Who is the manufacturer of TABLET COMMANDER?

Cardiocom, LLC filed the 510(k) submission for TABLET COMMANDER (K122285).

What is the FDA product code for TABLET COMMANDER?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for TABLET COMMANDER?

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

What are the predicate devices for TABLET COMMANDER?

Cardiocom Commander III (K053304); Intel Health Guide Express (K103276); Hommed Genesis Touch (K112858).

Who can help prepare an FDA 510(k) submission like TABLET COMMANDER?

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

TABLET COMMANDER

K122285 · Cardiocom, LLC · DRG · Aug 14, 2012 · Cardiovascular

Device Facts

Record ID	K122285
Device Name	TABLET COMMANDER
Applicant	Cardiocom, LLC
Product Code	DRG · Cardiovascular
Decision Date	Aug 14, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

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.

Device Story

Tablet Commander is a software application installed on commercially available Android tablets. It functions as a remote patient monitoring interface; it collects physiological data from external FDA-cleared medical devices via standard wired/wireless protocols and transmits this data to a remote database for caregiver review. The system includes a user interface for patient-caregiver communication, including surveys/questionnaires. It is intended for home use by patients capable of managing the device. It does not perform diagnosis, interpretation, or real-time monitoring; it provides no alarms. Caregivers access the transmitted data via a back-end database application to support clinical decision-making. The device benefits patients by facilitating remote health data transmission and communication with healthcare providers.

Clinical Evidence

Bench testing only. No clinical data was conducted. Verification and validation testing were performed according to FDA guidance for software in medical devices to ensure requirements and specifications were met.

Technological Characteristics

Software application running on Android-based commercial tablets. Interfaces with FDA-cleared medical devices via standard wired/wireless protocols. Data transmission via public telecommunications network. Uses checksums, re-transmit, and purge loops for data validation. Software development followed IEC 62304 standards.

Indications for Use

Indicated for patients to collect and transmit general health information, physiological measurements, and other data to a caregiver. Not for patients requiring direct medical supervision or emergency intervention. Not for diagnosis or as a substitute for medical care.

Regulatory Classification

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.

Predicate Devices

Cardiocom Commander III (K053304)
Intel Health Guide Express (K103276)
Hommed Genesis Touch (K112858)

Submission Summary (Full Text)

{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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "CARDIOCOM" in all caps. The "C" in "CARDIOCOM" is inside of a square. There is a registered trademark symbol next to the "M" in "CARDIOCOM". 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 K122285 - 11 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "CARDIOCOM" in a bold, sans-serif font. The "C" is inside of a square. There is a registered trademark symbol next to the "M". K122285 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 Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. #### 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 | |-----------|--------| |-----------|--------| ( ﺎ.

TABLET COMMANDER

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Indications for Use

Device Story

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TABLET COMMANDER

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Device Story

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Submission Summary (Full Text)

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