(15 days)
Not Found
No
The summary describes a software application for data collection and transmission, with no mention of AI, ML, or related concepts. The performance studies focus on software validation and risk assessment, not AI/ML model performance.
No.
The "Intended Use" explicitly states that "The Tablet Commander makes no diagnosis," "is not intended as a substitute for medical care," and clinical judgment is required. It solely functions as a data collection and transmission tool.
No
The "Intended Use / Indications for Use" section explicitly states, "The Tablet Commander makes no diagnosis." It is designed to collect and transmit data, not to interpret it for diagnostic purposes.
Yes
The device is explicitly described as a "software application" that is installed on a "commercially-available device" and uses "standard communication protocols" to exchange information. It does not include or require specific hardware components beyond the commercially available device it runs on.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for collecting and transmitting general health information and physiological measurements. It explicitly states it "makes no diagnosis" and is "not intended as a substitute for medical care." IVDs are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on software that collects data from other medical devices and transmits it. It doesn't mention any interaction with biological samples or performing analytical tests.
- Lack of IVD-Specific Information: The document lacks any information typically associated with IVDs, such as:
- Mentions of samples (blood, urine, etc.)
- Analytical methods or reagents
- Performance metrics related to analytical accuracy (sensitivity, specificity in the context of a diagnostic test)
The device functions as a data collection and transmission tool for remote patient monitoring, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.
Product codes
DRG
Device Description
The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.
The Tablet Commander is a software application capable of running on any hardware platform that uses the Android operating system. The Tablet Commander interfaces with other electronics including FDA-cleared medical devices using standard wired and wireless protocols. Many Tablet Commanders then communicate that data to a back-end database application using the public telecommunications network.
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
patients, caregiver, 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)
Risk based verification and validation testing according to FDA guidances "Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation" was completed to ensure the Tablet Commander functioned according to its requirements and specifications. Cardiocom used the voluntary standard IEC 62304 as a model for the software development environment to maintain quality throughout the software lifecycle. The Tablet Commander is identical to the tablet-based predicate devices in that the basic design principle is an application running on a commercial tablet. The data structuring and network communication design principles are identical to the predicate Commander III device. No new hazards to safety or effectiveness are presented by Tablet Commander, therefore, no clinical tests were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for CardioCom. The logo consists of a square with a stylized "C" inside, followed by the text "CARDIOCCOM" in a bold, sans-serif font. A registered trademark symbol is present to the right of the word "CARDIOCCOM".
EXPERTS IN TELEHEALTHツ
K122285
7980 Century Blvd Chanhassen, MN 55317 Toll-Free: 1-888-243-8881
510(k) Summary
.
AUG 1 4 2012
| Submitter: | Cardiocom, LLC
7980 Century Boulevard, Chanhassen, MN 55317 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel L. Cosentino, CEO, President, Cardiocom, LLC
Phone: 888-243-8881
Fax: 888-320-8881 |
| Date Prepared: | Tuesday, May 01, 2012 |
| Trade Name: | Tablet Commander |
| Common Name | Remote Patient Monitoring System |
| Classification: | Name: Radiofrequency physiological signal transmitter and
receiver
Regulation: 21 CFR §870.2910
Panel: Cardiovascular
Class: II |
| Product Code: | DRG |
| Predicate Device(s): | The subject device is equivalent to the following devices:
Cardiocom Commander III, K053304; Intel Health Guide Express,
K103276; Hommed Genesis Touch, K112858 |
| Device Description: | The Tablet Commander is a software application. Once installed on
a commercially-available device, the Tablet Commander software
uses standard communication protocols to exchange information
with other medical devices (peripherals). Data collected from the
medical devices is transmitted back to a database for review by a
caregiver. The Tablet Commander software has a user interface
which allows the patient and caregiver to communicate using
methods which include questions and answers. |
| Intended Use: | 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.
The Tablet Commander makes no diagnosis. Clinical judgment and
experience are required to check and interpret the information
transmitted. The Tablet Commander is not intended as a substitute
for medical care. |
Page 1 of 4
1
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E X P E R T S
Table 1 – Intended Use Comparison with Predicate Devices
| | Submission Device | Predicate #1-K103276
Intel Health Guide
Express | Predicate #2-K112858-Honeywell
Hommed Genesis
Touch | Predicate #3-K053304-
Commander III |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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.
