(319 days)
Not Found
No
The description focuses on data collection and transmission, explicitly stating the device makes "no interpretation, evaluation, medical judgements or recommendations for treatment." There is no mention of AI or ML in the text, and the performance study focuses on the accuracy of the blood pressure measurement algorithm, not an AI/ML component.
No.
The device collects and transmits vital sign data and patient responses to a healthcare professional, but it explicitly states that it "makes no interpretation, evaluation, medical judgements or recommendations for treatment" and is "not intended as a substitute for medical care." It is a monitoring and communication tool, not one that directly treats or provides therapy.
No
Explanation: The device collects and transmits vital signs and health information, but explicitly states it "makes no interpretation, evaluation, medical judgments or recommendations for treatment." It requires clinical judgment and experience to interpret the information, indicating it is not a diagnostic device itself.
No
The device description explicitly states that the Commander Flex devices have a "built-in non-invasive blood pressure measurement system" and "inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff," indicating it includes hardware components beyond just software.
Based on the provided information, the Commander Flex is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Commander Flex Function: The Commander Flex collects and transmits patient vital sign data (like blood pressure, weight, glucose, pulse oximetry) and patient-reported health questions. It does not analyze biological specimens.
- Data Source: The data collected by the Commander Flex comes directly from the patient or connected peripheral devices measuring physiological parameters, not from laboratory analysis of biological samples.
Therefore, the Commander Flex falls under the category of a home health monitoring device that collects and transmits physiological data and patient-reported information, rather than an IVD.
N/A
Intended Use / Indications for Use
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, DRG
Device Description
Commander Flex devices are home health monitoring tools typically used by patients with diseases such as congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD) asthma and coronary artery disease (CAD). Patients use Commander Flex to collect and send important health information to their health care team to allow a doctor and other health care team members to act before symptoms worsen.
Commander Flex devices have a built-in non-invasive blood pressure measurement system that measures systolic and diastolic blood pressure and displays the readings on the Commander Flex panel.
In addition to making blood pressure and heart rate measurements, Commander Flex devices store and transmit data from peripheral devices to remote locations. Commander Flex connects to a user's home phone line or cellular network. It has inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff. The display asks health-related questions to obtain objective biometric data such as: weight, blood pressure, glucose, and pulse oximetry. Patients may also answer a series of questions about their current symptoms. The patient can respond Yes or No or select from a list. Commander Flex devices collect data from peripherals and transmit the data using a cellular connection or toll-free telephone number and modelar design of the Commander Flex device allows for selection of the appropriate health monitoring devices for cost-effective patient care.
Commander Flex products are for home use. This 510(k) clearance achieves OTC designation for Commander Flex devices.
The peripheral devices are used as supplied by the manufacturer. The Commander Flex devices make no interpretation, evaluation, medical judgements or recommendations for treatment. Commander Flex is not used as an emergency response device. Clinical judgment and experience are required to interpret the information transmitted. Commander Flex devices are not intended as a substitute for medical care.
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
Not Found
Intended User / Care Setting
Used by patients, typically at home, and a health care professional at a remote site.
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)
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing conducted on the Commander device showed the device complies with IEC 60601-1-2:2014 Ed.4 Electromagnetic Emissions and Immunity (EMC/EMI) and 80601-2-30 Medical Electrical Equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
Software verification and validation testing: The software for this device is considered a 'moderate' level of concern. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," including software risk assessments, software verification testing. A cybersecurity threat assessment report was also provided.
Biomaterial safety information: The patient contact materials in the blood pressure cuff are identical to those in the predicate device, therefore no new biomaterial testing was needed to support substantial equivalence.
Human factors engineering information: Reports of usability engineering evaluations of Commander Flex devices, including use error analysis, user interface design analysis, and summative validation were provided. Usability test results show the user interface and user manual are sufficient for lay users to operate the device in a safe and effective manner. A Use-Related Risk Assessment (URRA) was performed. The risk assessment revealed no different or increased risks and no new or additional critical tasks associated with the OTC designation.
