(119 days)
No
The summary describes a device that collects, stores, and transmits vital signs and other health data. It performs standard diagnostic measurements (ECG, NIBP, SpO2, temperature, spirometry, audiometry). There is no mention of AI, ML, or any advanced analytical capabilities beyond basic calculations and data display. The performance studies focus on standard validation methods for medical devices, not AI/ML model performance.
No
Explanation: The device is intended for collecting, storing, and transmitting patient health information and vital signs data, and for diagnosis and evaluation, not for providing therapy or treatment.
Yes
The "Device Description" explicitly states that the IDM100 is an "integrated medical tablet with diagnostic equipment" and that its "diagnostic capabilities are designed for the clinical populations." Furthermore, the "Vital Sign and Cardiopulmonary Tests" section details various functions (e.g., ECG, spirometry, hearing tests) that are used for "evaluation and diagnosis."
No
The device description explicitly states it is an "integrated medical tablet with diagnostic equipment," indicating it includes hardware components beyond just software. The performance studies also detail testing of physical components like the tympanic thermometer, NIBP device, and patient contact sensor.
Based on the provided information, the IDM100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- IDM100 Functionality: The IDM100 collects and transmits in vivo (within the living body) data. It measures vital signs like ECG, blood pressure, temperature, SpO2, and performs tests like spirometry and hearing tests directly on the patient. It does not analyze samples taken from the patient.
The device description and intended use clearly indicate that the IDM100 is a multi-modal medical device for collecting and transmitting physiological data from the patient's body. This falls under the category of medical devices used for direct patient assessment and monitoring, not IVDs.
N/A
Intended Use / Indications for Use
The IDM100 is 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, except as noted below), adolescent (between 13 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only.
• Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
• 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), wulse rate, and optional Respiratory Rate.
• Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
• Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.
• Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.
• Manual interface for height, weight, respiratory rate, and other manually captured patient information.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DPS, DRX, DXN, DXQ, FLL, DOA, DOD, BZG, EWO
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. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.
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 with waveform measurements
- 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
- Spirometer. Spirometry tests are not to be administered by a patient.
- Audiometer. Audiometry tests (hearing tests) are not to be administered by a patient
- 2 internal HD cameras for images and video conferencing
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
neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (between 13 years and 17 years) and adult (18 years and older)
Intended User / Care Setting
Clinicians and patients; clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing.
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)
-
study type: Software Validation and Risk Assessment
-
key results: satisfactory
-
study type: Transportation Simulation Evaluation Testing
-
key results: satisfactory
-
study type: Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator
-
key results: satisfactory
-
study type: Tympanic Thermometer standard Compliance: Accuracy testing
-
key results: satisfactory
-
study type: NIBP Device Evaluation Testing: Visual inspections and testing to EN1060-3
-
key results: satisfactory
-
study type: Design validation (usability study) for the IMD100 indications for use in clinical and non-clinical settings
-
key results: satisfactory
-
study type: Additional mode validation: Audiometery. Tested to ANSI/ASA S3.6-2010
-
key results: satisfactory
-
study type: Additional mode validation: ECG Measurements were validated with three methods: CSE Database Verification, Data Collection, and a Clinical Verification
-
key results: satisfactory
-
study type: Additional mode validation: Spirometry, evaluated according to ATS/ERS Task Force Standardisation of Lung Function Testing: Standardisation of spirometry (2005)
-
key results: satisfactory
-
study type: Biocompatibility test reports (cytotoxicity, irritation, and sensitization) for the patient contact sensor
-
key results: satisfactory
-
study type: Human factors usability testing
-
key results: successfully conducted
-
study type: Standards testing protocols for IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-1-2 ed3.0 (2007-03), IEC 60601-2-25 ed 2.0 (2011-10), IEC 60601-2-49 ed 2.0, IEC 60601-1-11, ISTA Procedure 2A (2011), ASTM D4169-14
-
key results: All results were satisfactory.
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.
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
§ 870.2300 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.
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
July 14, 2017
Dictum Health, Inc. % Daniel Kamm Submission Correspondent Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114
Re: K170798
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, DPS, DRX, DXN, DXQ, FLL, DOA, DOD, BZG, EWO Dated: June 16, 2017 Received: June 16, 2017
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.
M.A. Wilhelm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170798
Device Name IDM100
Indications for Use (Describe)
The IDM100 is 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, except as noted below), adolescent (between 13 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only.
· Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
· 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), wulse rate, and optional Respiratory Rate.
· Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
· Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.
· Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.
· 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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3
Image /page/3/Picture/0 description: The image is a logo for Dictum Health. The logo features a circular design with a gradient of colors ranging from yellow to green to blue. In the center of the circle is a large, white letter "D". Below the circle, the word "DICTUMHEALTH" is written in a sans-serif font.
K170798 510(k) Summary As described in 21CFR807.92; K171098 Dictum Health Inc. 255 3rd Street, Suite 102 Oakland, CA 94607 (510) 295-4450 Fax: (510) 246-3293 www.dictumhealth.com Date prepared: July 10, 2017
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. This submission ADDS: ECG Measurement (DPS), Spirometry (BZG), and Audiometry (EWO) | 870.2300 |
- Substantially equivalent legally marketed device:
Manufacturer | Name of the Predicate Device | FDA 510(k) # | Regulation/Product Code |
---|---|---|---|
Dictum Health Inc. | IDM100 | K152645 | 21 CFR 870.2300/MWI |
-
- Indications for Use (intended use): The IDM100 is 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, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous monitoring.
Vital Sign and Cardiopulmonary Tests:
- Indications for Use (intended use): The IDM100 is 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, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous monitoring.
-
Signal acquisition and display for 12 lead ECG waveform and 3-lead rhythm for evaluation and diagnosis of patient cardiac function. ECG calculation of diagnostic measurements is provided for adult patients only.
-
. Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
-
. 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), pulse rate, and optional Respiratory Rate.
-
. Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
-
Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP)who is physically with the test subject. Spirometry tests are not to be administered by a patient.
-
Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be
4
performed by a health care professional (HCP) who is physically with the test subject. Audiometry tests (hearing tests) are not to be administered by a patient
- Manual interface for height, weight, respiratory rate, and other manually captured patient ● information.
-
- Description of the device: 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. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.
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
Diagnose, monitor, and consult with even the most at-risk patients from virtually anywhere. DIAGNOSTIC TOOLS
- 3 & 12-lead diagnostic resting ECG with waveform measurements
- 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
- · Spirometer. Spirometry tests are not to be administered by a patient.
- Audiometer. Audiometry tests (hearing tests) are not to be administered by a patient
- 2 internal HD cameras for images and video conferencing
The diagnostic tools other than ECG and Spirometry are implemented via modules and accessories which have all had previous FDA clearances:
Device Product Code and Name: | Regulation | Clearance |
---|---|---|
DRX: Electrode, Electrocardiograph (now exempt) | 870.2360 | K000690 |
DXN: Noninvasive blood pressure (NIBP) | 870.1130 | K151071 |
DXQ: Blood Pressure Cuff | 870.1120 | K051904 |
FLL: Patient (Tympanic) temperature | 880.2910 | K060649 |
DQA: Oximeter, SpO2, pulse rate, respiration rate | 870.2700 | K123581 |
DQD: Electronic Stethoscope | 870.1875 | K081032 |
DPS: ECG Measurement | 870.2340 | K062282 |
BZG: Spirometry | 868.1840 | (This submission) |
EWO: Audiometery (now exempt) | 874.1050 | N/A |
5
Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 | |
---|---|---|
Indications | ||
for 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 & |