Regulatory Class: Class II Product Code: LXV Dated: September 20, 2019 Received: September 23, 2019
Dear Bryan Greene:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Vasant Dasika Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183661
Device Name ClearEdge® Balance System
Indications for Use (Describe)
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
-
- Date Summary Prepared: 21 October 2019
-
- Submitter: Quadrant Biosciences dba Motion Intelligence, Inc. 505 Irving Avenue, Suite 3100AB Syracuse, NY 13210 Contact: Bryan Greene Ph: 315-614-2325 ext 1001
- ClearEdge Balance System 3. Trade Name:
-
- Common Name: Recorder, Attention Task Performance
- న్. Device Description: The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor.
Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.
6. Indication for Use:
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
| 7. | Classification: | Regulation: | Unclassified |
|---|---|---|---|
| Class II | 510(k) | ||
| Product Code: | LXV | ||
| Classification | Unclassified | ||
| Panel: | Ear Nose & Throat | ||
| 8. | Predicate Device(s): | 510(k) Number: | K121590 |
| Manufacturer: | Capacity Sports, LLC | ||
| Trade Name: | Sway™ Balance System | ||
| Product Code: | LXV | ||
| Classification: | Unclassified |
9. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
Technical / Product-Related Standards:
4
- IEC 60601-1:2012 Ed 3.1 General requirements for basic safety and essential performance, FDA#19-5 ●
- IEC 60601-1-2:2014 Ed 4 Medical electrical equipment Part 1-2: General requirements for basic safety ● and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, FDA #19-8
- . IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability, FDA #5-89
- . IEC 60601-1-11 Issued: 2015/01/20 Ed. 2 Medical Elec. Equip.- Part 1-11: Gen. Req. for Basic Safety & Essential Performance - Collateral Standard - Req. for Medical Elec. Equip. & Medical Elec. Systems Used in the Home Healthcare Environment, FDA #19-14
- IEC 60529:2013 Degrees Of Protection Provided By Enclosures (IP Code), FDA #None
- . 47CFR Part 15 Federal Communications Commission (FCC), FDA #None
- . ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirement, FDA #5-90
Quality System, Risk Management & Process-Related Standards:
- 21CFR820: Part 820 Quality System Regulations, FDA #None ●
- IEC 62366 Issued: 2014/01/28 Ed. 1.1 Medical Devices Application of Usability Engineering to . Medical Devices, FDA #5-87
- . IEC 62304:2006 Medical device software - Software life cycle processes, FDA #13-8
- ISO 14971:2012 Medical devices Application of risk management to medical devices, FDA #5-40 .
- . HIPAA Compliant, FDA #None
10. Technological Characteristics
The main differences between Motion Intelligence, Inc.'s ClearEdge Balance System, Model 1055, and the Predicate Devices the Sway Balance System cleared under K121590 are the following:
- The ClearEdge Balance® System measures postural sway with a proprietary sensor located at a person's ● center of mass, midline at approximately L5, while the Sway Balance system measure postural thoracic sway, using the built-in motion sensors of any iOS device.
- . The Sway Balance System is a mobile application that must be downloaded and run on an iOS mobile device that is supplied by the end user. The ClearEdge Balance System provides The Edge Sensor, friction pad, and balance pad to the end user and requires a mobile application that must be downloaded and run on an COTS Android device.
- . ClearEdge Balance System provides the Edge Sensor to measure the patient's balance. Sway Balance System relies on the accelerometer provided in iOS mobile operating devices.
- . ClearEdge Balance System and Sway Balance System use different methods in comparing the results on a series of balance stances. According to the predicate's public clearance records, Sway provides a comparison of raw scores on each balance stance and a comparison of test score against patients' average score. ClearEdge Balance provides a comparison of raw scores on each balance stance, and a comparison of raw scores on each balance stance overlaid with threshold lines representing the Minimal Detectible Change (MDC) for that test.