Clinical data: Clinical testing of the Commander Flex blood pressure 2.0 algorithm in 99 human subjects (41% male; small, medium and large cuffs) was performed to measure the accuracy of the blood pressure measurement. Simultaneous blood pressure measurements were made by the Commander device and a trained observer using the stethoscope auscultatory method. The results demonstrate that the Commander blood pressure algorithm performance meets ANSI/AAMI SP10 and ISO 81060-2 requirements for sphygmomanometers.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 15, 2020
Medtronic Care Management Services % Charmaine Sutton Consultant The Tamarack Group - MPLS, LLC 2584 Upton Ave. So Minneapolis, Minnesota 55405
Re: K191745
Trade/Device Name: Commander Flex Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, DRG Dated: April 10, 2020 Received: April 14, 2020
Dear Charmaine Sutton:
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
1
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 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 medical devices and radiation-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,
LT Stephen Browning 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
Enclosure
2
Indications for Use
510(k) Number (if known) K191745
Device Name
Commander Flex
Indications for Use (Describe)
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510k Summary:
Medtronic Commander Flex Series remote patient monitoring device
Date Prepared: May 11, 2020
| Submitter | |
|---|---|
| Applicant: | Medtronic Care Management Services |
| 7980 Century Boulevard | |
| Chanhassen, MN 55317 | |
| 888-243-8881 | |
| Contact: | Charmaine Dwyer (Sutton) |
| The Tamarack Group – MPLS, LLC | |
| charmaine.sutton@tgmpls.com | |
| Device Information | |
| Trade Name: | |
| Model Numbers: | |
| Common Name: | |
| Classification: | Medtronic Commander Flex |
| CD300, CD300C, CD310, CD315, CD320 | |
| Remote Patient Monitoring Device | |
| Class II | |
| Noninvasive Blood Pressure Measurement System - | |
| 21 CFR 870.1130 | |
| Oximeter – 21 CFR §870.2700 | |
| Product Codes DXN, DQA, DRG |
Predicate Device(s)
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| Identification | Commander III | |
| Model CD3xx | ||
| (Rx) | Tablet Commander | |
| Model TC200/TC210 | ||
| (Rx and OTC) | ||
| Manufacturer | Cardiocom, LLC | |
| (now Medtronic) | Cardiocom LLC | |
| (now Medtronic) | ||
| 510k number | K053303, K091821 | K122285 |
| Regulation number | 21 CFR 870.1130 | |
| 21 CFR 870.2700 | 21 CFR 870.2910 | |
| ProCode | DXN, DQA | DRG |
Device Description
Commander Flex devices are home health monitoring tools typically used by patients with diseases such as congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD) asthma and coronary artery disease (CAD). Patients use Commander Flex to collect and send important health information to their health care team to allow a doctor and other health care team members to act before symptoms worsen.
4
Commander Flex devices have a built-in non-invasive blood pressure measurement system that measures systolic and diastolic blood pressure and displays the readings on the Commander Flex panel.
In addition to making blood pressure and heart rate measurements, Commander Flex devices store and transmit data from peripheral devices to remote locations. Commander Flex connects to a user's home phone line or cellular network. It has inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff. The display asks health-related questions to obtain objective biometric data such as: weight, blood pressure, glucose, and pulse oximetry. Patients may also answer a series of questions about their current symptoms. The patient can respond Yes or No or select from a list. Commander Flex devices collect data from peripherals and transmit the data using a cellular connection or toll-free telephone number and modelar design of the Commander Flex device allows for selection of the appropriate health monitoring devices for cost-effective patient care.
Commander Flex products are for home use. This 510(k) clearance achieves OTC designation for Commander Flex devices.
The peripheral devices are used as supplied by the manufacturer. The Commander Flex devices make no interpretation, evaluation, medical judgements or recommendations for treatment. Commander Flex is not used as an emergency response device. Clinical judgment and experience are required to interpret the information transmitted. Commander Flex devices are not intended as a substitute for medical care.
