(15 days)
Not Found
No
The description focuses on data collection, transmission, and comparison to preset thresholds, which are standard functionalities for remote monitoring systems and do not indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
A therapeutic device is intended to treat a condition. This device is described as a "remote, retrospective monitoring tool" that does not replace existing treatments or consultations.
No
The device is described as a "remote, retrospective monitoring tool" and a "communications device" that collects data from "legally marketed diagnostic peripherals." It is explicitly stated that the system "is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan." This indicates that the device itself is not making a diagnosis but is rather a tool to facilitate the review of data collected by other diagnostic tools.
No
The device description explicitly states the system is comprised of a "home unit" and "legally marketed diagnostic peripherals," which are hardware components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electronic House Call System is described as a "remote, retrospective monitoring tool" that collects data from "legally marketed diagnostic peripherals" (like blood pressure monitors, weight scales, etc.) and the patient. It then transmits this data for review by healthcare practitioners.
- Lack of Sample Analysis: The system itself does not perform any analysis on biological samples. It collects data from other devices that may be IVDs (like a glucose meter, although that's not explicitly mentioned as a peripheral), but the Electronic House Call System's function is data collection, transmission, and presentation, not in vitro analysis.
- Intended Use: The intended use focuses on remote monitoring, communication, education, and reminders, not on diagnosing or screening based on in vitro analysis of samples.
In summary, the Electronic House Call System acts as a data aggregator and communication platform for remote patient monitoring. It relies on other devices to perform measurements, and its core function does not involve the in vitro analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Electronic House Call™ System (Electronic House Call™ Device + Electronic House Call™ Application + Electronic House Call™ website) is a remote, retrospective monitoring tool to supplement a patients' care. The Electronic House Call™ Device together with the Electronic House Call™ Application is intended to be a simple "store and forward" communications platform that allows clinicians and authorized users to access a patients' information for review through the Electronic House Call™ website. The Electronic House Call™ Device is a tool to monitor patients remotely and motivate them through education and reminders. The Electronic House Call™ System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call™ System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment or treatment plan. The Electronic House Call™ System is not intended to act as an emergency response system.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
The Express MD Electronic House Call™ System is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and the patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website. If a patient is found to be outside of a pre-set parameter, the healthcare practitioner will respond according to their set policies. In addition, an email will be sent to the clinician. This email indicates that the nurse/clinician should review the website. This is not a real time alert or an alarm but an email that does not identify a patient, parameter or clinical state.
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
Clinicians and authorized users. Remotely monitors patients at home.
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)
Verification, validation and electrical safety/electromagnetic compatibility testing was performed to determine that the Electronic House Call™ System functions as intended and is safe and effective for its' intended use.
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.
K993128, K040086, K042273, K050567, K060843, K022274, K023286, K062304, K032363, K042007, K060194
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
§ 870.2910 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
APR - 8 2009
510(k) Summary
for
Electronic House Call™ System
1. SPONSOR
Express MD Solutions, LLC 2001 Bomar Drive Suite 3 Palm Beach Gardens, FL 33408 Contact Person: Chris Doherty Telephone: (617) 595-2700
2. DEVICE NAME
| Proprietary Name: | Electronic House Call™ System |
|---|---|
| Common/Usual Name: | Telehealth System |
| Classification Name: | Physiological Signal Transmitters and Receiver |
3. PREDICATE DEVICES
- . Health Buddy with Glucose Connectivity (K993128)
- . Health Buddy with BuddyLink (K040086)
- Health Buddy with Device Connectivity(K042273) .
- Health Buddy Appliance (K050567) .
- . Health Buddy Appliance, Health Hero Network (K060843)
- . Neptec Care Companion Nurse and Patient Station K022274 and K023286
- . RTX DLM112 Daylink Monitor (K062304)
- . ZOLL M-Series NIBP Option (K032363)
- . ZOLL E-Series NIBP Option (K042007)
- . March Healthcare HMK (K060194)
DEVICE DESCRIPTION 4.
