(146 days)
No
The summary describes a device for collecting and transmitting vital signs and patient information, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The performance studies focus on equivalence to a predicate device for basic signal acquisition and display.
No.
The device is used to collect and transmit patient health information and vital signs, and is explicitly stated as not being for continuous patient monitoring, and it provides diagnostic information, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Signal acquisition and display for 12 lead ECG waveform and 3 lead rhythm: for evaluation and diagnosis of patient cardiac function," indicating its role in diagnosis. The "Device Description" also refers to it as having "diagnostic equipment."
No
The device description explicitly states it is an "integrated medical tablet with diagnostic equipment," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IDM100 Functionality: The IDM100 collects vital signs and cardiopulmonary data directly from the patient's body (ECG, NIBP, temperature, SpO2, auscultation). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the collection, storage, and transmission of general patient health information and vital signs, not the analysis of biological samples.
The device is a multi-functional medical device for patient monitoring and data collection, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IDM100 for use by clinicians and patients to collect, store, and transmit general patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3 lead thythm: for evaluation and diagnosis of patient cardiac function.
• Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP).
• Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures.
• SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
• Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece.
• Manual interface for height, weight, respiratory rate, and other manually captured patient information.
Product codes
MWI, DPS, DRX, DXN, DXQ, FLL, DQA, DQD
Device Description
The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection.
SYSTEM FEATURES
- Easy-to-use, 10.1 in/25.7 cm, high-resolution capacitive touch screen
- Lightweight, portable. Less than 4 pounds with battery.
- Secure audio/video conferencing and image capture while streaming data
- Expanded support for point-of care devices with 3 USB ports and Bluetooth
- Connects through WiFi, LAN,
- Oracle™ DMS Mobile Sync provides secure, fast data transfer
- Over 4.5 hours battery usage
DIAGNOSTIC TOOLS
- 3 & 12-lead diagnostic resting ECG
- NIBP with MAP and heart rate (SunTech Advantage Mini module)
- Covidien Genius 2™ Tympanic Temperature
- NellCor Oximax™ SpO2 with respiratory and pulse rate
- Electronic stethoscope with CD-quality audio
- 2 internal HD cameras for images and video conferencing
Mentions image processing
Secure audio/video conferencing and image capture while streaming data
2 internal HD cameras for images and video conferencing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years &
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Dictum Health, Inc. % Daniel Kamm Submission Correspondent Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K152645
Trade/Device Name: IDM100 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: January 5. 2016 Received: January 8, 2016
Dear Daniel Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K152645
Device Name IDM100
Indications for Use (Describe)
The IDM100 for use by clinicians and patients to collect, store, and transmit general patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3 lead thythm: for evaluation and diagnosis of patient cardiac function.
· Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP).
· Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures.
· SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
· Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece.
· Manual interface for height, weight, respiratory rate, and other manually captured patient information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Dictum Health. The logo is a circle with a gradient of colors, ranging from green to blue. In the center of the circle is a large, white letter "D". Below the circle is the word "DICTUMHEALTH" in blue, all-caps lettering. The logo is simple and modern, and the colors are bright and eye-catching.
510(k) Summary As described in 21CFR807.92 for K152645 Dictum Health Inc. 255 3rd Street, Suite 102 Oakland, CA 94607 (510) 295-4450 Fax: (510) 246-3293 www.dictumhealth.com Date prepared: January 30, 2016 Prepared by: Paul Landesman
-
- Identification of the Device: Proprietary - Trade Name: IDM100
Common Name: Integrated Medical Tablet
- Identification of the Device: Proprietary - Trade Name: IDM100
| Classification Names/Product code | Regulation |
|---|---|
| Primary: Monitor,Physiological, Patient | |
| (Without Arrhythmia Detection Or Alarms) Product Code MWI | |
| Other applicable product codes: DPS , DRX, DXN, DXQ, FLL, DQA, DQD. | 870.2300 |
2. Substantially equivalent legally marketed device:
| Manufacturer | Name of the Predicate Device | FDA 510(k) # | Regulation/Product Code |
|---|---|---|---|
| Remote Diagnostics | Tempus IC2 | K152124 | 21 CFR 870.2300/MWI |
| Technologies LTD |
-
- Indications for Use (intended use): The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years & 12 years &