The Tablet
Commander makes no
diagnosis. Clinical
judgment and
experience are
required to check and
interpret the
information
transmitted. The
Tablet Commander is
not intended as a
substitute for medical
care. | The Intel Health Guide
Express is intended to
collect vital sign
measurements from the
physiological
measurement devices
intended for use in the
home. Patients can
review the stored vital
sign measurement
information and receive
educational and
motivational content
from caregivers. Patients
can also engage in video
conferences with
caregivers and answer
the caregivers' questions
by participating in
surveys.
The Intel Health Care
Management Suite
allows the caregiver to
review patient data and
initiate video
conferencing with
patients, or select and
send educational and
motivational content to
patients.
The Intel Health Guide
Express is not
interpretive, nor is it
intended for diagnosis or
as a substitute for
medical care, and it is
not intended to provide
real time data. It is made
available to patients
when time-critical care is
not required. | The Honeywell
HomMed Genesis
Touch Retrospective
Physiological
Monitoring System is
designed to
retrospectively
monitor vital signs.
Vital signs include
noninvasive blood
pressure,
pulse oximetry, pulse
rate, weight and
manually entered
temperature. The
Genesis Touch
Retrospective
Physiological
Monitoring System
collects, displays and
transmits vital signs
measurements
captured from
commercially
available FDA cleared
wireless medical
devices designed for
home use. Collected
measurement data
from the Genesis
Touch System can be
transmitted via a
communication
module to a central
viewing station where
the data can be
viewed and analyzed
by a healthcare
professional.
The Genesis Touch
Retrospective
Physiological
Monitoring System is
intended for home use
by adult and pediatric
patients over twelve | The Commander III
device 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 Commander III
makes no
interpretation,
evaluation, medical
judgments, or
recommendations for
treatment. Clinical
judgment and
experience are
required to check
and interpret the
information
transmitted. The
Tablet Commander
is not intended as a
substitute for
medical care. |
Page 2 of 4
- 11
2
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EXPERTS | N TELEHEALTH™
| contraindicated for | years of age or in a | |
|---|---|---|
| patients requiring direct | healthcare related | |
| medical supervision or | environment by | |
| emergency intervention. | healthcare providers. | |
| It is intended for patients | The Genesis Touch | |
| who are willing and | Retrospective | |
| capable of managing its | Physiological | |
| use. Clinical judgment | Monitoring System is | |
| and experience by a | not | |
| caregiver are required to | intended for | |
| check and interpret the | emergency use or | |
| information delivered. | real-time monitoring | |
| and does not have | ||
| auditory or visual | ||
| alarms for out-of-limit | ||
| parameters. |
Table 2 – Technology Comparison with Predicate Devices
| Submission Device | Predicate #1-K103276 | Predicate #2-K112858 | Predicate #3-K053304 | |
|---|---|---|---|---|
| Basic | ||||
| Technology | ||||
| Description | The Tablet | |||
| Commander is a | ||||
| software application | ||||
| capable of running | ||||
| on any hardware | ||||
| platform that uses | ||||
| the Android | ||||
| operating system. | ||||
| The Tablet | ||||
| Commander | ||||
| interfaces with other | ||||
| electronics including | ||||
| FDA-cleared | ||||
| medical devices | ||||
| using standard wired | ||||
| and wireless | ||||
| protocols. Many | ||||
| Tablet Commanders | ||||
| then communicate | ||||
| that data to a back- | ||||
| end database | ||||
| application using the | ||||
| public | ||||
| telecommunications | ||||
| network. | Intel Health Guide | |||
| Express | ||||
| The Intel Health Guide | ||||
| Express is a software | ||||
| application capable of | ||||
| running on any hardware | ||||
| platform that uses the | ||||
| Windows 7 operating | ||||
| system. The Intel Health | ||||
| Guide Express interfaces | ||||
| with other electronics | ||||
| including FDA-cleared | ||||
| medical devices using | ||||
| standard wired and | ||||
| wireless protocols. | ||||
| Many "Guides" then | ||||
| communicate that data to | ||||
| a back-end database | ||||
| application (Guide | ||||
| Virtual Care Suite) using | ||||
| the public | ||||
| telecommunications | ||||
| network. | Honeywell HomMed | |||
| Genesis Touch | ||||
| The Honeywell HomMed | ||||
| Genesis Touch | ||||
| Retrospective | ||||