The Express MD Electronic House Call™ System is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and the
1
patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset The healthcare practitioners and privileged users access the server thresholds. through a secure website.
If a patient is found to be outside of a pre-set parameter, the healthcare practitioner will respond according to their set policies. In addition, an email will be sent to the clinician. This email indicates that the nurse/clinician should review the website. This is not a real time alert or an alarm but an email that does not identify a patient, parameter or clinical state.
5. INTENDED USE
The Electronic House Call™ System (Electronic House Call™ Device + Electronic House Call™ Application + Electronic House Call™ website) is a remote, retrospective monitoring tool to supplement a patients' care. The Electronic House Call™ Device together with the Electronic House Call™ Application is intended to be a simple "store and forward" communications platform that allows clinicians and authorized users to access a patients' information for review through the Electronic House Call™ website. The Electronic House Call™ Device is a tool to monitor patients remotely and motivate them through education and reminders. The Electronic House Call™ System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call™ System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment or treatment plan. The Electronic House Call™ System is not intended to act as an emergency response system.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Electronic House Call™ System and the predicate devices all consist of a home unit, peripheral devices, and a secure website. Both the proposed and predicate devices connect to a telephone line at the subject's home or assisted living The peripheral devices that are compatible with the Electronic House facility. Call™, the Neptec System, the RTX device and Health Buddy System include non-
2
invasive blood pressure cuffs, patient weight scales, and blood glucose meters. The proposed Electronic House Call™ System and the predicate Health Buddy devices are simple, user friendly devices that connect to a standard home telephone line. In addition to the standard phone line, the proposed Electronic House Call™ can connect to a Cingular 8525 cell phone or existing high-speed Ethernet line. These transmission protocols have been validated and do not affect safety or effectiveness of the device. The proposed and predicate device screens display information, take vital signs, and ask questions about symptoms and behaviors. Both the Electronic House Call™ System and the Health Buddy predicate devices provide education and reinforcement to the patient while delivering evaluation by a medical professional. Both the proposed Electronic House Call™ System and the RTX DLM112 Daylink Monitor include the option of communication using ECG systems. This option provides the user the ability to transmit ECG data from legally marketed ECG devices using standard digital communication technologies to the healthcare provider. This feature of the proposed and predicate devices does not raise any safety or effectiveness issues since verification and validation testing have been performed to support the function and compatibility of the ECG with the Electronic House Call™ System.
Like the proposed Electronic House Call™ System, the Health Buddy System includes software to record patient information and devices designed to receive information from the peripheral devices and then transfer the information to a secure website.
Additionally, a comparison of the intended use and technical characteristics of the proposed device with the Suntech Advantage Model 2 Blood Pressure kit and the Nonin IPod and their predicate devices demonstrates that the Electronic House Call™ System is substantially equivalent to both the ZOLL M-Series NIBP Option and the ZOLL E Series devices which utilize the Suntech Advantage Model 2 Blood Pressure kit and the March Healthcare HMK device which utilizes the Nonin iPod.
7. PERFORMANCE TESTING
Verification, validation and electrical safety/electromagnetic compatibility testing was performed to determine that the Electronic House Call™ System functions as intended and is safe and effective for its' intended use.
Express MD Solutions 510(k) Electronic House Call™ System March 11, 2009
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2009
Express MD Solutions LLC c/o Interteck Testing Services NA, Inc. 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087 Attn: Daniel Lehtonen
Re: K090801
Trade/Device Name: Electronic House Call System Regulation Number: 21 CFR 870.2910 Regulatory Class: Class II Product Code: DRG Dated: March 23, 2009 Received: March 24, 2009
Dear Mr. Lehtonen:
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 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.
4
Page 2 - Mr. Daniel Lehtonen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Electronic House Call System
Indications for Use:
The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' information for review through the Electronic House Call Website. The Electronic House Call Device is a tool to monitor patients' remotely and motivate them through education and reminders. The Electronic House Call System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan. The Electronic House Call System is also not intended to act as an emergency response system.
Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atilla Msz for B Zuckerman
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 09080
Express MD Solutions 510(k) Electronic House Call System