(48 days)
Not Found
No
The document explicitly states that the device "does not measure, interpret or make any decisions on the data that it conveys" and there are no mentions of AI, ML, or related terms.
No.
The device collects, records, and transmits physiological information but does not measure, interpret, or make decisions on the data, nor does it provide "real-time" or emergency monitoring, indicating it is not directly involved in treating or mitigating a disease or condition.
No
The device collects, records, and transmits physiological information but explicitly states it "does not measure, interpret or make any decisions on the data that it conveys." It is an accessory software application that facilitates data transfer for healthcare professionals to analyze, rather than performing diagnostic functions itself.
Yes
The device is described as a "software application" and a "software system" that collects, records, and transmits data. While it mentions being used "in combination with a variety of external vital sign devices," the description focuses solely on the software's function of data handling and transmission, not on any hardware components included with the Wellaho system itself.
Based on the provided information, the Wellaho™ Personalized Outpatient Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- Wellaho's function: The Wellaho system collects and transmits physiological data (like blood pressure and blood sugar levels) from the patient. It does not analyze or interpret these data, nor does it perform any tests on biological specimens. Its primary function is data management and transmission.
- Intended Use: The intended use clearly states that the system collects, records, and transmits physiological information and is used in combination with external vital sign devices. It explicitly states it "does not measure, interpret or make any decisions on the data that it conveys."
Therefore, the Wellaho system falls outside the scope of an In Vitro Diagnostic device. It functions more as a data management and communication tool for remote patient monitoring.
N/A
Intended Use / Indications for Use
Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
The Wellaho™ Personalized Outpatient Management System is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
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
patients in non-clinical settings (e.g. home)
healthcare professionals
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): 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.
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
Premarket Notification [510(k)] Summary
JAN 1 6 2013
| Device details | Name Trade: | Wellaho Personalized Outpatient Management
System |
|----------------|---------------------------|-----------------------------------------------------------------|
| | Common name: | Telemedicine System |
| | Classification name: | Radiofrequency Physiological Signal
Transmitter and Receiver |
| | Regulation number: | 870.2910 |
| | Product code: | DRG |
| | Classification panel: | Cardiovascular Devices |
| | Classification: | Class II device |
| Submitter: | Sanitas, Inc. | |
| | 1640 El Camino Del Teatro | |
| | La Jolla, CA 92037 | |
| | Tel: 858-945-0660 | |
Intended Use
Contact person:
Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
Mr. Naser Partovi, CEO
Indication for Use
The Wellaho™ Personalized Outpatient Management System is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Predicate Device Information:
The Wellaho Personalized Outpatient Management System is of comparable type and is
/
1
substantially equivalent to the following legally marketed predicate device:
| Company | Device | 510 (k) |
|---|---|---|
| Vignet Corporation | Vignet Tele-Health Manager | K113446 |
In further support of substantial equivalency, Section 12 provides a comparison table of the Wellaho Personalized Outpatient Management System and the predicate device.
The Wellaho Personalized Outpatient Management System is substantially equivalent (SE) to the predicate device, the Vignet Tele-Health Manager.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 written in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 6 2013
Sanitas, Inc c/o Mr. Alan Donald, MS, MBA, FRAPS 11440 W. Bernardo Court Suite 300 San Diego, CA 92127
Re: K123671
Trade/Device Name: Wellaho Personalized Outpatient Management System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: November 28, 2012 Received: November 29, 2012
Dear Mr. Donald:
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
3
Page 2 - Mr. Alan Donald
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.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4
510(k) Number:
Device Name: Management System Wellaho™ Personalized Outpatient
Indications For Use:
The Wellaho™ Personalized Outpatient Management System is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Prescription
Prescription Use
AND/OR
Over-The-Counter Use XX
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number R/2367/
Page 15 Premarket Notification - Wellaho™ Personalized Outpatient Management System [510(k)] Submission November 28, 2012