Other minor differences between ClearEdge Balance System and the Sway Balance System predicate also include:
- The ClearEdge Balance System provides the user with some of the hardware that is needed to use the system ●
- ClearEdge Balance System uses the Android operating system; Sway Balance System uses Apple's iOS
- ClearEdge Balance System uses a tablet; Sway Balance System uses smartphones or tablets.
- . The ClearEdge Sensor is powered by 3 AAA batteries, and the Sway Balance System uses the iPhone's lithium ion battery
11. Comparison Table
5
| Feature | ClearEdge Balance System
Model 1055
(System Under Review) | Sway™ Balance System
(Cleared under K121590) | Comments | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA
Regulation,
Number,
Product Code
& Description | Unclassified, LXV, Apparatus, Vestibular Analysis | Unclassified, LXV, Apparatus, Vestibular Analysis | Same. | |
| Intended Use | The ClearEdge® Balance System is a mobile software
system that analyzes balance through postural sway. The
System is comprised of application software and
accessory hardware, consisting of a mobile computing
device, proprietary sensor, balance pad, and friction pad.
The System measures the amount of motion of a
subject's center of gravity, while the subject attempts to
maintain various body posture stances, and translates the
amount of motion into a numeric score. | The Sway™ Balance System is a mobile measurement
system that analyzes balance through thoracic sway,
using the built in accelerometer of a mobile device. The
Sway Balance System is a stand-alone mobile operating
system software application that does not include any
peripheral hardware add-ons. | Both devices are mobile measurement systems that
analyzes balance through either postural (proposed) or
thoracic (predicate) sway. Both devices measure the
amount of motion of a subject while maintaining a body
posture stance and translate the amount of motion into a
score that represents balance. The difference in
measuring the type of sway is a function of where the
sensor/accelerometer is physically located. The subject
device places the sensor on the subject's lower back,
while the predicate device is held against the chest. The
subject device uses a proprietary sensor with a built-in
accelerometer while the predicate device uses the iPhone's
accelerometer. Neither of these issues raise new questions
of safety of effectiveness. | |
| Indication for
Use | The ClearEdge® Balance System is intended for use to
assess sway as an indicator of balance. Individual
suitability for assessment must be judged on a case by
case basis, by a qualified individual including those
certified and/or licensed in their state to prescribe and/or
use balance devices such as certified athletic trainers.
physical therapists, chiropractors, nurses and physicians.
The ClearEdge® Balance System can be used wherever
compatible Android mobile operating devices can be
used. | The Sway™ Balance System is intended for use to assess
sway as an indicator of balance. Individual suitability for
assessment must be judged on a case by case basis, by a
qualified individual including those certified and/or
licensed in their state to prescribe and/or use balance
devices such as certified athletic trainers and coaches,
physical therapists, nurses and physicians. Conditions
affecting postural sway include nausea, headache,
orthopedic injury, ear infection, medications, head injury,
dehydration and fatigue. The Sway™™ Balance System
can be used wherever an iOS mobile operating device is
available. | Both devices measure acceleration and motion and
convert the measurements into a numeric balance score
between 0 and 100, and both devices have the same
intended users and use environments. | |
| Intended User | Certified athletic trainers, physical therapists, nurses,
chiropractors, and physicians who are licensed to
prescribe and/or use balance devices. | Certified athletic trainers and coaches, physical
therapists, nurses and physicians who are licensed to
prescribe and/or use balance devices. | Same intended users. | |
| Intended Use
Environment | Anywhere mobile devices can be utilized | Wherever an iOS mobile operating device is available | Both devices use mobile platforms. | |
| Target Patient
Population | Athletes. Patients with balance issues | Athletes. Patients with balance issues | Same targeted patient populations. | |
| Contraindicati
ons | Contraindications:
Improper Testing
Unstable Surfaces
Wet or Slippery Surfaces
Cluttered Environments | Contraindications:
Improper Testing
Unstable Surfaces
Wet or Slippery Surfaces
Cluttered Environments | Same contraindications. | |
| Feature | ClearEdge Balance System
Model 1055
(System Under Review) | Sway™ Balance System
(Cleared under K121590) | Comments | |
| Use
limitations | Improper environment may lead to inaccurate results or
cause harm to the patient
A patient with an injury should not be tested, but instead
given medical attention
Individual suitability for assessment must be judged on a
case by case basis, by a qualified individual including
those certified and/or licensed in their state to prescribe
and/or use balance devices | Improper environment may lead to inaccurate results or
cause harm to the patient
A patient with an injury should not be tested, but instead
given medical attention
Individual suitability for assessment must be judged on a
case by case basis, by a qualified individual including
those certified and/or licensed in their state to prescribe
and/or use balance devices | Identical use limitations. | |
| System-Level
Components | The ClearEdge® Balance System is a mobile
measurement system that analyzes balance through
postural sway. As shipped, the ClearEdge Balance
System includes: the Edge Sensor- a proprietary sensor, a
Friction Pad, a Balance Pad, and a Carrying Case.