| Physiological Monitoring | ||||
| System is a software | ||||
| application running on a | ||||
| dedicated Commercially- | ||||
| Available Off-the-Shelf | ||||
| (COTS) tablet computer. | ||||
| The "Touch" interfaces | ||||
| with other electronics | ||||
| including FDA-cleared | ||||
| medical devices using | ||||
| standard wired and | ||||
| wireless protocols. Many | ||||
| "Guides" then | ||||
| communicate that data to | ||||
| a back-end database | ||||
| application (LifeStream | ||||
| Management Suite) using | ||||
| the public | ||||
| telecommunications | ||||
| network. | Commander III | |||
| The Commander III | ||||
| is an electronic | ||||
| device consisting of | ||||
| a blood pressure | ||||
| system and built-in | ||||
| proprietary | ||||
| software which | ||||
| allows it to | ||||
| interface with other | ||||
| FDA-cleared | ||||
| medical devices. | ||||
| Many Commander | ||||
| III's then | ||||
| communicate that | ||||
| data to a back-end | ||||
| database | ||||
| application using | ||||
| the public | ||||
| telecommunications | ||||
| network. | ||||
| Operating | ||||
| System | Android | Windows 7 | Android | Proprietary |
| firmware | ||||
| Hardware | ||||
| Characteris | ||||
| tics | Standard minimum | |||
| requirements for | ||||
| mobile devices | Standard minimum | |||
| requirements for mobile | ||||
| devices | Standard minimum | |||
| requirements for mobile | ||||
| devices | LCD Display: 240 | |||
| x 320 pixels | ||||
| CPU: Low speed | ||||
| Microcontroler | ||||
| Network |
Page 3 of 4
3
Image /page/3/Picture/0 description: The image shows the word "CARDIOCOM" in all capital letters. The "C" in "CARDIOCOM" is inside of a square. There is a registered trademark symbol to the right of the word "CARDIOCOM".
EXPERTS IN TELEHEALTH™
| િ | 1266 |
|---|---|
| Peripheral
Interface
Characteris
tics | The Tablet
Commander | The Guide | The Touch communicates | POTS or Cellular |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | interfaces with the
peripheral medical
devices using
standard wired and
wireless connections
according to the
protocols
established by the
manufacturer of the
peripheral. The
protocols include
checksums with re-
transmit and purge
loops for data
validation. | communicates with a
variety of peripherals
using standard wired and
wireless technologies. | with a variety of
peripherals using standard
wired and wireless
technologies. | The Commander III
is integrated with a
blood pressure
system and
connected to other
peripherals using
RS232 serial
connections
according to
protocols
established by the
manufacturer of the
peripheral. The
protocols include
checksums with re-
transmit and purge
loops for data
validation. |
Functional and Safety Analysis:
Risk based verification and validation testing according to FDA guidances "Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation" was completed to ensure the Tablet Commander functioned according to its requirements and specifications. Cardiocom used the voluntary standard IEC 62304 as a model for the software development environment to maintain quality throughout the software lifecycle. The Tablet Commander is identical to the tablet-based predicate devices in that the basic design principle is an application running on a commercial tablet. The data structuring and network communication design principles are identical to the predicate Commander III device. No new hazards to safety or effectiveness are presented by Tablet Commander, therefore, no clinical tests were conducted.
Cardiocom considers the Tablet Commander to be equivalent to the Conclusion: predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
Page 4 of 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 14 2012
Cardiocom LLC c/o Mr. Mark Job (Regulatory Technology Services, LLC) 1394 25" Street NW Buffalo, MN 55313
Re: K122285
Trade/Device Name: Tablet Commander Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver. Regulatory Class: Class II (two) Product Code: DRG Dated: July 27, 2012 Received: July 30, 2012
Dear Mr. Job:
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.
5
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sineerely purs,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K122285
ﺮ ﺍ
Indications for Use
510(k) Number (if known):
Device Name: Tablet Commander
Indications For Use:
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.
Contraindications, Precautions, and Warnings:
The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122285 |
| Page 1 of | 1 of 1 |
|---|---|
| ----------- | -------- |
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ﺎ.