Intended Use
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Comparison to Predicate Devices
| Feature | Subject Device
Commander Flex
Model CD300 -CD399
with OTC designation | Primary Predicate
Commander III, Model
CD300-CD399
K091821 & K053303 | Secondary Predicate
Tablet Commander
Model TC200 -TC299
K122285 | Comparison |
|---------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------|
| 510(k) Number | | K091821 & K053303 | K122285 | -- |
| Product Code &
Classification Name | DXN
System, Measurement,
Blood Pressure, Non-
Invasive
DQA
Oximeter | DXN
System, Measurement,
Blood Pressure, Non-
Invasive
DQA
Oximeter | DRG
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | Same as primary |
| Class | Class II | Class II | Class II | Same |
| Regulation | 21 CFR 870.1130
Non-Invasive Blood
Pressure Measurement
System | 21 CFR 870.1130
Non-Invasive Blood
Pressure Measurement
System | 21 CFR 870.2910
Radiofrequency
Physiological Signal
Transmitter and Receiver | Same as primary |
Regulatory and Intended Use Comparison
5
| Feature | Subject Device
Commander Flex
Model CD300 -CD399
with OTC designation | Primary Predicate
Commander III, Model
CD300-CD399
K091821 & K053303 | Secondary Predicate
Tablet Commander
Model TC200 -TC299
K122285 | Comparison |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 CFR 870.2700
Oximeter | 21 CFR 870.2700
Oximeter | | |
| Intended Users | All three devices are used by home users and health care professionals | | | Same |
| Location of Use | All three devices are used in the home | | | Same |
| Rx/OTC | Rx & OTC | Rx | Rx & OTC | Same as secondary;
same Rx as Primary |
| Intended Use | The Commander Flex is
for use by patients to
collect and transmit
general health
questions and patient
vital sign data (such as
weight, blood pressure,
glucose, pulse
oximetry) between the
patient, typically at
home, and a health
care professional at a
remote site. | The Commander III is
for use by patients to
collect and transmit
general health
questions and patient
vital sign data (such as
weight, blood pressure,
glucose, pulse
oximetry, peak flow)
between the patient,
typically at home, and
a health care
professional at a
remote site. | The Tablet Commander
device is for use by
patients to collect and
transmit general health
information, physiological
measurements and other
data between themselves
and a caregiver. | Same; all are for use
by patients to collect
and transmit general
health information
between themselves
and a healthcare
professional at a
remote monitoring
station |
| | All three devices make no interpretation, evaluation, medical judgments, or
recommendations for treatment. Clinical judgment and experience are
required to check and interpret the information transmitted, and they are
not intended as a substitute for medical care. | | | Same |
Technological and performance characteristics comparison
| Feature | Subject Device
Commander Flex
Model CD300 -CD399
Series with OTC
designation | Primary Predicate
Commander III, Model
CD300-CD399 Series
K091821 & K053033 | Secondary Predicate
Tablet Commander
Model TC200 -TC299
series
K122285 | Comparison |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Basic Technology
Description | The Commander Flex is an
electronic device with built-
in proprietary software.
The Commander Flex also
includes an integrated
blood pressure
measurement capability. | The Commander III is an
electronic device with
built-in proprietary
software.
The Commander III also
includes an integrated
blood pressure
measurement capability. | The Tablet Commander is
a software application
capable of running on any
hardware platform that
uses the Android
operating system. | Same as primary;
similar to
secondary |
| | All three devices interface with other electronic devices, including 510(k)-cleared or
Class I exempt medical devices, using standard wired and wireless protocols to
collect biometric data and communicate that data to a back-end database
application using public communications (phone, cellular or Wi-Fi). All three use the
same proprietary software to query and collect patient data. | | | Same |
| Feature | Subject Device
Commander Flex
Model CD300 -CD399
Series with OTC
designation | Primary Predicate
Commander III, Model
CD300-CD399 Series
K091821 & K053033 | Secondary Predicate
Tablet Commander
Model TC200 -TC299
series
K122285 | Comparison |
| Device Software | Embedded firmware and
patient database | Embedded firmware and
patient database | Embedded software and
patient database | Same as primary |
| | The software hazards for all three are: no data from peripheral, no data transmission
to remote monitoring site, and corrupt data at remote monitoring site. The related
risk is low because the patient data is used for trending and not to make immediate
treatment decisions. | Same | | |
| | Transmission /
communication
method | Cellular (network
connectivity: CDMA or
GPRS) or telephone modem
(POTS) | Telephone modem
(POTS) | Cellular (network
connectivity: CDMA or
GPRS) |
| Security & Privacy | FIPS 140-2 Level 2 and
native 4G/LTE encryption
for cellular transmissions
FIPS 140-2 Level 2
encryption for POTS (CD320
model) | Plain old telephone
system (POTS) | FIPS Level 140-2 Level 2
encryption for WIFI
transmissions | Subject device
adds FIPS 140-2
encryption for
cellular and POTS
transmissions |
| Peripheral device
interfaces | RS232 serial ports
USB: 2.0
Radio frequency
Supports battery charging
of MCMS-approved
peripherals via USB
connection | RS232 serial ports | WIFI: 802.11 b/n/g
USB: 2.0
Bluetooth: 3.0
Radio frequency
Supports battery charging
of MCMS-approved
peripherals via USB
connection | Same as
predicates,
collectively |
| | All three devices interface with the peripheral medical devices using standard
connections according to protocols established by the manufacturer of the
peripheral device. The protocols include checksums with re-transmit and purge
loops for data validation. The list of compatible peripherals will change according to
market demand, with each new peripheral being validated prior to making claims of
compatibility. | Same | | |