The user must download the software onto an approved
tablet | The Sway Balance System is a software solution that
utilizes the hardware of the Apple iOS mobile operating
system for products such as the iPhone 3G, 3G5, 4, 4S,
iPad, iPad2 and iPod Touch. The built in accelerometer
of these devices is accessed to analyze motion during a
balance test. | Fundamentally, both systems are software programs that
require the user to provide the operating platform. Both
have the same/equivalent components and offering some
of the needed hardware components as part of the system
does not raise and new questions of safety or
effectiveness. | |
| Additional
Required
Components | The ClearEdge® Balance System requires the user to
provide a tested and approved Android tablet, a stylet
(for data input) and headphones (for use with the tablet) | Sway Balance System requires the user to provide an
Apple iOS mobile device | The ClearEdge Balance System requires the user to
download the software onto an Android tablet, a mobile
device, while the Sway balance system requires the user
to download the software onto an iPhone, also a mobile
device. | |
| Testing
Methods | The ClearEdge Balance System tests for balance by
utilizing the Edge Sensor to measure acceleration and
motion. The Edge Sensor is attached to a subject with a
belt, located over the lower back, which is near the
anatomical center of mass. | Using the built-in motion sensors of any iPhone, iPad or
iPod Touch* device and Sway's mobile application,
health professionals can administer a medical grade
objective balance test in virtually any setting. | Both devices measure balance using an accelerometer
which is then displayed on a mobile device. The
differences in accelerometers (proprietary versus iPhone)
and platform (Android versus iOS) does not raise new
questions of safety or effectiveness. | |
| Testing
Protocol | The ClearEdge Balance System tests eight difference
balance stances, while measuring postural sway with a
proprietary sensor located at a person's center of mass,
midline at approximately L5. The stances include a
combination of feet together stance, tandem stance, eyes
open, eyes closed, on a firm surface, and on the balance
pad provided in the system. | To administer a test, an athlete or patient is instructed to
press the mobile device against their chest with both
hands, while performing a five-test protocol that includes
a combination of bipedal (feet together) stance, tandem
stance and single leg stance positions. Sway measures
thoracic postural sway using the built-in motion sensors
of any iOS device to estimate balance. | Both testing protocols are based on balance stances.
Although there are slight variations in implementation,
the basis of the stances for each device is fundamentally
similar. Both devices measure sway via accelerometers.
The Edge Sensor is placed at a person's center of mass to
measure postural sway and Sway Balance places an iOS
device at a person's chest to measure thoracic postural
sway. The differences do not raise any new questions of
safety or effectiveness. | |
| Scoring/Resul
ts | The ClearEdge Balance System recommends each
individual complete a baseline test for post event
comparison since individual balance will vary person to
person.
