(153 days)
Not Found
No
The description explicitly states the device is "not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts" and there is no mention of AI or ML in the text.
No.
The device is described as a means of receiving, storing, and transmitting patient biometric data, and explicitly states it is "not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts." All patient medical diagnosis and treatment are to be performed by a healthcare professional, indicating it does not directly provide therapy.
No.
The ALLY™ Platform "is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts." While it collects data from "legally marketed diagnostic peripherals," the ALLY™ Platform itself acts as a communication and data storage system, not a diagnostic device.
No
The device description explicitly states that the ALLY™ system is comprised of a "home unit" and a "server," in addition to software components. The home unit is described as a "communications device" and the ALLY™ Home Appliance (RTX 337X) is identified as a specific hardware component. This indicates the system includes hardware, not just software.
Based on the provided text, the ALLY™ Platform System 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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ALLY™ Platform System's Function: The ALLY™ Platform System's primary function is to receive, store, and transmit patient biometric data, specifically vital signs measurements, from legally marketed diagnostic peripherals. It acts as a communication and data management tool.
- No Specimen Analysis: The description explicitly states that the system collects data from diagnostic peripherals that measure parameters like blood pressure, pulse rate, and weight. It does not perform any analysis on biological specimens.
- Intended Use: The intended use focuses on data transmission and access for healthcare providers and family members, not on analyzing biological samples for diagnostic purposes.
- Lack of IVD-related terms: The text does not mention any terms related to specimen collection, analysis, reagents, or laboratory procedures, which are typical for IVD devices.
In summary, the ALLY™ Platform System is a data communication and management system for patient vital signs, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The ALLY TM Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biometric data including vital signs measurements. The ALLY TM Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.
The ALLY " Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed internet connections, serial port interfaces, or Bluetooth® radio transceivers.
The ALLY TM Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLY TM Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.
Product codes
DRG
Device Description
ALLY™ 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.
The ALLYTM Care Portal is intended to be used as an accessory to communication tools, such as the ALLYTM Home Appliance (RTX 337X). The ALLY TM Care Portal enables healthcare providers to request, receive, and review historical patient information. It is intended to be used in combination with a variety of external devices.
The ALLYTM Home Appliance (RTX 337X) is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable healthcare providers to receive historical patient information. It is intended to be used in combination with a variety of external devices.
The ALLY™ Home Appliance (RTX 337X) serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers.
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
The ALLY™ Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.
The ALLY TM Care Portal enables healthcare providers to request, receive, and review historical patient information.
The ALLY TM Home Appliance (RTX 337X) is for use in non-clinical settings (such as the 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)
Not Found
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92)
I. DATE PREPARED: 12/14/2009
MAY 2 0 2010
- II. SUBMITTER:
Continuity Health Solutions 9304 Forest Lane, Suite N272 Dallas, TX 75243 Telephone: 866.517.3135 Fax: 214.553.8946
III. CONTACT PERSON:
Bryan Poteet, CEO Telephone: 866.517.3135
IV. DEVICE NAME:
Trade/Proprietary Name: Common/Usual Name: Classification Name:
ALLYTM Platform System Telehealth System Physiological Signal Transmitters and Receivers
V. DEVICE CLASSIFICATION
Class II CFR section: 870.2910 Physiological Signal Transmitters and Receivers Product code: DRG Panel: Cardiology
VI. PREDICATE DEVICES:
K090801 Electronic House Call System Class II Decision Date: 04/08/2009
K063612 Health hero Network Class II Decision Date: 12/29/2006
1
K093895
p2/3
VII. SUBSTANTIAL EQUIVALENCE CONCLUSIONS:
Continuity Health Solutions concludes that the intended use for the Continuity Health Solutions ALLYTM Platform System is the same as that of the predicate devices, and that the technological characteristics demonstrate that they are equivalent to the predicate device. A comparison of the technological characteristics of the predicate and legally marketed devices available has been performed.
Thus, this premarket notification has demonstrated substantial equivalence.
VIII. DEVICE DESCRIPTION AND INTENDED USE:
Device Description:
ALLY™ 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.
ALLYTM Care Portal
The ALLY TM Care Portal is intended to be used as an accessory to communication tools, such as the ALLYTM Home Appliance (RTX 337X). The ALLY TM Care Portal enables healthcare providers to request, receive, and review historical patient information. It is intended to be used in combination with a variety of external devices.
ALLYTM Home Appliance (RTX 337X)
The ALLYTM Home Appliance (RTX 337X) is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable healthcare providers to receive historical patient information. It is intended to be used in combination with a variety of external devices.
The ALLY™ Home Appliance (RTX 337X) serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers.
2
Intended Use:
The ALLY™ Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biometric data including vital signs measurements. The ALLY™ Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.
The ALL YTM Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed internet connections, serial port interfaces, or Bluetooth® radio transceivers.
The ALLYM Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLY™ Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.
IX. SAFETY INFORMATION:
The ALLYTM Platform System has no patient contact and is utilized only by trained professionals. Trained professionals allow sufficient review to afford identification and intervention in the event of a malfunction have evaluated the output of the device. This will allow sufficient review to afford identification and intervention in the event of a malfunction.
X. CONCLUSION:
Continuity Health Solutions believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective including the component and accessory devices.
As a result of this analysis and the risk reduction activities, and has reviewed the guidance document for the content of premarket submissions for software contained in medical device, we conclude that there is no software or hardware component in the ALLY TM Platform System that would be expected to result in injury or death to a patient due to a failure or latent design flaw. Thus, the "Level of Concern" of the ALLY™ Platform System product is "Moderate".
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Continuity Health Solutions c/o Mr. Bryan Poteet CEO 9304 Forest Lane, Suite N272 Dallas. TX 75243
MAY 0 2010
K093895 Re:
Trade/Device Name: ALLYTM Platform System Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: 74 DRG Dated: April 13, 2010 Received: April 19, 2010
Dear Mr. Poteet:
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.
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,
4
Page 2 - Mr. Bryan Poteet
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/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): N/A
Device Name: ALLY™ Platform System
Intended Use:
The ALLY™ Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biometric data including vital signs measurements. The ALLY™ Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.
The ALLY " Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed internet connections, serial port interfaces, or Bluetooth® radio transceivers.
The ALLY™ Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLY™ Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (Per 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)
W.M. Wood.
510(k) Number K0613095