| Built-in
measurements | Non-invasive blood
pressure reading using
small, medium and large
size cuffs | Non-invasive blood
pressure reading using
small, medium and large
size cuffs | None | Same as primary |
| Power supply | All three use an external power supply that converts standard wall 120 volts AC to
DC | | | Same |
| Electrical Safety | All three devices are tested to IEC 60601-1,2. The subject device is tested to the
current version (2014). | | | Same |
| Communications
compliance | All three devices comply with FCC Part 68. | | | Same |
| User Interface /
Controls | All three communicate with patients using an on-screen LCD display in English,
Spanish or both, enlarged font size, voice prompts, user input buttons or keys, quick | | | Same |
| Feature | Subject Device
Commander Flex
Model CD300 -CD399
Series with OTC
designation | Primary Predicate
Commander III, Model
CD300-CD399 Series
K091821 & K053033 | Secondary Predicate
Tablet Commander
Model TC200 -TC299
series
K122285 | Comparison |
| | Start guide, user manuals, voice prompts, and customer support phone line 800 number. | | | |
| | physical keypad | physical keypad | virtual keypad /
touchscreen | Same as primary |
| Cleanability | All three are designed to be cleaned using common household cleaning agents. | | | Same |
| Memory | Biometric data collection: all three devices can display past readings. Biometric
review includes weight, blood pressure, glucose, oxygen saturation (and peak
flow for the predicate device)
Health check/subjective data: for all three devices only a single health check is
stored in memory at a given time. If a new health check is taken the new answers
will overwrite the previous answers. Answers are also removed from memory if the
device successfully transmits a health check to the remote monitoring system.
All three devices can read an external memory card. | | | Nearly identical;
the subject
device no longer
supports a peak
flow meter |
6
7
Performance Data
Commander Flex devices are already used and labeled for use in the home, therefore no different or increased risks were identified by the OTC designation. Accordingly, no design changes, including no hardware, software or labeling changes were needed to support the OTC designation.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing conducted on the Commander device showed the device complies with IEC 60601-1-2:2014 Ed.4 Electromagnetic Emissions and Immunity (EMC/EMI) and 80601-2-30 Medical Electrical Equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
Software verification and validation testing
The software for this device is considered a 'moderate' level of concern, since a failure or latent flaw in the software that controls the blood pressure circuit could directly result in minor injury to the patient or indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," including software risk assessments, software verification testing. A cybersecurity threat assessment report was also provided.
Biomaterial safety information
The patient contact materials in the blood pressure cuff are identical to those in the predicate device, therefore no new biomaterial testing was needed to support substantial equivalence.
K191745
8
Human factors engineering information
Reports of usability engineering evaluations of Commander Flex devices, including use error analysis, user interface design analysis, and summative validation were provided. Usability test results show the user interface and user manual are sufficient for lay users to operate the device in a safe and effective manner.
A Use-Related Risk Assessment (URRA) was performed for Commander Flex devices to identify known or foreseeable user actions and identify risk-related use scenarios related to OTC use. The URRA included user profiles, task analysis, use error analysis, user interface design, and summative justification in accordance with FDA 2016 Guidance Applying Human Factors and Usability Engineering to Medical Devices. Commander Flex devices have been home-use devices for over a decade (under an Rx designation). The risk assessment revealed no different or increased risks and no new or additional critical tasks associated with the OTC designation. Therefore, additional Human Factors Validation Testing was deemed not necessary to support the Commander Series OTC designation.
Clinical data
Clinical testing of the Commander Flex blood pressure 2.0 algorithm in 99 human subjects (41% male; small, medium and large cuffs) was performed to measure the accuracy of the blood pressure measurement. Simultaneous blood pressure measurements were made by the Commander device and a trained observer using the stethoscope auscultatory method. The results demonstrate that the Commander blood pressure algorithm performance meets ANSI/AAMI SP10 and ISO 81060-2 requirements for sphygmomanometers.
Summary
Commander devices have always been used in the home. The updated performance evaluations revealed no new information about the safety and effectiveness profile of Commander. Device labeling was updated to reflect current standards. Commander devices with the OTC designation have a safety and effectiveness profile identical to the predicate device.
Conclusion
Commander Flex with the OTC designation has the same regulatory classifications, substantively the same intended use, the same environment of use, the same patient population and the same fundamental technology as the previously cleared Commander III devices. Commander Flex devices have no performance differences when compared to the predicate devices collectively and have been shown to meet all applicable industry standards. There are no new questions of safety or performance compared to the predicate devices. The information supplied demonstrates Commander Flex devices with the OTC designation have substantively the same intended use and the same technological characteristics as the previously cleared Commander III and Tablet Commander devices. Commander Flex devices with the OTC designation are, therefore, substantially equivalent to the legally marketed predicate devices.