For each of the balance stances, the Edge Sensor
measures the patient's postural sway using an
accelerometer at 250 packets/second. For each test, the
patient's relative motion is converted to a balance score | The Sway score is intended to provide an individualized
baseline of each athlete or patient's own ability to
maintain postural control during the testing conditions.
Balance scores vary for each individual and should be
compared to each individual's "normal" baseline.
Sway Balance reports balance scores on 0 to 100 scale
for each individual tests. A composite score is reported, | Both devices recommend each individual complete a
baseline test since postural balance will vary for each
individual. Both systems report the balance result on a 0-
100 scale, reporting the scores for each individual tests,
as well as a composite average score.
Both devices use known statistical methods to evaluate
the balance scores that they compute in a similar manner.
These methods of statistical analysis are well known and | |
| | ClearEdge Balance System
Model 1055
(System Under Review) | Sway™ Balance System
(Cleared under K121590) | Comments | |
| Feature | on a 0 to 100 scale with a higher number representing
less motion and a lower number representing more
motion.
ClearEdge Balance is used to track changes in balance
scores over time. Comparisons between the Reference
Test and each Comparison Test are based on a
determination of whether the difference between the
Reference Test scores and Comparison Test scores
(Difference Scores) are large enough to represent
difference in performance. A Minimum Detectable
Change (MDC) is used to determine the threshold size of
a Difference Score that must be present to be deemed
significant at a prescribed statistical confidence level. | which is calculated by averaging the patient's individual
scores for each of the five balance tests. | the differences in analytic comparison of balance scores
do not raise any questions of safety or effectiveness.
Reference Device KOREBALANCE TM, K070676, for
monitoring over time, "Quantitative measurement of
patient balance performance while the patient executes a
preprogramed set of maneuvers or protocols... The
patient results are scored and saved (the information is
not a clinical measurement but provides a reproducible
quantitative measurement that the therapist can use to
plan and monitor therapy)...in conjunction with the
therapist's observations, to assess patient progress over
the course of multiple...sessions." | |
| Power Source | Edge Sensor requires 3 AAA batteries
The mobile device operates on lithium ion rechargeable
battery | Mobile device operates on lithium ion rechargeable
battery | Both devices operate on battery power. The type of
battery (AAA versus lithium ion) does not raise any new
questions of safety or effectiveness. | |
| Device Type | Sensor with accelerometer | iOS mobile device with accelerometer | Nearly identical outputs and performance, other than | |
| Measurement | Kinetic energy/balance | Kinetic energy/balance | marketing approaches that do not raise any questions of
safety or effectiveness. | |
| Delivery
System | Results shown on mobile device or other web capable
device | Results shown on mobile device or other web capable
device | | |
| Patient
Contact/Interf
ace Materials | Mobile device, Edge Sensor | Mobile device | Nearly identical patient contact/interface methods.
Including a separate motion sensor is done for improved
user experience. Doing so raises no new questions of
safety (no new biocompatibility issues) or effectiveness. | |
| Hardware
Specifications | Tablet | Hardware of the Apple iOS mobile operating system for
products such as the iPhone 3G, 3G5, 4, 4S, iPad, iPad2
and iPod Touch. | Nearly identical hardware specifications. | |
| Mobile
Operating
System | Android | iOS | Mobile operating systems are similar and the differences
between Android and iOS in this application do not raise
any questions of safety or effectiveness. | |
| User Input
Mechanism | Stylus | Unknown | Similar User Input Mechanisms. | |
| Display | Tablet | iPhone 3G, 3G5, 4, 4S, iPad, iPad2 and iPod Touch. | Nearly identical display. | |
| Dimensions | Case dimensions: 4 3/4" h x 16 1/2"w x 20 7/8"l | Software only (the hardware is provided by the iPhone,
but was excluded from consideration in their 510(k)
application) | ClearEdge has provided some hardware components
needed for ease of the customers and marketing
purposes. There are no questions of safety to the patient | |
| Weight | Under 15 lbs. | N/A (the hardware is provided by the iPhone, but was
excluded from consideration in their 510(k) application) | ClearEdge has provided some hardware components
needed for ease of the customers and marketing
purposes. There are no questions of safety to the patient | |
| | ClearEdge Balance System
Model 1055
(System Under Review) | | Sway™ Balance System
(Cleared under K121590) | Comments |
| Feature | Operating
Environment | Normal environment where the temperature and
humidity are maintained for normal human comfort. | Information not available, but assumed to be normal
environment where the temperature and humidity are
maintained for normal human comfort. | Within reasonable assumptions, the operating
environments are the same. |
| | Storage
Environment | Store in a dry location between 0°C / 32°F and 45°C /
113°F. Do not store items in direct sunlight.
All items should be stored in their designated space in
the ClearEdge Balance System storage case | Software only, no storage required (the hardware is
provided by the iPhone, but was excluded from
consideration in their 510(k) application) | ClearEdge has provided some hardware components
needed for ease of the customers and marketing
purposes. There are no questions of safety to the patient. |
| | | | | |
| | Standards | Technical / Product-Related Standards:
• IEC 60601-1:2012 Ed 3.1 General requirements for
basic safety and essential performance
• IEC 60601-1-2:2014 Ed 4 Medical electrical
equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical
Electrical Equipment - Part 1-6: General Requirements
for Basic Safety and Essential Performance -
Collateral Standard: Usability
• IEC 60601-1-11 Issued: 2015/01/20 Ed. 2 Medical
Elec. Equip.- Part 1-11: Gen. Req. for Basic Safety &
Essential Performance - Collateral Standard - Req. for
Medical Elec. Equip. & Medical Elec. Systems Used
in the Home Healthcare Environment
• IEC 60529:2013 Degrees Of Protection Provided By
Enclosures (IP Code), FDA #None
• 47CFR Part 15 Federal Communications Commission
(FCC)
• ISO 15223-1:2012 Medical devices - Symbols to be
used with medical device labels, labelling and
information to be supplied - Part 1: General
requirement
Quality System, Risk Management & Process-Related
Standards: | The Sway Balance™ System is a software only solution
that utilizes the hardware of the Apple iOS mobile
operating system for products such as the iPhone 3G,
3G5, 4, 4S, iPad, iPad2 and iPod Touch. The built in
accelerometer is accessed to analyze motion during a
balance test.
Note: With the above in mind, it is assumed that Sway
Balance did NOT consider the iPhone be a medical
device (even though the their SW platform is completely
dependent on the iPhone's accelerometer) and did not
conduct any electrical safety / EMI testing. | The proposed device was designed and testing according
to the applicable standards, importantly including testing
to IEC 60601-1-2, 4th edition for EMC compatibility in a
"home use" environment. The predicate devices did not.
However, ensuring compliance does not raise questions
of safety. |
| Feature | ClearEdge Balance System
Model 1055
(System Under Review) | Sway™ Balance System
(Cleared under K121590) | Comments | |
| | • IEC 62366 Issued: 2014/01/28 Ed. 1.1 Medical Devices - Application of Usability Engineering to
Medical Devices
• IEC 62304:2006 Medical device software - Software life cycle processes
• ISO 14971:2012 Medical devices - Application of risk management to medical devices
HIPAA Compliant | | | |
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12. Performance Testing; Laboratory and Human Performance:
Equivalence between ClearEdge Balance assessment of balance was demonstrated by Laboratory Testing and supplemental human performance testing. Laboratory Testing compared Clear Edge Balance scoring of movements of an inverted pendulum. Correlation of ClearEdge Balance and Sway Balance scores were evaluated using regression. Linear regression: r values for all tests were greater than 97, and the slopes of the liners regression in the tests ranged between 92 and 1.05 (p 80%) using a Two One Sided Test Procedure (TOST). The upper end of the 90% onfidence interval for the difference between means of ClearEder scores (Confidence Interval) was less than the upper end of the equivalence margin (r